Monthly Archives: July 2005

Kepivance (palifermin) Receives Positive Regulatory Opinion for Approval in Europe

  • 7/29/2005
  • Thousand Oaks, CA
  • press release
  • Business Wire (www.businesswire.com)

Amgen today announced that the European Committee for Medicinal Products for Human Use (CHMP), which is the scientific advisory panel to the European Medicines Agency (EMEA), has issued a positive opinion to approve marketing authorization for Kepivance(TM) (palifermin) in the European Union (EU). The CHMP opinion recommends authorization of palifermin to decrease the incidence, duration and severity of oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing myeloablative therapy associated with a high incidence of severe oral mucositis, and requiring autologus bone marrow transplant.

“Before palifermin, the best we could hope for in managing oral mucositis was to control the patient’s pain with narcotics and oral rinses,” said Jean-Luc Harousseau, M.D., head of the department of clinical hematology in the University Hospital of Nantes and former palifermin investigator. “With the potential approval of palifermin, physicians may be able to help protect transplant patients with hematologic malignancies from severe oral mucositis and may decrease their pain and discomfort.”

In patients with oral mucositis, the cells lining the mouth and throat are damaged by the chemotherapy drugs and/or radiation used in cancer treatment. Oral mucositis can be extremely painful and can have a devastating impact on patients. In fact, oral mucositis has been rated as the most debilitating side effect by patients with blood cancers undergoing bone marrow transplantation. Patients suffering from these debilitating mouth sores may require longer hospitalization, high doses of narcotics, such as morphine, and intravenous feeding to receive nutrition and maintain hydration. In the EU, approximately 13,000 cancer patients undergo autologus bone marrow transplant each year.

“Palifermin is an innovative medicine that helps meet a significant medical need for these cancer patients,” said Willard Dere, M.D., senior vice president of global development and chief medical officer at Amgen. “Oral mucositis can be extremely painful for these patients and can impact their everyday lives. Once approved, palifermin will be the first and only therapy available in the EU that will enable physicians to focus on helping to protect these patients from oral mucositis by decreasing its incidence, duration and severity.”

Recommendations from the CHMP are typically endorsed by the European Commission for marketing authorization within three to four months.

About Kepivance

Kepivance was approved by the U.S. Food and Drug Administration (FDA) in December 2004. In the U.S., Kepivance is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. Amgen has also applied for regulatory approval in Australia, Canada and Switzerland.

Kepivance, a recombinant human keratinocyte growth factor, reduces the incidence and duration of severe oral mucositis by helping to protect existing epithelial cells that line the mouth and throat from the damage caused by chemotherapy and radiation, and stimulating the growth and development of new epithelial cells to build up the mucosal barrier. By reducing the incidence and duration of severe mouth sores, Kepivance helps patients continue normal daily activities, like eating, drinking, swallowing and talking.

In patients with hematologic malignancies, the most common serious adverse reaction in clinical trials attributed to Kepivance was skin rash reported in less than one percent of patients. Other serious adverse reactions occurred at a similar rate in patients who received Kepivance or placebo with the most frequent being fever, gastrointestinal events, and respiratory events. The most commonly reported adverse reactions attributed to Kepivance were rash, erythema, edema, pruritus, dysesthesia, mouth/tongue thickness/discoloration, and taste alteration.

July, 2005|Archive|

Molecular Targeting With Cancer Vaccines

  • 7/29/2005
  • Seattle, WA
  • Mary L. Disis
  • Journal of Clinical Oncology, Vol 23, No 22 (August 1), 2005: pp. 4840-4841

The last decade has resulted in the identification of a multitude of tumor-associated antigens and the initiation of clinical trials to determine whether cancer patients can be vaccinated. In this issue of the Journal of Clinical Oncology, Carbone et al1 present an extensive analysis of the immunogenicity and potential clinical efficacy of vaccinating advanced-stage cancer patients against specific K-ras and p53 mutations present in their tumors. This report provides long-term follow-up after vaccination over a period of several years, so the length of time between initiation and publication of the trial allows evaluation of the data in the context of the evolution of more refined methods of vaccination. The authors also present data detailing the pitfalls of the clinical application of targeted therapy, which includes the need to evaluate large numbers of patients to find the few patients who may derive therapeutic benefit. Finally, the authors demonstrate an intriguing association between the development of an antigen-specific immune response and prolonged survival.

The vaccination strategy used in the trial was to incubate mutated K-ras and p53 peptide sequences with peripheral-blood mononuclear cells obtained from each patient. Presumably, antigen-presenting cells present in the peripheral blood would uptake K-ras and p53 peptides, process the peptides, and present the fragments in the context of class I major histocompatibility complex molecules, resulting in the stimulation of antigen-specific cytotoxic CD8+ T cells. It has only been in the last decade that clinical trials of cancer vaccines have been able to demonstrate any reproducible and detectable antigen-specific immunity resulting from such immunizations.2 As in the initial studies of this approach, Carbone et al1 describe low to moderate peptide-specific T-cell immunity developing in a minority of patients. Subsequent to the initiation of this trial, more potent antigen-presenting cells have been identified, such as dendritic cells.3 Over the last several years, methods have been developed to purify dendritic cells from the peripheral blood and to use them clinically to present tumor antigens to T cells. Methods continue to evolve to optimize the efficacy of dendritic cell vaccines.4 Potentially, the use of such professional antigen-presenting cells could increase the number of patients able to develop immune responses after vaccination. The authors also describe the lack of immunogenicity of vaccination in patients with rapidly progressing diseases such as pancreatic cancer. Findings such as this have resulted in a re-evaluation of the clinical application of cancer vaccines. Most cancer vaccine trials now focus on immunization in the adjuvant setting, aiming to prevent cancer relapse rather than to treat measurable disease. Even the most potent infectious disease vaccines are generally not used for treating established infections; likewise, cancer vaccines may have greatest benefit in the management of micrometastatic disease or even in the prevention of cancer in high-risk populations.

The explosion in the identification of tumor antigens was fueled by advances in molecular technology and immunology. Similarly, the identification of molecular targets that affect growth pathways in cancer has resulted in the generation of novel and promising cancer therapies.5 Data presented by Carbone et al1 underscore the need to develop rapid and inexpensive methods to screen patients for genetic alterations that may predict clinical efficacy of novel reagents. The authors evaluated nearly 300 patients to find the 14% of individuals whose tumors contained the appropriate mutations and were eligible for enrollment by clinical criteria. Recent studies with other forms of targeted cancer therapy, such as gefitinib in the treatment of lung cancer,6 highlight the need to choose patients most likely to respond to intervention, as Carbone et al1 did in this clinical trial. It is frustrating to refer patients for screening for such trials only to find out that they are ineligible for a particular therapy. However, studies such as this demonstrate that there is a need for persistence to define the utility of a promising approach. Hopefully, more rapid clinical successes resulting from early-stage studies enrolling only the most appropriate patient populations will facilitate the entry of novel agents into clinical practice.

The most provocative aspect of the trial is the association of a specific type of immune response with prolonged survival. The authors describe the identification of peptide-specific cytotoxic T cells and interferon gamma secretion, but not interleukin-5 secretion, as favorable prognostic markers. Both K-ras and p53 are proteins expressed within the cell and not on the surface of the cell. Intracellular proteins are generally processed and presented in major histocompatibility complex class I molecules, which represent the pathway for stimulating a cytotoxic T-cell response. T cells that elaborate interferon gamma support the proliferation of cytotoxic T cells. Interleukin-5 secretion does not. Therefore, the data suggest that the generation of peptide-specific cytotoxic T cells may impact tumor progression. Phase II trials focused on clinical outcome will help define the utility of mutated K-ras and p53 peptide-based vaccines in the treatment of cancer patients.

Cancer treatment may evolve to combined-modality regimens that initially use standard cytotoxic agents to debulk disease, followed by targeted approaches. One may imagine a future where K-ras–driven tumor growth is halted by a specific inhibitor and then K-ras mutation–containing tumor cells are eradicated by mutation-specific cytotoxic T cells. Hopefully soon, cancer growth pathways will be silenced via multiple targeted mechanisms.

Author’s affiliation:

University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA

References:

(1)Carbone DP, Ciernik IF, Kelley MJ, et al: Immunization with mutant p53- and K-ras–derived peptides in cancer patients: Immune response and clinical outcome. J Clin Oncol 23: 5099-5107, 2005

(2)Gjertsen MK, Bakka A, Breivik J, et al: Vaccination with mutant ras peptides and induction of T-cell responsiveness in pancreatic carcinoma patients carrying the corresponding RAS mutation. Lancet 346: 1399-1400, 1995

(3)Banchereau J, Steinman RM: Dendritic cells and the control of immunity. Nature 392: 245-252, 1998

(4)Steinman RM, Pope M: Exploiting dendritic cells to improve vaccine efficacy. J Clin Invest 109: 1519-1526, 2002[Free Full Text]
Sawyers C: Targeted cancer therapy. Nature 432: 294-297, 2004

(5)Paez JG, Janne PA, Lee JC, et al: EGFR mutations in lung cancer: Correlation with clinical response to gefitinib therapy. Science 304: 1497-1500, 2004

July, 2005|Archive|

Tapping a Cure for Dry Mouth

  • 7/27/2005
  • Tampa, FL
  • Tania Hershman
  • Business 2.0 (www.business2.com)

What do you get when you cross a dentist with an engineer? A high-tech remedy for dry mouth.

Granted, it’s not much of a punch line, but it’s also no joke. In fact, the dental implant developed by Saliwell Medical Systems — an Israeli startup founded by dentist Andy Wolff and engineer Benzi Beiski — could unlock a $2 billion market.

Triggered by radiation therapy, blood-pressure medication, and autoimmune diseases, dry mouth, or xerostomia, interferes with swallowing, sleeping, and speech. But drugs to treat it often have debilitating side effects. Saliwell’s implant, the Crown, is equipped with electrodes, sensors, and a 16-bit microprocessor. If the sensors detect dryness, the electrodes stimulate the lingual nerve to jump-start saliva flow.

The company hopes to have the Crown on the market by 2006. If it does, Wolff and Beiski will pocket nearly all of the profits, thanks to the clever strategy they used to launch the company. Rather than relying on venture funding, the duo landed a $2 million European Union grant for medical R&D, which meant they didn’t have to give up any equity — a deal sweet enough to make any entrepreneur salivate.

July, 2005|Archive|

The role of the dental professional

  • 7/26/2005
  • Patti DeGrangi, RDH, BS
  • RDH Magazine, September 2005

Humble beginnings often wind their way down unexpected paths toward unthink-able destinations. Ribbons we wear, rib-bons on our cars, and wristbands have become not only methods to bring aware-ness of various cancers and causes; they have become a fad of nearly epic proportions. Discovering the history of the ribbon craze is tricky, with different groups and individuals taking credit. Some give credit to the black armbands worn in Victorian times or the yellow ribbons from the Tony Orlando song. But whatever the origination, these symbols can bring attention, understanding, and most importantly, funding to organizations and individuals struggling with disease.

For several years, oral cancer awareness and screening has had a part in each program I give, for some very specific and personal reasons. Using my skills and intuition as a dental hygienist, I saw a suspicious area on a client. The client denied it, saying she wasn’t a smoker. The lesion was on the palate. The client said it was from eating taco chips. There was something about it that just didn’t resonate for me. I had to talk her into allowing a brush biopsy. The biopsy came back showing atypical cells; the scalpel biopsy showed early squamous cell carcinoma. The client was my sister. The good news was that we found it so early that the very early scalpel biopsy has thus far, after six years, seemed to have removed everything and there has been no recurrence. CDx Labs (www.oralcdx.com) has been using my case study for several years as the first case they published about an RDH. My sister had none of the usual risk factors; the location of the lesion was not one of the most common sites and could easily have been missed if I hadn’t been specifically looking.

This was followed by another experience with a 29-year-old school teacher, again with seemingly no risk factors. She complained of some TMJ discomfort, often had swollen glands, and noninflammatory enlarged tonsils. After evaluation and careful documentation, she was referred to her physician. Her physician did not pick up on her situation right away and gave the usual rounds of antibiotics. Finally the symptoms were pursued, and based on my suspicions and referral, she was diagnosed with lymphoma earlier than she might otherwise have been.

My stories are not really different from those of many other hygienists. Many of us have saved people’s lives through our efforts. But we aren’t doing it well enough yet. Dr. Michael C. Alfano, DMD, PhD, dean of New York University College of Dentistry, states, “Right now the majority of oral cancer is still diagnosed by physicians. That’s because it is diagnosed late, when people are symptomatic.” In my presentations,I have often said it’s too bad there is not more public awareness of oral cancer like a ribbon or walk.

Recently, it came to my attention that head and neck cancer does have a ribbon. SPOHNC, which stands for Support People with Oral Head and Neck Cancer, is a patient-directed, self-help organization dedicated to meeting the needs of oral and head and neck cancer patients. SPOHNC, founded in 1991 by an oral cancer survivor, addresses the broad emotional, physical, and humanistic needs of this population. During the last several years, SPOHNC has received numerous inquiries about a ribbon to help raise awareness of oral and head and neck cancer. On June 3, 2001, at the 10th Anniversary Celebration of the Founding of SPOHNC, an awareness ribbon was introduced to the public for the first time. This ribbon consists of three stripes, one burgundy and two ivory, symbolizing oral and head and neck cancer. It is SPOHNC’s hope that by wearing and displaying this ribbon in various forms, we can all do our part in supporting cancer survivors and raising public awareness of this disease.

Awareness alone doesn’t change behavior
“Dental lifesavers: An oxymoron? Perhaps not. We know that dentists and hygienists are not thought of by the public, and do not think of themselves, as people who engage in the saving of lives. After all, they are not ER doctors. But when either of these dental professionals finds an oral cancer in the course of their examinations, especially at an early stage one or two, they have undoubtedly saved a life.”

This is a quote from Brian Hill, oral cancer survivor and founder and executive director of The Oral Cancer Foundations, Inc. (OCF). The question is: Do you really believe it?

There is and has been a world of information on oral cancer available for many years. Now, with a pin we can get the message out even more, but will we really change our behavior? Dental health professionals KNOW about oral cancer, yet our statistics on early detection are abysmal. According to many sources, oral cancer is the sixth deadliest cancer in the world with close to 390,000 new cases accounting for 4 percent of all cancers diagnosed annually. Approximately 8,000 Americans die each year — an average of one per hour — compared to cervical cancer with 3,710 deaths per year. Sixty-six percent of the oral cancer cases are not diagnosed until they are in the late stages, and approximately 50 percent of the victims will die within five years. This death rate is higher than Hodgkin’s disease and cervical, skin, ovarian, and brain cancers.The real issue is that oral cancer is 80 to 90 percent survivable if caught early. The bad news for dental professionals is that mortality rates have been basically unchanged for 50 years.

Why aren’t dental health professionals doing more to bring this information forward? Whose arena is oral cancer? How much pathology can you identify? How much have you seen but possibly didn’t notice? Do you ever find yourself performing tasks by rote such that you don’t pay attention? The last question is the heart of the issue when it comes to oral cancer screening.

The learning cycle
Dental hygiene, like most other work, includes repetition. Repetition is one of the ways new skills are acquired – practice, practice, practice is the mantra for learning. Though this is very true, it can lead to performing repetitive tasks nearly unconsciously.

Abraham Maslow describes the four stages of skill development: unconscious incompetence, conscious incompetence, conscious competence, and unconscious competence (Figure 1). These stages can be illustrated by following the efforts of a person who is learning to surf.

The first day, after much effort, the new surfer may be half-standing, half-stooping on the board fighting each swell of the water. The surfer is “dumb and happy” and perhaps a little sunburned. He is ignorant of the deeper skill level required to become a master surfer. He has found the unconscious incompetence stage of skill development. If he sticks with the task, he will quickly move to the consciously incompetent stage. At this stage, he is now aware of the skills he lacks, but resolved to learn more. He knows what he doesn’t know. He will eventually move, with practice, to the consciously competent stage of skill development. At the third stage of the cycle, the surfer can skillfully catch a wave, knows a lot about the equipment, and has a good time each day on the beach. But he returns home exhausted by his efforts. He then crosses an invisible frontier in which surfing gets easier. He takes on a bigger wave at exactly the right moment on a beach he knows as well as the curves of his face. He comes off the wave energized and exhilarated, not exhausted. He has found the fourth level of competency – unconscious competency.

Just as with our surfer, dental hygienists believe they have attained this level of unconscious competency a few years into their clinical practice. Some new graduates like to think they have attained this level of competency by the end of their initial educational process. During our educational years, each step of the dental hygiene process of care is evaluated. Our educational process teaches us to perform to the level that is inspected, rather than to a level that should be expected. This behavior pattern carries over to clinical practice. Often dentists do not inspect the dental hygiene process of care, because they expect that it has been completed. This is assuming the dentist truly understands each of the aspects of the dental hygiene process, which is a highly questionable assumption.

Beyond that,in the transition from our educational years to the real world of clinical practice, the alligator of time starts nipping. To fulfill what are generally artificial time parameters in clinical practice, steps in the dental hygiene process of care are skipped, dropped, or quickly glossed over. Hygiene professionals believe they are practicing at a level of unconscious competency when,in reality,they have slipped back into unconscious incompetence. Just like the surfer, the hygienist is “dumb and happy,” or maybe not so happy but the bills are being paid.

What steps are skipped, glossed over, and performed by rote? Review of medications and implications, vital signs/ blood pressure screening, occlusal evaluation, periodontal charting, complete documentation, and the subject of this article — oral cancer screening … to name a few.

It seems like “dumb and happy” or maybe “not so happy but the bills are being paid” is a choice you may have been able to get away with in the past. But as Bob Dylan said back in the 1960s, “The times they are a-changin’.” Our clients expect and believe they pay for mastery.

Our clients want more
The world is speeding up. Expectations are rising. Our clients expect service and responses right now. We expect and demand that our problems be solved right now. We are impatient and demand more than we previously expected. We can make airline reservations online, shop for cars online, make appointments online, and find lots of information online. The aging population is now more health conscious than ever before. Americans want to stay young and healthy regardless of their age. Take a look at the amount of plastic surgery going on,the personal trainer phenomenon, and more. While much has been made of the fattening of America, there is a group on the other end of the scale that is more health conscious than ever.

Speaker and coach, Dr. Greg Tarantol (www.tarantoladentallearning.com) said our clients expect and even demand genuine, individual attention. They are Internet savvy and are used to having information available at their fingertips. They expect a broad choice of therapeutic options. They think for themselves and are less likely to take the word of authority figures than previous generations. They further expect to be active participants, at every level, in their own health care because of a strong self-image. They view themselves as healthy and active.

How will this affect oral cancer screening? Clients will help drive the profession to do what we are trained to do. They will demand this service more and more just as the public has been the driving force in nutritional supplements. If the professionals don’t do it, consumers will find a way to do it for themselves.

There are still other driving forces that influence dentistry,including our standards of care and the insurance industry.

Standard of care and dental benefit codes
Oral cancer screening should be a routine part of every evaluation procedure; our standard of care requires it. But just what does the term standard of care really mean? The Dentist Insurance Company (TDIC) describes it this way:

“The standard of care is a relative standard, not a strict legal prescription. It is based on the actions of the reasonable person of ordinary prudence.Since the conduct of a reasonable person varies with the situation he or she is confronted with, negligence is, therefore, defined as the failure to do what this reasonable person would do under the same or similar circumstances. In other words, the standard represents the minimum level of conduct below which members of society must not fall. Persons with a higher level of knowledge, skill, and intelligence — such as dental health professionals — are held to a correspondingly higher standard. The conduct of the dental health professional will be judged by the conduct of other dental health professionals practicing under the same or similar circumstances.”

Standard of care is NOT a maximum standard, but a minimum level of conduct below which we should not fall.

So what creates a standard? Standard of care is created by research, rules, laws, professional organizations through guidelines, position papers, parameters of care, statements, policies, and codes, including the Common Dental Terminology (CDT) codes. The CDT coding process is created by the American Dental Association. In 1986, the ADA Council on Dental Benefits elected to develop an educational manual. As stated by the ADA, the goals of the CDT manual are to serve as an educational resource, communicate accurate information, and act as a standard to document procedures. Therefore, it follows that the ADA states that CDT is part of the standard of care or the minimum level of conduct.

Whether a practice or a practitioner chooses to be involved with insurance benefits is a philosophical choice. Practicing below the standard of care is not. Examination and evaluation are routinely performed daily in clinical practice. The CDT codes for evaluations commonly used in clinical practice include D0150 Comprehensive Oral Evaluation and D0180 Comprehensive Periodontal Oral Evaluation. In the CDT descriptor of these codes, it states:

“This would include the evaluation and recording of patient’s dental and medical history and a general health assessment. It may typically include the evaluation and recordings of dental caries, missing or unerupted teeth, restorations, occlusal relationships, periodontal conditions (including periodontal charting), hard-and soft-tissue anomalies, oral cancer screening, etc.”

It therefore follows that because the CDT code includes oral cancer screening in the descriptor and the code helps create our standard of care,to NOT perform an oral cancer screening is falling below the standard of care. Further, to submit for these codes without performing oral cancer screening could be considered insurance fraud because it would be submitting for care not performed.

The most commonly used evaluation code D0120 Periodic Oral Evaluation includes this wording:
“An evaluation performed on a patient of record to determine any changes es patient’s dental and medical health status since a previous comprehensive or periodic evaluation.”

Does that mean oral cancer screening should be included? Absolutely! The code and the standard it sets are an evaluation for changes. We can’t determine changes if we don’t look. Once again, filing a claim without performing the services could be considered fraud.

Behavior still hasn’t changed, but it can!
A published study in the Journal of the American Dental Association (Horowitz AM, Alfano MC. Performing a death-defying act. JADA Nov. 2001; Vol. 132:5S-6S) states that only 13 percent of those who visit a dentist regularly report having had an oral cancer screening. Brian Hill (www.oralcancerfoundation.org), a survivor of a late-stage oral cancer that was not found by three members of his dental team, says, “This is unfortunate when you consider that historically, the greatest strides in combating most cancers have come from increased awareness and aggressive campaigns directed at early detection. It is now commonplace to annually get a Pap smear for cervical cancer, a mammogram to check for breast cancer, or PSA and digital rectal exams for prostate cancer. These screening efforts have been possible as a result of the increased public awareness of the value of catching cancers in their earliest forms, combined with effective technologies for conducting the examinations.

Oral cancer is no different. Actually, it is potentially easier to obtain public compliance for oral cancer screenings, since unlike many other cancer screening procedures, there is no invasive technique necessary to look for it, no discomfort or pain involved, and it is very inexpensive to have your mouth examined for the early signs of disease. Education of the public regarding the risk factors that lead to oral cancer and the development of public awareness are primary responsibilities of the dental community.”

In focus groups, OCF found that dental office staff members from the business area to the assistants to the dentists were reluctant to begin a dialog with clients regarding oral cancer. They just wouldn’t do it. OCF offers buttons — “We look for it” for the business staff and “I look for it” designed for the hygiene staff and the doctor. These buttons can be an excellent way to begin the dialog with your clients about having a screening while they are in the office. The idea behind the OCF buttons is the clients see the statement which leaves them with a question in their minds. Clients then initiate the dialog prompted by the saying on the button. This presents an opportunity for the dental staff member to answer the question with a statement such as, “We look for oral cancer. While you are here today, we are going to see that you get a through screening during
your appointment.”

If you don’t feel you know enough, take a CE course such as was offered at RDH Magazine’s UOR meeting. Dental industry further supports our learning through the Oral CDx free online four-hour course at www.oralcdx. com. Zila Pharmaceuticals offers training at www.vizilite training.com.

With companies bringing new diagnostic devices to the marketplace, organizations like OCF pushing for public literacy and awareness, and oral cancer now being called out by name in the Surgeon General’s recommendations, let alone in world-wide declarations from the World Health Organization, dentistry has a unique opportunity. Brian Hill sums it up when he states, “We must catch this wave of momentum and turn it into a positive force, reversing decades of past neglect.”

Each of us has an opportunity on a daily basis. Individuals can make a difference. Just ask yourself, what difference can I make today? How can I change the status quo? How can I change those statistics? On the back of the OCF business card I noticed a quote that reflects not only the organization’s position about effecting change, but my own: “You must be the change you wish to see in the world” — Gandhi.

Note: This article is dedicated to my mom, Arlene Clinger, who recently lost her battle with kidney cancer. She was my life example of how to make a difference not just through our words but through our actions.

Patti DiGangi, RDH, BS, is a speaker, author, and practicing dental hygiene clinician offering CE courses to national audiences through her company, Professional Direction Conferences. Courses cover eagle-eye dental hygiene assessments, minimal intervention, high-tech diagnostics, and her favorite hobby horse — early oral cancer detection. She can be reached to schedule courses at pdigangi@comcast.net or (630) 292-1473.

July, 2005|OCF In The News|

The role of the dental professional

  • 7/26/2005
  • Patti DeGrangi, RDH, BS
  • RDH September 2005

Humble beginnings often wind their way down unexpected paths toward unthink-able destinations. Ribbons we wear, rib-bons on our cars, and wristbands have become not only methods to bring aware-ness of various cancers and causes; they have become a fad of nearly epic proportions. Discovering the history of the ribbon craze is tricky, with different groups and individuals taking credit. Some give credit to the black armbands worn in Victorian times or the yellow ribbons from the Tony Orlando song. But whatever the origination, these symbols can bring attention, understanding, and most importantly, funding to organizations and individuals struggling with disease.

For several years, oral cancer awareness and screening has had a part in each program I give, for some very specific and personal reasons. Using my skills and intuition as a dental hygienist, I saw a suspicious area on a client. The client denied it, saying she wasn’t a smoker. The lesion was on the palate. The client said it was from eating taco chips. There was something about it that just didn’t resonate for me. I had to talk her into allowing a brush biopsy. The biopsy came back showing atypical cells; the scalpel biopsy showed early squamous cell carcinoma. The client was my sister. The good news was that we found it so early that the very early scalpel biopsy has thus far, after six years, seemed to have removed everything and there has been no recurrence. CDx Labs (www.oralcdx.com) has been using my case study for several years as the first case they published about an RDH. My sister had none of the usual risk factors; the location of the lesion was not one of the most common sites and could easily have been missed if I hadn’t been specifically looking.

This was followed by another experience with a 29-year-old school teacher, again with seemingly no risk factors. She complained of some TMJ discomfort, often had swollen glands, and noninflammatory enlarged tonsils. After evaluation and careful documentation, she was referred to her physician. Her physician did not pick up on her situation right away and gave the usual rounds of antibiotics. Finally the symptoms were pursued, and based on my suspicions and referral, she was diagnosed with lymphoma earlier than she might otherwise have been.

My stories are not really different from those of many other hygienists. Many of us have saved people’s lives through our efforts. But we aren’t doing it well enough yet. Dr. Michael C. Alfano, DMD, PhD, dean of New York University College of Dentistry, states, “Right now the majority of oral cancer is still diagnosed by physicians. That’s because it is diagnosed late, when people are symptomatic.” In my presentations,I have often said it’s too bad there is not more public awareness of oral cancer like a ribbon or walk.

Recently, it came to my attention that head and neck cancer does have a ribbon. SPOHNC, which stands for Support People with Oral Head and Neck Cancer, is a patient-directed, self-help organization dedicated to meeting the needs of oral and head and neck cancer patients. SPOHNC, founded in 1991 by an oral cancer survivor, addresses the broad emotional, physical, and humanistic needs of this population. During the last several years, SPOHNC has received numerous inquiries about a ribbon to help raise awareness of oral and head and neck cancer. On June 3, 2001, at the 10th Anniversary Celebration of the Founding of SPOHNC, an awareness ribbon was introduced to the public for the first time. This ribbon consists of three stripes, one burgundy and two ivory, symbolizing oral and head and neck cancer. The ribbon will be sent to you at no charge by calling SPOHNC at (800) 377-0928. SPOHNC also offers an enameled pin that can only be purchased online through their Web site at www.spohnc.org or by calling (800) 377-0928. It is SPOHNC’s hope that by wearing and displaying this ribbon in various forms, we can all do our part in supporting cancer survivors and raising public awareness of this disease.

Awareness alone doesn’t change behavior
“Dental lifesavers: An oxymoron? Perhaps not. We know that dentists and hygienists are not thought of by the public, and do not think of themselves, as people who engage in the saving of lives. After all, they are not ER doctors. But when either of these dental professionals finds an oral cancer in the course of their examinations, especially at an early stage one or two, they have undoubtedly saved a life.”

This is a quote from Brian Hill, oral cancer survivor and founder and executive director of The Oral Cancer Foundations, Inc. (OCF). The question is: Do you really believe it?

There is and has been a world of information on oral cancer available for many years. Now, with a pin we can get the message out even more, but will we really change our behavior? Dental health professionals KNOW about oral cancer, yet our statistics on early detection are abysmal. According to many sources, oral cancer is the sixth deadliest cancer in the world with close to 390,000 new cases accounting for 4 percent of all cancers diagnosed annually. Approximately 8,000 Americans die each year — an average of one per hour — compared to cervical cancer with 3,710 deaths per year. Sixty-six percent of the oral cancer cases are not diagnosed until they are in the late stages, and approximately 50 percent of the victims will die within five years. This death rate is higher than Hodgkin’s disease and cervical, skin, ovarian, and brain cancers.The real issue is that oral cancer is 80 to 90 percent survivable if caught early. The bad news for dental professionals is that mortality rates have been basically unchanged for 50 years.

Why aren’t dental health professionals doing more to bring this information forward? Whose arena is oral cancer? How much pathology can you identify? How much have you seen but possibly didn’t notice? Do you ever find yourself performing tasks by rote such that you don’t pay attention? The last question is the heart of the issue when it comes to oral cancer screening.

The learning cycle
Dental hygiene, like most other work, includes repetition. Repetition is one of the ways new skills are acquired – practice, practice, practice is the mantra for learning. Though this is very true, it can lead to performing repetitive tasks nearly unconsciously.

Abraham Maslow describes the four stages of skill development: unconscious incompetence, conscious incompetence, conscious competence, and unconscious competence (Figure 1). These stages can be illustrated by following the efforts of a person who is learning to surf.

The first day, after much effort, the new surfer may be half-standing, half-stooping on the board fighting each swell of the water. The surfer is “dumb and happy” and perhaps a little sunburned. He is ignorant of the deeper skill level required to become a master surfer. He has found the unconscious incompetence stage of skill development. If he sticks with the task, he will quickly move to the consciously incompetent stage. At this stage, he is now aware of the skills he lacks, but resolved to learn more. He knows what he doesn’t know. He will eventually move, with practice, to the consciously competent stage of skill development. At the third stage of the cycle, the surfer can skillfully catch a wave, knows a lot about the equipment, and has a good time each day on the beach. But he returns home exhausted by his efforts. He then crosses an invisible frontier in which surfing gets easier. He takes on a bigger wave at exactly the right moment on a beach he knows as well as the curves of his face. He comes off the wave energized and exhilarated, not exhausted. He has found the fourth level of competency – unconscious competency.

Just as with our surfer, dental hygienists believe they have attained this level of unconscious competency a few years into their clinical practice. Some new graduates like to think they have attained this level of competency by the end of their initial educational process. During our educational years, each step of the dental hygiene process of care is evaluated. Our educational process teaches us to perform to the level that is inspected, rather than to a level that should be expected. This behavior pattern carries over to clinical practice. Often dentists do not inspect the dental hygiene process of care, because they expect that it has been completed. This is assuming the dentist truly understands each of the aspects of the dental hygiene process, which is a highly questionable assumption.

Beyond that,in the transition from our educational years to the real world of clinical practice, the alligator of time starts nipping. To fulfill what are generally artificial time parameters in clinical practice, steps in the dental hygiene process of care are skipped, dropped, or quickly glossed over. Hygiene professionals believe they are practicing at a level of unconscious competency when,in reality,they have slipped back into unconscious incompetence. Just like the surfer, the hygienist is “dumb and happy,” or maybe not so happy but the bills are being paid.

What steps are skipped, glossed over, and performed by rote? Review of medications and implications, vital signs/ blood pressure screening, occlusal evaluation, periodontal charting, complete documentation, and the subject of this article — oral cancer screening … to name a few.

It seems like “dumb and happy” or maybe “not so happy but the bills are being paid” is a choice you may have been able to get away with in the past. But as Bob Dylan said back in the 1960s, “The times they are a-changin’.” Our clients expect and believe they pay for mastery.

Our clients want more
The world is speeding up. Expectations are rising. Our clients expect service and responses right now. We expect and demand that our problems be solved right now. We are impatient and demand more than we previously expected. We can make airline reservations online, shop for cars online, make appointments online, and find lots of information online. The aging population is now more health conscious than ever before. Americans want to stay young and healthy regardless of their age. Take a look at the amount of plastic surgery going on,the personal trainer phenomenon, and more. While much has been made of the fattening of America, there is a group on the other end of the scale that is more health conscious than ever.

Speaker and coach, Dr. Greg Tarantol (www.tarantoladentallearning.com) said our clients expect and even demand genuine, individual attention. They are Internet savvy and are used to having information available at their fingertips. They expect a broad choice of therapeutic options. They think for themselves and are less likely to take the word of authority figures than previous generations. They further expect to be active participants, at every level, in their own health care because of a strong self-image. They view themselves as healthy and active.

How will this affect oral cancer screening? Clients will help drive the profession to do what we are trained to do. They will demand this service more and more just as the public has been the driving force in nutritional supplements. If the professionals don’t do it, consumers will find a way to do it for themselves.

There are still other driving forces that influence dentistry,including our standards of care and the insurance industry.

Standard of care and dental benefit codes
Oral cancer screening should be a routine part of every evaluation procedure; our standard of care requires it. But just what does the term standard of care really mean? The Dentist Insurance Company (TDIC) describes it this way:

“The standard of care is a relative standard, not a strict legal prescription. It is based on the actions of the reasonable person of ordinary prudence.Since the conduct of a reasonable person varies with the situation he or she is confronted with, negligence is, therefore, defined as the failure to do what this reasonable person would do under the same or similar circumstances. In other words, the standard represents the minimum level of conduct below which members of society must not fall. Persons with a higher level of knowledge, skill, and intelligence — such as dental health professionals — are held to a correspondingly higher standard. The conduct of the dental health professional will be judged by the conduct of other dental health professionals practicing under the same or similar circumstances.”

Standard of care is NOT a maximum standard, but a minimum level of conduct below which we should not fall.

So what creates a standard? Standard of care is created by research, rules, laws, professional organizations through guidelines, position papers, parameters of care, statements, policies, and codes, including the Common Dental Terminology (CDT) codes. The CDT coding process is created by the American Dental Association. In 1986, the ADA Council on Dental Benefits elected to develop an educational manual. As stated by the ADA, the goals of the CDT manual are to serve as an educational resource, communicate accurate information, and act as a standard to document procedures. Therefore, it follows that the ADA states that CDT is part of the standard of care or the minimum level of conduct.

Whether a practice or a practitioner chooses to be involved with insurance benefits is a philosophical choice. Practicing below the standard of care is not. Examination and evaluation are routinely performed daily in clinical practice. The CDT codes for evaluations commonly used in clinical practice include D0150 Comprehensive Oral Evaluation and D0180 Comprehensive Periodontal Oral Evaluation. In the CDT descriptor of these codes, it states:

“This would include the evaluation and recording of patient’s dental and medical history and a general health assessment. It may typically include the evaluation and recordings of dental caries, missing or unerupted teeth, restorations, occlusal relationships, periodontal conditions (including periodontal charting), hard-and soft-tissue anomalies, oral cancer screening, etc.”

It therefore follows that because the CDT code includes oral cancer screening in the descriptor and the code helps create our standard of care,to NOT perform an oral cancer screening is falling below the standard of care. Further, to submit for these codes without performing oral cancer screening could be considered insurance fraud because it would be submitting for care not performed.

The most commonly used evaluation code D0120 Periodic Oral Evaluation includes this wording:
“An evaluation performed on a patient of record to determine any changes es patient’s dental and medical health status since a previous comprehensive or periodic evaluation.”

Does that mean oral cancer screening should be included? Absolutely! The code and the standard it sets are an evaluation for changes. We can’t determine changes if we don’t look. Once again, filing a claim without performing the services could be considered fraud.

Behavior still hasn’t changed, but it can!
A published study in the Journal of the American Dental Association (Horowitz AM, Alfano MC. Performing a death-defying act. JADA Nov. 2001; Vol. 132:5S-6S) states that only 13 percent of those who visit a dentist regularly report having had an oral cancer screening. Brian Hill (www.oralcancerfoundation.org), a survivor of a late-stage oral cancer that was not found by three members of his dental team, says, “This is unfortunate when you consider that historically, the greatest strides in combating most cancers have come from increased awareness and aggressive campaigns directed at early detection. It is now commonplace to annually get a Pap smear for cervical cancer, a mammogram to check for breast cancer, or PSA and digital rectal exams for prostate cancer. These screening efforts have been possible as a result of the increased public awareness of the value of catching cancers in their earliest forms, combined with effective technologies for conducting the examinations.

Oral cancer is no different. Actually, it is potentially easier to obtain public compliance for oral cancer screenings, since unlike many other cancer screening procedures, there is no invasive technique necessary to look for it, no discomfort or pain involved, and it is very inexpensive to have your mouth examined for the early signs of disease. Education of the public regarding the risk factors that lead to oral cancer and the development of public awareness are primary responsibilities of the dental community.”

In focus groups, OCF found that dental office staff members from the business area to the assistants to the dentists were reluctant to begin a dialog with clients regarding oral cancer. They just wouldn’t do it. OCC offers buttons — “We look for it” for the business staff and “I look for it” designed for the hygiene staff and the doctor. These buttons can be an excellent way to begin the dialog with your clients about having a screening while they are in the office. The idea behind the OCF buttons is the clients see the statement which leaves them with a question in their minds. Clients then initiate the dialog prompted by the saying on the button. This presents an opportunity for the dental staff member to answer the question with a statement such as, “We look for oral cancer. While you are here today, we are going to see that you get a through screening during
your appointment.”

If you don’t feel you know enough, take a CE course such as was offered at RDH Magazine’s UOR meeting. Dental industry further supports our learning through the Oral CDx free online four-hour course at www.oralcdx. com. Zila Pharmaceuticals offers training at www.vizilite training.com.

With companies bringing new diagnostic devices to the marketplace, organizations like OCF pushing for public literacy and awareness, and oral cancer now being called out by name in the Surgeon General’s recommendations, let alone in world-wide declarations from the World Health Organization, dentistry has a unique opportunity. Brian Hill sums it up when he states, “We must catch this wave of momentum and turn it into a positive force, reversing decades of past neglect.”

Each of us has an opportunity on a daily basis. Individuals can make a difference. Just ask yourself, what difference can I make today? How can I change the status quo? How can I change those statistics? On the back of the OCF business card I noticed a quote that reflects not only the organization’s position about effecting change, but my own: “You must be the change you wish to see in the world” — Gandhi.

Note: This article is dedicated to my mom, Arlene Clinger, who recently lost her battle with kidney cancer. She was my life example of how to make a difference not just through our words but through our actions.

Patti DiGangi, RDH, BS, is a speaker, author, and practicing dental hygiene clinician offering CE courses to national audiences through her company, Professional Direction Conferences. Courses cover eagle-eye dental hygiene assessments, minimal intervention, high-tech diagnostics, and her favorite hobby horse — early oral cancer detection. She can be reached to schedule courses at pdigangi@comcast.net or (630) 292-1473.

July, 2005|Archive|

Many Cancer Survivors Make Healthy Changes

  • 7/26/2005
  • Jennifer Warner
  • WebMD (www.webmd.com)

Male, Older, and Less-Educated Patients Less Likely to Change Lifestyle After Cancer

Cancer survivors often make healthy lifestyle changes after their cancer treatment, but a new study suggests many may not go far enough in adopting healthy habits.

Researchers found up to 60% of cancer survivors follow a healthier diet after diagnosis and treatment, yet less than half are eating the recommended five or more servings of fruits and vegetables per day.

The study also showed that about 70% of breast and prostate cancer survivors remain overweight or obese.

There are almost 10 million cancer survivors in the U.S., and that number is expected to grow thanks to improvements in cancer diagnosis and treatment. For example, only about 50% of people diagnosed with cancer in 1971 were expected to be alive after five years, compared with 64% of those diagnosed with cancer today.
Researchers say adopting healthy lifestyle changes is especially important for cancer survivors because they are at increased risk for second cancers as well as other diseases, such as osteoporosis, obesity, heart disease, and diabetes.

A Healthier Life After Cancer?

In their study, researchers reviewed 100 studies on cancer survivors to examine the impact of cancer diagnosis and treatment on lifestyle and behavior changes. The results appear in the Aug. 20 issue of the Journal of Clinical Oncology.

Overall, they found that many cancer survivors adopt healthier behaviors, such as:

30%-60% eat a healthier diet.
46%-96% of smokers with tobacco-related cancers (lung, head, or neck) quit smoking.
47%-59% of those with head and neck cancers linked to alcohol use abstain from alcohol.
70% engage in regular physical activity of 30 minutes of exercise a day at least five days a week.

However, the study showed that cancer survivors who were male, less educated, over age 65, or who live in urban areas were less likely to start or maintain healthy lifestyle changes.

The study also showed that only 25%-42% of cancer survivors eat adequate amounts of fruits and vegetables.

Researchers also found that only 20% of oncologists (cancer doctors) provided guidance to their patients on adopting a healthier lifestyle due to time constraints, treatment or health concerns, and uncertainty about how the message would be received or affect their patient’s health.

‘Teachable Moment’ for Patient and Doctor

In an editorial that accompanies the study, Patricia A. Ganz, MD, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, says the diagnosis of cancer and transition to cancer survivor are “teachable moments” for oncologists to encourage their patients to adopt a healthier lifestyle.

“Cancer survivors are looking for important ways to prevent a recurrence of their cancer, and to enhance the quality and length of their lives,” writes Ganz.

But Ganz says it’s also a teachable moment for oncologists to focus more attention on this new posttreatment phase of cancer care.

July, 2005|Archive|

What to Do With a Patient Who Smokes

  • 7/26/2005
  • San Francisco, CA
  • Steven A. Schroeder, MD
  • JAMA. 2005;294:482-487

Despite the reality that smoking remains the most important preventable cause of death and disability, most clinicians underperform in helping smokers quit. Of the 46 million current smokers in the United States, 70% say they would like to quit, but only a small fraction are able to do so on their own because nicotine is so highly addictive. One third to one half of all smokers die prematurely.

Reasons clinicians avoid helping smokers quit include time constraints, lack of expertise, lack of financial incentives, respect for a smoker’s privacy, fear that a negative message might lose customers, pessimism because most smokers are unable to quit, stigma, and clinicians being smokers. The gold standard for cessation treatment is the 5 A’s (ask, advise, assess, assist, and arrange). Yet, only a minority of physicians know about these, and fewer put them to use. Acceptable shortcuts are asking, advising, and referring to a telephone “quit line” or an internal referral system. Successful treatment combines counseling with pharmacotherapy (nicotine replacement therapy with or without psychotropic medication such as bupropion).

Nicotine replacement therapy comes in long-acting (patch) or short-acting (gum, lozenge, nasal spray, or inhaler) forms. Ways to counter clinicians’ pessimism about cessation include the knowledge that most smokers require multiple quit attempts before they succeed, that rigorous studies show long-term quit rates of 14% to 20%, with 1 report as high as 35%, that cessation rates for users of telephone quit lines and integrated health care systems are comparable with those of individual clinicians, and that no other clinical intervention can offer such a large potential benefit.

July, 2005|Archive|

Combination Scanner and Detecting Spread, Recurrence of Head, Neck Cancer

  • 7/26/2005
  • Chapel Hill, NC
  • staff
  • Newswise (www.newswise.com)

A highly powerful scanner combining two state-of-the-art technologies – computed tomography (CT) and positron emission tomography (PET) – may detect the spread of head and neck cancer more accurately than other widely used imaging examinations.

These findings, based on new research from the University of North Carolina at Chapel Hill School of Medicine, appear in the July issue of the medical journal The Laryngoscope.

The whole-body PET/CT also is highly accurate for detecting head and neck cancer recurrence, the researchers said.

“PET/CT is very helpful in determining where we should pinpoint our biopsies for recurrent disease,” said Dr. Carol Shores, assistant professor of otolaryngology/head and neck surgery at UNC and the report’s senior author. Shores is a member of the UNC Lineberger Comprehensive Cancer Center.

“We can pick up cancer where we thought none existed. The new scans are so precise that in some cases cancer had been detected that probably would not have been through any other noninvasive imaging exam.”

Since its development in 2000, PET/CT imaging has enabled collection of both anatomical and biological information during a single examination. The PET component picks up the metabolic signal of actively growing cancer cells in the body, and the CT provides a detailed picture of the internal anatomy that reveals the size and shape of abnormal cancerous growths.

“Alone, each test has its limitations, but when the results of the scans are integrated they provide the most complete information on cancer location and metabolism,” said Shores.

In cancer detection, the PET/CT has helped detect a variety of tumors, including cancers of the breast, esophagus, cervix, lung, colon and ovaries, as well as melanoma and lymphoma.

“Until now, no published study has specifically evaluated clinical outcomes with PET/CT for head and neck tumors, including its accuracy, use and implications for patient care,” said Shores.

“In our review of nearly 100 patients at UNC, we wanted to find out where our best accuracy is in detecting these tumors with PET/CT.”

In PET/CT scanning, the patient lies on a table and is moved through the machine’s doughnut-shaped tunnel twice, first to obtain the PET data and again for the CT.

Cancer cells require a great deal of sugar, or glucose, to have enough energy to grow. PET scanning uses a radioactive molecule similar to glucose called fluorodeoxyglucose (FDG), which accumulates within malignant cells because of their high rate of glucose metabolism. The patient receives an injection of this agent, and the whole-body scanner detects evidence of cancer that may have been overlooked or difficult to characterize by conventional CT, PET, X-ray or MRI.

In the new study, the PET/CT was shown to be 80 percent accurate for staging of distant metastasis, such as the spread of head and neck cancer to the lungs. This could affect the “intent of treatment,” including decisions to preserve quality of life, Shores said.

Lung metastasis of head and neck cancer is not curable, Shores added. In these cases, patients receive palliative care rather than aggressive therapy, including major surgery or combined chemotherapy and radiation treatment. Such intensive treatments may cause difficulties swallowing and speaking, severe pain and other problems.

In addition to detecting distant metastasis, the study found the PET/CT more than 70 percent accurate in evaluating cancer recurrence.

Future PET/CT studies at UNC will hone accuracy, Shores said. “We’ll get more usable correct information because we now have a good idea of where we are most accurate.”

July, 2005|Archive|

Cancer survivors initiate diet, exercise, and other beneficial lifestyle changes following a cancer diagnosis

  • 7/25/2005
  • Durham, NC
  • staff
  • News-Mediacl.net (www.news-medical.net)

An analysis of more than 100 studies of cancer survivors shows that many survivors initiate diet, exercise, and other beneficial lifestyle changes following a cancer diagnosis, but that those who are male, older, and less educated are less likely to adopt such changes. The term “cancer survivor” refers to a person who has been diagnosed with cancer.

The review, which will be published online July 25 in the Journal of Clinical Oncology (JCO), says that a cancer diagnosis often prompts immediate changes in health behavior, including significant modifications in diet and physical activity.

Using the MEDLINE and PubMed databases, lead author Wendy Demark-Wahnefried, PhD, RD, LDN, of Duke University Medical Center, and colleagues from the National Cancer Institute and Brown University identified and reviewed more than 100 studies of cancer survivors published since 1996.

Researchers found that many survivors adopt healthier behaviors, such as following a healthier diet (30-60% of survivors), quitting smoking (46-96% of smokers with tobacco-related cancers, such as lung or head and neck), abstaining from alcohol (47-59% of those with head and neck cancers, which are closely linked to alcohol use), and regular physical activity (with up to 70% of survivors reporting 30 minutes of exercise a day, at least 5 days a week). Many of these changes should be beneficial because cancer survivors are a vulnerable population, at increased risk for second cancers, osteoporosis, obesity, cardiovascular disease, and diabetes.

However, researchers noted that not all cancer patients adopted healthier behaviors, with only 25-42% of survivors consuming adequate amounts of fruits and vegetables, and roughly 70% of breast and prostate cancer survivors remaining overweight or obese. The analysis also found conflicting data on physical activity, as well as smoking status, noting that although survivors with tobacco- or alcohol-related cancers were more likely to reduce or eliminate these behaviors, 20% of survivors continue to smoke, a figure that is not much different from smoking status in the general population (24%).

In addition, researchers found that males, less educated individuals, survivors over age 65, and those who live in urban areas were less likely to initiate or maintain healthy lifestyle changes.

The study also found that while physicians are among the most powerful catalysts for promoting behavior change, only 20% of oncologists provide such guidance because of time constraints, competing treatment or health concerns, and uncertainty regarding the delivery of health behavior messages and their potential impact on a patient’s outcome.

An accompanying editorial by Patricia A. Ganz, MD, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, and co-chair of the ASCO Survivorship Task Force, noted that while a recent survey of ASCO members found that the majority of oncologists believe it is their role to provide ongoing medical care, “it is not yet clear how focused that care is on surveillance for cancer recurrence versus health promotion, disease prevention, and monitoring or prevention of late effects.”

Dr. Ganz pointed to the transition time at the end of cancer treatment as a “teachable moment” for oncologists as well, adding, “Cancer survivors are looking for important ways to prevent a recurrence of their cancer, and to enhance the quality and length of their lives. Oncologists too are faced with a teachable moment, and have an opportunity to define what care of the cancer survivor should include, and what each survivor can expect after completing their initial curative-intent therapy.”

More than 10 million cancer survivors live in the United States today, and an estimated 64% of those diagnosed with cancer can expect to be alive after five years, up from less than 50% in 1971.

“Riding the Crest of the Teachable Moment: Promoting Long-Term Health After the Diagnosis of Cancer.” Wendy Demark-Wahnefried et al, Duke University Medical Center, Durham, NC.

“A Teachable Moment for Oncologists: Cancer Survivors, 10 Million Strong and Growing!” Patricia A. Ganz, Jonsson Comprehensive Cancer Center at University of California Los Angeles, Los Angeles, CA.

July, 2005|Archive|

Pathology Diagnosis: Do You Need a Second Opinion?

  • 7/24/2005
  • Raleigh, NC
  • staff
  • Cancer Wire (July 2005 Edition)

John, age eight, was diagnosed with an Anaplastic Astrocytoma (AA) which is an aggressive and often fatal brain tumor. He underwent brain surgery followed by high-dose chemotherapy and radiation therapy (equivalent to about 50,000 dental x-rays). These treatments are highly toxic to the developing brain of a child and, if he were to survive, his IQ and cognitive abilities would be seriously compromised. The family moved to a different state and took John to the local children’s hospital for follow-up care. There, the doctors reviewed John’s pathology slides. They discovered that John’s tumor was not an AA, but was benign. This diagnosis was subsequently confirmed by two other hospitals. John never needed chemotherapy or radiation therapy. Today, John’s IQ decreases at a rate of about 6 points a year as he suffers from the side-effects of a treatment he never needed.

Pathology is the medical specialty that deals with the examination of tissues and cells under the microscope in order to arrive at a diagnosis. When it comes to cancer, a pathological diagnosis is the gold standard that indicates the presence or absence of cancer, the type of cancer, and its classification. Because therapeutic decisions are based on the presumed reliability of the pathology diagnosis, a misdiagnosis can result in unnecessary, harmful and aggressive therapy (like John’s story) or inadequate treatment. Unfortunately, medical studies over the last two decades have demonstrated that this gold standard is not consistently reliable. In fact, multiple studies have demonstrated discrepancy rates of up to 30% with an average of approximately 10%. A “discrepancy” happens when one pathologist renders a diagnosis and another pathologist looks at the same material and renders a different opinion. See for example, Gupta D, Layfield LJ. Am J Surg Pathol. 2000 Feb;24(2):280-4. Prevalence of inter-institutional anatomic pathology slide review: a survey of current practice.

Here are some examples from the medical literature:

Bladder Cancer – Wrong Pathology Would Have Led to Five Unnecessary Cystectomies

The pathology of 97 patients (131 specimens) with suspected urothelial carcinoma of the bladder was reviewed. Twenty-four of the 131 specimens “exhibited significant discrepancies.” This included two patients who showed no evidence of tumor. As a result of the review, five radical cystectomies were avoided.

(Coblentz TR, Mills SE, Theodorescu D. Cancer. 2001 Apr 1;91(7):1284-90. Impact of second opinion pathology in the definitive management of patients with bladder carcinoma.)

Brain Tumors – Pathologists Often Disagree With Themselves or Others
Pathologists agreed with their original diagnosis only 51.43% for anaplastic astrocytomas, 74.73% for glioblastoma multiforme, and 65.22% for low-grade astrocytomas. Pathologists agreed with other pathologists only 62.41% for glioblastomas, 36.04% for AA, and 57.14% for low-grade astrocytomas.

(Mittler MA, et al., J Neurosurg. 1996 Dec;85(6):1091-4. Observer reliability in histological grading of astrocytoma stereotactic biopsies.)

Breast Cancer – Different Treatment Recommendations 43% of the Time

Seventy-five women with a total of 77 breast lesions were examined. The reviewing panel disagreed with the treatment recommendations 43% of the time (32 cases). The disagreements included breast-conservation therapy instead of mastectomy (13 patients) and different treatment based on a “major change in diagnosis on pathology review. (3.9%).”

(Chang JH, et al., Cancer. 2001 Apr 1;91(7):1231-7. The impact of a multidisciplinary breast cancer center on recommendations for patient management: the University of Pennsylvania experience.)

Ovarian Cancer – 12.7% Did Not Have Ovarian Cancer

The medical records and pathology slides of 339 women diagnosed with ovarian cancer were reviewed. Forty-three women (12.7%) were discovered not to have ovarian cancer. (28 had other types of cancer and 15 had benign tumors.)

(McGowan L, Norris HJ. Surg Gynecol Obstet. 1991 Sep;173(3):211-5. The mistaken diagnosis of carcinoma of the ovary.)

Prostate Cancer – Wrong Pathology Would Have Led to Six Unnecessary Prostatectomies

A total of 535 men referred for radical prostatectomy were reviewed. Seven (1.3%) of the men were found to have a benign pathology. “Upon subsequent clinical work up, six of seven men were considered not to have adenocarcinoma, and their surgery was cancelled.”

(Epstein JI, et al., Am J Surg Pathol. 1996 Jul;20(7):851-7. Clinical and cost impact of second-opinion pathology. Review of prostate biopsies prior to radical prostatectomy.)

Soft Tissue Lesions – Benign Considered Malignant and Malignant Considered Benign

In this study 266 cases of soft tissue lesions were reviewed. A major discrepancy was found in 25% of cases. Of these discrepancies, 45% consisted of benign lesions diagnosed as sarcomas, and 23% were sarcomas diagnosed as benign tumors.

(Arbiser ZK, Folpe AL, Weiss SW. Am J Clin Pathol. 2001 Oct;116(4):473-6. Consultative (expert) second opinions in soft tissue pathology. Analysis of problem-prone diagnostic situations.)

Getting the pathology wrong is not limited to the U.S. Other countries have found similar problems. For example, in the United Kingdom, 413 cases of sarcoma were reviewed and the diagnosis was confirmed only 76% of the time. The study concluded that “second opinion is essential in cases of presumed sarcoma…to ensure that appropriate treatment is selected.”

(Harris M, Hartley AL, et al., Br J Cancer. 1991 Aug;64(2):315-20. Sarcomas in north west England: I.Histopathological peer review)

Do You Need a Second Opinion?

The vast majority of pathologists are excellent physicians and that the diagnoses they render are correct. However, a minority of cases benefit from a second opinion. The problem, of course, is accurately identifying which cases should get a second opinion. One factor to consider is how rare your cancer is. If it is rare, chances are that your pathologist has not seen many of your type. However, even if your cancer is more common, you might consider erring on the side of caution and requesting a second opinion.

Writing in the journal Cancer, Joseph D Kronz, M.D. and his colleagues at Johns Hopkins Department of Pathology stated, “Second opinion surgical pathology can result in major therapeutic and prognostic modifications for patients sent to large referral hospitals. Although the overall percentage of affected cases is not large, the consistent rate of discrepant diagnosis uncovered by second opinion surgical pathology may have an enormous human and financial impact. Accordingly, the authors recommend that review of the original histologic material should be undertaken prior to the institution of a major therapeutic endeavor.”

(Kronz JD, et al., Cancer 1999 Dec 1;86(11):2426-35. Mandatory second opinion surgical pathology at a large referral hospital)

Getting a Second Opinion

The microscopic glass slides, pathology reports, and possibly paraffin (wax) blocks taken from your blood, aspirate, or tumor are archived in the pathology department of the hospital where your surgery or biopsy took place. As the patient, you can request that this material be released for the purpose of obtaining a second opinion from another pathologist. You can do this even if you have already started treatment. (Be sure to find out if there is a charge for this, how much, and whether your insurance will pay.) Large academic medical centers where doctors are trained often have the most experienced pathologists. When requesting a second opinion, ask that it be sent to a prominent medical center that sees many patients like you. Also request that the pathologist who actually does the review has special experience with your type of cancer. For example, for brain cancer you would want a neuro-pathologist to perform the review. Your surgeon or oncologist should help facilitate such a second opinion.

July, 2005|Archive|