Monthly Archives: February 2007

Re-Irradiation Combined With Chemotherapy After Salvage Surgery for Head and Neck Cancer Improves Progression-Free Survival Rates, Not Overall Survival Rates

  • 2/28/2007
  • Barcelona, Spain
  • Bruce Sylvester
  • Doctor’s Guide (www.docguide.com)

Re-irradiation combined with chemotherapy after salvage surgery improves progression-free survival rates in patients with head and neck cancer but does not affect their overall survival rate, researchers report.

“In this first randomised trial on the subject, we found that this combination treatment can indeed improve disease-free survival after salvage surgery, but we note that there was no effect on overall survival,” said investigator and presenter Dominique de Raucourt, MD, radiologist, Centre Francois Baclesse, Caen, France.

Dr. de Raucourt presented the results in an oral session here on February 24th at the International Meeting on Innovative Approaches in Head and Neck Oncology. The meeting was co-sponsored by the European Head and Neck Society (EHNS) and the European Society for Therapeutic Radiology and Oncology (ESTRO).

The investigators enrolled 130 head and neck cancer patients who had been treated with salvage surgery. Patients were randomised to receive either full dose re-irradiation combined with chemotherapy (arm A) or no postoperative treatment after the salvage surgery (arm B).

Eligibility for enrolment included the following criteria: recurrence of disease or appearance of second primary cancer site in a previously irradiated area (up to at least 45 Gy); absence of distant metastasis; salvage surgery with macroscopic complete resection; possibility of starting adjuvant treatment within 6 weeks after salvage surgery.

Subjects in arm A received 60 Gy radiation within 12 weeks combined with concomitant 5-fluorouracil (5FU) and hydroxyurea.

After the end of the trial the 29 surviving subjects who did not have carcinological events completed European Organisation for Research and Treatment of Cancer quality of life questionnaires (QLQ-C30 and QLQ H&N35).

Sixty-five subjects were randomised to each arm of the trial, including 71% having local and/or regional relapse and 29% having a second primary site of disease. Age, sex, tumour site, tumour depth of invasion (T) and staging of regional lymph nodes (N) restaging and histological gravity signs were all balanced between the 2 arms.

The investigators found that the most important acute toxicity related to re-irradiation was mucositis grade 3 or 4 in 29% of subjects. They also reported a grade 3 or 4 Radiation Therapy Oncology Group late toxicity (trismus, mucosa, fibrosis) in 40% of arm A subjects and in 10% of arm B subjects.

In addition, progression-free survival was significantly improved in arm A with a hazard ratio of 1.6 (P =.01), “but overall survival was not statistically different,” they noted.

For the 20 subjects who finished the questionnaires, global health was similar in both arms of the trial.

The authors concluded, “This is the first randomised trial to evaluate the effect of full dose re-irradiation combined with chemotherapy after salvage surgery. The results showed that re-irradiation and chemotherapy were able to significantly improve progression-free survival, with no significant impact on overall survival and acceptable quality of life among surviving patients.”

Source:
Presentation title: Randomised Trial of Re-Irradiation Combined With Chemotherapy After Salvage Surgery in Head and Neck Carcinoma: Carcinologic And Quality of Life Results GETTEC and GORTEC Groups. Abstract 55

February, 2007|Archive|

Auriga Laboratories Launches Aquoral(TM) for Xerostomia or ”Dry Mouth”

  • 2/28/2007
  • New Rochelle, NY
  • press release
  • Genetic Engineering News (www.genengnews.com)

Auriga Laboratories, Inc., a specialty pharmaceutical company with products for the treatment of acute respiratory diseases and dermatological conditions, announces the launch of Aquoral(TM) for the treatment of xerostomia, also known as “dry mouth.” This new, patent-pending, prescription-only product introduction marks Auriga’s entrance into the $1 billion xerostomia marketplace.

Beginning in March, Aquoral will be rolled out to high-prescribing physicians nationwide via Auriga’s expanding 200-member national sales force. Auriga will also launch www.aquoral.com as part of a direct-to-patient campaign.

“Millions of people suffer from dry mouth caused by prescription medications or medical conditions,” said Alan Roberts, Auriga’s senior vice president of scientific affairs. “Left untreated, dry mouth can have significant consequences including increased tooth decay, mouth ulcerations and infections, painful and difficult speech and swallowing. Aquoral offers a novel, non-systemic approach to treating this widespread condition. It is a lipid-based solution that moistens and lubricates the oral cavity, but unlike water-based, saliva substitutes, forms a lipidic film that helps reduce additional moisture loss and protects against further inflammation.”

A recent poll conducted by the Academy of General Dentistry (AGD) revealed that more than 80 percent of dental patients complain about dry mouth and dry mouth symptoms(1). Dry mouth is listed as a side effect for over 400 prescription drugs, including popular antidepressants, anti-anxiety medications, and treatments for overactive bladder. There are an estimated 300 million prescriptions written annually for these dry mouth causing medications. In some instances the dry mouth side effect is severe enough that a patient will discontinue the prescribed medication in order to eliminate the discomfort of the dry mouth.

Patients suffering from dry mouth caused by a medical condition, like diabetes or Sjogren’s syndrome, are likely to be taking multiple medications and would also benefit from Aquoral’s long-lasting relief for dry mouth. In clinical trials and patient experience to date, Aquoral’s non-systemic treatment has yielded very few minor adverse events. Aquoral has no known drug interactions. The product is contraindicated for any patient with a known history of hypersensitivity to any of its ingredients.

(1) “AGD Launches Dry Mouth Awareness Effort. Some medication warning labels are tough to swallow.” www.agd.org. 11/6/2006

February, 2007|Archive|

Sentinel Node Biopsy Is Accurate for Assessing Neck Status in Patients With Oral Cavity Tumours

  • 2/28/2007
  • Barcelona, Spain
  • Bruce Sylvester
  • Doctor’s Guide (www.docguide.com)

Sentinel node biopsy (SNB) is an accurate method of assessing the neck status of patients with squamous cell cancer grade T1T2 NO (early stage tumours) of the oral cavity, researchers report.

The findings were presented in an oral session here on February 24th at the International Meeting on Innovative Approaches in Head and Neck Oncology, sponsored by the European Head and Neck Society (EHNS) and the European Society for Therapeutic Radiology and Oncology (ESTRO).

“We saw a remarkable lack of false negatives in our use of sentinel node biopsy for assessing the patients. It is a viable procedure,” said lead investigator and presenter Gerard Mamelle, MD, clinical oncologist, Institut Gustave Roussy, Villejuif, France.

In the first part of their study, the investigators included 55 subjects; 53 of the subjects underwent SNB and an elective neck dissection (END) during the same surgery.

The investigators compared results of pathological examinations with stepped serial sectioning and immunohistochemistry of sentinel nodes to results of routine pathologal examinations of remaining END nodes.

They found positive sentinel nodes in 12 subjects, and no false positives among them. For up to 3 years after the tests, there was no node recurrence for any patient with negative sentinel node findings.

In a second part of their study, 48 new subjects underwent SNB without END. Sentinel node was not found in 4 subjects. Eleven of the remaining 44 subjects (25%) had a positive sentinel node. And follow-up showed node recurrence in 2 subjects with negative sentinel nodes; a pathological reexamination revealed a micrometastasis in sentinel node of 1 of these subjects.

For the 103 subjects from both parts of the study, SNB failure rate was less than 2%.

The authors concluded that, “SNB is a viable procedure. Failure rate is less than in traditional END.”

Source:
Presentation title: Results of Prospective Study of Sentinel Node Biopsy in Oral Cavity Tumours. Abstract 45

February, 2007|Archive|

Clinical Evidence and Advanced Technology Supporting Hyperthermia Therapy Emphasized at Annual ACRO Conference

  • 2/26/2007
  • Salt Lake City, UT
  • press release
  • PRNewswire (www.prnewswire.com)

BSD Medical Corp. today reviewed the presentations made at the annual conference of the American College of Radiation Oncology (ACRO) held February 22-24 in San Diego. The emphasis was on the clinical science behind hyperthermia therapy for treating cancer and BSD Medical’s advanced systems used to deliver the therapy. In addition to a 45-minute lecture by Dr. Mark Hurwitz of Harvard Medical School on the results of clinical studies on hyperthermia and the technological capabilities now emerging to deliver the cancer therapy, a commercial exhibit by BSD Medical also showcased the science supporting the therapy and the advanced features of the BSD’s cancer therapy systems.

The Science
The lecture included a review of Phase III clinical studies that have been conducted adding hyperthermia to radiation treatments as compared to radiation treatments alone.

* In a clinical study conducted in Italy involving 41 patients (44 nodes) with inoperable Stage IV head and neck cancer, patients receiving hyperthermia and radiation therapy had an 83% complete response rate compared to 41% for patients who received radiation therapy alone, and the 3-year local relapse-free survival rate was 24% for patients receiving only radiation and 68% for those who received both radiation and hyperthermia therapy. (See International Journal of Radiation Oncology, Biology, Physics Vol. 28, pp. 163-169.)

* In an international clinical study conducted in Denmark, the Netherlands and Norway involving 128 patients with recurrent or metastatic malignant melanoma, patients who received hyperthermia therapy along with radiation had a complete response rate for recurrent malignant melanoma lesions of 62% compared to 35% for those who received radiation treatments alone, and the local relapse-free survival rate at 5 years was 46% for those who received both hyperthermia and radiation and 28% for those who received radiation alone. (See International Journal of Hyperthermia, Vol., 12, No. 1, 3-20.)

* In a clinical study conducted at UCSF involving 112 patients with glioblastoma maltiforme (brain cancer), patients who received both hyperthermia and interstitial radiation therapy (brachytherapy) had a more than double 2-year survival rate as compared to patients who received brachytherapy alone. (See International Journal of Radiation Oncology, Biology, Physics, Vol. 40, No. 2, pp. 287-295.)

* In a clinical study conducted in the Netherlands involving 358 patients with locally advanced pelvic tumors, bladder cancer patients who received radiation alone had a complete response rate of 51% compared to 73% for those who received hyperthermia and radiation. The complete response rate for patients with advanced cervical cancer was 83% for those who received radiation plus hyperthermia and 57% for those who received radiation alone. (See The Lancet, Vol. 355, pp. 1119-1125.) In addition, a clinical study of 61 patients at Duke University using the tri-modality treatments hyperthermia, radiation and chemotherapy together for the treatment of advanced cervical cancer resulted in a complete remission in 90%. (See CANCER, August 14, 2005, Vol. 104, No. 4.)

* In a clinical study conducted in the United Kingdom, the Netherlands and Canada involving 306 patients with superficial localized breast cancer, patients who received both hyperthermia and radiation therapy had a complete response rate of 59% compared to 41% for those who received radiation treatments alone. Local relapse-free survival was 50% for those who received both therapies and 30% for those who received radiation alone. (See International Journal of Radiation Oncology, Biology, Physics, Vol. 35, No. 4, pp. 731-744.) In addition, a clinical study conducted at Duke University involving patients with previously irradiated superficial tumors, 23.5% had a complete response when treated with radiation alone compared to a response rate of 68.2% for patients treated with hyperthermia plus radiation. (See Journal of Clinical Oncology, Vol. 23, No. 13, May 1, 2005.)

The Technology
Dr. Hurwitz reviewed the advanced technology that has emerged for delivering hyperthermia therapy in treating cancer. He showed the technology for treating superficial cancers near the surface of the body and for treating cancers in combination with interstitial radiation, both therapies provided by the BSD-500 hyperthermia system. He explained the technology for treating tumors deep in the body, as provided by the BSD-2000, including the ability to monitor hyperthermia therapies in progress using advanced MRI images with color gradations that correspond to temperature changes observed during treatments, as provided by the BSD-2000/3D/MR. Dr. Hurwitz also noted growing support for these technologies as illustrated by the recent listing of hyperthermia therapy in the new NCCN guidelines.

About BSD Medical Corp.
BSD Medical Corp. is a leading developer of systems used to deliver precision-focused thermal treatments for cancer. Hyperthermia therapy is used to kill cancer directly and increase the effectiveness of companion radiation treatments. Research has also shown promising results from the use of hyperthermia therapy in combination with chemotherapy, and for tumor reduction prior to surgery.

February, 2007|Archive|

High-tech cancer fighter

  • 2/26/2007
  • Staten Island, NY
  • Diane O’Donnell
  • Staten Island Advance (www.silive.com)

TomoTherapy combines daily CT scans to check for any changes in size or location of a tumor with the ability to target it with high doses of radiation while decreasing damage to the surrounding healthy tissues and organs

Paul Lewek takes off his Mets baseball cap and settles his lanky 6-foot-5 frame onto a movable table connected to a large donut-shaped machine.

For the 57-year-old retired cop, this is day 11 of his 6 1/2 week Monday to Friday regimen of TomoTherapy, a relatively new approach to treating cancerous tumors. After having his right tonsil and a golf ball-size mass removed from his neck in December to battle advanced tonsillar cancer, Lewek shruggingly accepts the routine.

Lewek is the first head-and-neck cancer patient to be treated with the more than $3 million, state-of-the-art machine at TomoTherapy of Staten Island, housed in West Brighton-based Regional Radiology.

The TomoTherapy Hi-Art System machine, which debuted on the Island last month, is one of only two in the New York City area and 71 nationwide. According to Patty Kitowski, marketing communications manager of Madison, Wis.-based TomoTherapy Incorporated, which created the machine, there are 102 units worldwide.

TomoTherapy combines daily CT scans to check for any changes in size or location of a tumor with the ability to accurately target it with high doses of radiation while sparing healthy surrounding tissue to a greater degree than was previously possible. The process is achieved through Image Guided Radiation Therapy (IGRT).

“We’re able to acquire images on a daily basis and guide the patient’s radiation based on the images, which is the most accurate way to give radiation,” says Dr. Hoon Lee, a radiation oncologist at TomoTherapy of Staten Island. With conventional radiation, treatment design and delivery is based solely on one CT scan.

PREPARING FOR THE SCAN

After lying on the table, Lewek’s head and neck are placed on top of a custom-fitted plastic mold. A white plastic mesh mask is placed over his face and fastened to the mold to keep his head from moving.

Next, the Dongan Hills resident anchors his index fingers into harnesses attached to a foot platform to steady his shoulders.

The table glides Lewek inside the machine’s spherical opening, where a CT scan of the tumor is taken.

Moments later, the latest image is superimposed onto the original one used to plan the treatment weeks earlier.

“Everyday you can fine-tune the target of radiation based on that day’s anatomy,” says Dr. Lee as he compares the two scans on a computer outside the treatment room.

Today’s yellow scan is off by 3 millimeters compared to the initial white one. The difference has been as great as 5 millimeters, but usually averages between 2 to 3 millimeters a day.

The minuscule discrepancies may seem irrelevant, says Dr. Lee, but critical structures, such as the eyes, optic nerves, brainstem, spinal cord and salivary glands are all in close proximity to the tumor.

TREATMENT TIME

After radiation therapists Rob Colavito and Dennis Damico reposition Lewek on the table, the patient is ready. Both therapists leave the room, which is enclosed by 6-foot-thick reinforced concrete walls to protect other patients and staff from radiation.

During the treatment, the radiation therapists watch Lewek through two closed-circuit television monitors.

Inside the machine’s donut-shaped portal, a rotating ring delivers pencil-thin beams of high dose radiation to Lewek in a 360 degree angle. Using a more advanced form of Intensity Modulated Radiation Therapy (IMRT), the beams are adjusted in size, shape and intensity to conform to Lewek’s tumor.

TomoTherapy’s ability to zap tumors differs from conventional radiation, which typically attacks tumors from one to four directions, explains Dr. Lee, or the four to seven fields usually afforded by standard IMRT.

“You pretty much have 360 fields focusing in on that one area,” says Dr. Lee. “So you’re able to get a very tight radiation just to the area you want to give it and a very low dose elsewhere.”

LESS SIDE EFFECTS

TomoTherapy also cuts down on Lewek’s treatment time — seven minutes compared to 45 for IMRT — and side effects, says Dr. Lee.

Since the radiation can be narrowly focused to Lewek’s tumor, there is less damage to areas around it, such as the parotid (salivary) glands, and less of a chance of xerostomia (dry mouth) — a common side effect for head-and-neck cancer radiation patients.

For Lewek, the only drawback to TomoTherapy, which is supplemented by chemo at Richmond University Medical Center, is the daily commitment.

“It’s a little bit of pain in the butt to come five days a week,” says Lewek, “but outside of that no problem, no pain, no puss, no muss.”

According to Dr. Lee, TomoTherapy is ideal for deep-seeded cancers, such as prostate, lung, central nervous system — which includes the brain and the spine, gastrointestinal tumors and head and neck tumors.

Currently, the West Brighton facility is treating 20 TomoTherapy patients a day, and expects to increase to 30 by next month, says Dr. Lee. The machine can be used on both children and adults.

Another benefit of the new radiation treatment is the possibility of retreating an area should cancerous cells return.

Many radiation oncologists are reluctant to give repeat radiation to the same part of the body that has already received radiation for fear of complications, such as excessive scarring or permanent nerve damage.

“With TomoTherapy we are finding that for certain patients we may be able to give a second course of radiation,” says Dr. Lee.

“We are able to do this because vital organs, such as the spinal cord, can be completely avoided using TomoTherapy.”

February, 2007|Archive|

Oral tongue cancer in young patients: A matched analysis

  • 2/26/2007
  • Monza, Italy
  • Werner Garavello et al.
  • Oral Oncol, February 15, 2007

Previous studies on squamous cell carcinoma of the tongue have reported conflicting results with respect to age and prognosis. The aim of this study is to elucidate if any differences in outcome exist between patients younger and older than 40 years.

A case-control study was performed. Patients recorded in the head and neck cancer registry of Milano-Bicocca School of Medicine between January 1981 and December 1998 were reviewed. Cases were patients with squamous cell carcinoma of the tongue aged 40 years or less. Controls were patients older than 40 who were matched to cases for diagnosis, sex and TNM classification.

Two controls were matched for each case, thus forty-six cases and 92 controls were selected. The frequency of recurrences was found to be significantly higher in younger patients. The survival analysis further supports this conclusion (log-rank test, p=0.002). The number of cancer-related deaths in patients younger and older than 40 years were 23 (50%) and 31 (34%), respectively (p=0.10). A statistical significant difference emerged when the number of deaths was compared using survival curves (log-rank test, p=0.05).

In conclusion, in patients with squamous cell carcinoma of the tongue, young age is an independent predictor of worse survival.

Authors:
Werner Garavello, Roberto Spreafico, and Renato Maria Gaini

Authors’ affiliation:
Department of Otorhinolaryngology, Head and Neck Surgery, University of Milano-Bicocca, DNTB, Ospedale San Gerardo, 20052 Monza (MI), Italy.

February, 2007|Archive|

Since 1995, nicotine increased by 11% in cigarettes

  • 2/26/2007
  • Boston, MA
  • staff
  • Medical Matrix (www.hemonctoday.com)

An analysis of nicotine yield from major brand-name cigarettes sold in Massachusetts between 1997 and 2005 has confirmed that manufacturers have steadily increased the levels of this agent in cigarettes.

The analysis, based on data submitted to the Massachusetts Department of Public Health by the manufacturers, found that increases in smoke nicotine yield per cigarette average 1.6% each year, or about 11% through a seven-year period.

A research team from the Tobacco Control Research Program at the Harvard School of Public Health performed the data analysis.

“Cigarettes are finely-tuned drug delivery devices, designed to perpetuate a tobacco pandemic,” Howard Koh, MD, associate dean for public health practice at the Harvard School of Public Health said in a press release. “Yet precise information about these products remains shrouded in secrecy, hidden from the public. Policy actions today requiring the tobacco industry to disclose critical information about nicotine and product design could protect the next generation from the tragedy of addiction.”

In addition to the increase in yield, the researchers concluded that manufacturers accomplished the increase not only by intensifying the concentration of nicotine in the tobacco but also by modifying several design features of cigarettes to increase the number of puffs per cigarette. The end result is a product that is potentially more addictive.

The researchers also examined all market categories and found that smoke nicotine yields were increased in the cigarettes of each of the four major manufacturers and across all the major cigarette market categories.

Increased regulation
Gregory Connolly, MD, professor of the practice of public health at the Harvard School of Public Health said the discovery of an 11% increase in nicotine content confirms recent statements by the U.S. District Court for the District of Columbia that manufacturers have the ability to manipulate addictive additives, and, he said, “it underscores the need for continued surveillance of nicotine delivery in products created by an unregulated industry.

“Our findings call into serious question whether the tobacco industry has changed at all in its pursuit of addicting smokers since signing the Master Settlement Agreement of 1998 with the State Attorneys General,” Connolly said in a written statement.

Connolly said scrutiny by the attorneys general is imperative. Senator Ted Kennedy of Massachusetts introduced legislation that would bring the tobacco industry under the rules that regulate other manufacturers of drugs.

Beginning in 1997, Massachusetts’s regulations have required that an annual report be filed with the Massachusetts Department of Public Health by all manufacturers of cigarettes sold in Massachusetts. The reported data include machine-based measures of nicotine yield as well as measures of cigarette design related to nicotine delivery.

The researchers suggest that the Massachusetts Department of Public Health amend its unique reporting requirements to include more information about cigarette and smokeless tobacco product design features that affect nicotine delivery, as well as testing of a sample of brands for the actual delivery of nicotine to the body.

February, 2007|Archive|

Efficacy of the ViziLite System in the Identification of Oral Lesions

  • 2/26/2007
  • Chapel Hill, NC
  • ES Oh and DM Laskin
  • J Oral Maxillofac Surg, March 1, 2007; 65(3): 424-6

Purpose:
Early detection of oral cancer is crucial in improving survival rate. To improve early detection, the use of a dilute acetic acid rinse and observation under a chemiluminescent light (ViziLite; Zila Pharmaceuticals, Phoenix, AZ) has been recommended. However, to date, the contributions of the individual components of the system have not been studied. The present study was done to investigate the efficacy of the individual components of the ViziLite system in providing improved visualization of early oral mucosal lesions.

Patients and Methods:
A total of 100 patients, 39 males and 61 females, age 18 to 93 years (mean age, 44 years), who presented to the Virginia Commonwealth University School of Dentistry for dental screening were examined. There were 58 Caucasians, 29 African-Americans, 5 Hispanics, 6 Asians, and 2 of mixed ethnicity. Thirty-five patients smoked, 53 used alcohol, and 25 both smoked and drank. After written consent, the oral cavity was examined under incandescent light for soft tissue abnormalities. After 1-minute rinse with 1% acetic acid, the mouth was re-examined for additional mucosal abnormalities. Then, the mouth was examined once again using the ViziLite system’s chemiluminescent light. Any lesions detected by these 3 examinations that were clinically undiagnosable were brush biopsied (Oral CDx) for determination of cellular representation.

Results:
In the original examination of the 100 patients, 57 clinically diagnosable benign lesions (eg, linea alba, leukoedema) and 29 clinically undiagnosable lesions were detected. After the rinse, 6 additional diagnosable lesions (linea alba) and 3 undiagnosable lesions were found. No additional lesions were detected with the chemiluminescent light. Of the 32 undiagnosable lesions that were brush biopsied, 2 were positive for atypical cellular characterization and warranted further investigation with a scalpel biopsy. Neither of these lesions was found to be premalignant or malignant.

Conclusion:
Although the acid rinse accentuated some lesions, the overall detection rate was not significantly improved. The chemiluminescent light produced reflections that made visualization more difficult and thus was not beneficial.

Authors’ affiliation:
Resident in Oral and Maxillofacial Surgery, School of Dentistry, University of North Carolina, Chapel Hill, NC

February, 2007|Archive|

GSK Initiates First Global Phase III Study of TYKERB(R) (lapatinib) in Head and Neck Cancer

  • 2/26/2007
  • Barcelona, Spain
  • press release
  • PRNewswire (www.prnewswire.com)

GlaxoSmithKline (GSK) today announced the start of an international Phase III trial of its investigational cancer treatment TYKERB(lapatinib) in squamous cell carcinoma of the head and neck (SCCHN). This announcement coincided with the International Meeting on Innovative Approaches in Head & Neck Oncology, Barcelona, Spain, February 22-24 supported by the European Society for Therapeutic Radiology and Oncology (ESTRO), where GSK presented results from a Phase I study of lapatinib in SCCHN. Lapatinib is an investigational
drug that is not yet approved for marketing by any regulatory body.

This large adjuvant trial will compare the effectiveness of oral lapatinib versus placebo given in high-risk patients following surgery.

SCCHN is the sixth most common cancer worldwide (1): 600,000 people are diagnosed with SCCHN annually (1), 40,000 in the United States (2) and 100,800 in Europe alone.(3) 40,000 people die from the disease every year.(3)

The design of this Phase III trial was based on recent results from two large-scale, independent randomized studies which have established the addition of chemotherapy to radiation therapy as the new standard of care in the post-operative treatment of high-risk SCCHN patients with additional use of chemotherapy.(4, 5) However, research suggests that approximately one quarter to one third of advanced head and neck cancers that are primarily treated with surgery and radiation therapy come back following treatment.(4, 5)

“The initiation of this trial represents another exciting step towards understanding the role of lapatinib in other tumor types beyond breast cancer,” says Professor Jean Bourhis, Head of Radiation-Oncology Department, Institute Gustave Roussy, France and principal investigator for this trial. “There is a significant group of patients who are at high-risk of disease recurrence following surgery, and they need new treatments that can be combined with standard chemoradiation therapy.”

This global, Phase III study will enroll 680 high-risk patients with locally advanced head and neck cancer (stages II, III and IVa) that have undergone surgery. Patients will receive, within four to seven weeks after surgery, either lapatinib (1500 mg) or placebo tablets once-daily with radiotherapy and cisplatin for seven weeks. After this time, patients will continue with either lapatinib or placebo treatment for one year. The principal objective will be to investigate the length of time without disease symptoms, and overall survival with other clinical factors will also be measured. Side effects will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Results from a Phase I dose-escalation study of lapatinib (doses ranged from 500 mg to 1500 mg) plus chemoradiation in 31 head and neck cancer patients were also presented at the conference. Results identified 1500 mg of lapatinib taken once-daily with chemotherapy and radiotherapy as the optimal dose for this combination, and this dose was selected for the Phase III study. Additionally, 89% of patients had a tumor response to this combination treatment. The most common side effects in the Phase I study were mouth ulcers (87%), radiation skin injury (65%), nausea (61%), swallowing difficulties (52%) and vomiting (52%).(6)

“Having already shown promise as a breast cancer treatment, we are very excited to continue investigating lapatinib in SCCHN,” said Paolo Paoletti, MD, Senior Vice President, Oncology Medicine Development Centre, GSK. “We recognize the importance of developing a new treatment approach to difficult- to-treat tumor types, such as head and neck cancer, which may offer hope to patients in need of a further treatment option.”

Lapatinib blocks the activation of two key receptors, EGFR (ErbB1) and HER2 (ErbB2), associated with increased growth and development of this type of head and neck tumor. Stimulation of these receptors is associated with multiple processes involved in tumor growth. An excessive presence of these receptors has been reported in a variety of human tumors and is associated with poor outcome and reduced survival.

About SCCHN:
SCCHN is the most common form of cancer of the head and neck, and approximately two-thirds of all patients are diagnosed with advanced disease. EGFR and HER2 are two types of receptors found on tumors which play a key role in the development of this type of head and neck cancer. Researchers have found that the excessive expression of EGFR receptors is nearly universal in SCCHN disease, with large numbers of HER2 receptors present in 20 to 40 percent of tumors.(7, 8)

About Lapatinib:
Lapatinib was discovered and developed by GSK as an oral once daily therapy, and is currently being investigated in breast cancer and other solid tumors. Phase III results of lapatinib plus capecitabine show superior efficacy to capecitabine alone in women with HER2 positive advanced breast cancer who have progressed following prior therapy, including trastuzumab.(9)

The most frequent side effects related to lapatinib from clinical trials to date are mild to moderate (grade 1 or 2) diarrhea, nausea, vomiting, fatigue and rash.(10)

GSK is using advanced technologies, including pharmacogenomics, to better define patient populations that may respond to lapatinib.

Lapatinib, in combination with capecitabine, has been submitted for marketing approval in the United States, European Union and Switzerland for the treatment of advanced or metastatic HER2 positive breast cancer in women who have progressed despite prior therapy, including trastuzumab. Registration dossiers have also been filed in Australia, Canada and New Zealand.

GSK in Oncology:
GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK’s “bench to bedside” approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes partnerships with more than 160 cancer centres. GSK is developing a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.

About GlaxoSmithKline:
GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information, visit GlaxoSmithKline at http://www.gsk.com. For further information on the trial please visit http://www.clinicaltrials.gov.

REFERENCES
(1) Study EGF102988 protocol.
(2) Wang J, Xi L, Hunt J, et al. American Association for Cancer Research. “Expression Pattern of Chemokine Receptor 6 (CCR6) and CCR7 in Squamous Cell Carcinoma of the Head and Neck Identifies a Novel Metastatic Phenotype,” citing Greenlee, R. T., Hill-Harmon, M. B., Murray, T., and Thun, M. Cancer statistics, 2001. CA Cancer J. Clin., 51: 15- -36, 2001.
(3) Mouth Cancer Foundation. Initiative of the Restorative Dentistry Oncology Clinic: http://www.rdoc.org.uk/ accessed 3rd Jan 2007.
(4) Bernier J, Domenge C et al. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. NEJM; 2004 May 6;350(19):1945-52.
(5) Cooper J, Pajak TF et al. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. NEJM; 2004 May 6;350(19):1937-44.
(6) El-Hariry, I., Harrington K. et al. A phase I, open label study (EGF100262) of lapatinib plus chemoradiation in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Oral st presentation, 1 International Meeting on Innovative Approaches in nd th Head & Neck Oncology, Barcelona, Spain. 22 – 24 February 2007.
(7) Khademi B, Shirazi FM, Vasei M, et al. The expression of p53, cerbB-1 and cerbB-2 molecules and their correlation with prognostic markers in patients with head and neck tumors. Cancer Letters 2002;184:223-230.
(8) O-Charoenrat P, Modjtahedi H, Rhys-Evans P et al. Epidermal Growth Factor-like Ligands Differentially Up-Regulate Matrix Metalloproteinase 9 in Head and Neck Squamous Carcinoma Cells. Cancer Research, 2000; 60:1121-1128.
(9) Geyer C, Forster J, Lindquist D, Chan S, Romieu C et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006; 355;2733-43. (10) GSK data on file. Ongoing studies to 15 November 2005.

February, 2007|Archive|

More Teens Are Saying, ‘Have a Cigar’

  • 2/26/2007
  • Atlanta, GA
  • staff
  • Atlanta Journal-Constitution (ajc.com)

Slowly but surely, American kids have gotten the message that cigarette smoking is stinky, smelly and a hazard to your health.

Now, if only they would believe the same about cigars.

While cigarette consumption declined in the United States by 10 percent from 2000 to 2004, cigar consumption jumped 28 percent, according to a recent report published in the American Journal of Public Health.

Other studies have found that teens who smoke cigars are definitely behind some of that increase. For instance, a 2004 survey conducted in Cleveland found that 23 percent of the 4,409 teens polled preferred cigars, compared to 16 percent choosing cigarettes.

And the increase may not yet have peaked, said John Banzhaf, executive director of Action on Smoking and Health, a national legal action anti-smoking organization based in Washington, D.C.

“Many of the factors that began leading to the [cigar] increase are still present,” Banzhaf said. They include the perception that cigars look fashionable and the fact that high-profile politicians and others are seen smoking them regularly, he said.

“We have Arnold (Schwarzenegger, California’s governor), smoking cigars and occasionally, Bill Clinton,” he said. “More and more women are smoking cigars.”

But it’s not just politicians and women who are fueling the image that cigars are hip, said Scott Goold, director of Tobacco Freedom, an Albuquerque, N.M.-based group. “Our popular culture is filled with images of cigars,” he said.

Your neighbor passes them out, for instance, when the family has a new baby. And businessmen smoke them when they cinch a business deal, he noted.

For cash-strapped teens, finances may play a role in their tobacco of choice, Banzhaf said. “Many states raise cigarette taxes but not cigar [taxes],” he said.

There’s also the perception that cigars are just not as dangerous as cigarettes in terms of cancer risk, a perception Banzhaf and other experts said is incorrect.

While it’s difficult to compare cigarettes and cigars head-to-head in terms of health risk, Banzhaf said, it’s clear both are risky. Cigar smoking is strongly linked to a host of deadly cancers of the lip, tongue, mouth, throat, esophagus, larynx and lung. According to data from the U.S. National Institutes of Health, smoking just one or two cigars a day doubles the risk for oral and esophageal cancer and increases larynx cancer risk six-fold.

Risks rise even higher once users decide to inhale cigar smoke. Compared to nonsmokers, cigar smokers who inhale deeply face 27 times the risk of oral cancer and 53 times the risk of cancer of the larynx, according to the NIH report.

So, what works and what doesn’t if you’re a parent trying to convince your teen to avoid cigars and other tobacco?

Dwelling on the long-term risk of cancer — that they may come down with lung cancer at 40 — is not usually effective, Banzhaf said, because the typical teen thinks of the 40th birthday as an eternity away.

Teens also have a hard time personalizing risk. They tend to think they are immune to life’s dangers — that something bad could happen to the next person, but not them.

Parents should instead focus on the reasons kids light up to begin with. “Kids like to start smoking not so much for the taste but because it is a sign of growing up,” Banzhaf said. Peer pressure plays a role, too.

“If parents can start to convince kids that smoking makes you stinky and smelly, not sexy and sophisticated, that can have a great impact,” he said.

Goold tells parents to maintain an ongoing dialogue with their children, the same as they would when talking about not taking drugs. Spending time together as a family, such as eating dinner together, can help make that conversation flow more naturally, he said.

February, 2007|Archive|