Oral Cancer News

Source: http://www.newswise.com
Author: University of Texas M. D. Anderson Cancer Center

A team from The University of Texas MD Anderson Cancer Center is receiving a national award for a research article tackling a question vital to the future of health care with reform regulations looming, competition growing and costs rising.

The MD Anderson study took on the complex question of defining value in health care and for its paper that outlines one approach, the team has been awarded the 2012 Edgar C. Hayhow Article of the Year Award.

Presented by the American College of Healthcare Executives (ACHE), the winning paper appeared in the organization’s publication, the Journal of Healthcare Management, in the November/December 2010 issue. The Hayhow Award was created in 1959 as a tribute to the organization’s 14th chair and the first practicing administrator to earn a doctoral degree. The award will be presented in March at the ACHE’s annual Congress on Healthcare Leadership in Chicago.

“The medical community understands how fundamental the concept of value is to improve the quality and delivery of care because it impacts patients, hospitals, physicians, insurance providers and regulators,” said Thomas W. Feeley, M.D., professor and head of the Division of Anesthesiology and Critical Care and the corresponding author of the study. “We’ve been looking at this complex question for many years and our paper outlines an approach that has been successful at MD Anderson and one that, we believe, can be applied throughout our institution. While we don’t assert that this approach will work for everyone, we think it’s important information to advance the national conversation.”

The study details MD Anderson’s method of testing the value proposition first described in 2006 by Professor Michael Porter of the Harvard Business School and his collaborator, Elizabeth Teisberg, and defines and measures outcomes and costs in a set of three specific head and neck cancers. It was Porter who first described value in health care as the balance between patient outcomes and costs.

With the Head and Neck Center as its clinical “lab,” the research team studied more than 2,400 patients diagnosed with cancers of the larynx, throat and mouth, and gathered data and costs to define quality in that single setting. Researchers looked at patient survival, the time it took for patients to go through treatment and return to work, and quality of life issues such as swallowing and speaking. The team then analyzed the costs of care based on the diagnosis and stage of disease and found, not surprisingly, that the majority of costs were incurred during treatment.

The model used in the Head and Neck Center for establishing outcomes and defining quality is one that the MD Anderson team believes can be replicated in other clinical areas, though each center will have its own outcomes. For example, while swallowing and eating are important measures for patients with head and neck cancer, for breast cancer survivors, the leading outcomes may be the cosmetic result of treatment and hormonal health.

The study also points out that the true measure of the value proposition lies in a patient’s ability to access accurate and useful information about a provider’s outcomes, costs and experience. As a result, researchers urge providers to seek patient feedback and learn what information is most valuable when making health care decisions.

In addition, the study notes the need for electronic medical records to better integrate and pull key information and a time-driven, activity-based cost accounting system that will detail true costs of treatment for specific conditions and diagnoses.

The team honored for the outstanding article includes Feeley; Heidi Albright, project director in the Department of Clinical Operations; Ronald Walters, MD, MBA, associate vice president for Medical Operations and Informatics and professor in the Department of Breast Medical Oncology; and Thomas W. Burke, MD, executive vice president and physician in chief and professor in the Department of Gynecologic Oncology and Reproductive Medicine.

These four people also form the leadership core of MD Anderson’s Institute for Cancer Care Excellence, a collaborative group that focuses its study on cancer economics, patient safety and quality improvement, information technology, education and outreach development. The institute recently launched initiatives to explore ways to eliminate waste, reduce costs and quantify quality care.

About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention. MD Anderson is one of only 40 comprehensive cancer centers designated by the National Cancer Institute. For eight of the past 10 years, including 2011, MD Anderson has ranked No. 1 in cancer care in “America’s Best Hospitals,” a survey published annually in U.S. News & World Report.

Source: www.sacbee.com
Author: staff

Commonly used in many Eastern countries, tumeric has been found to suppress cancer growth and reduce brain tumors by an astounding 81% without evidence of toxicity. While the benefits of turmeric are just coming to light within the mainstream and alternative media, it has been known for quite some time that this inexpensive spice can profoundly improve biological function.

Curcumin, a natural phenol and derivative of turmeric, may be responsible for many of these effects — particularly the anti-cancer benefits. Used by ancient Chinese and Indian systems of medicine, curcumin has been shown to reduce brain tumor size by 81% in 9 out of 11 studies. With the research published in the July edition of the Journal of Nutritional Biochemistry, scientists found that curcumin dramatically decreased the size of brain tumors by 81% in 9 out of 11 studies without evidence of toxicity.

Additional research has found that turmeric and curcumin also inhibit the spread of cancer by actually blocking a key enzyme responsible for its growth. Given chewable curcumin supplements containing 1,000 milligrams of curcumin each, 21 study participants with head and neck cancer experienced a halt in cancer spread after intake. Conducted by the UCLA, the results were examined by an independent lab in Maryland which confirmed that curcumin supplements ultimately stopped the spread of malignant cancer cells.

Curcumin gives turmeric its unique color, and each 100 grams of turmeric contains 3 to 5 grams of the compound. Some health experts believe that turmeric will soon reach the popularity level of vitamin D, which is now almost universally recognized as a fantastic health-promoting substance.

“Turmeric and curcumin are both extremely cheap methods of boosting your health, and are readily available almost worldwide. The ubiquitous nature of turmeric both in the form of supplementation and spice sets up turmeric to be the next vitamin D over the next few years. As more medical professionals begin to recognize the benefits of turmeric and curcumin, a major media blitz will follow as it did regarding the multiple known effects of vitamin D,” said Mike Barrett, Co-Founder of alternative health organization Natural Society.

Both turmeric and curcumin can be purchased as a spice, or in the form of supplementation.

Source: www.oncologyreport.com
Author: Miriam E. Tucker

Adding chemotherapy to radiotherapy improved 10-year survival of resectable head and neck carcinomas among high-risk patients who had microscopically involved resection margins and/or extracapsular spread of disease – but not in high-risk patients who only had tumor in multiple lymph nodes.

The findings come from a long-term update and unplanned subset analysis of 410 evaluable patients from the RTOG (Radiation Therapy Oncology Group) 9501 phase III study, which previously showed no overall survival advantage from the addition of cisplatin chemotherapy to radiation.

The new data are “good news,” according to lead author Dr. Jay Cooper, director of Maimonides Cancer Center in Brooklyn, N.Y.

“We now can eradicate some advanced head and neck tumors that we couldn’t before by adding chemotherapy to radiation therapy. At the same time, we can spare other patients who would not do better with the addition of chemotherapy from its side effects,” he said at a head and neck cancer symposium sponsored by the American Society for Radiation Therapy.

The RTOG 9501 study randomized 459 patients with high-risk, resected head and neck cancers to receive either radiation therapy of 60 Gy in 6 weeks (RT), or identical radiotherapy plus cisplatin at 100 mg/m2 IV on days 1, 22, and 43 (RT+CT).

When reported at a median follow-up of 45.9 months, the locoregional control rate was significantly higher in the combined-therapy group than in the group given radiotherapy alone (hazard ratio for locoregional recurrence, 0.61); disease-free survival was significantly longer with combined therapy (HR for disease or death, 0.78), but overall survival was not (HR for death, 0.84). Moreover, four patients who received combination therapy died as a result of treatment (N. Engl. J. Med. 2004;350:1937-44).

In the current updated analysis conducted 10 years post treatment, none of the primary outcomes differed significantly between the two groups. The evaluable population comprised 208 patients who received RT and 202 given RT+CT. For patients treated by RT vs. RT+CT, the rates were, respectively, 28.8% vs. 22.3% (P = .10) for locoregional failure, 19.1% vs. 20.1% (P = .25) for disease-free survival, and 27.0% vs. 29.1% (P = .31) for overall survival.

In a subset analysis that had not been performed previously, however, statistically significant differences appeared within the 242 patients who had microscopically involved resection margins and/or extracapsular spread of disease. In this group, 115 patients received RT and 127 were given RT+CT. Locoregional failure occurred in 33.1% of the CT group vs. 21.0% of those treated with RT+CT (P = .02). The disease-free survival rate was 12.3% vs. 18.4% (P = .05), and the overall survival rate was 19.6% vs. 27.1% (P = .07), with both end points favoring RT+CT.

That left 168 patients who did not have involved margins or extracapsular extension and were included in the trial solely because they had multiple involved nodes. In this group, 93 received RT and 75 RT+CT, with no significant difference in long-term outcomes.

There was a trend in improved cause-specific survival with RT+CT for patients whose death resulted from head and neck cancer, but more deaths not due to the study cancer were observed in patients treated with concurrent cisplatin. This is a hypothesis-generating finding that needs to be investigated in future trials, Dr. Cooper noted.

In an interview, he explained that the rationale for looking specifically at the patients with microscopically involved resection margins and/or extracapsular spread came from a previous analysis of the raw data from the RTOG trial combined with those of a concurrently published study conducted by the EORTC (European Organisation for Research and Treatment of Cancer).

Although the design of the EORTC 22931 study was similar, the outcome was different. Of a total 167 patients who had been randomized to RT or RT+CT, the rate of progression-free survival at a median follow-up of 60 months was significantly higher in the combined-therapy group than in the group given radiotherapy alone (P = .04) (N. Engl. J. Med. 2004;350:1945-52).

When the data from RTOG and EORTC were combined, it became clear that the main reason for the difference in outcome was in the different entry criteria for the two trials, and that extracapsular extension (ECE) and/or microscopically involved surgical margins were the only risk factors for which the impact of adjuvant chemotherapy-enhanced radiation therapy was significant in both trials (Head Neck 2005;27:843-50).

“What we learned from that analysis is that the patients who got on one of the trials but wouldn’t have qualified for the other trial were not getting much benefit from the study regimen, whereas those who qualified for either study – due to having involved margins and/or extracapsular extension – did better with chemotherapy on all three measures.

“These results were highly significant. But more importantly, the data suggested a subgroup where the big bang for the buck was,” Dr. Cooper said in the interview.

The findings don’t mean that the patients who did not benefit are not “high risk,” Dr. Cooper said. “Would they benefit from other chemotherapy? We don’t know. Would they benefit from different drugs or different regimens? Maybe. But we can now fairly comfortably say that in both the short and long run, if patients are high risk only because of involved lymph nodes, don’t treat them with this combination, and spare them the toxicity.”

Dr. Cooper stated that he has no disclosures, as did nine coauthors. One additional coauthor is an employee of Lilly USA.

Source: MedicalNewsToday.com

According to an investigation published on bmj.com, cancer patients who have completed their primary cancer-related treatment, who engage in physical activity, can enhance their health.

Earlier studies discovered that individuals with cancer anticipate to return to normal daily activities after completing their primary cancer-related treatment. However, these patients often find they experience lower physical activity, increased fatigue and a decrease in quality of life (QOL). Although, several health factors including QOL can be enhanced through engaging in exercise, according to studies.

Investigators from the University of Hong Kong examined the results of 34 human trials that evaluated how exercise effects adult individuals with cancer. Each trial consisted of an average of 93 participants who had either suffered from prostate, breast, lung, colorectal, gynecologic or gastric cancer. The average age of the participants was 55 years.

The trials included resistance, strength and aerobic training for a median duration of 13 weeks.

Health improvements, such as BMI and body weight, blood sugar control, lower limb strength, fatigue, depression and QOL, were observed among participant’s who received breast cancer treatment who engaged in a period of physical activity.

Improvements, such as oxygen consumption, depression, BMI, body weight, handgrip strength and QOL, were also observed among patients who completed treatments for other types of cancer.

Furthermore, variations in intensity and type of physical activity influenced the physical health of cancer patients and played a vital role in the effects of the exercise. Individuals with breast cancer found that resistance and aerobic exercise was considerably more effective on emotional and physical fitness, as well as concerns regarding breast cancer and overall well-being, than aerobic activity alone.

In addition, the researchers found that the effect of exercise was greater on younger patients. However, this finding was not fully conclusive, as they were able to engage in physical activity for longer durations.

According to the researchers, additional trials are required, particularly on the intensity of activity needed and on individuals with cancer types other than breast cancer.

They conclude that:

“Quality of life was a clear significant benefit of physical activity and that clinically, there were important positive effects on physical functions and quality of life.”

Source: MedicalNewsToday.com

A two-year study of nearly 190,000 girls and women, finds that Gardasil, the human papillomavirus (HPV) vaccine made by Merck & Co, does not trigger autoimmune disorders such as lupus, rheumatoid arthritis, type 1 diabetes and multiple sclerosis. The results are published in the Journal of Internal Medicine.

Study lead author Dr Chun Chao, a research scientist at the Kaiser Permanente Department of Research & Evaluation in Pasadena, California, said in a statement released on Friday, that:

“This kind of safety information may help parents with vaccination decisions.”

“”These findings offer some assurance that among a large and generalizable female population, no safety signal for autoimmune conditions was found following HPV4 vaccination in routine clinical use,” said Chao.

Gardasil is a “quadrivalent” vaccine because it helps protect against 4 types of HPV. In girls and young women age 9 to 26, it targets 2 types that cause about 75% of cervical cancers, and 2 other types that cause 90% of cases of genital warts.

The vaccine, which is given as three injections over six months, also helps protect boys and men age 9 to 26 against 90% of cases of genital warts.

Genital warts is the most common sexually transmitted infection in the US, where it infects about 6.2 million people every year. It can also lead to cervical cancer in women.

Gardasil received US Food and Drug Administration (FDA) approval in 2006. But a longstanding concern about links with autoimmune disorders has surrounded the vaccine, and many parents won’t let their children be vaccinated because of this.

However, Chao and fellow co-investigators from Kaiser Permanente told the press “most speculated associations have stemmed from case reports that have not been confirmed by large, controlled epidemiologic studies”, and their investigation “presents findings from a well-designed, post-licensure safety study of the vaccine on a large, ethnically diverse population”.

For the study, Chao and colleagues used electronic health records of 189,629 girls and women age 9 to 26 years in California. The participants had been followed for six months after receiving each dose of the quadrivalent HPV vaccine in 2006-2008.

They found no increase in any of 16 autoimmune disorders in the vaccinated population compared to a matched population of non-vaccinated girls and women. The 16 autoimmune disorders they looked for were:

“… immune thrombocytopenia, autoimmune hemolytic anemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, type 1 diabetes, Hashimoto’s disease, Graves’ disease, multiple sclerosis, acute disseminated encephalomyelitis, other demyelinating diseases of the central nervous system, vaccine-associated demyelination, Guillain-Barré syndrome, neuromyelitis optica, optic neuritis and uveitis.”

The researchers explained that the clinical trial data on the vaccine, and the subsequent adverse event reports, have important limitations when it comes to assessing its safety profile.

This is because clinical trials are often based on a highly selected group of participants, the sample sizes are too small, and the follow up is too short, to catch rare safety events such as autoimmune disorders.

And the adverse event reports are not easy to interpret because there is no comparison group, and it is hard to tell if the condition developed before or after the vaccine.

So in their study, Chao and colleagues used methods like in-depth reviews of medical charts to ensure accuracy of diagnosis and that the disease occurred after vaccination. Plus, disease incidence in the vaccinated group was contrasted with incidence in a comparable unvaccinated group.

The results showed that:

• Overall, there were 1,014 new-onset cases of an autoimmune disorder, of which 719 were eligible for case review, and 31 (40%) were confirmed as new onset (ie emerged after vaccination).
•  Of these cases, “no cluster of disease onset in relation to vaccination timing, dose sequence or age was found for any autoimmune condition”.
•  None of the estimated incidence rate ratios was signficantly raised, except that for Hashimoto’s disease (IRR = 1.29, 95% confidence interval: 1.08-1.56).
• “Further investigation of temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for autoimmune thyroid conditions.”

The authors note that neither the investigators, nor an independent safety review committee, found any autoimmune safety concerns in the study.

The study appears to have been well received by experts not connected to the investigation.

Dr. Harry Fischer, chief of the division of rheumatology at Beth Israel Medical Center in New York City welcomed the findings and described the study as well-designed:

“This article speaks to the safety of the vaccine and helps to confirm that it does not contribute to the development of autoimmune diseases,” he said, in a report from USA Today.

Merck & Co funded the study.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Source: OncologyNurseAdvisor.com

The presence of “matted” lymph nodes in persons with oropharyngeal squamous cell carcinoma (SCC)—that is, nodes that are connected together—was associated with a 3-year survival rate of 69%, compared with 94% among patients without matted nodes. Such a marker could help clinicians identify patients who are at heightened risk for metastasis and who might benefit from additional systemic therapy. Conversely, a person without matted nodes could be a candidate for less therapy, which would in turn reduce uncomfortable side effects.

The study, led by Matthew E. Spector, MD, a resident in the department of otolaryngology – head and neck surgery at the University of Michigan Health System in Ann Arbor, focused on 78 previously untreated persons with stage III or IV oropharyngeal SCC. All patients were undergoing chemotherapy in combination with intensity-modulated radiation therapy (IMRT) as part of a clinical trial.

The 3-year disease-specific survival rate for the 16 patients presenting with matted nodes was 69%, compared with 94% among the 61 other patients. Matted nodes were found to be a poor prognostic factor independent of tumor classification, human papillomavirus (HPV) status, epidermal growth factor receptor (EGFR), and smoking status. Matted nodes did appear to be an especially strong indicator of increased risk among HPV-positive persons, despite the fact that these patients had better overall outcomes than did those who were HPV-negative. The best outcomes were seen among HPV-positive nonsmokers.

The investigators, who reported their findings in Head & Neck, say the reasons for the survival differences between persons with and without matted nodes are unclear.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Source: HealthCanal.com

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Source: University of Minnesota

It’s a researcher’s dream: a simple, noninvasive test to detect life-threatening cancer, heart disease, or other maladies while they’re still treatable.

A team of University of Minnesota researchers is in hot pursuit of that goal, using one of the simplest means imaginable: testing spit. They’ve discovered that conditions such as breast and oral cancer leak certain proteins into saliva, and if detected, such proteins can be “biomarkers” for the disease.

“This would be an easy way to monitor oral cancer,” says Timothy Griffin, an associate professor of biochemistry, molecular biology and biophysics. “Every year in the United States there are about 40,000 cases, more than cervical or ovarian cancer, melanoma, or lymphoma, and it has a higher mortality.”

Saliva contains at least 2,000 proteins, but the most abundant ones tend to be the least informative, he notes. But he and his colleagues have become the world experts on snagging rare proteins from spit and detecting both their presence and their abundance.

Promising discoveries

In a study of 10 women with metastatic breast cancer, the researchers sifted through their salivary proteins and found a handful that were already known to seep into the blood of women with this cancer. The proteins appeared only at very low levels in saliva of healthy controls.

“The next idea is, can you take this back through the earlier stages to detect nonmetastatic cancer?” says Griffin.

Biomarker proteins also appear in saliva of patients with oral cancer. Team members Frank Ondrey, an otolaryngology professor who collects tissue samples from volunteers, and oral cancer expert Nelson Rhodus of the Department of Diagnostic and Biological Sciences have been invaluable in figuring out the basic biology of this phenomenon.

Hearing the whispers

To detect proteins that occur at extremely low levels in spit, the team uses an ingenious technique called DRC (dynamic range compression). It involves running a solution of spit proteins over a bed containing thousands of different tiny molecules that act as baits. Each protein will latch onto its own particular bait. For rare proteins, most will find a bait to attach to. But for abundant proteins, only a small proportion will attach, and the excess can be washed off. Thus, the collection of proteins left on the bait bed will be enriched in rare proteins.

“The technique is like shouts and whispers,” says John Carlis. “When you get rid of the shouts, you can hear the whispers.”

The team found that two major structural proteins in cells—the proteins actin and myosin—were more abundant in the saliva of patients with malignant oral lesions than in those with pre-malignant ones. The proteins could come from epithelial cells of the cheek lining.

“Epithelial cells can degrade into mobile [connective tissue cells] and end up in saliva,” Rhodus says. It’s possible, adds Griffin, that actin and myosin, being normally central to the motions of cells, could confer some of the mobility that lands the connective tissue cells in saliva.

Rhodus devised a way to collect fluid straight from an oral lesion so that proteins unique to lesions can be identified. Any that subsequently turn up in spit could then be easily collected and analyzed as a way of monitoring activity in a lesion.

“About 35 percent of lesions turn to cancer,” says team member John Carlis, a professor of computer science and engineering who relishes the herculean task of analyzing the data. “We’re following protein profiles in the saliva of about 40 patients with [noncancerous lesions] that Nelson brings in.”

World leaders

The team has carved out a distinct niche in the world of proteomics—the large-scale study of proteins.

“We’re the world leader in doing in-depth proteomics as applied to saliva,” says Rhodus. “It would be great if we could eventually separate out lethal and nonlethal cancers, oral inflammation, and other conditions. Probably, there’s a specific protein signature for each condition that appears in saliva at a specific time during its development.”

All this is part of an effort to develop a clinical spit test. Now, the only way to catch oral cancer before it strikes is to keep biopsying a patient’s oral lining, sometimes every couple of months over several years. This is hardly pleasant, so it’s no wonder many people with benign-looking lesions forego the follow-up.

“We’re to the point of going from discovering biomarkers to validating them,” says Griffin. “Ultimately, the goal would be if somebody goes to Nelson’s clinic with a suspicious lesion, he can run a saliva sample through a machine and tell whether it’s trouble or not.”

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Source: MedpageToday.com

PHOENIX — Osteoradionecrosis of the jaw (ORNJ) occurred more than twice as often as reported in the literature, according to a population-based study of patients treated with radiation for oral cancer.

A review of national medical records showed that 16.1% of patients had jaw complications or interventions consistent with ORNJ compared with published rates of 5% to 7%.

However, when investigators applied the definition of ORNJ to patients who had interventions associated with jaw complications, the rate approximated the published rates, as reported here at the Multidisciplinary Head and Neck Cancer Symposium.

“The rates of all jaw complications in the SEER-Medicare database are higher than reported rates from prospective and retrospective institutional reports,” said Beth M. Beadle, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston. “If we limited the definition to interventions, the rates are similar to those of published reports.”

Radiation therapy has documented efficacy for locoregional control of head and neck cancer, but therapy confers a substantial risk of long-term complications, even with modern delivery techniques.

ORNJ is recognized as a potential risk of radiation therapy. Prospective and retrospective single-institution studies have suggested that 5% to 7% of patients with head and neck cancer develop ORNJ following treatment with radiation.

The frequency of ORNJ in the general population of patients with head and neck cancers has not been studied extensively. Moreover, the true impact of newer radiation techniques, such as intensity-modulated radiation therapy (IMRT), on the frequency of ORNJ has not been clearly established.

In an effort to clarify the current frequency of and risk factors for ORNJ, Beadle and colleagues reviewed data from the NCI Surveillance, Epidemiology, and End Results database, linked to Medicare claims records. They searched for patients with oral cancers treated with radiation therapy during 2000 to 2007.

Using the Medicare records, the investigators identified patients who developed ORNJ, as determined by diagnostic and intervention codes associated with jaw complications.

The review produced records for 1,848 patients. During a median follow up of 2.54 years, 297 patients (16.1%) developed jaw complications following treatment with radiation therapy. The median time from treatment to jaw complication was 387 days.

The total ORNJ group comprised 226 (12.2%) patients identified by diagnostic code only, 41 (2.2%) patients identified by intervention code only, and 30 (1.6%) patients whose records had codes associated with diagnoses and interventions.

Univariate analysis identified three factors associated with the risk of ORNJ:

• Female sex (HR 0.667)
• No chemotherapy (HR 1.452)
• Lower Charlson comorbidity index (HR 0.726)

Previous studies had suggested that use of IMRT was associated with a reduced incidence of ORNJ, but that was not borne out in the study by Beadle and colleagues. The rate was lower with IMRT, but the difference did not achieve statistical significance.

Patients treated with IMRT did have a different pattern of ORNJ development as compared with patients treated with other forms of radiation therapy. Treatment with IMRT was associated with a median time to jaw event of 462 days as compared with 386 days for patients treated with other radiation therapy modalities.

The symposium is sponsored by the American Head and Neck Society, the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO), and SNM.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Source: www.medscape.com
Author: Nancy A. Melville

A long-term follow-up of patients with head and neck squamous cell carcinoma suggests that only certain high-risk subgroups benefit from radiation plus chemotherapy. This information will spare patients who will not benefit from undergoing the additional treatment.

According to the study, presented here at the 2012 Multidisciplinary Head and Neck Cancer Symposium, patients with microscopically involved resection margins and/or extracapsular spread of disease had a lower risk for cancer recurrence with radiation plus chemotherapy 10 years later, whereas those with tumors in multiple lymph nodes did not benefit from combination treatment; they fared better with radiation alone.

“The clinical implication of these findings is that the high-risk group of patients is not as homogenous a group as we believed it was before the study started,” lead author Jay S. Cooper, MD, director of the Maimonides Cancer Center, in Brooklyn, New York, told Medscape Medical News.

Dr. Cooper and his colleagues analyzed 10 years of follow-up data from the Radiation Therapy Oncology Group (RTOG) 9501/Intergroup phase 3 trial, which examined 410 patients with high-risk resected head and neck cancers.

The patients were considered high risk for cancer recurrence because they had microscopically involved resection margins, extracapsular spread of disease, or multiple lymph node involvement.

“The allocation was equally divided [according to treatment regimen] at the beginning of the study; the groups were not intended to be balanced for the different [risk] factors,” Dr. Cooper said. “We thought they were all equally important.”

The treatment regimen was either postoperative radiation therapy (60 Gy in 6 weeks) or identical radiation therapy plus intravenous cisplatin 100 mg/m² on days 1, 22, and 43.

Whereas an earlier follow-up of surviving patients at 45.9 months showed improvements in local-regional control and disease-free survival in the radiation plus chemotherapy group in general, the different responses in risk-factor subgroups was not observed, Dr. Cooper said.

In the 10-year follow-up, however, the analysis showed trends in the subgroups.

The local-regional failure rate with radiation alone was 28.8% and with radiation plus chemotherapy was 22.3% (P = .10). Disease-free survival was 19.1% and 20.1% (P = .25) and overall survival was 27.0% and 29.1% (P = .31), respectively.

In the unplanned subgroups of patients with microscopically involved resection margins and/or extracapsular spread of disease, local-regional failure occurred in 33.1% of the group treated with radiation alone and in 21.0% of the group treated with radiation plus chemotherapy (P = .02).

Disease-free survival in the high-risk subgroups was 12.3% with radiation alone and 18.4% with radiation plus chemotherapy group (P = .05); overall survival was 19.6% and 27.1%, respectively (P = .07).

Patients with tumors in multiple lymph nodes received no benefit from postoperative radiation plus chemotherapy in the longer-term follow-up, compared with radiation alone.

Cause-specific survival rates showed a trend toward improved outcome in patients receiving radiation plus chemotherapy whose death was due to the study cancer, compared with those receiving radiation alone. However, an increased number of deaths related to causes other than the study cancer was observed in patients treated with radiation plus chemotherapy, the authors noted.

“These findings tell us that these subgroups of high-risk patients — who had either a tumor at the margin or extracapsular spread of the disease — do benefit from the addition of chemotherapy in terms of better local control, even at 10-year follow-up. Simultaneously, patients who have multiple node involvement but who don’t have a tumor at the margin or extracapsular spread of the disease do not benefit from chemotherapy,” Dr. Cooper said.

“In a crazy way, it’s a win–win situation, in that we now know how to spare some of the patients we thought were high risk from the toxicity of chemotherapy,” he said.

“For patients we identified as truly high risk, at least in terms of their response to chemotherapy, we now have a better therapy.”

Although similar findings have been observed before, this analysis sheds light on the longer-term response of high-risk patients, said Stuart J. Wong, MD, associate professor of medicine and otolaryngology at the Medical College of Wisconsin in Milwaukee, who moderated the session.

“There was a combined analysis of RTOG 9501 and the EORTC postop study, which had an identical study design,” said Dr. Wong.

“This was a landmark analysis that defines how we currently treat high-risk patients in the postoperative setting.”

“The long-term analysis of RTOG 9501 by Dr. Cooper and colleagues reiterates these findings,” he added. “These key study results are being used in the design of ongoing and future Radiation Therapy Oncology Group (RTOG) studies.”

The study authors and Dr. Wong have disclosed no relevant financial relationships.

Source: 2012 Multidisciplinary Head and Neck Cancer Symposium (MHNCS): Abstract 1. Presented January 26, 2012.