Anne Burke

October 31, 2007

October 31, 2007 (Los Angeles) -- A 10-year phase 3 randomized study found that chemotherapy used concurrently with hyperfractionated accelerated radiotherapy (HART) produced better outcomes than radiotherapy alone for head and neck cancers, a researcher reported at the American Society for Therapeutic Radiology and Oncology (ASTRO) 49th Annual Meeting.

Study coordinator Volker Budach, MD, PhD, professor and chair of the clinical research division at the European Organisation for Research and Treatment of Cancer, in Berlin, Germany, told Medscape Oncology in an interview after his presentation that he was pleasantly surprised by the results.

The study found a statistically significant improvement in overall survival, local-regional control, and cause-specific survival with mitomycin-C plus 5-fluorouracil and concurrent HART of 70.6 Gy over dose-escalated HART of 77.6 Gy alone.

"In head and neck cancer, most published studies [report] improvement of local-regional control and cause-specific survival, but never an improvement in overall survival," Dr. Budach told Medscape. "This is 1 of the few studies that shows overall improvement. And these were very advanced cases. In 2 other studies, they did not have very advanced cases and, still, our results are nearly the same."

Of the 384 participants in Dr. Budach's study, 94.5% were stage 4, he said

Commenting on what he called an "excellent" study, Robert J. Amdur, MD, associate professor at the University of Florida, in Gainesville, told the audience that Dr. Budach's work provides further evidence that "combined treatment for advanced head and neck cancer is more efficacious and not more toxic than hyperfractionated irradiation alone."

The evidence notwithstanding, "90% of academic and community practitioners are unequivocal: you are a bad doctor if you give concurrent chemotherapy with hyperfractionated radiotherapy," continued Dr. Amdur, who was not associated with Dr. Budach's study. He said that when he talks to practitioners and recommends combined treatment, "there is kind of dead silence — where did you come from?"

Dr. Budach emphasized that mitomycin is highly effective in treating head and neck cancer but underappreciated and underused. "It's a good drug — very simple and tolerable and cheap," he told Medscape Oncology. However, mitomycin is often ignored in favor of newer and more toxic drug combinations. "It's a little like a lost child," Dr. Budach said of mitomycin-C.

Dr. Budach's study did not arrive at a reduction in distant metastasis rate but, he said, he hopes to achieve that result in a successor study that will involve 420 patients.

Dr. Budach, whose study was funded by the nonprofit Deutsche Krebshilfe (German Cancer Aid), reported no relevant financial relationships.

American Society for Therapeutic Radiology and Oncology 49th Annual Meeting: Abstract 19. Presented October 29, 2007.

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