NEW ORLEANS—The addition of concurrent cisplatin(Drug information on cisplatin) (Platinol) chemotherapy to radiation therapy after surgery failed to significantly improve locoregional control of high-risk head and neck cancers in the RTOG 9501/Intergroup phase III trial reported at the plenary session of the American Society for Therapeutic Radiology and Oncology (abstract plenary 3).
"We are disappointed to learn that despite added toxicity from the addition of chemotherapy, locoregional control, distant control, overall survival, and disease-free survival were not significantly improved," said Jay S. Cooper, MD, of New York University Medical Center.
Locoregional recurrence of disease has been the most common mode of failure in advanced head and neck cancer, despite grossly or microscopically complete surgical resection and postoperative radiation therapy, Dr. Cooper noted.
Between 1995 and 2000, this prospectively randomized phase III study enrolled 459 patients with resected, high-risk squamous cell carcinomas of the head and neck region. Subjects were considered high-risk by having two or more involved lymph nodes, extracapsular disease, and/or microscopically involved mucosal margins of resection.
Patients were randomized after resection to radiotherapy alone (60 to 66 Gy in 30 to 33 fractions over about 6 weeks) or identical radiotherapy plus cisplatin 100 mg/m2 on days 1, 22, and 43. Sixty-one percent of patients received all three doses of chemotherapy.
Study Results
At 37 months median follow-up of 415 patients, the addition of cisplatin provided no statistically significant improvement over radiotherapy alone in preventing locoregional or distant recurrence or in enhancing overall survival, Dr. Cooper reported.
