NEW ORLEANSThe addition of concurrent 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
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.
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.