Multidrug chemotherapy (vincristine-bleomycin-methotrexate) followed by radiotherapy in inoperable carcinomas of the head and neck: a pilot study of the Radiation Therapy Oncology Group.

This is a report on the Radiation Therapy Oncology Group (RTOG) Pilot Study 77-08, of a combination of chemotherapy with vincristine-bleomycin-methotrexate, followed by curative radiotherapy for inoperable carcinomas of the head and neck. The main objectives of the study were to determine toxicity, tumor control, and survival. Included were patients with untreated advances carcinomas, with no distant metastasis. Chemotherapy started with vincristine--1.5 mg/m2 (maximum of 2 mg) by I.V. injection, followed by bleomycin drip of 48 hours (15 units per day), and then methotrexate (200 mgs/m2 divided in equal doses 6 hours apart) with folinic acid rescue. Forty patients were registered for the study. Eleven of these received 1 course of the stated chemotherapy, and 28 were given 2 courses, with a 1-week rest period between them. Radical curative radiotherapy was usually started 2 weeks after chemotherapy. Salvage surgery was considered for persistent or recurrent tumor in the primary area, neck, or both. The level of toxicity that resulted from this combined therapy was considered acceptable. The percentage of complete response in the primary tumor was 6% with chemotherapy; 46% after irradiation; and 65% when surgery was added. The complete response (C.R.) in the primary tumor ranged from 54% for T-4 to 100% for T-2, 20% of T-3, and N with this therapeutic regime was--41% initially, 24% at one year, 19% at two years, and 16% at three years. The survival at one, two and three years after beginning radiotherapy was 54%, 30%, and 16%, respectively. This is considered a very satisfactory result for these very advances inoperable patients.

Does preoperative irradiation increase the rate of surgical complications in carcinoma of the head and neck? A Radiation Therapy Oncology Group Report.

This is a comparison of the rate of surgical complications in a group of patients with advanced but operable carcinoma of the head and neck who underwent surgery after preoperative radiotherapy (5000 rad in five weeks, 200 rad fractions, directed to the primary tumor area and neck) versus another group operated without prior irradiation. Both groups of patients formed part of a randomized prospective multiinstitutional trial of the Radiation Therapy Oncology Group (73-03). Of 229 patients who had planned operations, 88 (38%) developed some degree of surgical complications, and in 28 (12%) the complications were rated as severe. The most frequently reported complications were delayed healing and fistula formation each occurring in approximately one-fourth of each of the two treatment groups. Carotid blow-out occurred in 5% or less of the cases. No significant statistical difference between treatment groups was noted for the overall complication rate or specific type of surgical complications. A trend was noted towards more complications in the preoperative group for patients with lesions in the oropharynx and supraglottic larynx. However, an opposite trend towards more complications in the no prior irradiation group was observed among patients with lesions in the oral cavity and hypopharynx. Surgical mortality and postoperative hospital stay were not significantly different between treatment groups. We conclude that preoperative irradiation for carcinoma of the head and neck, with the stated dose, followed by surgery in 4-6 weeks, does not substantially increase the rate of overall or specific type of surgical complications, surgical mortality or hospital stay versus those patients operated without prior irradiation.

Tolerance of surgery after radical radiotherapy of carcinoma of the oropharynx.

The complications of salvage surgery after radical irradiation were studied in a group of 52 patients with oropharyngeal carcinomas. These patients were selected for surgery from a group of patients who had failed protocol therapy and who were registered in the Split-Course Study of the Radiation Therapy Oncology Group. The operative mortality was 1.9% (1/52). The most frequent serious complication was pharyngocutaneous fistua in 12% (6/52) of patients who underwent operations. The overall incidence of serious complications was 21% (11/52). The actuarial estimated five-year survival for the group who had undergone operation was 27%. We conclude that salvage surgery for residual or recurrent disease in oropharyngeal cancer after radical radiotherapy is feasible with a low surgical mortality and acceptable complication rates.