title: 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.
abstract: 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.
mesh_terms: D001761:Bleomycin / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D010865:Pilot Projects; D011379:Prognosis; D011879:Radiotherapy Dosage; D014750:Vincristine / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001761:Bleomycin; D014750:Vincristine; D008727:Methotrexate