The adjuvant treatment of inoperable stage III and IV epidermoid carcinoma of the head and neck with platinum and bleomycin infusions prior to definitive radiotherapy: an RTOG pilot study.

Twenty-nine previously untreated patients with advanced unresectable Stage III or IV epidermoid carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx were entered on a pilot protocol to evaluate the effectiveness and toxicity of platinum-bleomycin infusion chemotherapy administered prior to definitive radiotherapy. Platinum was given by 24-hour continuous I. V. infusion (in an attempt to decrease gastrointestinal and renal toxicity) without mannitol diuresis at a dose of 80--100 mg/m2 on day 1 and repeated on day 22. Bleomycin was administered 15 U/m2 I. V. push on day 3 and was then followed by a five-day continuous I. V. infusion of 15 U/m2/day. Fourteen of 29 (48%) patients achieved an objective partial response on chemotherapy alone (an additional 5 patients or 17% had a minor response). Chemotherapy was well tolerated with 10/29 experiencing no nausea, 4/29 mild nausea alone, and 14/29 experiencing controllable nausea/vomiting. Transient reversible azotemia was noted in 4, skin rash in 3, and anemia in 9 patients. All 29 patients began radiotherapy on day 28; 25 completed radiotherapy and 12/25 (48%) achieved complete tumor clearance; all 12 are currently free of disease with short follow-up. The radiotherapy was well tolerated, completed on schedule, and no unexpected toxicities were encountered. This combined modality approach demonstrated substantial antitumor activity and was able to reduce the significant morbidity from platinum-bleomycin chemotherapy for the treatment of unresectable head and neck carcinoma.