Concurrent radiation therapy and chemotherapy for locally unresectable squamous cell head and neck cancer: an Eastern Cooperative Oncology Group pilot study

• Published in: Journal of clinical oncology Vol. 11; no. 11; p. 2136
• Main Authors: Adelstein, D J, Kalish, L A, Adams, G L, Wagner, Jr, H, Oken, M M, Remick, S C, Mansour, E G, Haselow, R E
• Format: Journal Article
• Language: English
• Published: United States 01.11.1993
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - radiotherapy; Cisplatin - administration & dosage; Combined Modality Therapy - adverse effects; Feasibility Studies; Female; Fluorouracil - administration & dosage; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - radiotherapy; Humans; Infusions, Intravenous; Injections, Intravenous; Male; Middle Aged; Pilot Projects; Regression Analysis; Survival Analysis; Treatment Outcome
• ISSN: 0732-183X
• DOI: 10.1200/JCO.1993.11.11.2136

The feasibility and success of an intensive chemoradiotherapeutic protocol for patients with locally advanced, unresectable squamous cell head and neck cancer was tested in this limited-institution, Eastern Cooperative Oncology Group phase II pilot study. Between December 1987 and September 1989, 57 patients were entered onto this trial. The treatment protocol consisted of three courses of a 4-day continuous fluorouracil infusion, a single cisplatin bolus injection, and concurrent split-course radiotherapy. After 30 Gy of radiation and two chemotherapy courses, patients were evaluated for response and for the possibility of surgical resection. Fifty-five of 57 registered patients are assessable for toxicity and 52 are assessable for response and survival. Toxicity was significant, but tolerable, although there were three toxic deaths. A complete response to this treatment was ultimately achieved by 77% of patients. Twenty-four patients remain relapse-free. The projected Kaplan-Meier 4-year relapse-free survival rate is 45% and the overall survival rate is 49%. Median relapse-free and overall survival durations are 26 and 37 months, respectively. Of the 28 treatment failures, 79% were locoregional. Fourteen patients underwent surgery. Six remain relapse-free. This aggressive concurrent chemoradiotherapy protocol appears feasible within a cooperative group. Treatment results are promising and appear durable. A randomized phase III clinical trial is currently underway.