IS A SURGICAL RESECTION LEAVING POSITIVE MARGINS OF BENEFIT TO THE PATIENT WITH LOCALLY ADVANCED SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - A COMPARATIVE-STUDY USING THE INTERGROUP STUDY 0034 AND THE RADIATION-THERAPY ONCOLOGY GROUP HEAD AND NECK DATABASE

Purpose: The purpose of this study was to determine whether or not for patients with squamous cell carcinomas of the head and neck, a surgic al resection leaving positive margins followed by postoperative adjuva nt therapy improves the outcome compared to a matched group of patient s treated with definitive radiotherapy alone. Methods and Materials: F rom January 1985 through January 1990 a consortium of national coopera tive groups (Radiation Therapy Oncology Group, Cancer and Leukemia Gro up B, Eastern Cooperative Oncology Group, Northern California Oncology Group, Southeast Group, and Southwest Oncology Group) conducted a pha se III clinical trial testing the efficacy of adjuvant chemotherapy fo r patients with resectable, squamous cell carcinomas of the head and n eck. One hundred and nine patients were excluded from this study due t o positive surgical margins. These patients have been followed prospec tively with regards to local/regional tumor control, development of di stant metastases, and survival. The postoperative treatment of these p atients was not specified by the protocol but the majority of patients received postoperative radiotherapy +/-chemotherapy. These patients w ere compared with a matched group of patients from the Radiation Thera py Oncology Group head and neck database of patients treated with defi nitive radiotherapy alone using a standard fractionation schema. Match ing parameters included primary tumor site, T-stage, N-stage, Karnofsk y performance status, and age. Results: Actuarial curves are presented for local/regional control and survival. At 4 years the local/regiona l control rate is 44% for the positive margin patients compared to 24% for the patients from the data base (p = 0.007). However, there is no significant difference between the survival curves (p = 0.76) with re spective median survivals being 18.1 months vs. 17.9 months and 4-year survivals being 29% vs. 25%. Conclusion: While an incomplete excision followed by postoperative therapy does not seem to improve survival c ompared to treatment with radiotherapy alone, it appears to yield sign ificantly better local/regional control. This would argue for its appl icability in selected palliative settings. A follow-up, Phase III tria l for patients with advanced tumors may be warranted to test tradition al resectability criteria.