Alternating irradiation and chemotherapy in stage III A and B nonsmall cell lung cancer: report of a cancer and Leukemia Group B phase II study 8636.

PURPOSE: A pilot trial testing the feasibility of chemotherapy and radiotherapy was done in Stage III A and B nonsmall cell lung cancer. The schedule was designed to be consistent with the laboratory model of Looney and Hopkins. METHODS AND MATERIALS: Treatment began with thrice-per-day radiotherapy for 3 days (16.2 Gy/nine fractions), followed by chemotherapy (cis-platinum 100 mg/m2 day 10, and vinblastine 4 mg/m2 days 10 and 12). A second cycle started on day 22, a third on day 43, and a fourth on day 64. We treated three cohorts. The first cohort received three cycles of radiotherapy alone, (48.6 Gy). The second cohort received three completed cycles, and the third received three completed cycles and a fourth radiotherapy course (64.8 Gy). Patients were evaluated for toxicity, protocol compliance, response, and survival. RESULTS: The patients in the first cohort experienced no toxicity. Fifty-six percent (56%) of the patients treated in cohort 2 experienced severe or life-threatening myelosuppression as did 82% of those in cohort 3. Nonhematologic toxicity was not severe; one case of Grade 3 esophagitis, one of reversible adult respiratory distress syndrome, and one radiation pneumonitis. We closed the trial after accrual to the third cohort because of significant myelosuppression. CONCLUSION: This schedule is too myelosuppressive to be used without modification.

Duke Scholars

Author James Emmett Herndon II Biostatistics & Bioinformatics, Division of Biostatistics