Pilot study of multiple-fraction daily radiotherapy alternating with chemotherapy in patients with stage IV non-oat cell lung cancer.

From March 1982, 31 patients with stage IV non-oat cell lung cancer have been treated. Radiotherapy was given as three 2.00-Gy fractions on Days 1 and 2, 8 and 9, 22 and 23, and 29 and 30, for a total dose of 48 Gy over a 30-32-day treatment period. A three-drug combination of cyclophosphamide (400 mg/m2), doxorubicin (17 mg/m2), and methotrexate (15 mg/m2) was given on Days 3 and 24 and repeated thereafter every 21 days. Three of 31 evaluable patients (10%) achieved objective complete response and 18 of 31 (58%) achieved partial response (ie, regression of 50%-90%), while no change or disease progression was observed in ten of 31 (32%). The overall response rate in our study was 68%, which is a response much higher than other results in extensive disease. However, controlled trials will be necessary to definitively establish the superiority of this regimen to conventional trials. There was a significant shift of performance status towards higher values after treatment: 12 of the 27 patients classified in the 70-80 Karnofsky category before treatment moved to the higher category, 13 remained in the same status, and only two shifted to the worst category, indicating that the treatment had been effective in giving patients a better quality of life during their survival. The median survival was 35 weeks for the entire group of patients and 44 and 15 weeks for the responders and nonresponders, respectively. One of the primary findings of this pilot study was the ability to give one course of 12 Gy of radiation as multiple fractions per day during each of the first 2 weeks of treatment alternated with one course of chemotherapy, with most patients having very mild or no side effects. Giving multiple daily fractions greater than or equal to 4 hours apart permits the delivery of a large amount of irradiation over a short time period (ie, 1-2 days) within the limits of normal tissue toxicity. Increasing the recovery time of radiotherapy by alternation with chemotherapy offers the possibility of increasing the total radiation dose beyond the upper limits now considered feasible by conventional radiation schedules for induction therapy.(ABSTRACT TRUNCATED AT 400 WORDS)