Abstract

This pilot phase II study was aimed at determining the feasibility, toxicity, response rate, local control, and survival of concomitant chemotherapy with cisplatin-etoposide and radiotherapy in stage IIIA or IIIB non small-cell lung cancer (NSCLC). Between February 1992 and February 1994, 67 patients with either medically or technically inoperable stage III NSCLC were treated with concomitant chemoradiotherapy. Thoracic radiotherapy was administered to a median dose of 60 Gy over 6 weeks. Concomitant chemotherapy consisted of cisplatin 20 mg/m2/day plus etoposide 50 mg/m2/day from day 1 to day 5, every 4 weeks over four cycles. Medically operable patients were evaluated for surgical resection after a 45-Gy irradiation and two cycles of concomitant chemotherapy. Only 14 patients could undergo subsequent surgery. With a median 49-month and a minimum 34-month follow-up, the overall survival rate was 42% at 2 years, and 34% at 4 years. The median survival was 19 months and the actuarial local control rate was 57% at 3 years. Toxicity was mainly associated with myelosuppression and esophagitis, but could be treated and was of short duration. Concomitant chemoradiotherapy with cisplatin and etoposide at this dose level provides a well tolerated outpatient regimen that results in high local control rate and encouraging survival at 2.4 years. A similar regimen is being compared in a phase III trial including induction chemotherapy followed by radiotherapy.

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