Preoperative chemotherapy (cisplatin and fluorouracil) and radiation therapy in stage III non-small-cell lung cancer: a phase II study of the Lung Cancer Study Group.

The Lung Cancer Study Group conducted a phase II pilot study of concurrent chemotherapy and radiation therapy (chemoradiotherapy) before surgery in 85 eligible patients with non-small-cell cancer limited to the chest but in whom attempted resection would have been likely to leave residual disease (advanced stage IIIA and minimal stage IIIB disease). Cisplatin, 75 mg/m2, was given on days 1 and 29; fluorouracil, 1 g/m2 per 24 hours, was administered as a continuous infusion on days 1 through 4 and on days 29 through 32; and thoracic radiation, 30 Gy in 15 fractions, was administered on days 1 through 19. Two patients achieved a complete response and 46 patients had a partial response for an overall response rate of 56%. Toxicity from chemoradiotherapy was moderate but acceptable. Eight weeks after therapy was initiated, 54 patients underwent thoracotomy and tumor resection was attempted: 29 (34%) had complete resection and 15 (18%) had incomplete resection. Although surgical dissection was generally more difficult than in patients not pretreated with chemoradiotherapy, there was no apparent increase in postoperative complications. In 8 patients (9%), no viable tumor was detected pathologically in the resection specimen. Of the 18 patients whose tumors were completely resected and had disease recurrence, none had recurrence only in the chest, 12 (67%) had recurrence only in distant sites, and 3 developed second primary tumors. Median survival of all patients was 13 months. The overall results do not indicate a major benefit from this preoperative chemoradiotherapy regimen in patients with advanced but potentially resectable non-small-cell lung cancer. These results suggest a need to define better the relative roles of preoperative radiotherapy and chemotherapy.