Radiosensitization with carboplatin for patients with unresectable stage III non-small-cell lung cancer: A phase III trial of the Cancer and LeukemiaGroup B and the Eastern Cooperative Oncology Group

Purpose: to determine whether the administration of carboplatin concurrentl y with radiation treatment improves survival in patients with inoperable st age III non-small-cell lung cancer. Patients and Methods: Two hundred eighty-three patients with inoperable sta ge ill non-small-cell lung cancer were entered onto a randomized trial by t he Cancer and Leukemia Group B and the Eastern Cooperative Oncology Group. Randomization was performed before initiation of any therapy. All patients received an induction chemotherapy program with vinblastine and cisplatin f or 5 weeks, followed by 6,000 cGy of radiation therapy over 6 weeks. One hu ndred thirty-seven patients were randomized to this therapy regimen alone; 146 patients were randomized to receive carboplatin at 100 mg/m(2)/wk concu rrent with the radiation therapy. Results: The complete response was 18% with concurrent carboplatin versus 1 0% with radiotherapy alone (P = .101). There was no difference with respect to failure-free survival (10% with carboplatin and 9% with radiotherapy al one) or overall survival (13% with carboplatin and 10% with radiotherapy al one) at 4 years. In patients not receiving carboplatin, the relapse rate wa s 69% within the field of radiation and 53% in the boost volume. In patient s receiving carboplatin, the relapse rare was 59% within the field of radia tion and 43% in the boost volume. patients with cancers more than 70 cm(2) in size had significantly poorer survival (P = .01). Conclusion: Carboplatin at the dose and schedule used did not significantly impact on disease central or survival. The relapse rate within the chest r emained more than 50%. More effective regimens will be required to impact o n local disease central and survival. J Clin Oncol 17:4- 11. (C) 1999 by American Society of Clinical Oncology.