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

Purpose: to determine whether the administration of carboplatin concurrently with radiation treatment improves survival in patients with inoperable stage III non-small-cell lung cancer. Patients and Methods: Two hundred eighty-three patients with inoperable stage ill non-small-cell lung cancer were entered onto a randomized trial by the 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 for 5 weeks, followed by 6,000 cGy of radiation therapy over 6 weeks. One hundred thirty-seven patients were randomized to this therapy regimen alone; 146 patients were randomized to receive carboplatin at 100 mg/m(2)/wk concurrent with the radiation therapy. Results: The complete response was 18% with concurrent carboplatin versus 10% with radiotherapy alone (P = .101). There was no difference with respect to failure-free survival (10% with carboplatin and 9% with radiotherapy alone) or overall survival (13% with carboplatin and 10% with radiotherapy alone) at 4 years. In patients not receiving carboplatin, the relapse rate was 69% within the field of radiation and 53% in the boost volume. In patients receiving carboplatin, the relapse rare was 59% within the field of radiation 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 remained more than 50%. More effective regimens will be required to impact on local disease central and survival. J Clin Oncol 17:4- 11. (C) 1999 by American Society of Clinical Oncology.