Randomized Phase II Trial of Adjuvant Chemotherapy with Docetaxel plus Cisplatin versus Paclitaxel plus Carboplatin in Patients with Completely Resected Non-Small Cell Lung Cancer: TORG 0503

Abstract Objective Adjuvant chemotherapy is standard of care for patients with completely resected stage IB, II and IIIA NSCLC. However, optimum chemotherapy regimen has not been determined. TORG0503 was undertaken to select a preferred platinum-based 3rd generation regimen in this clinical setting. Materials and Methods Patients with completely resected stage IB, IIA, IIB or stage IIIA NSCLC were stratified by stage (IB/IIA vs. IIB/IIIA) and institutions, and randomized to receive 3 cycles of docetaxel (60 mg/m2) plus cisplatin (80 mg/m2) (arm A) or paclitaxel (200 mg/m2) plus carboplatin (AUC 6) (arm B) on day 1, every 3 weeks. The primary endpoint of the study was 2-year relapse free survival, and the key secondary endpoints included overall survival, feasibility and toxicity. Results 111 patients were randomized, 58 patients to arm A and 53 to arm B. Patient demographics were balanced between the two arms. 93% (54/58) of patients on the arm A and 92% (49/53) patients on the arm B completed the planned 3 cycles of chemotherapy. There was no treatment-related death in both arms. The 2 and 5 year relapse free survival was 74.5% (95%CI: 68.6-80.4) and 61.6% in the arm A, and 72.0% (95%CI: 65.7-78.3) and 46.0% in the arm B. The overall 2, 5-year survival was 89.7%, 73.9% in the arm A and 86.9%, 67.5% in the arm B. Conclusion Both docetaxel plus cisplatin and paclitaxel plus carboplatin are safe and feasible regimens as adjuvant chemotherapy. We choose docetaxel plus cisplatin as the control regimen for the next clinical trial.