Feasibility study for biweekly administration of cisplatin plus gemcitabine as adjuvant-chemotherapy for completely resected non-small cell lung cancer

Purpose To evaluate the feasibility of biweekly administration of cisplatin and gemcitabine as adjuvant chemotherapy for patients with completely resected non-small cell lung cancer (NSCLC). Patients and methods This was a single-arm, single-institutional study. Patients with completely resected NSCLC (p-Stages IB-IIIA) with no previous chemotherapy or radiotherapy were eligible. Simon's optimal two-stage design was applied. Both cisplatin (50 mg/m(2)) and gemcitabine (1,000 mg/m(2)) were given on days 1 and 15, every 28 days. The primary endpoint of this study was the feasibility of this combination in the four cycles of treatment. Results Twenty patients (19 lobectomies and 1 pneumonectomy) were enrolled in this study. Nine (45%) of patients had grade 3/4 neutropenia, and 6 (30%) had grade 3/4 anemia. Severe non-hematologic toxicities were uncommon in this series. No treatment-related death was encountered. Thirteen (65%) patients completed the planned 4 cycles of chemotherapy. The median intensity was 24 (range 21-25) mg/(m(2) week) with an average of 24.0 (21-25) mg/(m(2) week) cisplatin and 483 (range 412-500) mg/(m(2) week) with an average of 481.0 (412-500) mg/(m(2) week) gemcitabine. The median relative dose intensity of cisplatin was 100 (range 25-100) % with an average of 87.4 (25-100) % and that of gemcitabine was 100 (range 25-100) % with an average of 86.8 (25-100) %. Conclusion This regimen is feasible in the treatment of patients with completely resected NSCLC. A multicenter phase III trial is warranted to assess the efficacy of this regimen at promoting survival and preventing recurrence.