Prospective Trial on Tolerability and Efficacy of Adjuvant Nedaplatin Plus Docetaxel for Non-Small Cell Lung Cancer.

Nedaplatin is a second-generation platinum compound with reduced nephrotoxicity compared with cisplatin. Given its favorable tolerability in advanced non-small cell lung cancer (NSCLC), we prospectively evaluated the tolerability and efficacy of an adjuvant nedaplatin plus docetaxel chemotherapy regimen in patients with completely resected NSCLC. Patients with stage IB-IIIA NSCLC who had undergone complete surgical resection received nedaplatin (80 mg/m2) and docetaxel (60 mg/m2) intravenously on day 1 once every 4 weeks for up to four cycles. The primary endpoint was treatment tolerability, defined as completion of the planned four cycles, and compared with historical data for the standard cisplatin plus vinorelbine regimen. The secondary endpoint was efficacy, determined by relapse-free survival (RFS) after surgery. Thirty-five patients were enrolled, with median age of 65 years (range, 36-77 years). Adenocarcinoma (57.1%) and stage II disease (60.0%) were most common. Dose reductions were needed in some patients, however, 74.3% of patients (n = 26) completed all four cycles, meeting the primary endpoint. Grade 3 or 4 neutropenia and anorexia occurred in 67.8% and 9.0% of patients, respectively. No grade 3 or 4 renal dysfunction was noted. Concerning efficacy, the median RFS time was 63 months (95% confidence interval [CI], 20-NE), and the 5-year overall survival rate was 85.7% (95% CI, 70.0-93.9). Long-term retrospective follow-up (median: 119 months) showed that the 10-year RFS rate was 52.9% (95% CI, 36.1-69.1). These results indicate that adjuvant chemotherapy with nedaplatin plus docetaxel is tolerable and effective in patients with completely resected NSCLC. Trial Registration: UMIN number: 000004634.