A pilot study of nedaplatin plus docetaxel as adjuvant chemotherapy in patients with resected non-small-cell lung cancer

Background: Recent clinical trials have shown that adjuvant cisplatin-based chemotherapy improved survival for patients with completely resected stage II-IIIA non-small-cell lung cancer (NSCLC). In terms of toxicities, hematological or nonhematological toxicities are frequently observed in cisplatin-based chemotherapy. Adjuvant chemotherapy should be conducted safely, with potent activity. Thus, more suitable regimen with these criteria needs to be developed as adjuvant chemotherapy. Nedaplatin is a cisplatin derivative developed in Japan. It has similar activity to cisplatin in NSCLC when combined with vindesine, and causes less nausea/vomiting and nephrotoxicity compared with cisplatin. The purpose of this pilot study was to evaluate the safety of combination chemotherapy with nedaplatin plus docetaxel as adjuvant chemotherapy in patients with resected NSCLC. Methods: In this pilot study, patients with resected NSCLC were received nedaplatin (64 mg/m2) and docetaxel (48 mg/m2) on day 1, every 4 weeks, 4 cycles. The primary end point was the feasibility. Adverse events were graded according to National Cancer Institute Common Toxicity Criteria (version 4.0). Results: Between April 2009 and December 2011, 9 patients received combination chemotherapy of nedaplatin plus docetaxel. The demographics of patients were; mean age 60.6 years (range, 51-70 years), gender male/female 8/1 cases, stage I/II/III/ IV 0/2/6/1, and histologic type adenocarcinoma/ squamous cell carcinoma 4/5. Seven patients (78%) received four cycles of chemotherapy, and 2 patients (22%) did not complete four cycles. No treatmentrelated death was observed and the hematologic toxicities included grades 3-4 leukopenia (22%), neutropenia (44%), anemia (11%), and thrombocytopenia (0%). Nonhematologic toxicities included grade 3-4 nausea/vomiting, anorexia, and fever did not be observed. Conclusion: Adjuvant chemotherapy of nedaplatin plus docetaxel was shown to be well tolerable in patient with resected NSCLC. On the basis of these results, phase II study of the combination of nedaplatin plus docetaxel as an adjuvant chemotherapy is required.