Phase II study of nedaplatin and irinotecan as adjuvant chemotherapy for completely resected non-small cell lung cancer.
INTRODUCTION
Cisplatin-based chemotherapy is the standard adjuvant therapy for patients with completely resected stage II or III non-small cell lung cancer (NSCLC). However, the completion rate of four cycles of cisplatin-based chemotherapy is about 50%. This phase II study was conducted to evaluate the tolerability and efficacy of nedaplatin and irinotecan as adjuvant chemotherapy.


METHODS
Patients with pathological stage II or III NSCLC who underwent complete resection were enrolled. Treatment consisted of four cycles of nedaplatin (50 mg/m2) and irinotecan (50 mg/m2) on days 1 and 8 every 4 weeks. The primary end-point was the completion rate of four cycles of nedaplatin and irinotecan.


RESULTS
Between January 2009 and March 2012, 39 patients (23 males and 16 females; median age 68 years) were registered. Overall, 36/39 (92.3%) patients completed four cycles. The median clinical follow-up time was 56 months (range 11-88 months). There were no differences in adverse events between patients with UGT1A1 polymorphisms and patients with wild-type UGT1A1. The median disease-free survival (DFS) was 49.4 months (95% confidence interval 14.2-84.5 months). Median overall survival (OS) was not reached. There were no treatment-related deaths, and adverse events were acceptable. The 5-year DFS and OS rates were 43.1 and 69.8%, respectively.


CONCLUSION
Nedaplatin and irinotecan is a tolerable regimen for adjuvant chemotherapy, and was associated with adequate 5-year DFS and OS rates.
['Murakami|Shuji|S|', 'Saito|Haruhiro|H|', 'Kondo|Tetsuro|T|', 'Ito|Hiroyuki|H|', 'Oshita|Fumihiro|F|', 'Yamada|Kouzo|K|']
D000328:Adult D000368:Aged D000971:Antineoplastic Combined Chemotherapy Protocols D002289:Carcinoma, Non-Small-Cell Lung D017024:Chemotherapy, Adjuvant D018572:Disease-Free Survival D005240:Feasibility Studies D005260:Female D006801:Humans D000077146:Irinotecan D008175:Lung Neoplasms D008297:Male D008875:Middle Aged D009944:Organoplatinum Compounds D015996:Survival Rate
Nedaplatin Irinotecan Adjuvant chemotherapy Non-small cell lung cancer