Phase II study of adjuvant vinorelbine and cisplatin in Japanese patients with completely resected stage II and III non-small cell lung cancer

• Published in: Cancer chemotherapy and pharmacology 2014-12, Vol.74 (6), p.1199-1206
• Main Authors: Sonobe, Makoto, Okubo, Ken-ichi, Teramukai, Satoshi, Yanagihara, Kazuhiro, Sato, Masaaki, Sato, Toshihiko, Chen, Fengshi, Sato, Kiyoshi, Fujinaga, Takuji, Shoji, Tsuyoshi, Omasa, Mitsugu, Sakai, Hiroaki, Miyahara, Ryo, Bando, Toru, Date, Hiroshi
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Asian Continental Ancestry Group; Biological and medical sciences; Cancer Research; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Carcinoma, Non-Small-Cell Lung - surgery; Chemotherapy, Adjuvant - methods; Cisplatin - administration & dosage; Disease-Free Survival; Female; Follow-Up Studies; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Lung Neoplasms - surgery; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Neoplasm Staging; Oncology; Original Article; Pharmacology. Drug treatments; Pharmacology/Toxicology; Pneumology; Survival Rate; Tumors; Tumors of the respiratory system and mediastinum; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-014-2595-5

Purpose Adjuvant vinorelbine and cisplatin chemotherapy is recognized as a standard regimen for patients with completely resected stage II and III non-small cell lung cancer (NSCLC). However, efficacy of adjuvant chemotherapy in Japanese phase III trials with cisplatin-containing regimen has been controversial, and data are limited on the long-term outcome of adjuvant vinorelbine and cisplatin chemotherapy for NSCLC patients. Methods This was a single-arm phase II study in patients with completely resected pathological stage II or III NSCLC, who had not received prior chemotherapy or radiotherapy. Patients received 4 cycles of vinorelbine [25 mg/m 2 of body surface area (BSA)] and cisplatin (40 mg/m 2 of BSA) on day s 1 and 8, every 4 weeks. Primary end point was the 3-year relapse-free survival; secondary end points were overall survival and safety. Results Between December 2006 and January 2011, 60 patients (40 men and 20 women, median age 64 years) were enrolled; all patients were evaluable for survival and safety. Three-year relapse-free survival rate was 55.0 % (95 % confidence interval 42.4–67.6 %). Three- and five-year overall survival rates were 83.3 and 77.8 %, respectively. There were no chemotherapy-related deaths, and adverse effects were acceptable. Conclusions Adjuvant vinorelbine and cisplatin chemotherapy was safe and showed a valid relapse-free survival rate. This regimen could be used as a standard regimen and deserves to be a control arm of trials on adjuvant chemotherapy in the Japanese NSCLC patient population.