Perng R P, Shih J F, Chen Y M, Delgado F M, Tsai C M, Chou K C, Liu J M, Chern M S, Whang-Peng J
Chest Department, Veterans' General Hospital-Taipei, Taiwan, ROC.
Am J Clin Oncol. 2000 Feb;23(1):60-4. doi: 10.1097/00000421-200002000-00017.
Weekly vinorelbine injection with cisplatin had been used in treatment of non-small-cell lung cancer. We performed a phase II trial to evaluate the efficacy and toxicity of a new schedule of vinorelbine and cisplatin in patients with previously untreated, inoperable (stage IIIB or stage IV) non-small-cell lung cancer. From April 1996 to May 1997, 52 patients were enrolled for study, and 50 patients were eligible and evaluable for both response and toxicity assessment. Therapy consisted of vinorelbine, 30 mg/m2, intravenously on days 1 and 5 of a 21-day cycle, and cisplatin 100 mg/m2 (reduced to 80 mg/m2 after the first seven patients) given on day 1. A total of 211 treatment courses were administered; the median number of cycles administered per patient was 4.5 (range: 1-6), the median dose intensity for vinorelbine was 16.9 mg/m2/week (84.4%), whereas that of cisplatin was 22.8 mg/m2/week (84.7%). Twenty-five patients responded to therapy for an overall response rate of 50%; one patient attained a complete response (2%). The main toxicities were vomiting, myelosuppression, and diarrhea, which included World Health Organization grade 3 or 4 nausea/vomiting (58% patients), anemia (41% patients), neutropenia (12% patients), and diarrhea (14%). The median duration of responses was 9 months. The median time to disease progression was 6.8 months (range 0.4-18.1 months). Median survival was 13 months, and 54% of patients were alive at 1 year. We conclude that this new schedule of vinorelbine and cisplatin achieves a high response with acceptable toxicity profile in patients with advanced non-small-cell lung cancer.
长春瑞滨联合顺铂每周给药方案已用于非小细胞肺癌的治疗。我们开展了一项II期试验，以评估长春瑞滨和顺铂新给药方案对先前未接受过治疗、无法手术（IIIB期或IV期）的非小细胞肺癌患者的疗效和毒性。1996年4月至1997年5月，52例患者入组研究，50例患者符合条件且可进行疗效和毒性评估。治疗方案为：在21天周期的第1天和第5天静脉注射长春瑞滨30mg/m²，第1天给予顺铂100mg/m²（前7例患者后减至80mg/m²）。共进行了211个疗程的治疗；每位患者接受的周期数中位数为4.5（范围：1 - 6），长春瑞滨的剂量强度中位数为16.9mg/m²/周（84.4%），而顺铂为22.8mg/m²/周（84.7%）。25例患者对治疗有反应，总有效率为50%；1例患者达到完全缓解（2%）。主要毒性反应为呕吐、骨髓抑制和腹泻，其中包括世界卫生组织3级或4级恶心/呕吐（58%的患者）、贫血（41%的患者）、中性粒细胞减少（12%的患者）和腹泻（14%）。缓解持续时间中位数为9个月。疾病进展时间中位数为6.8个月（范围0.4 - 18.1个月）。中位生存期为13个月，54%的患者1年后仍存活。我们得出结论，长春瑞滨和顺铂的这种新给药方案在晚期非小细胞肺癌患者中可实现高缓解率且毒性可接受。
