Chen Yuh-Min, Lee Chia-San, Lin Wei-Chun, Tsai Chun-Ming, Perng Reury-Perng
Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
J Chin Med Assoc. 2003 Apr;66(4):241-6.
We conducted a phase II study of vinorelbine and cisplatin chemotherapy in non-small cell lung cancer (NSCLC) patients who had failed previous chemotherapy, to assess the response and toxicity of this combination chemotherapy.
Twenty-two patients were enrolled from September 1999 to March 2001. The median age was 70 years. All patients had a performance status of 2. Vinorelbine was administered on days 1, 8 and 15, at a dose of 20 mg/m2; and cisplatin was given on day 1 at a dose of 50 mg/m2, every 4 weeks.
Sixty-eight cycles of treatment were given, with a median of 3 cycles. All patients were evaluable for toxicity profile, and 21 patients were evaluable for response rate. The major toxicity was myelosuppression. Grade 3 or 4 neutropenia occurred in 40.9% of the patients, and grade 3 or 4 anemia occurred in 13.6% of the patients during treatment. Uneventful febrile neutropenia occurred in 1 patient. Other toxicities were few and mild in severity. After 2 cycles of treatment, 2 of 21 patients (9.5%) had a partial response (95% confidence interval 0%-22%). The median time of disease progression was 3.7 months, the median survival was 7.6 months, and the one-year survival was 12.3%. Median survival was 8.7 and 4.9 months in those patients receiving this treatment as second-line and > or = third-line chemotherapy, respectively.
Vinorelbine and cisplatin salvage chemotherapy produced a modest anti-tumor response, a mild toxicity profile, and reasonable survival in our elderly NSCLC patients with a poor performance status. This regimen deserves further study in elderly NSCLC patients who have failed previous chemotherapy.
我们对既往化疗失败的非小细胞肺癌（NSCLC）患者进行了长春瑞滨和顺铂联合化疗的II期研究，以评估该联合化疗的疗效和毒性。
1999年9月至2001年3月共纳入22例患者。中位年龄为70岁。所有患者的体能状态均为2级。长春瑞滨于第1、8和15天给药，剂量为20mg/m²；顺铂于第1天给药，剂量为50mg/m²，每4周重复一次。
共进行了68个周期的治疗，中位周期数为3个。所有患者均可评估毒性，21例患者可评估缓解率。主要毒性为骨髓抑制。治疗期间，40.9%的患者出现3或4级中性粒细胞减少，13.6%的患者出现3或4级贫血。1例患者发生无并发症的发热性中性粒细胞减少。其他毒性较少且严重程度较轻。2个周期治疗后，21例患者中有2例（9.5%）部分缓解（95%置信区间0%-22%）。疾病进展的中位时间为3.7个月，中位生存期为7.6个月，1年生存率为12.3%。接受二线和≥三线化疗的患者中位生存期分别为8.7个月和4.9个月。
长春瑞滨和顺铂挽救性化疗在我们体能状态较差的老年NSCLC患者中产生了适度的抗肿瘤反应、轻度的毒性反应和合理的生存期。该方案值得在既往化疗失败的老年NSCLC患者中进一步研究。
