吉西他滨和顺铂二线治疗晚期非小细胞肺癌的临床观察

Phase II Study of Gemcitabine and Vinorelbine as Second-Line Chemotherapy in Non-Small Cell Lung Cancer.

出版信息

Cancer Res Treat. 2003 Aug;35(4):294-8. doi: 10.4143/crt.2003.35.4.294.

DOI:10.4143/crt.2003.35.4.294

Abstract

PURPOSE

With the increased use of chemotherapy for non small cell lung cancer (NSCLC), a growing group of patients can now be considered for second-line chemotherapy. However, guidelines for the second line treatment remain to be developed. The objective of this study was to evaluate the efficacy and safety of the gemcitabine and vinorelbine combination therapy in patients with advanced NSCLC, pretreated with taxane and platinum based regimens. Gemcitabine has already demonstrated activity in this patient group, with the combination therapy having been reported to be well tolerated in previous phase I/II studies.

MATERIALS AND METHODS

Forty two patients with advanced NSCLC (stages III/IV), having received prior taxane and platinum based chemotherapy, with an ECOG performance status (PS) 0~2, and unimpaired hematopoietic and organ function, were treated with vinorelbine, 20 mg/m2, followed by gemcitabine, 1, 000 mg/m2, both administered on days 1, 8 and 15, every 4 weeks.

RESULTS

Out of the 42 patients enrolled, 41 were evaluable for their response, and all 42 for their toxicity. The patient's characteristics were as follows; median age=60 years (42~~73), median PS=1 (range 0~~2), a gender ratio 31: 11 males/females, with stages IIIA, IIIB and IV in 3, 14 and 25 cases. The objective responses included a partial response (PR) 8/41 (19.5%), a stable disease 15/41 (36.6%) and a progressive disease 18/41 (43.9%). The median time-to progression (TTP) and survival were 4 months, ranging from 2 to 14 months, and 8 months, ranging from 2 to 17+ months, respectively. Grade 3 neutropenia was seen in 19% of the patient, and there was no grade 4 neutropenia or episodes of febrile neutropenia. No grade 4 thrombocytopenia or other grade 3/4 non-hematological toxicities were observed.

CONCLUSION

The combination of gemcitabine/vinorelbine is active and well tolerated in patients with advanced NSCLC having failed prior taxane/platinum therapy.

摘要

目的

随着非小细胞肺癌（NSCLC）化疗的广泛应用，越来越多的患者现在可以考虑二线化疗。然而，二线治疗的指南仍有待制定。本研究的目的是评估吉西他滨联合长春瑞滨治疗晚期 NSCLC 患者的疗效和安全性，这些患者先前接受过紫杉烷和铂类方案治疗。吉西他滨在该患者群体中已显示出活性，先前的 I/II 期研究报道联合治疗耐受性良好。

材料和方法

42 例晚期 NSCLC（III/IV 期）患者，先前接受过紫杉烷和铂类化疗，ECOG 表现状态（PS）0~2，造血和器官功能不受影响，接受长春瑞滨，20mg/m2，随后给予吉西他滨，1000mg/m2，均于第 1、8 和 15 天给药，每 4 周一次。

结果

42 例患者中，41 例可评估疗效，42 例可评估毒性。患者的特征如下；中位年龄 60 岁（42~~73），中位 PS=1（范围 0~~2），男女比例 31:11（男性/女性），3 例为 IIIA 期，14 例为 IIIB 期，25 例为 IV 期。客观反应包括部分缓解（PR）8/41（19.5%），稳定疾病 15/41（36.6%）和进展疾病 18/41（43.9%）。中位无进展生存期（TTP）和生存期分别为 4 个月（2~~14 个月）和 8 个月（2~~17+个月）。19%的患者出现 3 级中性粒细胞减少症，无 4 级中性粒细胞减少症或发热性中性粒细胞减少症。未观察到 4 级血小板减少症或其他 3/4 级非血液学毒性。