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长春瑞滨、异环磷酰胺和顺铂联合化疗:一项针对IIIB-IV期非小细胞肺癌的II期研究。

Combination chemotherapy with vinorelbine, ifosfamide, and cisplatin: a phase II study in stage IIIB-IV non-small cell lung cancer.

作者信息

Baldini E, Tibaldi C, Chella A, Angeletti C A, Romanini A, Andrei A, Algeri R, Silvano G, Conte P F

机构信息

Department of Medical Oncology, S. Chiara Hospital, Pisa, Italy.

出版信息

Semin Oncol. 1994 Jun;21(3 Suppl 4):12-5.

PMID:8209271
Abstract

Forty-five stage IIIB-IV non-small cell lung cancer (NSCLC) patients entered a phase II study designed to evaluate the toxicity and the activity of a combination chemotherapy regimen consisting of vinorelbine (25 mg/m2 days 1 and 8), ifosfamide (3 g/m2 day 1 with uroprotective mesna), and cisplatin (80 mg/m2 day 1). The regimen, VIP, was administered on an outpatient basis every 3 weeks. White blood cell counts were checked weekly, and granulocyte colony-stimulating factor was administered in case of grade 4 neutropenia lasting for more than 48 hours. Leukopenia was the most frequent toxicity, with grades 3 and 4 neutropenia reported in 25% of cycles and 11 episodes of febrile neutropenia recorded in 175 evaluable courses. The combination of vinorelbine and cisplatin did not result in additive neurotoxicity: only five patients experienced grade 2 neurotoxicity after six courses of treatment. Thirty-five patients were evaluable for response. Twenty partial responses (57%) and one complete response (2.8%) were observed, for an overall response rate of 60% (95% confidence interval, 42% to 76%). The median time to progression, measured from the start of treatment, was 7 months (range, 1 to 18+), and median survival for the whole group was 12 months (range, 1 to 18+). VIP is a well-tolerated regimen and shows interesting activity in advanced NSCLC.

摘要

45例IIIB-IV期非小细胞肺癌(NSCLC)患者进入一项II期研究,旨在评估由长春瑞滨(第1天和第8天,25mg/m²)、异环磷酰胺(第1天,3g/m²,同时使用尿路保护剂美司钠)和顺铂(第1天,80mg/m²)组成的联合化疗方案的毒性和活性。该方案(VIP)每3周在门诊给药一次。每周检查白细胞计数,若4级中性粒细胞减少持续超过48小时,则给予粒细胞集落刺激因子。白细胞减少是最常见的毒性反应,25%的周期出现3级和4级中性粒细胞减少,在175个可评估疗程中记录到11例发热性中性粒细胞减少。长春瑞滨和顺铂联合使用未导致叠加性神经毒性:仅5例患者在六个疗程治疗后出现2级神经毒性。35例患者可评估疗效。观察到20例部分缓解(57%)和1例完全缓解(2.8%),总缓解率为60%(95%置信区间,42%至76%)。从治疗开始测量的中位进展时间为7个月(范围,1至18+),全组的中位生存期为12个月(范围,1至18+)。VIP是一种耐受性良好的方案,在晚期NSCLC中显示出有意义的活性。

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引用本文的文献

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Br J Cancer. 1998 Jun;77(12):2367-70. doi: 10.1038/bjc.1998.393.
2
Clinical phase I and pharmacokinetic trial of vinorelbine administered as single intravenous bolus every 21 days in cancer patients.长春瑞滨每21天静脉推注一次用于癌症患者的I期临床和药代动力学试验。
Invest New Drugs. 1996;14(4):371-8. doi: 10.1007/BF00180813.
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Vinorelbine. A review of its pharmacological properties and clinical use in cancer chemotherapy.长春瑞滨。其药理特性及在癌症化疗中的临床应用综述。
Drugs Aging. 1994 Sep;5(3):200-34. doi: 10.2165/00002512-199405030-00006.