多西他赛联合吉西他滨加重组人粒细胞集落刺激因子支持作为非小细胞肺癌的二线治疗。一项多中心II期研究。

Docetaxel in combination with gemcitabine plus rhG-CSF support as second-line treatment in non-small cell lung cancer. A multicenter phase II study.

作者信息

Kakolyris S, Papadakis E, Tsiafaki X, Kalofonos C, Rapti A, Toubis M, Bania E, Kouroussis C, Chainis K, Androulakis N, Agelaki S, Sarra E, Vardakis N, Georgoulias V

机构信息

Department of Medical Oncology, University General Hospital of Heraklion, Heraklion 71110, Crete, Greece

出版信息

Lung Cancer. 2001 May;32(2):179-87. doi: 10.1016/s0169-5002(00)00212-9.

DOI:10.1016/s0169-5002(00)00212-9

PMID:11325489

Abstract

BACKGROUND

Docetaxel in combination with gemcitabine is an active front-line chemotherapy regimen against non-small cell lung cancer (NSCLC) with acceptable toxicity. A multicenter phase II study was conducted in order to determine the toxicity and efficacy of this combination, as salvage treatment in patients progressing after a cisplatin-based front line regimens.

PATIENTS AND METHODS

Thirty-two patients with histologically confirmed, bidimensionally measurable NSCLC, who failed prior cisplatin-based chemotherapy were enrolled. The patients' median age was 62.5 years, 29 (91%) were male, 23 (72%) had disease stage IV, and 22 (69%) had a performance status (WHO) 0-1. Gemcitabine (900 mg/m(2)) was administered on days 1 and 8 and docetaxel (100 mg/m(2)) on day 8, after appropriate premedication. rhG-CSF (150 microg/m(2)) was given prophylactically from day 9 to 15. Treatment was repeated on an outpatient basis every three weeks.

RESULTS

A total of 127 chemotherapy cycles were administered. In an intention-to-treat analysis five patients (15.6%; 95% CI: 3.04-28.21%) achieved a partial response, 11 (34.4%) stable disease, and 16 (50%) progressive disease. The median duration of response was 9 months, the median TTP 7 months, and the overall median survival 6.5 months; the overall 1-year survival probability was 27.6%. Grade 3/4 neutropenia was observed in five (15.6%) patients and in two of them associated with fever. Grade 3 anemia and thrombocytopenia occurred in three (9%) and two (6.5%) patients, respectively. Non-hematologic toxicity was very mild with only one episode of grade 4 diarrhea and mucositis, respectively; two (6%) patients complained for grade 3 asthenia.

CONCLUSION

The combination of gemcitabine and docetaxel with prophylactic use of rhG-CSF is a safe and well-tolerated regimen for the treatment of patients with advanced NSCLC, who failed front-line treatment with cisplatin-based regimens.

摘要

背景

多西他赛联合吉西他滨是一种针对非小细胞肺癌（NSCLC）的有效的一线化疗方案，毒性可接受。进行了一项多中心II期研究，以确定该联合方案作为基于顺铂的一线方案治疗后进展患者的挽救治疗的毒性和疗效。

患者与方法

纳入32例经组织学确诊、二维可测量的NSCLC患者，这些患者先前基于顺铂的化疗失败。患者的中位年龄为62.5岁，29例（91%）为男性，23例（72%）疾病分期为IV期，22例（69%）体力状况（WHO）为0 - 1。在适当的预处理后，吉西他滨（900 mg/m²）于第1天和第8天给药，多西他赛（100 mg/m²）于第8天给药。从第9天至第15天预防性给予重组人粒细胞集落刺激因子（rhG - CSF，150 μg/m²）。治疗每三周在门诊重复进行。

结果

共给予127个化疗周期。在意向性分析中，5例患者（15.6%；95% CI：3.04 - 28.21%）达到部分缓解，11例（34.4%）疾病稳定，16例（50%）疾病进展。中位缓解持续时间为9个月，中位无进展生存期为7个月，总体中位生存期为6.5个月；总体1年生存概率为27.6%。5例（15.6%）患者观察到3/4级中性粒细胞减少，其中2例伴有发热。3例（9%）和2例（6.5%）患者分别发生3级贫血和血小板减少。非血液学毒性非常轻微，分别仅有1例4级腹泻和黏膜炎；2例（6%）患者主诉有3级乏力。