吉西他滨联合紫杉醇用于既往接受过蒽环类药物治疗的转移性乳腺癌患者的II期研究。

Phase II study of gemcitabine plus paclitaxel in metastatic breast cancer patients with prior anthracycline exposure.

作者信息

Demiray Mutlu, Kurt Ender, Evrensel Turkkan, Kanat Ozkan, Arslan Murat, Saraydaroglu Ozlem, Ercan Ilker, Gonullu Guzin, Gokgoz Sehsuvar, Topal Ugur, Tolunay Sahsine, Tasdelen Ismet, Manavoglu Osman

机构信息

Department of Medical Oncology, Uludag University Medical School, Bursa, Turkey.

出版信息

Cancer Invest. 2005;23(5):386-91. doi: 10.1081/cnv-67133.

DOI:10.1081/cnv-67133

PMID:16193637

Abstract

UNLABELLED

Chemotherapy provides palliation and modest prolongation of symptom-free survival in metastatic breast cancer. Taxane containing regimens are commonly considered to be among the initials in metastatic setting due to earlier use of anthracyclines in the course of breast cancer. Therefore, we conducted this Phase II study to assess efficacy and safety of gemcitabine plus paclitaxel (GT) combination therapy in anthracycline pretreated metastatic first-line setting.

PATIENTS AND METHODS

The study enrolled 26 women with pathologically confirmed and measurable metastatic breast cancer who were previously treated with anthracycline but no prior chemotherapy for metastatic disease. Twenty six and twenty four patients were eligible for toxicity and efficacy evaluations respectively. Mean age was 47.3 years and median ECOG performance status was 0. Twenty patients (76.9 percent) had visceral metastases, most commonly located in liver and lung. Treatment schedule was as follows: paclitaxel 175 mg/m2 was administered intravenously in 3 hours on Day 1 and gemcitabine 1000 mg/m2 was administered intravenously in 30 minutes on Day 1 after paclitaxel application, and on Day 8 every 21 days.

RESULTS

Objective response rate was 41.7 percent (95 percent CI: 21.9-61.4) with 16.7 percent (95 percent CI: 1.7-31.6 percent) CR, and 25.0 percent (95 percent CI: 7.6-42.3 percent) PR. Median time to progression and overall survival were 9.6 and 14.5 months, respectively. Grade 3-4 toxicity was observed in 34.6 percent (9) patients. Treatment of two patients was discontinued due to toxicity, consisting of Grade 3 hypersensitivity reactions and Grade 4 infections in one patient each. Dose reductions due to myelotoxicity were performed in 4 (15.3 percent) patients. Hematologic toxicities were generally manageable with appropriate dose modifications and supportive care.

CONCLUSION

Gemcitabine and paclitaxel combination regimen is effective and has manageable toxicity profile as first line metastatic setting.

摘要

未标注

化疗可缓解转移性乳腺癌症状并适度延长无病生存期。由于在乳腺癌治疗过程中更早使用了蒽环类药物，含紫杉烷的方案通常被认为是转移性乳腺癌初始治疗方案之一。因此，我们开展了这项II期研究，以评估吉西他滨联合紫杉醇（GT）方案在接受过蒽环类药物治疗的转移性一线乳腺癌患者中的疗效和安全性。

患者与方法

本研究纳入了26例经病理确诊且可测量的转移性乳腺癌女性患者，这些患者既往接受过蒽环类药物治疗，但未接受过转移性疾病的化疗。分别有26例和24例患者符合毒性和疗效评估标准。平均年龄为47.3岁，中位ECOG体能状态为0。20例（76.9%）患者有内脏转移，最常见于肝脏和肺部。治疗方案如下：第1天静脉滴注紫杉醇175mg/m²，持续3小时，在紫杉醇输注后第1天的30分钟内静脉滴注吉西他滨1000mg/m²，每21天重复一次，第8天同样给药。

结果

客观缓解率为41.7%（95%CI：21.9 - 61.4），其中完全缓解率为16.7%（95%CI：1.7 - 31.6%），部分缓解率为25.0%（95%CI：7.6 - 42.3%）。中位疾病进展时间和总生存期分别为9.6个月和14.5个月。34.6%（9例）患者出现3 - 4级毒性反应。2例患者因毒性反应停止治疗，其中1例出现3级过敏反应，另1例出现4级感染。4例（15.3%）患者因骨髓毒性进行了剂量调整。通过适当的剂量调整和支持性治疗，血液学毒性通常可控。