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吉西他滨联合多西他赛二线治疗恶性胸膜间皮瘤的 II 期研究:单中心研究。

Phase II study of gemcitabine plus docetaxel as second-line treatment in malignant pleural mesothelioma: a single institution study.

机构信息

Oncology Unit, Third Department of Medicine, Sotiria General Hospital, Athens School of Medicine, Greece.

出版信息

Am J Clin Oncol. 2011 Feb;34(1):38-42. doi: 10.1097/COC.0b013e3181cae90e.

Abstract

OBJECTIVE

The combinations of cisplatin-pemetrexed and cisplatin-gemcitabine are considered the standard systemic therapy for malignant pleural mesothelioma (MPM), which is a rapidly progressive tumor. The purpose of the present study is to evaluate the efficacy, safety, and clinical benefit of the gemcitabine plus docetaxel regimen in the second-line treatment of this disease.

PATIENTS AND METHODS

A total of 37 patients with MPM were treated with the combination of docetaxel (80 mg/m) and gemcitabine (1000 mg/m) on day 1 and 14 of a 28-day cycle. The regimen was repeated for a maximum of 6 cycles or until disease progression or unacceptable toxicity.

RESULTS

There was partial response of the disease in 7 patients (18.9%), whereas it remained stable in 23 patients (62.2%) and progressed in 7 patients (18.9%). The median time to disease progression was 7 months (range: 5.8-8.2 months) with a mean survival of 16.2 months (range: 13-19.3 months).

CONCLUSION

The biweekly administration of docetaxel and gemcitabine, along with granulocyte colony-stimulating factor support, constitutes a safe, tolerable, and convenient regimen for the treatment of MPM, suggesting that this combination may be a viable option, especially in previously treated patients.

摘要

目的

顺铂-培美曲塞和顺铂-吉西他滨联合方案被认为是恶性胸膜间皮瘤(MPM)的标准系统治疗方法,MPM 是一种进展迅速的肿瘤。本研究旨在评估吉西他滨联合多西他赛方案在该疾病二线治疗中的疗效、安全性和临床获益。

患者和方法

共 37 例 MPM 患者接受多西他赛(80mg/m2)和吉西他滨(1000mg/m2)联合治疗,每 28 天为一个周期,第 1 天和第 14 天用药。该方案最多重复 6 个周期或直至疾病进展或不可接受的毒性。

结果

7 例(18.9%)患者疾病部分缓解,23 例(62.2%)患者疾病稳定,7 例(18.9%)患者疾病进展。疾病进展中位时间为 7 个月(范围:5.8-8.2 个月),平均生存时间为 16.2 个月(范围:13-19.3 个月)。

结论

吉西他滨联合多西他赛,每周两次给药,并辅以粒细胞集落刺激因子支持,是一种安全、耐受和方便的 MPM 治疗方案,提示该联合方案可能是一种可行的选择,特别是在既往治疗过的患者中。

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