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卡铂联合培美曲塞一线治疗恶性胸膜间皮瘤的Ⅱ期临床研究。

Carboplatin plus pemetrexed as first-line treatment of patients with malignant pleural mesothelioma: a phase II study.

机构信息

Oncology Unit, 3rd Department of Medicine, Sotiria General Hospital, Athens School of Medicine, Athens, Greece.

出版信息

Clin Lung Cancer. 2010 Jan;11(1):30-5. doi: 10.3816/CLC.2010.n.005.

DOI:10.3816/CLC.2010.n.005
PMID:20085865
Abstract

INTRODUCTION

Malignant pleural mesothelioma (MPM) is a rapidly progressive tumor that is increasing in frequency worldwide. Treatment options are limited, and response to chemotherapy is poor. The aim of this phase II study was to evaluate the activity of the carboplatin/pemetrexed combination as first-line chemotherapy in patients with unresectable MPM.

PATIENTS AND METHODS

Chemotherapy-naive patients with histologically confirmed MPM and an Eastern Cooperative Oncology Group performance status of 0-2 were enrolled. Treatment consisted of pemetrexed 500 mg/m2 and carboplatin area under the concentration-time curve of 5 mg/mL/min, both administered on day 1 of a 21-day cycle. The treatment continued until 6 cycles were completed or until unacceptable toxicity or disease progression were observed.

RESULTS

A total of 62 patients were enrolled. Of these patients, 18 (29%) had a confirmed partial response, whereas the disease remained stable in 34 patients (54.9%) and progressed in 10 patients (16.1%). The median overall survival (OS) was estimated at 14 months (95% CI, 11.8-16.2 months), and the median time to progression was 7 months (95% CI, 5.8-8.2 months). The difference in median OS between the epithelial histologic subtype (16 months) and the sarcomatoid subtype (11 months) was statistically significant.

CONCLUSION

This study confirmed the activity of the carboplatin/ pemetrexed combination in the first-line treatment of patients with MPM. It is a viable option, especially in cases in which side effects are generally anticipated.

摘要

简介

恶性胸膜间皮瘤(MPM)是一种在全球范围内发病率不断上升的快速进展性肿瘤。治疗选择有限,对化疗的反应较差。本 II 期研究旨在评估卡铂/培美曲塞联合作为不可切除 MPM 患者一线化疗的疗效。

患者和方法

入组患者为组织学证实的 MPM 且东部肿瘤协作组体能状态为 0-2 的初治患者。治疗方案为培美曲塞 500mg/m2 和卡铂浓度-时间曲线下面积 5mg/mL/min,均于 21 天周期的第 1 天给药。治疗持续进行,直至完成 6 个周期,或出现不可耐受毒性或疾病进展。

结果

共入组 62 例患者。其中,18 例(29%)患者确认部分缓解,34 例(54.9%)患者疾病稳定,10 例(16.1%)患者疾病进展。总生存期(OS)的中位数估计为 14 个月(95%CI,11.8-16.2 个月),中位无进展生存期为 7 个月(95%CI,5.8-8.2 个月)。上皮组织学亚型(16 个月)和肉瘤样亚型(11 个月)之间的中位 OS 差异具有统计学意义。

结论

本研究证实了卡铂/培美曲塞联合在 MPM 患者一线治疗中的疗效。对于那些预计副作用普遍的患者来说,这是一种可行的选择。

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