培美曲塞联合卡铂治疗恶性胸膜间皮瘤（MPM）患者的II期研究。

Phase II study of pemetrexed in combination with carboplatin in patients with malignant pleural mesothelioma (MPM).

作者信息

Castagneto B, Botta M, Aitini E, Spigno F, Degiovanni D, Alabiso O, Serra M, Muzio A, Carbone R, Buosi R, Galbusera V, Piccolini E, Giaretto L, Rebella L, Mencoboni M

机构信息

Department of Oncology, Novi Ligure Hospital, viale Giolitti, Novi Ligure (AL), Italy.

出版信息

Ann Oncol. 2008 Feb;19(2):370-3. doi: 10.1093/annonc/mdm501. Epub 2007 Dec 20.

DOI:10.1093/annonc/mdm501

PMID:18156144

Abstract

BACKGROUND

The aim of this study was to evaluate the activity and toxicity of pemetrexed and carboplatin combination as first-line chemotherapy in malignant pleural mesothelioma (MPM).

PATIENTS AND METHODS

Patients with measurable advanced MPM and a zero to two Eastern Cooperative Oncology Group (ECOG) performance status (PS) were enrolled. The schedule was pemetrexed 500 mg/m(2) in combination with carboplatin area under the curve 5, every 21 days. In all, 76 patients were treated. Median age was 65 years; median ECOG PS was zero.

RESULTS

Grade 3 hematological toxicity according to World Health Organization criteria was seen in 36 (47.3%) patients; grade 4 hematological toxicity in 5 (6.5%) patients. There were 16 (21%) partial responses and 3 (4%) complete responses, for an overall response rate of 19 (25%) [95% confidence interval (CI) 15.3-34.7]. In all, 29 (39%) (95% CI 28-48) patients reported stable disease. The median survival was estimated at 14 months.

CONCLUSION

This combination of carboplatin and pemetrexed is moderately active and the toxicity is acceptable.

摘要

背景

本研究旨在评估培美曲塞与卡铂联合作为恶性胸膜间皮瘤（MPM）一线化疗的活性和毒性。

患者与方法

纳入具有可测量的晚期MPM且东部肿瘤协作组（ECOG）体能状态（PS）为0至2的患者。方案为培美曲塞500mg/m²联合卡铂曲线下面积为5，每21天一次。共治疗76例患者。中位年龄为65岁；中位ECOG PS为0。

结果

根据世界卫生组织标准，36例（47.3%）患者出现3级血液学毒性；5例（6.5%）患者出现4级血液学毒性。有16例（21%）部分缓解和3例（4%）完全缓解，总缓解率为19例（25%）[95%置信区间（CI）15.3 - 34.7]。共有29例（39%）（95% CI 28 - 48）患者报告疾病稳定。中位生存期估计为14个月。