培美曲塞单药或联合顺铂治疗腹膜间皮瘤患者的开放标签研究：扩大可及项目的结果

Open-label study of pemetrexed alone or in combination with cisplatin for the treatment of patients with peritoneal mesothelioma: outcomes of an expanded access program.

作者信息

Jänne Pasi A, Wozniak Anoinette J, Belani Chandra P, Keohan Mary-Louise, Ross Helen J, Polikoff Jonathan A, Mintzer David M, Taylor Loretta, Ashland Joseph, Ye Zhishen, Monberg Matthew J, Obasaju Coleman K

机构信息

Lowe Center for Thoracic Oncolgy, Dana-Farber Cancer Institute, Boston, MA, USA.

出版信息

Clin Lung Cancer. 2005 Jul;7(1):40-6. doi: 10.3816/CLC.2005.n.020.

DOI:10.3816/CLC.2005.n.020

PMID:16098243

Abstract

BACKGROUND

To date, few large studies have been reported of patients with peritoneal mesothelioma, and treatment of this disease has been largely extrapolated from the treatment of pleural disease. Hence, it was considered important to study and report on this specific patient population. Before the regulatory approval of pemetrexed, an expanded access program (EAP) provided access to eligible patients with malignant pleural or peritoneal mesothelioma.

PATIENTS AND METHODS

Patients received pemetrexed 500 mg/m2 alone or in combination with cisplatin 75 mg/m2 once every 21 days for > or = 6 cycles. All patients received folic acid, vitamin B12, and steroid prophylaxis. Serious adverse events (SAEs) were compiled in a pharmacovigilance database, which included all patients in the EAP with pleural or peritoneal mesothelioma. From June 12, 2002 to February 18, 2004, 1056 patients with malignant mesothelioma were enrolled and received > or = 1 dose of treatment at 462 sites in the United States. Of these patients, 98 (9.3%) had peritoneal mesothelioma (57 previously treated, 38 chemotherapy-naive, and 3 with missing data).

RESULTS

Response data were available for 73 patients (43 previously treated, 28 chemotherapy-naive, and 2 not classified), indicating response rates of 23.3% for previously treated patients (0 complete responses [CRs], 10 partial responses [PRs], 21 cases of stable disease [SDs], 12 cases of progressive disease [PDs]) and 25% for chemotherapy-naive patients (3 CRs, 4 PRs, 12 SDs, and 9 PDs). Median survival was 13.1 months for previously treated patients and has not been reached for chemotherapy-naive patients. The most commonly reported SAEs for the total EAP were dehydration (7.2%), nausea (5.2%), and vomiting (4.9%).

CONCLUSION

Pemetrexed with or without cisplatin had a favorable safety profile, and the disease control rate (CR + PR + SD) of 71.2% in the subset of patients with peritoneal mesothelioma indicated activity in this patient population.

摘要

背景

迄今为止，关于腹膜间皮瘤患者的大型研究报道较少，该疾病的治疗方法大多是从胸膜疾病的治疗中推断而来。因此，研究并报告这一特定患者群体被认为很重要。在培美曲塞获得监管批准之前，一项扩大准入计划（EAP）为符合条件的恶性胸膜或腹膜间皮瘤患者提供了用药机会。

患者与方法

患者接受培美曲塞500mg/m²，单独使用或与顺铂75mg/m²联合使用，每21天一次，共进行≥6个周期。所有患者均接受叶酸、维生素B12和类固醇预防用药。严重不良事件（SAEs）被汇总到一个药物警戒数据库中，该数据库包括EAP中所有患有胸膜或腹膜间皮瘤的患者。从2002年6月12日至2004年2月18日，1056例恶性间皮瘤患者在美国462个地点入组并接受了≥1剂治疗。其中，98例（9.3%）患有腹膜间皮瘤（57例曾接受过治疗，38例未接受过化疗，3例数据缺失）。

结果

73例患者（43例曾接受过治疗，28例未接受过化疗，2例未分类）有疗效数据，表明曾接受过治疗的患者缓解率为23.3%（0例完全缓解[CR]，10例部分缓解[PR]，21例病情稳定[SD]，12例病情进展[PD]）；未接受过化疗的患者缓解率为25%（3例CR，4例PR，12例SD，9例PD）。曾接受过治疗的患者中位生存期为13.1个月，未接受过化疗的患者中位生存期尚未达到。整个EAP中最常报告的SAEs为脱水（7.2%）、恶心（5.2%）和呕吐（4.9%）。