Pemetrexed plus cisplatin or pemetrexed plus carboplatin for chemonaive patients with malignant pleural mesothelioma: Results of the International Expanded Access Program

Santoro, Armando; O'Brien, Mary E; Stahel, Rolf A; Nackaerts, Kristiaan; Baas, Paul; Karthaus, Meinolf; Eberhardt, Wilfried; Paz-Ares, Luis; Sundstrom, Stein; Liu, Yushan; Ripoche, Veronique; Blatter, Johannes; Visseren-Grul, Carla M; Manegold, Christian

doi:10.1097/JTO.0b013e31817c73d6

Pemetrexed plus cisplatin or pemetrexed plus carboplatin for chemonaive patients with malignant pleural mesothelioma: Results of the International Expanded Access Program

Author:

Santoro, Armando

O'Brien, Mary E ; Stahel, Rolf A ; Nackaerts, Kristiaan ; Baas, Paul ; Karthaus, Meinolf ; Eberhardt, Wilfried ; Paz-Ares, Luis ; Sundstrom, Stein ; Liu, Yushan ; Ripoche, Veronique ; Blatter, Johannes ; Visseren-Grul, Carla M ; Manegold, Christian

Keywords:

mesothelioma, cisplatin, carboplatin, pemetrexed, expanded access program, malignant pleural mesothelioma, phase-ii, open-label, combination chemotherapy, patients pts, cancer, doxorubicin, platinum, outcomes, eap, mpm, Science & Technology, Life Sciences & Biomedicine, Oncology, Respiratory System, PHASE-II, OPEN-LABEL, COMBINATION CHEMOTHERAPY, PATIENTS PTS, CANCER, DOXORUBICIN, PLATINUM, OUTCOMES, EAP, MPM, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carboplatin, Cisplatin, Disease Progression, Female, Folic Acid Antagonists, Glutamates, Guanine, Humans, Male, Mesothelioma, Middle Aged, Pemetrexed, Pleural Neoplasms, Survival Rate, Thymidylate Synthase, 1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences, 1112 Oncology and Carcinogenesis, Oncology & Carcinogenesis, 3202 Clinical sciences, 3211 Oncology and carcinogenesis

Abstract:

Introduction: Previously published results from a randomized phase III study of pemetrexed plus cisplatin in patients with malignant pleural mesothelioma (MPM) demonstrated a significant survival benefit and higher response rate compared with cisplatin. Although pernetrexed was under review by regulatory agencies, an International Expanded Access Program (EAP) provided more than 3000 mesothelioma patients with access to single-agent pemetrexed or pernetrexed in combination with cisplatin or carboplatin in 13 countries. This manuscript reports the safety and efficacy data from the nonrandomized open-label study in chemonaive patients receiving pernetrexed plus platinum under the EAP.