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- W2280722450 abstract "e19084 Background: Approximately 1000 patients are newly diagnosed as malignant pleural mesothelioma (MPM) each year in Japan, however MPM patient profile and their outcome are not well understood. Pemetrexed is the only approved chemotherapeutic agent for MPM. Limited safety information was available at launch of pemetrexed in Japan where drug induced interstitial pneumonitis are reported at higher rate than the rest of the world. Therefore postmarketing drug registered study (PDRS) for pemetrexed was conducted in Japan to investigate patient characteristics, adverse events and survival of MPM patients based on a regulatory requirement for approval. Methods: From February 2007 to May 2008, all of histologically proven MPM patients to be treated with pemetrexed were required to register the PDRS in Japan. The observation period was six-months. Supply of pemetrexed was restricted to institutes with experienced medical oncologists based on pre-determined criteria. Results: During the 15-months enrollment period, 948 MPM patients were registered. Until August 3 th 2008, data for 437 patients were collected. Among these, 389 were male, 48 female, median of age 65 (35–86). 72.3% patients had a known history of being exposed to asbestos. The treatment regimen mainly consists of 500 mg/m 2 of pemetrexed and 75 mg/m 2 of cisplatin every 21 days. Median treatment cycle was 3.0. Hematological NCI-CTC Grade ¾ adverse events in laboratory data were hemoglobin decrease 19.9 %, neutropenia 20.1%, thrombocytopenia 7.6%. Serious non-hematological adverse events were nausea 3%, vomiting 3.2%, fatigue 0.2%, constipation 0.2%, diarrhea 0.9%. Pneumotoxicity was found in 1.4%. 152 deaths (34.8%) were observed and six-month survival rate estimated by Kaplan-Meier method was 70.9%. Conclusions: This large size PDRS shows that safety profile of pemetrexed appeared similar to the previous clinical trial without additional safety signal. The study has minimum selection bias and provides useful information to health care professionals on safety and effectiveness of pemetrexed in real clinical setting in Japan. [Table: see text]" @default.
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- W2280722450 date "2009-05-20" @default.
- W2280722450 modified "2023-09-27" @default.
- W2280722450 title "Safety and effectiveness of malignant pleural mesothelioma patients treated with pemetrexed: A postmarketing drug registered study under performance linked access system" @default.
- W2280722450 doi "https://doi.org/10.1200/jco.2009.27.15_suppl.e19084" @default.
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