TY - JOUR
T1 - Malignant peritoneal mesothelioma-Results from the International Expanded Access Program using pemetrexed alone or in combination with a platinum agent
AU - Carteni, G.
AU - Manegold, C.
AU - Garcia, G. Martin
AU - Siena, S.
AU - Zielinski, C. C.
AU - Amadori, D.
AU - Liu, Y.
AU - Blatter, J.
AU - Visseren-Grul, C.
AU - Stahel, R.
PY - 2009/5
Y1 - 2009/5
N2 - Aim: Peritoneal mesothelioma (PM) has rarely been studied. The Expanded Access Program (EAP) provided access to 109 patients with PM. Methods: This was a nonrandomized, open-label study conducted in chemo-naïve or previously treated patients with PM not amenable to curative surgery. Patients received pemetrexed (PEM) 500 mg/m2 alone or with cisplatin (CIS) 75 mg/m2 or carboplatin (CARBO) AUC 5 every 21 days, supplemented with standard vitamin B12, folate, and dexamethasone. Results: Response rates (95% CI) for PEM, PEM/CIS, and PEM/CARBO were 12.5% (3.5, 29.0), 20.0% (7.7, 38.6), and 24.1% (10.3, 43.5), respectively. Median survival for PEM was 10.3 months. One-year survival rates for PEM/CIS and PEM were 57.4% (95% CI: 10.3, 100) and 41.5% (95% CI: 4.6, 78.4), respectively, and were not available for PEM/CARBO. Anemia was the most common serious adverse event (6.4%). Neutropenia (34.6%) was the most frequent CTC grade 3 or 4 toxicity reported. Concluding statement: PEM with or without a platinum agent was both active and well tolerated in patients with peritoneal mesothelioma.
AB - Aim: Peritoneal mesothelioma (PM) has rarely been studied. The Expanded Access Program (EAP) provided access to 109 patients with PM. Methods: This was a nonrandomized, open-label study conducted in chemo-naïve or previously treated patients with PM not amenable to curative surgery. Patients received pemetrexed (PEM) 500 mg/m2 alone or with cisplatin (CIS) 75 mg/m2 or carboplatin (CARBO) AUC 5 every 21 days, supplemented with standard vitamin B12, folate, and dexamethasone. Results: Response rates (95% CI) for PEM, PEM/CIS, and PEM/CARBO were 12.5% (3.5, 29.0), 20.0% (7.7, 38.6), and 24.1% (10.3, 43.5), respectively. Median survival for PEM was 10.3 months. One-year survival rates for PEM/CIS and PEM were 57.4% (95% CI: 10.3, 100) and 41.5% (95% CI: 4.6, 78.4), respectively, and were not available for PEM/CARBO. Anemia was the most common serious adverse event (6.4%). Neutropenia (34.6%) was the most frequent CTC grade 3 or 4 toxicity reported. Concluding statement: PEM with or without a platinum agent was both active and well tolerated in patients with peritoneal mesothelioma.
KW - Carboplatin
KW - Cisplatin
KW - Compassionate-use program
KW - Expanded Access Program (EAP)
KW - Pemetrexed
KW - Peritoneal mesothelioma
KW - Platinum
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U2 - 10.1016/j.lungcan.2008.08.013
DO - 10.1016/j.lungcan.2008.08.013
M3 - Article
C2 - 19042053
AN - SCOPUS:63449105164
VL - 64
SP - 211
EP - 218
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 2
ER -