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Journal of Thoracic Oncology:
doi: 10.1097/01.JTO.0000283216.33273.f0
Profferred Paper Abstracts: Session C5: Mesothelioma: Wednesday, September 5: Mesothelioma, Wed, 10:30 - 12:15

Open-label study of pemetrexed alone or in combination with a platinum in chemonaïve patients (pts) with malignant pleural mesothelioma (MPM): Results from the International Expanded Access Program (EAP): C5-01

Manegold, Christian1; Santoro, Armando2; O'Brien, Mary E.r.3; Stahel, Rolf A.4; Nackaerts, Kristiaan5; Bass, Paul6; Paz-Ares, Luis7; Sundstrom, Stein8; Visseren-Grul, Carla9; Blatter, Johannes10

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1 Heidelberg University Medical Center, Mannheim, Germany 2 Istituto Clinico Humanitas, Milano, Italy 3 Royal Marsden Hospital, Sutton, UK 4 Clinic and Policlinic of Oncology, Zurich, Switzerland 5 University Hospital Gasthuisberg, Leuven, Belgium 6 Netherlands Cancer Institute, Amsterdam, The Netherlands 7 Hospital Universitario Doce de Octubr, Madrid, Spain 8 St. Olavs University Hospital, Trondheim, Norway 9 Eli Lilly Netherlands, Utrecht, The Netherlands 10 Eli Lilly, Bad Homburg, Germany

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An EAP was developed for the use of pemetrexed (P) in patients with MPM before and during review by regulatory agencies. Previous studies showed promising results for the use of single-agent P or the combination of P+platinum for chemonaive pts with MPM. The phase II study (Scagliotti 2003) of P showed a response rate (RR) of 14.1% (95% CI 6.6, 25.0), time to progressive disease (TtPD) of 4.7 mos (95% CI 4.2, 5.8), and median survival time of 10.7 mos (95% CI 7.7, 14.5), with a 1-yr survival rate of 47.8%. The phase III study of P+cisplatin (Cis) versus Cis in MPM demonstrated a significantly different RR (41.3% vs 16.7% p<0.001), TtPD (5.7 mos vs 3.9 mos, p=0.001), and survival benefit (median survival: 12.1 mos vs 9.3 mos, p=0.020; 1-yr survival: 50.3% vs 38.0%, p=0.012) in favor of P+Cis (Vogelzang 2003). The EAP provided access to P alone or P plus Cis or carboplatin (Cb) for 3312 pts in 13 countries. Safety and efficacy data for chemonaïve pts receiving P or P+platinum are summarized in this abstract.

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Eligible pts had histologic or cytologic diagnosis of MPM not amenable to curative surgery. P 500 mg/m2 alone or in combination with either Cis 75 mg/m2 or Cb AUC 5 was given on day 1 of each 21-day cycle, with standard premedication consisting of vitamin B12, folic acid, and dexamethasone. Investigator-determined best response (RR) and survival data (with censoring) were recorded at the end of study participation. Myelosuppression data (NCI CTC, version 2.0) were also collected.

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In this nonrandomized, open-label study 2023 chemonaïve pts received ? 1 dose of P (319 pts), P+Cis (843 pts) or P+Cb (861 pts) and were evaluable for safety. Of the study participants, 247 P pts, 745 P+Cis pts, and 752 P+Cb pts were evaluable for efficacy. Baseline characteristics, and efficacy and safety data are summarized in the table.

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In this large, nonrandomized study, all three treatment arms (P, P+Cis, and P+Cb) had clinically similar one-year survival rates, whereas the combination arms had higher response rates than P alone. These results confirm the efficacy of P or P+platinum in the treatment of chemonaive pts with MPM.

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Cited By:

This article has been cited 2 time(s).

Journal of Thoracic Oncology
Single-Agent Pemetrexed for Chemonaïve and Pretreated Patients with Malignant Pleural Mesothelioma: Results of an International Expanded Access Program
Taylor, P; Castagneto, B; Dark, G; Marangolo, M; Scagliotti, GV; van Klaveren, RJ; Labianca, R; Serke, M; Schuette, W; van Meerbeeck, JP; Heigener, D; Liu, Y; Adachi, S; Blatter, J; von Pawel, J
Journal of Thoracic Oncology, 3(7): 764-771.
PDF (473) | CrossRef
Journal of Thoracic Oncology
Pemetrexed Plus Cisplatin or Pemetrexed Plus Carboplatin for Chemonaïve Patients with Malignant Pleural Mesothelioma: Results of the International Expanded Access Program
Manegold, C; Santoro, A; O’Brien, ME; Stahel, RA; Nackaerts, K; Baas, P; Karthaus, M; Eberhardt, W; Paz-Ares, L; Sundstrom, S; Liu, Y; Ripoche, V; Blatter, J; Visseren-Grul, CM
Journal of Thoracic Oncology, 3(7): 756-763.
PDF (327) | CrossRef
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Copyright © 2007 by the European Lung Cancer Conference and the International Association for the Study of Lung Cancer.


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