Skip Navigation LinksHome > August 2007 - Volume 2 - Issue 8 > Open-label study of pemetrexed alone or in combination with...
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

Free Access
Article Outline
Collapse Box

Author Information

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

Back to Top | Article Outline

Background:

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.

Back to Top | Article Outline

Methods:

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.

Back to Top | Article Outline

Results:

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.

Back to Top | Article Outline

Conclusions:

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.

Table. No caption av...
Image Tools

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.
10.1097/JTO.0b013e31817c73ec
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.
10.1097/JTO.0b013e31817c73d6
PDF (327) | CrossRef
Back to Top | Article Outline

Copyright © 2007 by the European Lung Cancer Conference and the International Association for the Study of Lung Cancer.

Login

Article Tools

Images

Share

Other Ways to Connect

Twitter
twitter.com/JTOonline

 



Visit JTO.org on your smartphone. Scan this code (QR reader app required) with your phone and be taken directly to the site.

 For additional oncology content, visit LWW Oncology Journals on Facebook.