Abstract | BACKGROUND: METHODS:
Chemotherapy naïve patients with unresectable MPM were stratified by histology and performance status, and randomized 2:1 to pemetrexed/ cisplatin plus CBP501 25mg/m(2) IV (Arm A) or pemetrexed/ cisplatin alone (Arm B). The primary endpoint was progression free survival (PFS) at 4 months. RESULTS: 65 patients were randomized, and 63 were treated. Patient characteristics in the two arms were balanced. Based on independent radiology review of the treated population, 25/40 patients (63%) in Arm A and 9/23 (39%) in Arm B had PFS≥4mo; the median PFS was 5.1mo (95% CI, 3.9, 6.5) vs 3.4mo (2.5, 6.7). Median OS was 13.3mo (9.2, 16.3) in Arm A and 12.8 (6.5, 16.1) in Arm B. Adverse events were not different than expected from standard chemotherapy, and comparable in the two arms, aside from infusion reactions which occurred in 70% of patients treated with CBP501. CONCLUSIONS: While this randomized phase II trial met its primary endpoint of PFS at 4 months, other parameters such as response rate and overall survival suggest that the addition of CBP501 does not improve the efficacy of standard chemotherapy for MPM.
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Authors | L M Krug, A J Wozniak, H L Kindler, R Feld, M Koczywas, J L Morero, C P Rodriguez, H J Ross, J E Bauman, S V Orlov, J C Ruckdeschel, A C Mita, L Fein, X He, R Hall, T Kawabe, S Sharma |
Journal | Lung cancer (Amsterdam, Netherlands)
(Lung Cancer)
Vol. 85
Issue 3
Pg. 429-34
(Sep 2014)
ISSN: 1872-8332 [Electronic] Ireland |
PMID | 25047675
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 Elsevier Ireland Ltd. All rights reserved. |
Chemical References |
- Cdc25C phosphatase (211-221)
- Glutamates
- Peptide Fragments
- Pemetrexed
- Guanine
- cdc25 Phosphatases
- Cisplatin
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Cisplatin
(administration & dosage)
- Female
- Glutamates
(administration & dosage)
- Guanine
(administration & dosage, analogs & derivatives)
- Humans
- Lung Neoplasms
(drug therapy, mortality, pathology)
- Male
- Mesothelioma
(drug therapy, mortality, pathology)
- Mesothelioma, Malignant
- Middle Aged
- Neoplasm Staging
- Pemetrexed
- Peptide Fragments
(administration & dosage)
- Treatment Outcome
- cdc25 Phosphatases
(administration & dosage)
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