Skip Navigation LinksHome > July 2014 - Volume 9 - Issue 7 > Final Efficacy and Safety Results of Pemetrexed Continuation...
Journal of Thoracic Oncology:
doi: 10.1097/JTO.0000000000000207
Original Articles

Final Efficacy and Safety Results of Pemetrexed Continuation Maintenance Therapy in the Elderly from the PARAMOUNT Phase III Study

Gridelli, Cesare MD*; de Marinis, Filippo MD; Thomas, Michael MD; Prabhash, Kumar MD§; El Kouri, Claude MD; Blackhall, Fiona MD; Bustin, Frederique MD#; Pujol, Jean-Louis MD**; John, William J. MD, FACP††; San Antonio, Belen PhD‡‡; Zimmermann, Annamaria MS††; Chouaki, Nadia MD§§; Visseren-Grul, Carla MD‖‖; Paz-Ares, Luis G. MD, PhD¶¶

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Abstract

Introduction:

The PARAMOUNT Phase III trial showed that maintenance pemetrexed after pemetrexed plus cisplatin induction was well tolerated and effective for patients with advanced nonsquamous non–small-cell lung cancer. Approximately 17% of patients receiving maintenance therapy in this study were 70 years of age or older. Here we report efficacy and safety results from the PARAMOUNT study for elderly (≥70 years) and non-elderly (<70 years) patients.

Methods:

Final efficacy and safety data from the PARAMOUNT study were analyzed post hoc using subgroup analyses for elderly and non-elderly patients.

Results:

The median age was 73 years in the elderly subgroup (n = 92) and 60 years in the non-elderly subgroup (n = 447). Subgroups had similar baseline characteristics, except for a higher percentage of males and patients with a performance status of one in the elderly subgroup. For elderly patients, the median PFS was 6.4 months for pemetrexed and 3.0 months for placebo; the median OS was 13.7 months for pemetrexed and 12.1 months for placebo. For non-elderly patients, the median PFS was 4.0 months for pemetrexed and 2.8 months for placebo; the median OS was 13.9 months for pemetrexed and 10.8 months for placebo. Elderly patients experienced similar levels of low-grade toxicities, but had a higher percentage of grade 3/4 anemia and neutropenia than non-elderly patients, although importantly, this did not translate into increased febrile neutropenia.

Conclusions:

Continuation maintenance pemetrexed had comparable survival and toxicity profiles in the elderly and non-elderly subgroups. However, grade 3/4 anemia and neutropenia were numerically higher for elderly patients.

Copyright © 2014 by the International Association for the Study of Lung Cancer

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