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

• Published in: Journal of thoracic oncology Vol. 9; no. 7; pp. 991 - 997
• Main Authors: Gridelli, Cesare, de Marinis, Filippo, Thomas, Michael, Prabhash, Kumar, El Kouri, Claude, Blackhall, Fiona, Bustin, Frederique, Pujol, Jean-Louis, John, William J., San Antonio, Belen, Zimmermann, Annamaria, Chouaki, Nadia, Visseren-Grul, Carla, Paz-Ares, Luis G.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2014; Copyright by the European Lung Cancer Conference and the International Association for the Study of Lung Cancer
• Subjects: Age Factors; Aged; Anemia - chemically induced; Antimetabolites, Antineoplastic - adverse effects; Antimetabolites, Antineoplastic - therapeutic use; Carcinoma, Non-Small-Cell Lung - drug therapy; Disease-Free Survival; Double-Blind Method; Elderly; Female; Glutamates - adverse effects; Glutamates - therapeutic use; Guanine - adverse effects; Guanine - analogs & derivatives; Guanine - therapeutic use; Humans; Lung Neoplasms - drug therapy; Maintenance Chemotherapy - adverse effects; Maintenance therapy; Male; Middle Aged; Neutropenia - chemically induced; Non–small-cell lung cancer; Pemetrexed; Survival Rate; Non–small-cell lung cancer; Maintenance therapy; Pemetrexed; Elderly
• ISSN: 1556-0864; 1556-1380; 1556-1380
• DOI: 10.1097/JTO.0000000000000207

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