Final efficacy and safety results of pemetrexed continuation maintenance therapy in the elderly from the PARAMOUNT phase III study.

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.

• Authors: Cesare Gridelli, Filippo de Marinis, Michael Thomas, Kumar Prabhash, Claude El Kouri, Fiona Blackhall, Frederique Bustin, Jean-Louis Pujol, William J John, Belen San Antonio, Annamaria Zimmermann, Nadia Chouaki, Carla Visseren-Grul, Luis G Paz-Ares
• Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 9 Issue 7 Pg. 991-997 (Jul 2014) ISSN: 1556-1380 [Electronic] United States
• PMID: 24926544 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antimetabolites, Antineoplastic
• Glutamates
• Pemetrexed
• Guanine

Topics

• Age Factors
• Aged
• Anemia (chemically induced)
• Antimetabolites, Antineoplastic (adverse effects, therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy)
• Disease-Free Survival
• Double-Blind Method
• Female
• Glutamates (adverse effects, therapeutic use)
• Guanine (adverse effects, analogs & derivatives, therapeutic use)
• Humans
• Lung Neoplasms (drug therapy)
• Maintenance Chemotherapy (adverse effects)
• Male
• Middle Aged
• Neutropenia (chemically induced)
• Pemetrexed
• Survival Rate