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Final efficacy and safety results of pemetrexed continuation maintenance therapy in the elderly from the PARAMOUNT phase III study.
- Source :
-
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer [J Thorac Oncol] 2014 Jul; Vol. 9 (7), pp. 991-997. - Publication Year :
- 2014
-
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.<br />Methods: Final efficacy and safety data from the PARAMOUNT study were analyzed post hoc using subgroup analyses for elderly and non-elderly patients.<br />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.<br />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.
- Subjects :
- Age Factors
Aged
Anemia chemically induced
Antimetabolites, Antineoplastic adverse effects
Disease-Free Survival
Double-Blind Method
Female
Glutamates adverse effects
Guanine adverse effects
Guanine therapeutic use
Humans
Male
Middle Aged
Neutropenia chemically induced
Pemetrexed
Survival Rate
Antimetabolites, Antineoplastic therapeutic use
Carcinoma, Non-Small-Cell Lung drug therapy
Glutamates therapeutic use
Guanine analogs & derivatives
Lung Neoplasms drug therapy
Maintenance Chemotherapy adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1556-1380
- Volume :
- 9
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 24926544
- Full Text :
- https://doi.org/10.1097/JTO.0000000000000207