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Medline ® Abstract for Reference 53

of 'Systemic therapy for the initial management of advanced non-small cell lung cancer without a driver mutation'

Final efficacy and safety results of pemetrexed continuation maintenance therapy in the elderly from the PARAMOUNT phase III study.
Gridelli C, de Marinis F, Thomas M, Prabhash K, El Kouri C, Blackhall F, Bustin F, Pujol JL, John WJ, San Antonio B, Zimmermann A, Chouaki N, Visseren-Grul C, Paz-Ares LG
J Thorac Oncol. 2014;9(7):991.
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.
*Division of Medical Oncology, S. Giuseppe Moscati Hospital, Avellino, Italy;†Department of Lung Diseases, San Camillo Hospital, Rome, Italy;‡Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg (TLRC-H), Heidelberg, Germany;§Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India;‖Centre Catherine De Sienne, Nantes, France;¶Christie Hospital NHS Foundation Trust, Manchester, England; #CHR La Citadelle, Liege, Belgium; **Centre Hospitalier Regional Universitaire de Montpellier, Montpellier, France;††Eli Lilly and Company, Indianapolis, IN;‡‡Eli Lilly and Company, Madrid, Spain;§§Eli Lilly and Company, Neuilly-sur-Seine Cedex, France;‖‖Eli Lilly and Company, Houten, The Netherlands; and¶¶University Hospital, Virgen del Rocio, Seville, Spain.