title: Final efficacy and safety results of pemetrexed continuation maintenance therapy in the elderly from the PARAMOUNT phase III study.
abstract: BACKGROUND
  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.affiliation: Division of Medical Oncology, S. Giuseppe Moscati Hospital, Avellino, Italy. Electronic address: cgridelli@libero.it.
authors.forename: Cesare
authors.initials: C
authors.lastname: Gridelli
authors.affiliation: Department of Lung Diseases, San Camillo Hospital, Rome, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: de Marinis
authors.affiliation: Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg (TLRC-H), Heidelberg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
authors.forename: Kumar
authors.initials: K
authors.lastname: Prabhash
authors.affiliation: Centre Catherine De Sienne, Nantes, France.
authors.forename: Claude
authors.initials: C
authors.lastname: El Kouri
authors.affiliation: Christie Hospital NHS Foundation Trust, Manchester, England.
authors.forename: Fiona
authors.initials: F
authors.lastname: Blackhall
authors.affiliation: CHR La Citadelle, Liege, Belgium.
authors.forename: Frederique
authors.initials: F
authors.lastname: Bustin
authors.affiliation: Centre Hospitalier Regional Universitaire de Montpellier, Montpellier, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Pujol
authors.affiliation: Eli Lilly and Company, Indianapolis, IN.
authors.forename: William J
authors.initials: WJ
authors.lastname: John
authors.affiliation: Eli Lilly and Company, Madrid, Spain.
authors.forename: Belen
authors.initials: B
authors.lastname: San Antonio
authors.affiliation: Eli Lilly and Company, Indianapolis, IN.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Zimmermann
authors.affiliation: Eli Lilly and Company, Neuilly-sur-Seine Cedex, France.
authors.forename: Nadia
authors.initials: N
authors.lastname: Chouaki
authors.affiliation: Eli Lilly and Company, Houten, The Netherlands.
authors.forename: Carla
authors.initials: C
authors.lastname: Visseren-Grul
authors.affiliation: University Hospital, Virgen del Rocio, Seville, Spain.
authors.forename: Luis G
authors.initials: LG
authors.lastname: Paz-Ares
mesh_terms: D000367:Age Factors; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005971:Glutamates / Q000009:adverse effects / Q000627:therapeutic use*; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D060046:Maintenance Chemotherapy / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D000068437:Pemetrexed; D015996:Survival Rate
chemical_list: D000964:Antimetabolites, Antineoplastic; D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine