title: Safety and resource utilization by non-small cell lung cancer histology: results from the randomized phase III study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaïve patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  A prespecified analysis of the large, randomized, phase III study in advanced non-small cell lung cancer showed significant improvement in survival for nonsquamous patients treated with pemetrexed/cisplatin versus gemcitabine/cisplatin. Selected grade 3/4 toxicities and resource utilization favored pemetrexed in the overall population, but detailed safety results by histology have not been reported.
  
  
  METHODS
  Treated patients were included in this analysis of safety by histology. At each cycle, adverse events were assessed, and concomitant medications, transfusions, and hospitalizations were recorded. Measures were summarized by histology and compared between arms with Fisher's exact test.
  
  
  RESULTS
  When analyzed by squamous and nonsquamous histology, safety and resource utilization for each treatment arm paralleled those of the overall population. Selected toxicities did not vary by histology. Concomitant medication use and hospitalizations were also very similar to the patterns observed in the overall population.
  
  
  CONCLUSIONS
  Although previous efficacy analyses showed a significant pemetrexed treatment advantage for nonsquamous patients, results of this analysis indicate that safety and resource utilization do not vary by histology and are consistent with the overall population. The safety and resource utilization of patients treated with pemetrexed/cisplatin are predictable, reproducible, and consistent with the established favorable safety profile of pemetrexed, regardless of histology.
authors.affiliation: Thoracic Oncology Unit, University of Torino, San Luigi Hospital, Torino, Italy. silvia.novello@unito.it
authors.forename: Silvia
authors.initials: S
authors.lastname: Novello
authors.forename: Francisco Luis
authors.initials: FL
authors.lastname: Pimentel
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Douillard
authors.forename: Mary
authors.initials: M
authors.lastname: O'Brien
authors.forename: Joachim
authors.initials: J
authors.lastname: von Pawel
authors.forename: John
authors.initials: J
authors.lastname: Eckardt
authors.forename: Astra M
authors.initials: AM
authors.lastname: Liepa
authors.forename: Lorinda
authors.initials: L
authors.lastname: Simms
authors.forename: Carla
authors.initials: C
authors.lastname: Visseren-Grul
authors.forename: Luis
authors.initials: L
authors.lastname: Paz-Ares
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001803:Blood Transfusion; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005500:Follow-Up Studies; D005971:Glutamates / Q000008:administration & dosage; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives; D006295:Health Resources / Q000706:statistics & numerical data; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D003841:Deoxycytidine; D006147:Guanine; D002945:Cisplatin; D000093542:Gemcitabine