title: Quality of life analysis in patients with KRAS wild-type metastatic colorectal cancer treated first-line with cetuximab plus irinotecan, fluorouracil and leucovorin.
abstract: BACKGROUND
  In the CRYSTAL study adding cetuximab to first-line FOLFIRI significantly improved outcome in patients with KRAS wild-type metastatic colorectal cancer. Quality of life (QoL) was assessed, and associations with tumour response and survival were investigated.
  
  
  METHODS
  The European Organization for Research and Treatment of Cancer QoL questionnaire-core 30 was used, focusing on global health status (GHS)/QoL and social functioning scales. Radiological response was assessed by an independent review committee.
  
  
  RESULTS
  QoL was evaluable in 627/666 patients (94%) with KRAS wild-type tumours; of these 52% received FOLFIRI, and 48% FOLFIRI plus cetuximab. Pattern mixture analysis revealed no significant differences for GHS/QoL (P=0.12) and social functioning scores (P=0.43) between the treatment arms. In additional analyses: early skin reactions in patients receiving cetuximab did not significantly affect these QoL scales, and tumour response was more common (58% versus 40%, P=0.0002) and survival longer (Hazard ratio 1.68, P<0.0001) in asymptomatic compared with symptomatic patients at baseline. Adding cetuximab to FOLFIRI was associated with significantly higher tumour response irrespective of patient baseline symptomatic status, and enhanced symptom relief from baseline in those whose tumours had responded.
  
  
  CONCLUSIONS
  Adding cetuximab to FOLFIRI improved response rate and survival without either improving or negatively impacting on GHS/QoL and social functioning.
authors.affiliation: Department of Medical Oncology and Clinical Pharmacology B, National Institute of Oncology, Budapest, Hungary. lang@oncol.hu
authors.forename: István
authors.initials: I
authors.lastname: Láng
authors.forename: Claus-Henning
authors.initials: CH
authors.lastname: Köhne
authors.forename: Gunnar
authors.initials: G
authors.lastname: Folprecht
authors.forename: Philippe
authors.initials: P
authors.lastname: Rougier
authors.forename: Desmond
authors.initials: D
authors.lastname: Curran
authors.forename: Erika
authors.initials: E
authors.lastname: Hitre
authors.forename: Ute
authors.initials: U
authors.lastname: Sartorius
authors.forename: Ingolf
authors.initials: I
authors.lastname: Griebsch
authors.forename: Eric
authors.initials: E
authors.lastname: Van Cutsem
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000201:enzymology* / Q000235:genetics / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011518:Proto-Oncogene Proteins / Q000235:genetics*; D016283:Proto-Oncogene Proteins p21(ras); D011788:Quality of Life; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D055815:Young Adult; D018631:ras Proteins / Q000235:genetics*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C117307:KRAS protein, human; D011518:Proto-Oncogene Proteins; D000077146:Irinotecan; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins; D000068818:Cetuximab; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin