title: Quality of Life Analysis in Patients With RAS Wild-Type Metastatic Colorectal Cancer Treated With First-Line Cetuximab Plus Chemotherapy.
abstract: Adding cetuximab to FOLFIRI (5-fluorouracil, leucovorin, irinotecan) significantly improved progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in patients with KRAS or RAS (KRAS/NRAS, exons 2-4) wild-type (wt) metastatic colorectal cancer (mCRC) in the first-line CRYSTAL study. The present exploratory and descriptive retrospective analysis assessed the quality of life (QoL) of CRYSTAL study patients with RAS wt mCRC-the labeled indication for cetuximab in many countries.
  
  
  
  Patient QoL was investigated using the European Organisation for Research and Treatment of Cancer QoL questionnaire core-30 (EORTC QLQ-C30). QoL assessments were performed at baseline, after every 8 weeks of treatment, and at the final tumor assessment. RAS wt patients were considered evaluable for QoL if they had provided ≥ 1 evaluable EORTC QLQ-C30.
  
  
  
  Of the 367 patients with RAS wt tumors, 351 were evaluable for QoL. Global health status (GHS)/QoL and the time to worsening of Eastern Cooperative Oncology Group performance status were similar between the treatment groups. However, the analysis was complicated by a large decrease in the number of evaluable patients in the FOLFIRI arm between weeks 32 and 40. The individual dimensions of interest in mCRC (eg, social functioning, fatigue, nausea/vomiting, pain, appetite loss, constipation, diarrhea, and functional difficulties) were also similar between the treatment arms. Changes in GHS/QoL and social functioning from baseline to week 8 were similar, irrespective of whether patients experienced early skin reactions.
  
  
  
  The findings of the present descriptive retrospective analysis suggest that adding cetuximab to first-line FOLFIRI improves PFS, OS, and ORR without negatively affecting the QoL of CRYSTAL study patients with RAS wt mCRC.
authors.affiliation: Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. Electronic address: kensei.yamaguchi@jfcr.or.jp.
authors.forename: Kensei
authors.initials: K
authors.lastname: Yamaguchi
authors.affiliation: Center for Advanced Medicine and Clinical Research, Nagoya University Graduate School of Medicine, Aichi, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ando
authors.affiliation: Department of Gastroenterology, Saitama Cancer Center Hospital, Saitama, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Ooki
authors.affiliation: Merck KGaA, Darmstadt, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Beier
authors.affiliation: Merck KGaA, Darmstadt, Germany.
authors.forename: Silke
authors.initials: S
authors.lastname: Guenther
authors.affiliation: Merck KGaA, Darmstadt, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: von Hohnhorst
authors.affiliation: Digestive Oncology, University Hospitals Leuven and University of Leuven, Leuven, Belgium.
authors.forename: Eric
authors.initials: E
authors.lastname: Van Cutsem
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000068818:Cetuximab / Q000008:administration & dosage; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016283:Proto-Oncogene Proteins p21(ras) / Q000235:genetics*; D011788:Quality of Life; D012189:Retrospective Studies; D015996:Survival Rate; D055815:Young Adult; D018631:ras Proteins / Q000235:genetics
chemical_list: C117307:KRAS protein, human; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins; D000068818:Cetuximab; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: CRYSTAL; FOLFIRI; Global health status (GHS); QoL; mCRC