title: Health-related quality of life and colorectal cancer-specific symptoms in patients with chemotherapy-refractory metastatic disease treated with panitumumab.
abstract: OBJECTIVE
  Panitumumab monotherapy is approved for chemotherapy-refractory wild-type KRAS metastatic colorectal cancer (mCRC). Patient-reported outcomes-although important in the palliative setting-have not been reported in this patient population.
  
  
  METHODS
  In a phase 3 trial (n = 463), patients with chemotherapy-refractory mCRC were randomized 1:1 to panitumumab plus best supportive care (BSC) or BSC alone. Patient-reported outcomes were assessed using the NCCN/FACT CRC Symptom Index (FCSI) and EQ-5D Index. KRAS tumor status was analyzed in a prospectively defined, retrospective analysis. Average difference in change from baseline between treatment groups was evaluated using linear mixed and pattern-mixture models.
  
  
  RESULTS
  KRAS tumor status and post-baseline patient-reported outcomes were available for 363 patients. Linear mixed models indicated significant differences in the FCSI score (difference in least-squares [LS] adjusted means [95% CI]; 5.62 [2.38, 8.86]) and the EQ-5D Index (difference in LS adjusted means [95% CI]; 0.22 [0.12, 0.32]) favoring panitumumab over BSC in patients with wild-type KRAS mCRC. By pattern-mixture analysis, the advantage of panitumumab over BSC was more pronounced in those patients with wild-type KRAS mCRC who did not drop out of the study early. In patients with mutant KRAS mCRC, no differences were observed between groups.
  
  
  CONCLUSIONS
  Panitumumab-treated patients with wild-type KRAS mCRC maintained better control of CRC symptoms and quality of life compared with BSC alone, extending our understanding of the benefits of panitumumab treatment beyond improvements in progression-free survival.
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC 22709-2194, USA.
authors.forename: Dawn
authors.initials: D
authors.lastname: Odom
authors.forename: Beth
authors.initials: B
authors.lastname: Barber
authors.forename: Lee
authors.initials: L
authors.lastname: Bennett
authors.forename: Marc
authors.initials: M
authors.lastname: Peeters
authors.forename: Zhongyun
authors.initials: Z
authors.lastname: Zhao
authors.forename: James
authors.initials: J
authors.lastname: Kaye
authors.forename: Michael
authors.initials: M
authors.lastname: Wolf
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Wiezorek
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology*; D019008:Drug Resistance, Neoplasm; D006262:Health; D006801:Humans; D016018:Least-Squares Analysis; D016014:Linear Models; D009362:Neoplasm Metastasis; D000077544:Panitumumab; D011518:Proto-Oncogene Proteins / Q000235:genetics; D016283:Proto-Oncogene Proteins p21(ras); D011788:Quality of Life; D018631:ras Proteins / Q000235:genetics
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; C117307:KRAS protein, human; D011518:Proto-Oncogene Proteins; D000077544:Panitumumab; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins