title: Patient-reported outcomes and quality of life in PROFILE 1007: a randomized trial of crizotinib compared with chemotherapy in previously treated patients with ALK-positive advanced non-small-cell lung cancer.
abstract: BACKGROUND
  The main objective of the current post hoc analysis was to compare patient-reported outcomes between crizotinib (N = 172) and chemotherapy subgroups (pemetrexed [N = 99] and docetaxel [N = 72]) in previously treated patients with advanced ALK-positive non-small-cell lung cancer, in PROFILE 1007 study (Pfizer; NCT0093283).
  
  
  METHODS
  Patient-reported outcomes were assessed at baseline, day 1 of each cycle, and end of treatment. General health status was measured using the EuroQol-5D visual analog scale and health utility index scores were assessed using the EuroQol-5D descriptive system. Functioning, lung cancer symptoms, and global quality of life (QOL) were assessed using European Organisation for Research and Treatment of Cancer QLQ-C30 and the QLQ-LC13 lung cancer module. Repeated measures mixed-effects analyses compared overall scores and change from baseline scores, controlling for baseline scores.
  
  
  RESULTS
  The overall mean EQ-5D health utility index scores (95% CI) on treatment were significantly greater (p < 0.05) for crizotinib (0.82 [0.79-0.85]) than for chemotherapy (0.73 [0.70-0.77]; 0.74 [0.70-0.79] for pemetrexed and 0.66 [0.58-0.74] for docetaxel). A significantly greater improvement from baseline was observed with crizotinib versus pemetrexed and versus docetaxel treatment groups for general health status, physical functioning, global QOL, dyspnea, fatigue, and pain. Improvement rates for fatigue, cough, pain, dyspnea, and global QOL were significantly greater on crizotinib compared with pemetrexed and docetaxel, respectively. Worsening rates for diarrhea and constipation were higher with crizotinib.
  
  
  CONCLUSIONS
  The benefits of crizotinib in improving symptoms and QOL are demonstrated regardless of whether the comparator is pemetrexed or docetaxel.
authors.affiliation: *Department of Medical Oncology, Institute of Cancer Sciences, Manchester University, and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom; †Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea; ‡Department of Thoracic Oncology, Institut Gustave Roussy, Villejuif, France; §National Cancer Center Hospital, Tokyo, Japan; ‖Division of Translational & Clinical Research, Center for Lung Cancer, National Cancer Center, Goyang, South Korea; ¶Clinical Development, Pfizer Oncology, La Jolla, CA; #Biostatistics, Pfizer Global Innovative Pharma Business, New York, NY; **Global Outcomes & Evidence, Pfizer Oncology, New York, NY; ††Department of Oncology, McGill University Health Centre, Montreal, Canada; and ‡‡Hematology/Oncology, Department of Medicine, Massachusetts General Hospital, Boston, MA.
authors.forename: Fiona
authors.initials: F
authors.lastname: Blackhall
authors.forename: Dong-Wan
authors.initials: DW
authors.lastname: Kim
authors.forename: Benjamin
authors.initials: B
authors.lastname: Besse
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nokihara
authors.forename: Ji-Youn
authors.initials: JY
authors.lastname: Han
authors.forename: Keith D
authors.initials: KD
authors.lastname: Wilner
authors.forename: Arlene
authors.initials: A
authors.lastname: Reisman
authors.forename: Shrividya
authors.initials: S
authors.lastname: Iyer
authors.forename: Vera
authors.initials: V
authors.lastname: Hirsh
authors.forename: Alice T
authors.initials: AT
authors.lastname: Shaw
mesh_terms: D000077548:Anaplastic Lymphoma Kinase; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics; D000077547:Crizotinib; D000077143:Docetaxel; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics; D000068437:Pemetrexed / Q000627:therapeutic use; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011720:Pyrazoles / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D011788:Quality of Life; D020794:Receptor Protein-Tyrosine Kinases / Q000235:genetics / Q000378:metabolism; D057566:Self Report; D043823:Taxoids / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011720:Pyrazoles; D011725:Pyridines; D043823:Taxoids; D000068437:Pemetrexed; D000077143:Docetaxel; D000077547:Crizotinib; C000626173:ALK protein, human; D000077548:Anaplastic Lymphoma Kinase; D020794:Receptor Protein-Tyrosine Kinases