1226PD - Impact of crizotinib on patient-reported symptoms and global quality of life (QOL) compared with platinum based chemotherapy in phase III study of...

Date 29 September 2014
Event ESMO 2014
Session NSCLC, metastatic
Topics Anticancer Agents
Non-Small Cell Lung Cancer
Biological Therapy
Presenter Fiona Blackhall
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors F.H. Blackhall1, E. Felip2, F. Cappuzzo3, D.W. Kim4, Y. Wu5, B. Solomon6, K. Nakagawa7, T. Mekhail8, J. Paolini9, T. Usari10, S. Iyer11, A. Reisman12, K. Wilner13, J. Tursi14, T.S.K. Mok15
  • 1Medical Oncology, The Christie NHS Foundation Trust, M204BX - Manchester/GB
  • 2Medical Oncology, Vall d´Hebron University Hospital, Barcelona/ES
  • 3U.o. Oncologia Medica, Istituto Toscano Tumori-Ospedale Civile-Livorno-Italy, 56100 - Livorno/IT
  • 4Department Of Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 5Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, 510080 - Guangzhou/CN
  • 6Oncology, Peter MacCallum Cancer Centre, Melbourne/AU
  • 7Medical Oncology, Kinki University School of Medicine, JP-589-8511 - Osaka/JP
  • 8Medical Oncology, Florida Hospital Cancer Institute, 32804 - Orlando/US
  • 9Clin Dev Oncology, Pfizer Italy, Milan/IT
  • 10Oncology, Pfizer Italia, Milan/IT
  • 11Global Outcomes Research, Pfizer Oncology, New York/US
  • 12Statistics, Pfizer Inc., New York/US
  • 13Clinical Research, Pfizer Oncology, La Jolla/US
  • 14Gemini Center Building L- 3rd Floor, Pfizer Italia, IT-20152 - Milano/IT
  • 15Clinical Oncology, The Chinese University of Hong Kong, Hong Kong/CN




The main objective of our analysis was to compare patient-reported symptom and global QOL improvement and worsening rates between crizotinib and platinum based chemotherapy in treatment naïve patients with advanced ALK-positive NSCLC in PROFILE 1014 study (Pfizer; NCT01154140).


Patients in the ongoing PROFILE 1014 study were randomized to crizotinib (250 mg PO bid; n= 172) or chemotherapy (pemetrexed 500 mg/m2 + either cisplatin 75 mg/m2 or carboplatin AUC 5–6; all IV q3w for ≤6 cycles; n= 171). Patient-reported outcomes were assessed at baseline, day 7 and day 15 of cycle 1, day 1 of subsequent 3-week cycles and end of treatment using EORTC QLQ-C30 and lung can¬cer module QLQ-LC13. Higher scores (range 0 − 100) indicated higher symptom severity or better functioning/QOL. A clinically meaningful change was defined as a ≥10-point change from baseline. The percentage of patients classified as having improved (≥10-point increase for functioning/QOL scales / ≥ 10-point reduction for symptoms in average of change from baseline scores across cycles for a patient) or worsened (≥10-point reduction for functioning / ≥ 10-point increase for symptoms in average of change from baseline scores across cycles) was examined and compared between treatment groups using chi-square tests.


Completion rates at baseline were ≥95% in each group and scores were balanced. A significantly (p < 0.05) greater percentage of patients on crizotinib versus chemotherapy arm showed improvement for global QOL (36 % vs. 19.6%), physical functioning (31.3% vs. 15.3%), fatigue (42.2% vs. 28.2%), cough (57.8% vs. 44.2%) and dyspnea (39.8% vs. 23.3%). Worsening rates were significantly (p < 0.05) higher with crizotinib for diarrhea (44% vs. 19.0%) and lower for alopecia (14.5% vs. 34.4%) and sore mouth (13.3% vs. 25.8%) compared to chemotherapy. No significant difference was observed for cognitive functioning, dysphagia and constipation.


Treatment with crizotinib led to higher improvement rates in global QOL, physical functioning and key lung cancer symptoms compared with chemotherapy.


F. Blackhall: Advisory boards: Pfizer; E. Felip: Advisory boards: Boehringer-Ingelheim, Novartis, Roche, BMS, Lilly; F. Cappuzzo: Advisory boards: Pfizer; D.W. Kim: Advisory boards: Pfizer, Novartis; Y. Wu: Other substantive relationships (Honoraria): Roche, AstraZeneca, Eli Lilly; B. Solomon: Advisory boards: Pfizer, Novartis, Roche, Clovis Oncology, AstraZeneca, Merck, BMS, Lilly; T. Mekhail: Advisory boards: Pfizer, Genentech, Eli Lilly, Celgene; Corporate-spnsored research: Pfizer, Genentech, Lilly, Celgene, BMS, AstraZeneca; Other substantive relationships (Speakers' Bureau): Pfizer, Genentech, Eli Lilly, Celgene; J. Paolini: Employment and stock ownership: Pfizer; T. Usari: Employment and stock ownership: Pfizer; S. Iyer: Employment, stock ownership and corporate-sponsored research: Pfizer; A. Reisman: Employment and stock ownership: Pfizer; K. Wilner: Employment, stock ownership, advisory board and corporate-sponsored research: Pfizer; J. Tursi: Employment and stock ownership: Pfizer; T. Mok: Advisory boards: AstraZeneca, Roche, Eli Lilly, Merck Serono, Eisai, BMS, AVEO, Pfizer, Taiho, Boehringer-Ingelheim, Novartis, GSK Biologicals, Clovis Oncology, Amgen, Janssen, BioMarin; Board of directors: IASLC; Corporate-sponsored research: AstraZeneca. All other authors have declared no conflicts of interest.