1231PD - Impact of crizotinib treatment on patient-reported symptoms and quality of life (QOL) in advanced ALK-positive non-small cell lung cancer (NSCLC)

Date 30 September 2012
Event ESMO Congress 2012
Session NSCLC, metastatic
Topics Cytotoxic agents
Supportive and Palliative Care
Non-small-cell lung cancer
Biological therapy
Presenter Fiona Blackhall
Authors F.H. Blackhall1, T.L. Evans2, J. Han3, R. Salgia4, D. Moro-Sibilot5, S. Gettinger6, L. Crinò7, K. Wilner8, A. Reisman9, S. Iyer10
  • 1Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/UK
  • 2Medical Oncology, University of Philadelphia, Philadelphia/US
  • 3Center For Lung Cancer, National Cancer Center, Goyang/KR
  • 4Department Of Medicine, Section Of Hematology/oncology, University of Chicago, Chicago/US
  • 5Department Of Lung Cancer, CHU De Grenoble - Hôpital A. Michalon, Grenoble/FR
  • 6Thoracic Oncology Program, Yale University School of Medicine, CT - New Haven/US
  • 7Medical Oncology, S. Maria della Misericordia Hospital, Perugia/IT
  • 8Reseach And Development, Pfizer Oncology, La Jolla/US
  • 9Medical Oncology, Pfizer Inc, New York/US
  • 10Medical Oncology, Pfizer Oncology, New York/US




Crizotinib is a potent, selective, ATP-competitive ALK inhibitor demonstrating a high response rate in advanced ALK-positive NSCLC. The effect of crizotinib on patient-reported symptoms, functioning and QOL from PROFILE 1005 is presented.


PROFILE 1005 is an ongoing global, multicenter, open-label, single-arm, phase II study evaluating the safety and efficacy of crizotinib (250 mg BID in 3-week cycles) in previously treated patients with advanced ALK-positive NSCLC. Patient-reported outcomes (PROs) were assessed as secondary endpoints using the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ-C30) and lung cancer module (QLQ-LC13) at baseline, Day 1 of each cycle and at end of treatment. Functioning, symptoms and global QOL were assessed and scored on scales of 0–100. Higher scores indicate higher symptom severity or higher functioning/QOL. Change from baseline was assessed for statistical and clinical significance (defined as ≥10-point change from baseline).


As of Jan 2012, 901 patients were evaluable for safety and 797 (88%) of these patients had completed the entire questionnaire at baseline. The majority of patients was female (57%), never smokers (66%), and had adenocarcinoma (92%), with a median age of 52 years. A clinically meaningful (≥10-point) improvement from baseline was observed early and maintained in patient-reported symptoms of cough (Cycle 2 onwards), pain (Cycles 2 to 19), dyspnea from QLQ–C30 (Cycles 3 to 19), pain in chest (Cycles 3 to 20 except for Cycle 18), pain in arm and shoulder (Cycles 3 to 16) and fatigue (Cycles 4 to 21). Clinically significant deterioration was observed for constipation (Cycles 2 and 3) and diarrhea (Cycle 2 to 6, 9 and 10). Clinically meaningful improvements were observed for physical functioning (Cycle 8 and 9), role functioning (Cycles 9 and 10), social functioning (Cycles 4 to 15, except Cycle 12) and global QOL (Cycles 3 to 15, except Cycle 11).


Treatment with crizotinib in pretreated patients with advanced ALK-positive NSCLC showed an overall positive impact on patient-reported lung cancer symptoms and global QOL.


F.H. Blackhall: Advisory relationship with Pfizer. Honoraraia, research funding and other remuneration received from Pfizer.

D. Moro-Sibilot: Honoraria received from Pfizer.

K. Wilner: Employed by Pfizer as a Senior Director and has stock ownership with Pfizer.

A. Reisman: Employed by Pfizer and has stock ownership with Pfizer.

S. Iyer: Employed as a Director (Global Outcomes Research) by Pfizer.

All other authors have declared no conflicts of interest.