In the ongoing phase 3 PROFILE 1007 study of patients with previously treated anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer, crizotinib improved quality of life (QOL) and key lung cancer symptoms compared with chemotherapy (investigator’s choice: pemetrexed or docetaxel). Crizotinib was associated with a significantly higher improvement rate in global QOL compared with chemotherapy in all domains, said Vera Hirsh, MD, McGill University, Montreal, Canada.
“These improvements in QOL are particularly important for this palliative group of patients. Our findings support the improvement in PFS [progression-free survival] seen in the trial with crizotinib,” she said.
The QOL study randomized 172 patients to receive crizotinib and 171 to standard-of-care chemotherapy with either pemetrexed or docetaxel. Patient-reported outcomes were assessed at baseline, on day 1 of each cycle, and at the end of treatment using the European Organisation for Research and Treatment of Cancer Quaity of Life Questionnaire Core 30 (EORTC QLQ-C30) and lung cancer module QLQ-LC13. Scores on these instruments ranged from 0 to 100, with higher scores reflecting higher symptom severity or better functioning/QOL, depending on the instrument and question.
A 10-point or greater change from baseline was deemed clinically meaningful for either improvement or worsening.
As of March 30, 2012, 162 patients in the crizotinib arm and 151 in the chemotherapy arm completed at least 1 question at baseline, and this population was analyzed for QOL.
Baseline scores were well balanced between the 2 arms and were relatively low. Crizotinib achieved significantly greater improvement in global QOL versus chemotherapy (42.6% vs 20.7%, respectively; P <.001). Crizotinib also significantly improved physical functioning (27.2% vs 11.9%; P <.001), role functioning (30.9% vs 14.6%; P <.001), and emotional functioning (37.0% vs 24.0%; P <.05).
Lung cancer symptoms were significantly improved in the crizotinib arm versus chemotherapy (P <.001 for all comparisons): fatigue (46.3% vs 20.5%, respectively), pain (43.8% vs 20.5%), cough (55.3% vs 33.3%), dyspnea (39.1% vs 17.3%), chest pain (40.0% vs 22.3%), and pain in arm or shoulder (33.5% vs 19.5%).
Domains significantly worsened on crizotinib (P <.001 for both comparisons) were constipation (44.4% vs 22.5%) and diarrhea (41.4% vs 19.2%).
“Deterioration was slowed in a significantly greater proportion of patients in the crizotinib arm versus chemotherapy,” Hirsh reported.
The study was supported by Pfizer Inc. l —AG
Reference
Blackhall F, Hirsh V, Kim DW, et al. Impact of crizotinib on patient-reported symptoms and global quality of life (QoL) compared with chemotherapy in a phase III study of advanced alk-positive non-small cell lung cancer (NSCLC). Presented at: 2013 European Cancer Congress; September 27-October 1, 2013; Amsterdam, the Netherlands. Abstract 3400.