P3.02a-014 Patient Reported General Health Status in a Study of Crizotinib Versus Chemotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC): Topic: ALK Clinical

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Patients with advanced NSCLC typically experience symptoms compromising their quality of life (QoL), making this an important therapeutic goal. PROFILE 1029 (NCT01639001) is an ongoing open-label, Phase 3 study in East Asian patients with previously untreated, ALK+ advanced NSCLC in China, Hong Kong, Malaysia, Taiwan, and Thailand. Patient-reported health status outcomes are presented. Patients were randomized 1:1 (stratification: ECOG PS 0 or 1, 2) to crizotinib 250 mg PO BID or pemetrexed 500 mg/m2 IV with either cisplatin 75 mg/m2 or carboplatin (PCC) to achieve an AUC of 5–6 mg·min/mL, IV q3w for ≤6 cycles. Health status assessed using the EuroQoL 5D (EQ-5D) was a secondary endpoint of the study. The EQ-5D, consisting of a visual analogue scale (VAS) score ranging from 0 (worst imaginable health state) to 100 (best imaginable health state) and a descriptive measure (no, some or extreme) of problems in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, was to be completed at baseline and on day 1 of each cycle until treatment termination or withdrawal. The data were analyzed using a mixed model analysis. The proportion of patients completing at least one question on the EQ-5D questionnaire ranged from 97.6% to 100% for crizotinib-treated patients over 42 cycles of treatment and from 98.0% to 100% for PCC-treated patients over a maximum of 6 cycles of treatment. The estimated overall change from baseline in the EQ-5D VAS was 3.4209 (95% confidence interval [CI]:1.20, 5.64) for crizotinib and -0.4927 (95% CI: -2.75, 1.77) for PCC. The difference between crizotinib and PCC was 3.9136 (95% CI: 0.85, 6.98; P<0.05). The estimated overall change from baseline in the EQ-5D utility score was 0.0502 (95% CI: 0.02, 0.08) for crizotinib and 0.0077 (95% CI: -0.02, 0.04) for PCC. The difference in utility score changes for crizotinib versus PCC was 0.0425 (95% CI: 0.00, 0.08; P<0.05). End of treatment descriptive results showed no deterioration from baseline across most EQ-5D dimensions. A statistically significantly (p-value <0.05) greater improvement from baseline in general health status, as assessed by the EQ-5D VAS and utility scores, was observed for crizotinib-treated patients compared with PCC-treated patients.