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K.D. Wilner
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P3.02a - Poster Session with Presenters Present (ID 470)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02a-012 - Patient-Reported Symptoms and Quality of Life (QoL) in East Asian Patients with ALK+ NSCLC Treated with Crizotinib vs Chemotherapy (ID 5170)
14:30 - 14:30 | Author(s): K.D. Wilner
- Abstract
Background:
The phase 3 study PROFILE 1014 showed a superior outcome of crizotinib over pemetrexed-cisplatin/carboplatin (PCC) in ALK+ NSCLC.[1] PROFILE 1029 is an ongoing phase 3 study of similar design (NCT01639001) conducted in an East Asian population in China, Hong Kong, Malaysia, Taiwan, and Thailand. Here, we present findings on patient-reported symptoms and QoL.
Methods:
Patients with previously untreated, ALK+ advanced NSCLC were randomized 1:1 (stratification: ECOG PS 0 or 1 vs 2) to crizotinib 250 mg PO BID or pemetrexed 500 mg/m[2] with cisplatin 75 mg/m[2] or carboplatin to an AUC of 5–6 mg·min/mL, IV Q3W for ≤6 cycles. The EORTC QLQ-C30 and lung cancer-specific module (QLQ-LC13) questionnaires were completed at baseline, days 1, 7, and 15 of Cycle 1, day 1 of each subsequent cycle, and at end-of-treatment or withdrawal. Mixed model analyses were used to evaluate changes from baseline and between treatment arms.
Results:
Patients, who received crizotinib (n=103) had significantly longer median time to deterioration (TTD) for chest pain, dyspnea, or cough compared to PCC (n=98) (2.8 mo [95% CI: 1.4, 6.9] vs 0.3 mo [95% CI: 0.3, 0.5], respectively; HR=0.432 [95% CI: 0.307, 0.610]; P<0.0001). Crizotinib treatment, compared to PCC, was associated with a significantly greater change from baseline in global QoL and physical, role, cognitive, and social functioning (Table). QLQ-C30 results demonstrated that crizotinib-treated patients experienced either improvement or reduced worsening of most symptoms compared to PCC-treated patients. QLQ-LC13 data showed improvement or reduced worsening across all symptoms for crizotinib, relative to PCC. Figure 1
Conclusion:
Crizotinib treatment significantly delayed TTD of lung cancer symptoms (chest pain, cough, dyspnea). Crizotinib was associated with significantly greater improvements from baseline in key patient-reported lung cancer symptoms and global QoL, compared with PCC. Reference: 1. Solomon BJ, et al. J Clin Oncol. 2016 [Epub ahead of print].
