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Immunotherapy and next-generation TKIs: From second to frontline treatment (ID 55)
- Event: ELCC 2018
- Type: Poster Discussion session
- Presentations: 1
- Moderators:P. Garrido Lopez, S. Ekman, S. Ortiz-Cuaran, E. Wauters
- Coordinates: 4/12/2018, 07:45 - 09:00, Room A
138PD_PR - Patient-reported outcomes (PROs) in ALEX: A phase III study of alectinib (ALEC) vs crizotinib (CRIZ) in non-small-cell lung cancer (NSCLC) (ID 464)
07:45 - 09:00 | Author(s): R. Dziadziuszko
ALEC showed superior efficacy versus CRIZ in patients (pts) with treatment-naïve ALK+ NSCLC in the phase III ALEX trial (NCT02075840). PRO data (disease burden, symptom tolerability and health-related quality of life [HRQoL]) are reported here.
Pts (n = 303) were randomised 1:1 to receive ALEC (600 mg BID) or CRIZ (250 mg BID). Primary endpoint: investigator-assessed PFS. PROs were collected using EORTC QLQ-C30/QLQ-LC13 questionnaires. Pre-specified endpoints: time-to-deterioration (TTD) in lung cancer symptoms and HRQoL, longitudinal analyses of mean score changes from baseline, and proportion of pts with clinically meaningful change (≥10-point change from baseline) during treatment in the ITT population and patients with baseline CNS metastases.
Baseline completion rates and characteristics were balanced between arms in the PRO-evaluable population (ALEC n = 100, 65.8%; CRIZ n = 97, 64.2%). Median TTD in composite symptom endpoint (cough, dyspnoea, chest pain) was similar between arms (HR 1.10 [95% CI 0.72–1.68]). On average, ALEC pts reported a clinically meaningful improvement in baseline lung cancer symptoms for a longer duration of time versus CRIZ (cough, week 96 vs week 84; chest pain, week 96 vs week 80; fatigue, week 96 vs 68; pain in other parts, week 96 vs 68, respectively). Differences in lung symptoms between treatment arms tended to favour ALEC from 11.1 months (45 weeks), which was around the time of median PFS with CRIZ. ALEC pts reported a clinically meaningful improvement from baseline in HRQoL for a longer duration of time than CRIZ pts (week 88 vs 68, respectively). Fewer ALEC pts experienced a clinically meaningful worsening in treatment-related symptoms (nausea/vomiting, diarrhoea, appetite loss, dysphagia, peripheral neuropathy) than CRIZ pts.
TTD for lung cancer symptoms was comparable between arms. Clinically meaningful improvement in lung cancer symptoms was maintained for longer with ALEC versus CRIZ, consistent with the improved PFS with ALEC versus CRIZ. HRQoL was improved with ALEC versus CRIZ. PRO data are consistent with ALEX safety data and confirm greater tolerability with ALEC versus CRIZ.
Clinical trial identification:
BO28984; 15 April 2016
Legal entity responsible for the study:
F. Hoffmann-La Roche Ltd
F. Hoffmann-La Roche Ltd
M. Perol: Advisory role for Roche and Pfizer. S. Peters: Education grants, provided consultation, attended advisory boards and/or provided lectures for the following organisations: Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Clovis, Eli Lilly, F. Hoffmann-La Roche, Janssen, Merck Sharp and Dohme and Merck Serono, Pfizer, Regeneron and Takeda. N. Pavlakis: Advisory role for Novartis, Takeda, Roche and Pfizer. S. Novello: Speakers Bureau for: Eli Lilly, BMS, MSD, F. Hoffmann-La Roche Ltd and Astra Zeneca. T. Karagiannis: Employee of, owns stocks in and has taken part in company-sponsored research for Genentech. A. Zeaiter: Employee of F.Hoffman-La Roche Ltd. R. Dziadziuszko: Substantive relationships with Novartis, Pfizer and BMS. All other authors have declared no conflicts of interest.
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