University of Manchester, The Christie NHS Foundation Trust, Manchester, United Kingdom
Juan W. Valle , Antoine Hollebecque , Junji Furuse , Lipika Goyal , Funda Meric-Bernstam , Robert S. Epstein , Tehseen Salimi , Volker Wacheck , Mei Liu , Karim A. Benhadji , John A. Bridgewater
Background: In FOENIX-CCA2 (NCT02052778), a pivotal phase 2 study among iCCA patients (pts) with FGFR2 fusions/rearrangements, the highly selective, irreversible FGFR1–4 inhibitor futibatinib demonstrated a confirmed objective response rate of 41.7%, with a 9.7-month median duration of response. Adverse events were manageable with dosing modifications that did not adversely impact on response. We report outcomes for the preplanned analysis of Patient-Reported Outcomes (PROs) during futibatinib treatment as a secondary objective of FOENIX-CCA2. Methods: Pts enrolled in FOENIX-CCA2 had locally advanced/metastatic unresectable iCCA with FGFR2 fusions/rearrangements, ≥1 prior line of therapy (including gemcitabine/cisplatin) and ECOG PS 0-1. Pts received oral futibatinib 20 mg continuous QD dosing per 21-day cycle. PRO measures included EORTC-QLQ-C30 (1 global health, 5 functional, 9 symptom scales), EQ-5D-3L, and EQ visual analogue scale (VAS). PROs were collected at screening, cycles 2 and 4, every 3 cycles thereafter, and end of treatment. PRO data were evaluated up to cycle 13, the last visit before data were missing for >50% of the PRO population (PRO primary assessment time point). Results: 92/103 (89.3%) pts enrolled had PRO completion data at baseline and a minimum of 1 follow-up assessment (median age 58 y, 56.5% female), with 48 pts having PRO data at cycle 13. At baseline, mean (SD) EORTC QLQ-C30 global health status score was 70.1 (19.4) and EQ VAS score 71.7 (20.3). Mean EORTC QLQ-C30 global health status scores were maintained from baseline to cycle 13, corresponding to 9.0 months on treatment, with no clinically meaningful (≥10-point) changes in individual functional measures (Table). EORTC QLQ-C30 scores across individual symptom measures were also stable from baseline through cycle 13; only constipation showed an average of 10.0-point worsening at only cycle 4. Mean EQ VAS scores were sustained from baseline to cycle 13 (mean change ranging -1.8 to +4.8 across cycles), with values maintained within the population norm range from across 20 countries. Conclusions: Quality of life data from the phase 2 FOENIX-CCA2 trial show that physical, cognitive and emotional functioning, and overall health status were maintained among pts with advanced iCCA receiving futibatinib. Clinical trial information: NCT02052778
Functional scale | Cycle 2 n=84 | Cycle 4 n=80 | Cycle 7 n=66 | Cycle 10 n=59 | Cycle 13 n=48 |
---|---|---|---|---|---|
Global health | -1.0 (22.0) | +0.4 (20.6) | -0.5 (21.6) | +1.9 (22.8) | +0.9 (21.5) |
Physical | -1.1 (17.9) | +0.8 (15.0) | -0.4 (14.1) | -1.4 (15.4) | -2.0 (14.0) |
Role | -1.2 (26.0) | -2.3 (24.0) | -0.8 (24.2) | -3.7 (23.6) | -1.4 (25.7) |
Cognitive | -3.8 (15.9) | -5.7 (15.1) | -3.3 (12.2) | -4.0 (14.1) | -5.2 (12.5) |
Emotional | +3.0 (19.7) | +4.7 (17.6) | +3.7 (16.2) | +2.9 (16.6) | +4.9 (15.6) |
Social | +4.4 (27.9) | +0.6 (23.9) | +0.8 (19.9) | +2.9 (23.6) | -0.3 (20.5) |
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