FOENIX-CCA2 quality of life data for futibatinib-treated intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions/rearrangements
dc.contributor.author | Valle, Juan W | |
dc.contributor.author | Hollebecque, A. | |
dc.contributor.author | Furuse, J. | |
dc.contributor.author | Goyal, L. | |
dc.contributor.author | Meric-Bernstam, F. | |
dc.contributor.author | Epstein, R. S. | |
dc.contributor.author | Salimi, T. | |
dc.contributor.author | Wacheck, V. | |
dc.contributor.author | Liu, M. | |
dc.contributor.author | Benhadji, K. A. | |
dc.contributor.author | Bridgewater, J. A. | |
dc.date.accessioned | 2022-01-11T11:59:45Z | |
dc.date.available | 2022-01-11T11:59:45Z | |
dc.date.issued | 2021 | en |
dc.identifier.citation | Valle JW, Hollebecque A, Furuse J, Goyal L, Meric-Bernstam F, Epstein RS, et al. FOENIX-CCA2 quality of life data for futibatinib-treated intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions/rearrangements. Vol. 39, Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2021. p. 4097–4097. | en |
dc.identifier.doi | 10.1200/JCO.2021.39.15_suppl.4097 | en |
dc.identifier.uri | http://hdl.handle.net/10541/624867 | |
dc.description.abstract | 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. | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1200/JCO.2021.39.15_suppl.4097 | en |
dc.title | FOENIX-CCA2 quality of life data for futibatinib-treated intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions/rearrangements | en |
dc.type | Meetings and Proceedings | en |
dc.contributor.department | University of Manchester, The Christie NHS Foundation Trust, Manchester, | en |
dc.identifier.journal | Journal of Clinical Oncology | en |
dc.description.note | en] |