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dc.contributor.authorValle, Juan W
dc.contributor.authorHollebecque, A.
dc.contributor.authorFuruse, J.
dc.contributor.authorGoyal, L.
dc.contributor.authorMeric-Bernstam, F.
dc.contributor.authorEpstein, R. S.
dc.contributor.authorSalimi, T.
dc.contributor.authorWacheck, V.
dc.contributor.authorLiu, M.
dc.contributor.authorBenhadji, K. A.
dc.contributor.authorBridgewater, J. A.
dc.date.accessioned2022-01-11T11:59:45Z
dc.date.available2022-01-11T11:59:45Z
dc.date.issued2021en
dc.identifier.citationValle 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.doi10.1200/JCO.2021.39.15_suppl.4097en
dc.identifier.urihttp://hdl.handle.net/10541/624867
dc.description.abstractBackground: 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.isoenen
dc.relation.urlhttps://dx.doi.org/10.1200/JCO.2021.39.15_suppl.4097en
dc.titleFOENIX-CCA2 quality of life data for futibatinib-treated intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions/rearrangementsen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentUniversity of Manchester, The Christie NHS Foundation Trust, Manchester,en
dc.identifier.journalJournal of Clinical Oncologyen
dc.description.noteen]


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