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Quality of life (QoL) outcomes with futibatinib treatment in FOENIX-CCA2 - A phase II study in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions/rearrangements
Hollebecque, A. Furuse, J. Goyal, L. Meric-Bernstam, F. Morlock, R. He, Y. Benhadji, K. Bridgewater, J.
Hollebecque, A.
Furuse, J.
Goyal, L.
Meric-Bernstam, F.
Morlock, R.
He, Y.
Benhadji, K.
Bridgewater, J.
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Abstract
Background: Cancer treatment can produce AEs that result in a reduced QoL. Futibatinib,
a highly selective irreversible FGFR1e4 inhibitor, demonstrated an objective
response rate (ORR) of 37.3% and median 8.3-mo duration of response in the interim
analysis of FOENIX-CCA2, a mutlicenter phase II trial of pts with advanced, refractory
iCCA harboring an FGFR2 fusion/rearrangement; grade 3 treatment-related AEs
(TRAEs) occurred in 57% of pts (most commonly, hyperphosphatemia [26.9%]).
Change in pt-reported outcomes (PROs) from baseline (BL) for the interim data of the
phase II trial are presented here.
Methods: Pts enrolled into FOENIX-CCA2 (NCT02052778), had locally advanced/
metastatic unresectable iCCA and received oral futibatinib 20 mg once daily (QD) until
disease progression/intolerance. PRO measures included EORTC-QLQ-C30 (5 functional
and 9 physical measures) and EQ-5D-3L (utility index and 5 dimensions: anxiety/
depression, mobility, pain/discomfort, self-care, and usual activity). PROs were
collected at screening, cycles 2 and 4, every 3 cycles after cycle 4 and at the end of
treatment. Change in mean score from BL was assessed using predefined clinically
meaningful thresholds for each time point with 19 observations (through cycle 13).
Results: Sixty-seven of 103 enrolled pts had 6 months of follow-up and 57 (85.1%)
had PRO completion data at BL and 1 assessment. EORTC mean global health status
score was high at BL (68.7) and maintained through cycle 13 (70.8), a trend observed
across all EORTC measures. The only clinically meaningful changes ( 10-point
changes) in this timeframe were for constipation symptoms at cycles 2 and 4
(worsened +12.4 and +10.7, respectively) and dyspnea at cycle 10 (improved -12.2).
Mean EQ-5D-3L index scores improved from 70.9 at BL to 79.1 at cycle 13 (approximately
273 days on treatment).
Conclusions: Overall, the interim PROs from FOENIX-CCA2 were encouraging. These
data suggest that despite the occurrence of TRAEs, a 20-mg-QD dose of futibatinib in
pts with iCCA provides a promising clinical response without adversely impacting QoL.
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
Valle JW, Hollebecque A, Furuse J, Goyal L, Meric-Bernstam F, Morlock R, et al. 58P Quality of life (QoL) outcomes with futibatinib treatment in FOENIX-CCA2 - A phase II study in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions/rearrangements. Annals of Oncology. 2020;31:S263-S4.