Findings of patient-reported outcomes from the phase 2 FOENIX-CCA2 study indicate that quality-of-life data and overall health status were maintained among futibatinib-treated patients with advanced intrahepatic CCA.
The pivotal phase 2 FOENIX-CCA2 trial (ClinicalTrials.gov Identifier: NCT02052778) evaluated the investigational FGFR1-4 inhibitor futibatinib in patients with intrahepatic cholangiocarcinoma (iCCA) who harbored FGFR2 fusions/rearrangements. Results for the preplanned analysis of patient-reported outcomes (PROs) to evaluate health-related quality of life and health status during futibatinib treatment were reported at the 2021 American Society of Clinical Oncology Annual Meeting.
The FOENIX-CCA2 study enrolled patients from 36 international sites with unresectable/metastatic iCCA with an FGFR2 fusion/rearrangement and progressive disease (PD) after ≥1 prior treatments. Eligible patients received oral futibatinib 20 mg once daily until PD or intolerability. Data cutoff was October 1, 2020. PROs, which were assessed during futibatinib treatment as a secondary objective, 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), which corresponded to 9.0 months on treatment. PRO measures included EORTC QLQ-C30 (1 global health, 5 functional, 9 symptom scales); EuroQoL 5-dimensional instrument (EQ-5D-3L); and EQ visual analog scale (VAS).
Of the total enrolled population (n = 103), 92 participants had PRO completion data at baseline and a minimum of 1 follow-up assessment; 48 patients had PRO data at cycle 13. The median age of the PRO population was 58 years; 56.5% were female; 52.2% had an European Cooperative Oncology Group performance status score of 1. Mean time since diagnosis was 17.8 months, and mean time since most recent recurrence/relapse was 2.9 months.
During the PRO assessment period (from baseline to cycle 13), mean EORTC QLQ-C30 global health status scores and functional scales were maintained, with no clinically meaningful (≥10-point) changes in individual functional measures. In terms of individual symptom measures, EORTC QLQ-C30 scores were also mostly 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 maintained from baseline to cycle 13, with values maintained within the population norm range from across 20 countries. Mean EQ-5D-3L status change from baseline to cycle 13 remained unchanged or improved for the majority of patients across all dimensions. A large proportion of patients showed improvement in pain/discomfort and anxiety/depression scores, and worsening in mobility, usual activities, and self-care dimensions.
Based on these PRO results of the phase 2 FOENIX-CCA2 trial, the researchers concluded that quality-of-life data related to physical, cognitive, and emotional functioning, as well as overall health status, were maintained among futibatinib-treated patients with advanced iCCA.
Source: Valle JW, Hollebecque A, Furuse J, et al. FOENIX-CCA2 quality of life data for futibatinib-treated intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions/rearrangements. J Clin Oncol. 2021;39(suppl_15):4097-4097.
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