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Longitudinal Evaluation of Quality of Life in Patients with FGFR2-Driven CCA Treated with Pemigatinib

2021 Year in Review: Cholangiocarcinoma — December 17, 2021

Longitudinal evaluation of quality of life in pemigatinib-treated patients with advanced CCA harboring FGFR fusions/rearrangements showed that those who achieved complete response/partial response or stable disease exhibited stable overall health status and emotional functioning.

The single-arm, phase 2 FIGHT-202 study ( Identifier: NCT02924376) demonstrated the efficacy and safety of the selective oral FGFR1-3 inhibitor pemigatinib in patients with previously treated advanced cholangiocarcinoma (CCA) and FGFR2 fusions/rearrangements. The current analysis evaluated the exploratory end point of quality of life (QOL) in the FIGHT-202 study, the results of which were presented at the 2021 American Society of Clinical Oncology Annual Meeting.

In the FIGHT-202 study, a subset of patients who harbored FGFR2 gene rearrangements/fusions with disease progression after ≥1 prior treatments and documented FGF/FGFR gene status received oral pemigatinib 13.5 mg once daily (21-day cycle; 2 weeks on, 1 week off) until disease progression or unacceptable toxicity. QOL was assessed longitudinally by best overall response per RECIST version 1.1, with the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQ-C30) and the biliary tract cancer–specific EORTC-QLQ-BIL21 questionnaires. Descriptive statistics were used to analyze QOL scores and longitudinal changes from baseline. Treatment-related changes in QOL were a priori expected to be evident by cycle 6, day 1 (ie, week 16).

A total of 107 patients with FGFR2 fusions/rearrangements were enrolled in the study. Of these, 100 patients were evaluable for QOL, which included 36 patients with a complete response or partial response (CR/PR), 48 patients with stable disease (SD), and 15 patients with progressive disease (PD). Through the assessment period (from baseline to week 16), patients with CR/PR or SD QLQ-C30 demonstrated marginal changes in overall health status, which worsened in patients with PD. All response subgroups showed declines in role and social functioning; however, emotional functioning remained stable and similar in patients with CR/PR and SD. In terms of QLQ-BIL21 treatment side effects, all response subgroups showed increases by week 16, whereas those with CR/PR experienced the greatest increases as they remained on treatment longer than patients with SD or PD. Despite these increases in side effects, patients with CR/PR and SD experienced decreases in QLQ-BIL21 pain and anxiety.

Based on these results, the researchers concluded that among pemigatinib-treated patients with advanced CCA who harbor FGFR fusions/rearrangements, those who achieved CR/PD or SD had stable overall health status and emotional functioning.

Source: Valle JW, Bibeau K, Cho Y, et al. Longitudinal evaluation of quality of life (QoL) in patients (Pts) with FGFR2-driven cholangiocarcinoma (CCA) treated with pemigatinib. J Clin Oncol. 2021;39(suppl_15):267.

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