The Lynx Group
Cholangiocarcinoma News

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 (ClinicalTrials.gov 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.

Related Items

Phase 1 Results of Gunagratinib in Patients with Advanced Solid Tumors Harboring FGFR Pathway Alterations
2021 Year in Review: Cholangiocarcinoma
A phase 1/2a, first-in-human clinical study demonstrated that the highly selective, irreversible pan-FGFR inhibitor gunagratinib was safe and well-tolerated in patients with advanced solid tumors, including CCA.
Prognostic Value of FGFR2 Alterations in Patients Receiving Systemic Chemotherapy for Intrahepatic CCA
2021 Year in Review: Cholangiocarcinoma
A retrospective analysis indicated the prognostic value of FGFR2 fusions/rearrangements in patients with intrahepatic CCA receiving systemic chemotherapy, which warrants additional study.
FGFR2 Fusion and/or Rearrangement Profiling in Chinese Patients with Intrahepatic CCA
2021 Year in Review: Cholangiocarcinoma
Epidemiologic data assessed the incidence rate of FGFR2 gene fusion or rearrangement in Chinese patients with intrahepatic CCA, including those with heterogeneous FGFR2 partner genes.
A Comprehensive Genomic and Immune Profiling Study of IDH1- and IDH2-Driven Intrahepatic CCA
2021 Year in Review: Cholangiocarcinoma
A comprehensive genomic and immune characterization of IDH-mutated and wild-type intrahepatic CCA revealed significant differences in genetic alterations.
Characteristics of IDH Mutations in Bile Duct Carcinoma in a Chinese Population
2021 Year in Review: Cholangiocarcinoma
A retrospective analysis in a large Chinese patient cohort with bile duct carcinoma indicated that activating IDH1/2 mutations occurred at a lower rate compared with that previously reported in the global population.
Silmitasertib (CX-4945) plus Gemcitabine and Cisplatin as First-Line Treatment for Patients with Locally Advanced or Metastatic CCA
2021 Year in Review: Cholangiocarcinoma
Preliminary evidence suggests that combination treatment with silmitasertib plus gemcitabine/cisplatin as first-line therapy has promising efficacy and a favorable safety profile in patients with locally advanced or metastatic CCA.
Targeted Therapies in CCA: Assessment of US Oncologist Practice Patterns
2021 Year in Review: Cholangiocarcinoma
Findings from a clinical practice assessment identified gaps in knowledge, competence, and confidence regarding testing and the use of targeted therapies in patients with unresectable CCA, underscoring the important role of education in overcoming these gaps.
First-Line Toripalimab plus Lenvatinib in Combination with GemOx Chemotherapy for Advanced Intrahepatic CCA
2021 Year in Review: Cholangiocarcinoma
Results of a phase 2 study indicate that toripalimab and lenvatinib in combination with GemOx chemotherapy provide antitumor activity and reasonable tolerability in patients with advanced intrahepatic CCA.
Comparative Landscape of Actionable Somatic Alterations in Advanced CCA from Circulating Tumor and Tissue-Based DNA Profiling
2021 Year in Review: Cholangiocarcinoma
Findings from a retrospective analysis support the use of both tissue and liquid biopsy biomarker testing to guide therapy selection in patients with advanced CCA, particularly when tissue may not be readily available.
Tibsovo (Ivosidenib) FDA Approved for Advanced or Metastatic Cholangiocarcinoma and IDH1 Mutation
By Loretta Fala
2021 Year in Review: Cholangiocarcinoma
Cholangiocarcinoma (CCA) is an aggressive cancer of the bile duct that forms inside the liver (ie, intrahepatic) or outside the liver (ie, extrahepatic, including perihilar and distal tumors). Individuals with colitis or certain liver diseases may have an increased risk for CCA. Although the precise incidence of CCA is unknown, an estimated 8000 new cases of CCA are diagnosed annually in the United States. It is likely, however, that this number is higher, because CCA is difficult to diagnose and may be misclassified at times.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: