Pemigatinib for patients with previously treated, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements: A joint analysis of the French PEMI-BIL and Italian PEMI-REAL cohort studies.
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Parisi Alessandro, Delaunay Blandine, Pinterpe Giada, Hollebecque Antoine, Blanc Jean Frederic, Bouattour Mohamed, Assenat Eric, Ben Abdelghani Meher, Sarabi Matthieu, Niger Monica, Vivaldi Caterina, Mandalà Mario, Palloni Andrea, Bensi Maria, Garattini Silvio Ken, Tougeron David, Combe Pierre, Salati Massimiliano, Rimini Margherita, Cella Chiara Alessandra, Tucci Marco, Diana Anna, Mori Elena, Longarini Raffaella, Artru Pascal, Roth Gael, Evesque Ludovic, Vienne Agathe, Turpin Anthony, Hiret Sandrine, Bourgeois Vincent, Herve Camille, Paulon Rodolphe, Stacoffe Marion, Malka David, Neuzillet Cindy, Edeline Julien, Lievre Astrid, Guimbaud Rosine, Chapda Marie Christelle Pajiep, Rimassa Lorenza, Giampieri Riccardo, Valle Juan, Berardi Rossana, Fares Nadim
Аннотация
MATERIAL AND METHODS: A joint analysis of two multicentre observational retrospective cohort studies independently conducted in France and Italy was performed. All consecutive FGFR2-positive patients affected by CCA and treated with pemigatinib as second- or further line of systemic treatment in clinical practice, within or outside the European Expanded Access Program, were included.
RESULTS: Between July 2020 and September 2022, 72 patients were treated with pemigatinib in 14 Italian and 25 French Centres. Patients had a median age of 57 years, 76% were female, 81% had ECOG-PS 0-1, 99% had intrahepatic CCA, 74% had ≥ 2 metastatic sites, 67% had metastatic disease at diagnosis, while 38.8% received ≥ 2 previous lines of systemic treatment. At data cut-off analysis (April 2023), ORR and DCR were 45.8% and 84.7%, respectively. Median DoR was 7 months (IQR: 5.8-9.3). Over a median follow-up time of 19.5 months, median PFS and 1-year PFS rate were 8.7 months and 32.8%. Median OS and 1-year OS rate were 17.1 months and 60.6%. Fatigue (69.4%), ocular toxicity (68%), nail toxicities (61.1%), dermatologic toxicity (41.6%) hyperphosphataemia (55.6%), stomatitis (48.6%), and diarrhea (36.1%) were the most frequent, mainly G1-G2 AEs. Overall incidence of G3 AEs was 22.2%, while no patient experienced G4 AE. Dose reduction and temporary discontinuation were needed in 33.3% and 40.3% of cases, with 1 permanent discontinuation due to AEs.
CONCLUSIONS: These results confirm the effectiveness and safety of pemigatinib in a real-world setting.