Prognostic Impact of Concomitant Genomic Alterations in FGFR2-Positive Cholangiocarcinoma Treated With Pemigatinib.
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Liguori Carolina, Giampieri Riccardo, Delaunay Blandine, Pinterpe Giada, Mazzocca Adelaide, Hollebecque Antoine, Blanc Jean Frederic, Bouattour Mohamed, Assenat Eric, Abdelghani Meher Ben, Sarabi Matthieu, Niger Monica, Vivaldi Caterina, Mandalà Mario, Palloni Andrea, Bensi Maria, Garattini Silvio Ken, Tougeron David, Combe Pierre, Salati Massimiliano, Rimini Margherita, Casadei-Gardini Andrea, 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, Delaye Matthieu, Edeline Julien, Lievre Astrid, Guimbaud Rosine, Balsano Rita, Fares Nadim, Berardi Rossana, Parisi Alessandro
Аннотация
METHODS: This study included PEMIREAL-PEMIBIL patients treated with pemigatinib in second or later lines. Only patients who underwent extensive DNA- and/or RNA-based next-generation sequencing (NGS) analysis were considered. Primary endpoint was progression-free survival (PFS), with overall response rate, disease control rate and overall survival (OS) as secondary endpoint. OS and PFS were calculated by Kaplan-Meier and log-rank test. Multivariate analysis used cox-regression model. Level of statistical significance p was 0.05.
RESULTS: Of 72 patients of PEMIREAL-PEMIBIL, 63 patients had evaluable NGS data, with concomitant GAs identified in 28 patients (44.4%). The most frequently observed concomitant GAs involved BAP1 (7/63, 11.1%), CDKN2A (7/63, 11.1%), TP53 (6/63, 9.5%), CDKN2B (5/63, 7.9%), PTEN (3/63, 4.7%) and IDH1 (1/63, 1.5%). A significantly shorter PFS was observed in patients with CDKN2A mutations compared to CDKN2A wild-type tumours (4.79 vs. 8.66 months, p = 0.0011, HR: 3.48 95% CI: 0.91-13.24), and similarly in patients with BAP1 mutations compared to BAP1 wild-type tumours (5.97 vs. 8.52 months, p = 0.025, HR:2.55 95% CI: 0.72-9.00). No significant differences in OS were observed.
CONCLUSIONS: Our results support the negative prognostic role of BAP1 and CDKN2A GAs on PFS in patients with locally advanced or metastatic CCA with FGFR2 gene fusion/rearrangement treated with pemigatinib in a real-world setting.