Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
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Hörner Manuel, Tretschock Lara M, John Nelson, Ziegler Philipp, Häberle Lothar, Uhrig Sabrina, Goossens Chloë, Amann Niklas, Cieslik Jan-Philipp, Dannehl Dominik, Deutsch Thomas M, Dimpfl Moritz, Ehlert Max, Eichstädt Kathleen, Englisch Alexander, Köpke Melitta B, Krückel Annika, Link Theresa, Müller Annika, Reinhardt Kristin, Roth Jonas, Schäffler Henning, Sych Lea, Tegeler Christian M, Wichmann Catharina, Banys-Paluchowski Maggie, Princk Henriette, Rody Achim, Brucker Sara Y, Ditsch Nina, Ettl Johannes, Fehm Tanja, Hack Carolin C, Hadji Peyman, Hein Alexander, Janni Wolfgang W, Kolberg Hans-Christian, Lüftner Diana, Lux Michael P, Müller Volkmar, Schneeweiss Andreas, Taran Florin-Andrei, Tesch Hans, Wallwiener Diethelm, Marmé Frederik, Seitz Stephan, Belleville Erik, Hartkopf Andreas, Michel Laura L, Wallwiener Markus, Fasching Peter A, Tauber Nikolas
Аннотация
METHODS: 57 patients with advanced breast cancer receiving alpelisib and fulvestrant were identified. 55 Patients had received prior CDK4/6i therapy. Progression-free survival (PFS) and overall survival (OS) were calculated for all patients, and stratified according CDK4/6i pre-treatment, using the Kaplan-Meier method. Subgroups (age, line of therapy, concomitant disease among others), somatic PIK3CA mutations, reasons for discontinuation and adverse events (AEs) were analyzed.
RESULTS: The median PFS was 5.0 (95% confidence interval [CI], 3.1-9.4) months, and the median OS was 20.1 (95% CI, 14.6-30.8) months. Line of therapy and concomitant diseases appeared to affect PFS, while the line of therapy and preexisting diabetes influenced OS. However, subgroups were too small for statistical testing. Discontinuation was mainly due to tumor progression (56.1%). Hyperglycemia, rash and diarrhea were the most documented AEs.
CONCLUSION: This prospective real-world analysis shows slightly shorter median PFS and OS times compared with the pivotal trials. Patients in our analyses received alpelisib in later therapy lines, which may explain the poorer outcome.