BRCA1/2 and Other Predisposition Genes in High-Risk Hormone Receptor+/Human Epidermal Growth Factor Receptor 2- Breast Cancer Treated With Endocrine Therapy With or Without Palbociclib: A Secondary PENELOPE-B Study Analysis.
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Hahnen Eric, Hauke Jan, Gelmon Karen, Marmé Frederik, Ernst Corinna, Martin Miguel, Untch Michael, Bonnefoi Hervé, Knudsen Erik, Im Seock-Ah, DeMichele Angela, Van't Veer Laura, Kim Sung-Bae, Bear Harry, McCarthy Nicole, Rhiem Kerstin, Turner Nicholas, Witkiewicz Agnieszka, Rojo Federico, Filipits Martin, Martin Lesley-Ann, Fasching Peter A, Schem Christian, Becker Kerstin, García-Sáenz José A, Kelly Catherine M, Reimer Toralf, Toi Masakazu, Rugo Hope S, Denkert Carsten, Gnant Michael, Makris Andreas, Liu Yuan, Valota Olga, Felder Bärbel, Weber Karsten, Nekljudova Valentina, Loibl Sibylle
Аннотация
METHODS: In total, 445 patients were sampled following a case-cohort design and 442 were analyzed for germline PVs. Statistical analyses were performed for time-to-event end points (iDFS, distant disease-free survival [DDFS], and overall survival [OS]).
RESULTS: Of the 442 patients, 42 carried PVs in any cancer predisposition gene; 15 carried BRCA1/2 PVs. Irrespective of the treatment arms, PV status was not a prognostic factor. Regarding the treatment arms in BRCA1/2 PV carriers, numerically better 3-year outcomes were observed in the palbociclib arm (iDFS, 95%; DDFS, 95%; OS, 100%) than in the placebo arm (iDFS, 72.8%; DDFS, 72.8%; OS, 87.5%; hazard ratios palbociclib v placebo 0.349 [iDFS] and 0.562 [DDFS], not calculated for OS, too few events). In patients without BRCA1/2 PVs, the differences in 3-year outcomes were negligible. PVs in non-BRCA1/2 cancer predisposition genes did not influence the efficacy of palbociclib, although gene-specific effects could not be excluded.
CONCLUSION: Patients with BRCA1/2 PVs had numerically better outcomes after palbociclib. However, the number of BRCA1/2 carriers was small. Larger randomized clinical trials should consider the PV status to further evaluate whether BRCA1/2 PV carriers benefit from cyclin-dependent kinase 4 and 6 inhibitor treatment.