Palbociclib for Hormone-Receptor-Positive, HER2-Positive Advanced Breast Cancer.
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Metzger Otto, Mandrekar Sumithra, Goel Shom, Gligorov Joseph, Lim Elgene, Ciruelos Eva, Loibl Sibylle, Dockter Travis, Gonzàlez Farré Xavier, Francis Prudence A, Lynce Filipa, Lanzillotti Jane, DuFrane Carter, Wall Anna, Strand Carrie, Krop Ian, Vaz-Luis Ines, Tripathy Debu, Loi Sherene, Prat Aleix, Goetz Matthew, Escrivá-de-Romaní Santiago, Porter David, Spoenlein Jennifer, Stover Daniel G, Sardesai Sagar, Heudel Pierre, Koehler Maria, Huang Bartlett Cynthia, Holynskyj Ariadna, Gopalakrishna Prashanth, Gauthier Eric, Delaloge Suzette, Miller Kathy, Winer Eric P, Gianni Luca, Partridge Ann H, DeMichele Angela, Carey Lisa A
Аннотация
METHODS: In this phase 3, open-label, randomized trial, we enrolled patients with hormone-receptor-positive, HER2-positive metastatic breast cancer who did not have disease progression after four to eight cycles of chemotherapy plus HER2-targeted therapy. Patients were randomly assigned in a 1:1 ratio to receive maintenance HER2-targeted and endocrine therapies with or without palbociclib. The primary end point was investigator-assessed progression-free survival. Secondary end points included the objective response, clinical benefit, safety, and overall survival.
RESULTS: A total of 518 patients underwent randomization: 261 were assigned to receive palbociclib and 257 to receive standard therapy. At a median follow-up of 53.5 months, patients in the palbociclib group had significantly longer progression-free survival than those in the standard-therapy group (median duration, 44.3 months vs. 29.1 months; hazard ratio for disease progression or death, 0.75; 95% confidence interval, 0.59 to 0.96; two-sided P = 0.02). Grade 3 and 4 adverse events, predominantly from neutropenia, occurred in 79.7% and 10.0% of the patients, respectively, in the palbociclib group, as compared with 30.6% and 3.6% of the patients, respectively, in the standard-therapy group.
CONCLUSIONS: The addition of palbociclib to maintenance anti-HER2 and endocrine therapies led to a significant improvement in progression-free survival over standard therapy, with increased toxic effects, mainly neutropenia. (Funded by Pfizer and others; PATINA ClinicalTrials.gov number, NCT02947685.).