Abstract
BackgroundIn the double-blind, phase 3 PALOMA-2 and PALOMA-3 studies, palbociclib plus endocrine therapy (ET) demonstrated significant improvement in progression-free survival versus placebo plus ET in patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer. This analysis assessed subsequent treatment patterns after palbociclib therapy in Japanese patients enrolled in the PALOMA-2 and PALOMA-3 studies.MethodsPALOMA-2 included postmenopausal women who had not received prior systemic therapy for advanced disease. PALOMA-3 included pre- or postmenopausal women who had progressed on previous ET. Types of subsequent therapy were assessed, and treatment durations of subsequent therapy were estimated using the Kaplan–Meier method.ResultsJapanese patients were enrolled in PALOMA-2 (n = 46) and PALOMA-3 (n = 35). In both studies, the most common first subsequent therapy was ET (PALOMA-2, 77% in the palbociclib group and 75% in the placebo group; PALOMA-3, 55% and 43%, respectively), followed by chemotherapy (PALOMA-2, 18% and 8%; PALOMA-3, 32% and 57%). The median (95% CI) duration of first subsequent therapy was 6.4 (2.3‒13.9) months with palbociclib plus letrozole and 6.7 (2.8‒13.0) months with placebo plus letrozole in PALOMA-2 and 3.8 (2.4‒5.7) months with palbociclib plus fulvestrant and 9.7 (1.0‒not estimable) months with placebo plus fulvestrant in PALOMA-3.ConclusionsThe types of first subsequent therapy received by Japanese patients in the palbociclib plus ET and placebo plus ET groups were similar. Further evaluation of subsequent therapy data in the real-world setting is warranted considering the small sample size of this analysis.
Highlights
The incidence of breast cancer in Japan has increased, and it is the fifth leading cause of cancer-related mortality among Japanese women [1]
Recent analyses in the overall population from PALOMA-2 and PALOMA-3 have shown that the types of subsequent therapy received by patients in the palbociclib plus endocrine therapy (ET) group were similar to those received by patients in the placebo plus ET group and that progression-free survival (PFS) improvement associated with palbociclib plus ET was retained in subsequent lines of therapy [9, 10]
In the overall population in PALOMA-2 and PALOMA-3, the types of subsequent therapy received by patients in the palbociclib plus ET and placebo plus ET groups were similar (Online Resource—Supplemental Table 1) [9, 10]
Summary
The incidence of breast cancer in Japan has increased, and it is the fifth leading cause of cancer-related mortality among Japanese women [1]. Extended author information available on the last page of the article recommend a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in combination with endocrine therapy (ET) for the treatment of patients with hormone receptor‒positive (HR +)/human epidermal growth factor receptor 2‒negative (HER2‒) metastatic breast cancer (MBC) [2, 3]. In the double-blind, phase 3 PALOMA-2 and PALOMA-3 studies, palbociclib plus endocrine therapy (ET) demonstrated significant improvement in progression-free survival versus placebo plus ET in patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer. This analysis assessed subsequent treatment patterns after palbociclib therapy in Japanese patients enrolled in the PALOMA-2 and PALOMA-3 studies. Further evaluation of subsequent therapy data in the real-world setting is warranted considering the small sample size of this analysis
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