Abstract

The optimal treatment following endocrine therapy (ET) plus a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) has not been established. We aimed to investigate treatment patterns and time to treatment failure (TTF) of subsequent therapy after palbociclib in a Japanese real-world setting. This retrospective observational study used de-identified data of patients with advanced breast cancer treated with palbociclib, using a nationwide claims database (April 2008 to June 2021). Measures included the type of subsequent therapies after palbociclib (endocrine-based therapy: ET alone, ET+CDK4/6i, and ET+mammalian target of rapamycin inhibitor [mTORi]; chemotherapy; chemotherapy+ET; and others) and their TTFs. The median TTF and 95% confidence interval (CI) were estimated using the Kaplan-Meier method. Of 1170 patients treated with palbociclib, 224 and 235 received subsequent therapies after first- and second-line palbociclib treatment, respectively. Among them, 60.7% and 52.8% were treated with endocrine-based therapies as first subsequent therapy, including ET+CDK4/6i (31.2% and 29.8%, respectively). The median TTF (95% CI) of ET alone, ET+CDK4/6i, and ET+mTORi as first subsequent therapy after first-line palbociclib were 4.4 (2.8-13.7), 10.9 (6.5-15.6), and 6.1 (5.1-7.2) months, respectively. No apparent relationship between the treatment duration of prior ET+palbociclib and subsequent abemaciclib was observed. This real-world study revealed that one-third of the patients received sequential CDK4/6i after ET+palbociclib, and treatment duration of ET+CDK4/6i following ET+palbociclib was the longest among the treatment options. Further data are awaited to determine whether ET+targeted therapy with CDK4/6i and mTORi provides acceptable treatment options following ET+palbociclib.

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