Abstract:
Objective To investigate the efficacy and safety of palbociclib in combination with endocrine therapy in the treatment of hormone receptor (HR)-positive HER-2 negative advanced breast cancer.
Methods We retrospectively analyzed the clinical data of 78 patients with HR positive HER-2 negative advanced breast cancer who underwent palbociclib and endocrine combination therapy at Tianjin Medical University Cancer Institute and Hospital from September 2018 to December 2019.The efficacy and safety of this combination therapy was analyzed.
Results Median age of patients was 58 years, median progression-free survival (PFS) was 7 months, and overall objective response rate (ORR) was 36.7%(22/60).The clinical benefit rate (CBR) was 73.3%(44/60), and the ORR of previous palliative treatment, < 2 lines or ≥2 lines, was 71.4%(20/28) and 6.3%(2/32)(P < 0.001), respectively.Analysis showed that the number of metastatic sites and previous palliative treatment lines, and whether palliative chemotherapy was performed were independent factors influencing the efficacy of palbociclib and endocrine therapy.Neutropenia was the most common adverse event, affecting 96.2% of patients (75/78), with grade 3-4 neutropenia accounting for 62.8%(49/78) of all cases.Grade 3-4 leukopenia/neutropenia was evident in 14.1%(11/78)of patients, all of whom underwent dose adjustments.The most common non-hematological adverse event was fatigue, occurring in 23.1%(18/78) of cases.The rate of discontinuation due to adverse events was 7.7%(6/78).
Conclusions Palbociclib combined with endocrine therapy is more suitable for patients who have not received palliative chemotherapy.Adverse events can be controlled, and it may have a better curative effect than palliative chemotherapy.