Cancer Res Treat.  2021 Apr;53(2):409-423. 10.4143/crt.2020.451.

Real-World Clinical Data of Palbociclib in Asian Metastatic Breast Cancer Patients: Experiences from Eight Institutions

Affiliations
  • 1Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 2Cancer Research Institute, The Catholic University of Korea, Seoul, Korea
  • 3Division of Medical Oncology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 4Division of Medical Oncology, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 5Division of Medical Oncology, Department of Internal Medicine, Yeouido St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 6Division of Medical Oncology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 7Division of Medical Oncology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 8Division of Medical Oncology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 9Division of Medical Oncology, Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea

Abstract

Purpose
Use of cyclin-dependent kinase 4/6 inhibitors improved survival outcome of hormone receptor (HR) positive metastatic breast cancer (MBC) patients, including Asian population. However, Asian real-world data of palbociclib is limited. We analyzed the real-world clinical practice patterns and outcome in HR-positive, MBC Asian patients treated with palbociclib.
Materials and Methods
Between April 2017 to November 2019, 169 HR-positive, human epidermal growth factor-2–negative MBC patients treated with letrozole or fulvestrant plus palbocilib were enrolled from eight institutions. Survival outcome (progression-free survival [PFS]), treatment response and toxicity profiles were analyzed.
Results
Median age of letrozole plus palbociclib (145 patients, 85.8%) and fulvestrant plus palbociclib (24 patients, 14.2%) was 58 and 53.5 years, with median follow-up duration of 14.63 months (range 0.2 to 33.9 months). Median PFS (mPFS) of letrozole plus palbociclib and fulvestrant plus palbociclib was 25.6 (95% confidence interval [CI], 19.1 to not reached) and 6.37 months (95% CI, 5.33 to not reached), comparable to previous phase 3 trials. In letrozole plus palbociclib arm, luminal A (hazard ratio, 2.86; 95% CI, 1.20 to 6.80; p=0.017) and patients with good performance (Eastern Cooperative Oncology Group 0-1 [hazard ratio, 3.68; 95% CI, 1.70 to 7.96]) showed better mPFS. In fulvestrant plus palbociclib group, chemotherapy naïve patients showed better mPFS (hazard ratio, 12.51, 95% CI, 1.59 to 99.17; p=0.017). The most common grade 3 or 4 adverse event was neutropenia (letrozole 86.3%, fulvestrant 88.3%).
Conclusion
To our knowledge, this is the first real-world data of palbociclib reported in Asia. Palbociclib showed comparable benefit to previous phase 3 trials in Asian patients during daily clinical practice.

Keyword

Breast neoplasms; CDK4/6 inhibitor; Palbociclib; Menopause; Ovary suppression

Figure

  • Fig. 1 Consort diagram of total patient population. HER2, human epidermal growth factor-2.

  • Fig. 2 Progression-free survival (PFS) in letrozole (A) or fulvestrant (B) plus palbociclib treated patients. CI, confidence interval; mPFS, median progression-free survival; NA, not available.

  • Fig. 3 Progression-free survival (PFS) of subgroup analysis according to subtype (A), performance status (B) in letrozole plus palbociclib group and previous history of cytotoxic chemotherapy (CTx) (C) in fulvestrant plus palbociclib group. CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; NA, not available.

  • Fig. 4 Forest plot of post-hoc subgroup analysis. (A) Letrozole plus palbociclib. (B) Fulvestrant plus palbociclib. BSO, bilateral salphingo-oophrectomy; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; GnRH, gonadotropin-releasing hormone agonist.

  • Fig. 5 Progression-free survival (PFS) of subgroup analysis according to presence of endocrine resistance (A) in letrozole plus palbociclib group and primary or secondary endocrine resistance in letrozole or fulvestrant plus palbociclib group (B, C). CI, confidence interval; HR, hazard ratio; NA, not available.


Reference

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