Abstract

Background: Palbociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor used in combination with aromatase inhibitors or fulvestrant for patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2)-negative advanced/metastatic breast cancer (ABC/MBC). Palbociclib was the first CDK 4/6 inhibitor approved for HR+/HER2− ABC/MBC treatment in Canada in combination with letrozole (P+L) as an initial endocrine-based therapy (approved March 2016), or with fulvestrant (P+F) following disease progression after prior endocrine therapy (approved May 2017). The Ibrance Real World Insights (IRIS) study (NCT03159195) collected real-world outcomes data for palbociclib-treated patients in several countries, including Canada. Methods: This retrospective chart review included women with HR+/HER2− ABC/MBC receiving P+L or P+F in Canada. Physicians reviewed medical records for up to 14 patients, abstracting demographic and clinical characteristics, treatment patterns, and clinical outcomes. Progression-free rates (PFRs) and survival rates (SRs) at 6, 12, 18, and 24 months were estimated via Kaplan–Meier analysis. Results: Thirty-three physicians examined medical records for 247 patients (P+L, n = 214; P+F, n = 33). Median follow-up was 8.8 months for P+L and 7.0 months for P+F. Most patients were initiated on palbociclib 125 mg/d (P+L, 90.2%; P+F, 84.8%). Doses were reduced in 16.6% of P+L and 14.3% of P+F patients initiating palbociclib at 125 mg/d. The PFR for P+L was 90.3% at 12 months and 78.2% at 18 months; corresponding SRs were 95.6% and 93.0%. For P+F, 6-month PFR was 91.0%; 12-month SR was 100.0%. Conclusions: Dose reduction rates were low and PFR and SR were high in this Canadian real-world assessment of P+L and P+F treatments, suggesting that palbociclib combinations are well tolerated and effective.

Highlights

  • Breast cancer is predicted to be the most common non-melanoma cancer among women in Canada in 2020, with an estimated 27,400 breast cancer diagnoses and 5100 deaths [1]

  • Palbociclib (Ibrance: Pfizer, New York, NY, USA) was the first selective cyclin-dependent kinase (CDK) 4/6 inhibitor approved in Canada for use in combination with letrozole for the treatment of post-menopausal women with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2 (HER2)– advanced breast cancer (ABC) as an initial endocrine-based therapy for their metastatic disease [8], and later in combination with fulvestrant for the treatment of women with HR+/HER2– locally advanced or metastatic breast cancer (MBC) whose disease progressed after prior endocrine therapy [9]

  • At the time of data collection, treatment with palbociclib + an aromatase inhibitor was broadly available via provincial public reimbursement or private insurance; palbociclib + fulvestrant was only covered by private insurance

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Summary

Introduction

Breast cancer is predicted to be the most common non-melanoma cancer among women in Canada in 2020, with an estimated 27,400 breast cancer diagnoses and 5100 deaths [1]. Palbociclib (Ibrance: Pfizer, New York, NY, USA) was the first selective cyclin-dependent kinase (CDK) 4/6 inhibitor approved in Canada for use in combination with letrozole for the treatment of post-menopausal women with estrogen receptor-positive (ER+) HER2– ABC as an initial endocrine-based therapy for their metastatic disease [8], and later in combination with fulvestrant for the treatment of women with HR+/HER2– locally advanced or MBC whose disease progressed after prior endocrine therapy [9]. The approval of palbociclib was subsequently expanded to encompass overall use in combination with other aromatase inhibitors as initial endocrine-based therapy in post-menopausal women with HR+/HER2− ABC/MBC (June 2018) [10]. Palbociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor used in combination with aromatase inhibitors or fulvestrant for patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2)-negative advanced/metastatic breast cancer (ABC/MBC). Conclusions: Dose reduction rates were low and PFR and SR were high in this Canadian real-world assessment of P+L and P+F treatments, suggesting that palbociclib combinations are well tolerated and effective

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