Analysis of subsequent therapy in Japanese patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer who received palbociclib plus endocrine therapy in PALOMA-2 and -3.

Abstract

BACKGROUND:

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.

METHODS:

PALOMA-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.

RESULTS:

Japanese 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.

CONCLUSIONS:

The 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.

• Authors: Norikazu Masuda, Hirofumi Mukai, Kenichi Inoue, Yoshiaki Rai, Shinji Ohno, Shoichiro Ohtani, Chikako Shimizu, Satoshi Hashigaki, Yasuaki Muramatsu, Yoshiko Umeyama, Hiroji Iwata, Masakazu Toi
• Journal: Breast cancer (Tokyo, Japan) (Breast Cancer) Vol. 28 Issue 2 Pg. 335-345 (Mar 2021) ISSN: 1880-4233 [Electronic] Japan
• PMID: 33085032 (Publication Type: Clinical Trial, Phase III, Journal Article)

Chemical References

• Antineoplastic Agents, Hormonal
• Piperazines
• Pyridines
• Receptors, Estrogen
• Fulvestrant
• Letrozole
• ERBB2 protein, human
• Receptor, ErbB-2
• palbociclib

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Hormonal (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Breast Neoplasms (drug therapy, epidemiology, metabolism)
• Double-Blind Method
• Female
• Fulvestrant (administration & dosage)
• Hormone Replacement Therapy (methods)
• Humans
• Japan (epidemiology)
• Letrozole (administration & dosage)
• Middle Aged
• Piperazines (administration & dosage)
• Postmenopause
• Premenopause
• Progression-Free Survival
• Pyridines (administration & dosage)
• Random Allocation
• Receptor, ErbB-2 (deficiency)
• Receptors, Estrogen (metabolism)