Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Apr 11;3(4):289-303.
doi: 10.1200/JGO.2016.008318. eCollection 2017 Aug.

PALOMA-3: Phase III Trial of Fulvestrant With or Without Palbociclib in Premenopausal and Postmenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer That Progressed on Prior Endocrine Therapy-Safety and Efficacy in Asian Patients

Hiroji Iwata  1 , Seock-Ah Im  1 , Norikazu Masuda  1 , Young-Hyuck Im  1 , Kenichi Inoue  1 , Yoshiaki Rai  1 , Rikiya Nakamura  1 , Jee Hyun Kim  1 , Justin T Hoffman  1 , Ke Zhang  1 , Carla Giorgetti  1 , Shrividya Iyer  1 , Patrick T Schnell  1 , Cynthia Huang Bartlett  1 , Jungsil Ro  1
Affiliations

PALOMA-3: Phase III Trial of Fulvestrant With or Without Palbociclib in Premenopausal and Postmenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer That Progressed on Prior Endocrine Therapy-Safety and Efficacy in Asian Patients

Hiroji Iwata et al. J Glob Oncol. .

Abstract

Purpose: To assess efficacy and safety of palbociclib plus fulvestrant in Asians with endocrine therapy-resistant metastatic breast cancer.

Patients and methods: The Palbociclib Ongoing Trials in the Management of Breast Cancer 3 (PALOMA-3) trial, a double-blind phase III study, included 521 patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer with disease progression on endocrine therapy. Patient-reported outcomes (PROs) were assessed on study treatment and at the end of treatment.

Results: This preplanned subgroup analysis of the PALOMA-3 study included premenopausal and postmenopausal Asians taking palbociclib plus fulvestrant (n = 71) or placebo plus fulvestrant (n = 31). Palbociclib plus fulvestrant improved progression-free survival (PFS) compared with fulvestrant alone. Median PFS was not reached with palbociclib plus fulvestrant (95% CI, 9.2 months to not reached) but was 5.8 months with placebo plus fulvestrant (95% CI, 3.5 to 9.2 months; hazard ratio, 0.485; 95% CI, 0.270 to 0.869; P = .0065). The most common all-cause grade 3 or 4 adverse events in the palbociclib arm were neutropenia (92%) and leukopenia (29%); febrile neutropenia occurred in 4.1% of patients. Within-patient mean trough concentration comparisons across subgroups indicated similar palbociclib exposure between Asians and non-Asians. Global quality of life was maintained; no statistically significant changes from baseline were observed for patient-reported outcome scores with palbociclib plus fulvestrant.

Conclusion: This is the first report, to our knowledge, showing that palbociclib plus fulvestrant improves PFS in asian patients. Palbociclib plus fulvestrant was well tolerated in this study.

PubMed Disclaimer

Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/site/ifc. Hiroji IwataConsulting or Advisory Role: Chugai Pharma, Eisai, AstraZenecaSeock-Ah ImConsulting or Advisory Role: AstraZeneca, Novartis, Roche, Spectrum Pharmaceuticals, Pfizer Research Funding: AstraZenecaNorikazu MasudaHonoraria: Chugai Pharma, AstraZeneca Research Funding: Chugai Pharma (Inst), Pfizer (Inst), Novartis (Inst), Eli Lilly (Inst), AstraZeneca (Inst), Kyowa-Kirin (Inst)Young-Hyuck ImNo relationship to discloseKenichi InoueResearch Funding: Pfizer (Inst), Eli Lilly (Inst), Chugai Pharma, Daiichi-Sankyo (Inst), Taiho Pharmaceutical (Inst), MSD (Inst), Parexel (Puma) (Inst)Yoshiaki RaiNo relationship to discloseRikiya NakamuraNo relationship to discloseJee Hyun KimNo relationship to discloseJustin T. HoffmanEmployment: Pfizer Stock or Other Ownership: Pfizer Travel, Accommodations, Expenses: PfizerKe ZhangEmployment: Pfizer (former employer), Janssen Research and Development (current employer) Stock or Other Ownership: PfizerCarla GiorgettiEmployment: Pfizer Stock or Other Ownership: PfizerShrividya IyerEmployment: Pfizer Stock or Other Ownership: PfizerPatrick T. SchnellEmployment: Pfizer Stock or Other Ownership: PfizerCynthia Huang BartlettEmployment: Pfizer Stock or Other Ownership: PfizerJungsil RoNo relationship to disclose

Figures

Fig 1
Fig 1
Patient disposition. (*) None of the patients discontinued treatment because of adverse events (AEs). (†) One patient (0.4%) discontinued treatment because of AEs. (‡) Two patients (1.4%) discontinued treatment because of AEs.
Fig 2
Fig 2
Investigator-assessed progression-free survival (PFS) in Asian and non-Asian patients. FUL, fulvestrant; HR, hazard ratio; NR, not reached; PAL, palbociclib; PCB, placebo.
Fig 3
Fig 3
Plasma palbociclib within-patient mean steady-state trough concentration in Asian and non-Asian patients. Diamonds represent the subpopulation geometric mean values, and open circles represent individual patient values. The dashed line represents the arithmetic mean value of all data from all patients. The box plot provides median and 25% and 75% quartiles with whiskers to the last point within 1.5 times the interquartile range.
Fig A1
Fig A1
Overall mean (SE) change from baseline in patient-reported scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 of (A) global quality of life (QOL) and function and (B) symptoms in Asian patients. (*) P < .05 for palbociclib plus fulvestrant versus placebo plus fulvestrant.
See this image and copyright information in PMC

References

    1. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin. 2011;61:69–90. - PubMed
    1. Li J, Zhang BN, Fan JH, et al. A nation-wide multicenter 10-year (1999-2008) retrospective clinical epidemiological study of female breast cancer in China. BMC Cancer. 2011;11:364. - PMC - PubMed
    1. American Cancer Society Breast Cancer Facts & Figures 2015-2016. http://www.cancer.org/acs/groups/content/@research/documents/document/ac...
    1. Youlden DR, Cramb SM, Yip CH, et al. Incidence and mortality of female breast cancer in the Asia-Pacific region. Cancer Biol Med. 2014;11:101–115. - PMC - PubMed
    1. Ghiasvand R, Adami HO, Harirchi I, et al. Higher incidence of premenopausal breast cancer in less developed countries: Myth or truth? BMC Cancer. 2014;14:343. - PMC - PubMed