Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Efficacy and safety of palbociclib plus fulvestrant in Asian women with hormone receptor-positive (HR+)/human epidermal growth factor-2 negative (HER2-) metastatic breast cancer (MBC) that progressed on prior endocrine therapy (ET)

Date

19 Dec 2015

Session

Breast cancer

Presenters

Jungsil Ro

Citation

Annals of Oncology (2015) 26 (suppl_9): 16-33. 10.1093/annonc/mdv519

Authors

J. Ro1, S. Im2, N. Masuda3, Y. Im4, K. Inoue5, Y. Rai6, R. Nakamura7, J.H. Kim8, K. Zhang9, C. Giorgetti10, P. Schnell11, C. Huang Bartlett12, H. Iwata13

Author affiliations

  • 1 Center For Breast Cancer, National Cancer Center, 410-769 - Goyang/KR
  • 2 Medical Oncology, Seoul National University, SEOUL/KR
  • 3 Department Of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka/JP
  • 4 Professor, Division Of Hematology/medical Oncology, Department Of Medicine, Samsung Medical Center, Sungkyunkwan University School Of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul/KR
  • 5 Division Of Breast Oncology, Saitama Cancer Center, Saitama/JP
  • 6 Principal Of Sagara Hospital, Breast Surgery, Sagara Hospital, Hakuaikai Medical Corporation Sagara Hospital, Kagoshima/JP
  • 7 Division Of Breast Surgery, Chiba Cancer Center Hospital, Chiba/JP
  • 8 Professor Division Of Hematology/medical Oncology, Seoul National University Bundang Hospital, Gyeonggi-do/KR
  • 9 Oncology Clinical Statistics, Pfizer Inc., San Diego/US
  • 10 Clinical Oncology, Pfizer, Italy, Milan/IT
  • 11 Senior Medical Director, Pfizer Inc., New York/US
  • 12 Clinical Oncology, Pfizer Inc., New York/US
  • 13 Department Of Breast Oncology, Aichi Cancer Center Hospital, Nagoya/JP
More

Aim/Background

Endocrine resistance is a major clinical issue for patients (pts) with HR + /HER2- breast cancer. The standard of care (SOC) is to re-challenge with ET before switch to chemotherapy (CT). PALOMA3 assessed whether Palbociclib (P) + fulvestrant (F) prolonged progression-free survival (PFS) vs F + placebo (PLB) in pts with HR + /HER2- MBC whose disease had progressed on prior ET. Primary analysis showed median PFS of 9.2 vs 3.8 m (HR 0.42, P < 0.001) in full population (Turner et al NEJM 2015). We present the efficacy and safety in Asian pts with longer follow-up.

Methods

In the Ph 3 PALOMA3 study, 521 pts were randomized 2:1 to P (125 mg/d oral [3 wks drug, 1 wk off]) + F (500 mg, SOC) or PLB + F. Pre-/perimenopausal pts also received goserelin. One previous line of CT for MBC was allowed. Safety assessments occurred at baseline and on D1 per cycle; blood counts every 2 wks for first 2 cycles and on D1 of subsequent cycles. Primary endpoint was investigator-assessed PFS. Secondary endpoints: overall survival, response assessment, patient-reported outcomes, safety. PALOMA3 enrolled pts in Korea and Japan.

Results

By March 2015, 105 Asian pts were randomized (P + F, 74; PLB + F, 31). Baseline characteristics were well balanced. Compared to non-Asians, median age was lower in Asians (52 vs 58 y) and more were pre/perimenopausal (42% vs 15%). 59% of Asian pts had visceral disease, 80% had documented endocrine responsiveness, 34% had 1 line of CT for MBC. Median PFS in Asian pts was not reached for P + F (95% CI 9.2–NR) and 5.8 m for PLB + F (3.5–9.5m) (HR 0.485 [95% CI 0.270–0.869], P = 0.0065). Most common Grade 3/4 adverse events (AEs) in Asian pts were neutropenia (92%) and leucopenia (29%); febrile neutropenia occurred in 4.1% (P + F). No pt stopped P + F due to AEs. 51% of Asian pts had dose reduction due to AEs. 48% were on 100 mg dose.

Conclusions

P + F improved PFS in Asians with HR + /HER2- MBC that progressed on prior ET. The safety profile was consistent with that seen in Non-Asians; neutropenia was the most common AE, and can be managed by dose reduction. P + F may be a reasonable therapeutic option in Asian pts.

Clinical trial identification

NCT01942135

Disclosure

J. Ro: served as a consultant/advisor to Nippon Kayaku (NK) and received travel support from Eisai.

S.-A. Im: consulting fees (e.g. advisory boards): Roche, Novartis, AstraZeneca; Contracted Research: AstraZeneca in 2014. N. Masuda: fees for Non-CME Services received directly from commercial interest or their agents (speaker's Bureaus): Chugai, AstraZenaca Contracted Research Chugai, Novaltis, Pfizer, AstraZeneca, Lilly. K. Inoue: research funding from Pfizer, Lilly, Chugai, Taiho, Daiichi-Sankyo, Parexel. K. Zhang, C. Giorgetti, P. Schnell, C. Huang Bartlett: employee of and owns stock in Pfizer Inc and receive stock options from Pfizer Inc. H. Iwata: honoraria from AstraZeneca, Eisai, Daiichi-Sankyo, Chugai, and Pfizer Inc. All other authors have declared no conflicts of interest.

Resources from the same session

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings