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Presidential Symposium 1

5410 - Overall survival (OS) with palbociclib plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2_) advanced breast cancer (ABC): Analyses from PALOMA-3


20 Oct 2018


Presidential Symposium 1


Cytotoxic Therapy;  Targeted Therapy

Tumour Site

Breast Cancer


Massimo Cristofanilli


M. Cristofanilli1, D.J. Slamon2, J. Ro3, I. Bondarenko4, S. Im5, N. Masuda6, M. Colleoni7, A. DeMichele8, S. Loi9, S. Verma10, H. Iwata11, N. Harbeck12, S. Loibl13, F. André14, K. Puyana Theall15, X. Huang16, C. Giorgetti17, C. Huang Bartlett18, N.C. Turner19

Author affiliations

  • 1 Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, 60611 - Chicago/US
  • 2 Geffen School Of Medicine, UCLA - School of Medicine, 90095 - Los Angeles/US
  • 3 Oncology, National Cancer Center, Goyang-si/KR
  • 4 Dnipropetrovsk Medical Academy, City Multiple-Discipline Clinical Hospital #4, Dnipropetrovsk/UA
  • 5 Cancer Research Institute, Seoul National University Hospital, 3080 - Seoul/KR
  • 6 Dept. Of Surgery, Breast Oncology, NHO Osaka National Hospital, 540-0006 - Osaka/JP
  • 7 Divisione Di Senologia Medica, Istituto Europeo di Oncologia, Milan/IT
  • 8 Abramson Cancer Center, University of Pennsylvania, Philadelphia/US
  • 9 Peter Maccallum Cancer Centre, University of Melbourne, 3002 - Melbourne/AU
  • 10 Tom Baker Cancer Centre, University of Calgary, T2N 4N2 - Calgary/CA
  • 11 Department Of Breast Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 12 Dept. Of Obstetrics And Gynecology, Brustzentrum der Universität München (LMU), 81377 - Munich/DE
  • 13 German Breast Group, c/o GBG Forschungs GmbH, Neu-Isenburg/DE
  • 14 Department Of Medical Oncology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 15 Pfizer Oncology, Pfizer Inc, Cambridge/US
  • 16 Pfizer Oncology, Pfizer Inc, San Diego/US
  • 17 Pfizer Oncology, Pfizer Inc, Milan/IT
  • 18 Pfizer Oncology, Pfizer Inc, Collegeville/US
  • 19 Breast Cancer Now Research Centre, Royal Marsden Hospital and Institute of Cancer Research, London/GB


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Abstract 5410


Endocrine therapy (ET)–resistant ABC is dependent on cyclin dependent kinase (CDK) 4/6. In the prospective, randomized, double-blind, phase 3 PALOMA-3 study, the CDK4/6 inhibitor PAL in combination with FUL significantly improved progression-free survival (PFS) vs placebo (PBO)+FUL (median PFS, 11.2 vs 4.6 mo; absolute difference, 6.6 mo; hazard ratio [HR] 0.50 [95% CI, 0.40–0.62]; P<0.000001). Here, we report OS analysis with a median follow up of 44.8 mo.


HR+/HER2– ABC (N=521) patients (pts) who had relapsed or progressed on prior ET were randomized 2:1 to PAL (125 mg/d orally, schedule 3/1) + FUL (500 mg per standard of care) or PBO+FUL. Primary endpoint was investigator-assessed PFS. A key secondary endpoint was OS. OS analysis occurred when approximately 60% (n≈310) of the 521 pts died.


Median OS improved with PAL+FUL vs PBO+FUL by an absolute difference of 6.9 mo (Table). In pts with sensitivity to prior ET, the absolute improvement in median OS was 10.0 mo with PAL+FUL vs PBO+FUL. In pts without visceral disease, median OS significantly improved with PAL+FUL vs PBO+FUL (11.5 mo). Time to end of the next-line treatment was 18.8 (PAL+FUL) and 14.1 (PBO+FUL) mo (HR 0.68 [95% CI, 0.56–0.84]; P<0.0001). Improvements in median OS, although not statistically significant at the prespecified level, were shown with PAL+FUL vs PBO+FUL regardless of ESR1 mutation status or prior lines of therapy. Median time on subsequent therapy was similar in both arms; median time to chemotherapy was 17.5 (PAL+FUL) and 8.8 (PBO+FUL) mo (HR 0.58; P<0.000001). No new safety signals were observed with longer follow-up.

Table. OS in the ITT Population and by Subgroup
Subgroup n (%) HR (95% CI) PAL+FUL
median OS (95% CI)
median OS (95% CI)
P value
P value
ITT, stratified 521 (100) 0.81 (0.64–1.03) 34.9 (28.8–40.0) 28.0 (23.6–34.6) 0.043
ITT, unstratified 521 (100) 0.79 (0.63–1.00) 34.9 (28.8–40.0) 28.0 (23.6–34.6) 0.025
Sensitivity to previous endocrine therapy
Endocrine sensitive 410 (78.7) 0.72 (0.55–0.94) 39.7 (34.8–45.7) 29.7 (23.8­–37.9) 0.124
Endocrine resistant 111 (21.3) 1.14 (0.71–1.84) 20.2 (17.2–26.4) 26.2 (17.5–31.8)
Site of metastatic disease
Visceral disease 311 (59.7) 0.85 (0.64–1.13) 27.6 (24.4–31.2) 24.7 (20.8–31.8) 0.442
Nonvisceral disease 210 (40.3) 0.69 (0.46–1.04) 46.9 (39.3–NE) 35.4 (24.6–NE)
Menopausal status at study entry
Postmenopausal 413 (79.3) 0.73 (0.57–0.95) 34.8 (28.8–40.1) 27.1 (22.8–32.1) 0.251
Pre/perimenopausal 108 (20.7) 1.07 (0.61–1.86) 38.0 (24.4–NE) 38.0 (22.2–NE)
FUL=fulvestrant; HR=hazard ratio; ITT=intent-to-treat; NE=not estimable; OS=overall survival; PAL=palbociclib; PBO=placebo.


In HR+/HER2– ABC pts, PAL+FUL showed a clinically meaningful improvement in OS (6.9 mo vs PBO+FUL), especially in pts with sensitivity to prior ET. The absolute difference of PFS gain was maintained in OS.

Funding: Pfizer (NCT01942135)

Clinical trial identification


Editorial Acknowledgement

Editorial support was provided by Jennifer Fetting, PhD, and Kevin O’Regan, PhD, of Complete Healthcare Communications, LLC (North Wales, PA), a CHC Group company, and funded by Pfizer Inc.

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