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Cited by 171Advanced Breast Cancer TherapiesBreast Cancer Treatment StudiesPARP inhibition in cancer therapy

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Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2.

Finn, Richard S., Rugo, Hope S., Dieras, Veronique C, Harbeck, Nadia, Im, Seock-Ah, Gelmon, Karen A., Walshe, Janice Maria, Martin, Miguel, Chavez Mac Gregor, Mariana, Bananis, Eustratios, Gauthier, Eric Roland, Lu, Dongrui Ray, Kim, Sindy, Slamon, Dennis J.·2022·Journal of Clinical Oncology
DOI 10.1200/jco.2022.40.17_suppl.lba1003
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Abstract

LBA1003 Background: PAL was the first cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved for ER+/HER2– ABC based on the randomized, phase 2 PALOMA-1 study. PALOMA-2 is a randomized, double-blind, phase 3 trial in first-line ER+/HER2– ABC that confirmed a clinically and statistically significant improvement in progression-free survival (PFS) with PAL+LET versus PBO+LET (median PFS, 27.6 vs 14.5 months; hazard ratio, 0.56 [95% CI, 0.46–0.69]; P<0.0001). At the time of the final PFS analysis, OS data were not mature. Herein, we report OS results. Methods: 666 postmenopausal women with ER+/HER2– ABC who had not received prior systemic therapy for advanced disease were randomized 2:1 to receive PAL (125 mg/d orally, 3/1 week schedule) plus LET (2.5 mg/d orally, continuously) or PBO+LET. The primary endpoint was investigator-assessed PFS and a key secondary endpoint was OS. Per study design, 390 OS events are required to have 80% power to detect a hazard ratio <0.74 at a significance level of 0.025 (1-sided) using a stratified log-rank test. The planned final OS analysis was conducted when the number of events required for the analysis was observed. Results: At data cut-off (November 15, 2021), with a median follow-up of 90 months, 43 patients (pts; 10%) remained on PAL+LET and 5 pts (2%) on PBO+LET. With 405 deaths, median OS (95% CI) was 53.9 months (49.8–60.8) in the PAL+LET arm and 51.2 months (43.7 –58.9) in the PBO+LET arm (hazard ratio, 0.956 [95% CI, 0.777–1.177]; stratified 1-sided P=0.3378). In this OS analysis, a proportion of pts were not available for follow-up (withdrew consent or lost to follow-up) and were censored: 21% in the PBO+LET arm versus 13% in the PAL+LET arm. A posthoc sensitivity analysis excluding these pts resulted in a median OS (95% CI) of 51.6 months (46.9–57.1) with PAL+LET and 44.6 months (37.0–52.3) with PBO+LET (hazard ratio, 0.869 [95% CI, 0.706–1.069]). Of the pts who discontinued study treatment, 81% in the PAL+LET arm and 88% in the PBO+LET arm received post-study systemic therapy; 12% and 27% of pts who discontinued received CDK4/6 inhibitor, respectively. In pts with disease-free interval (DFI) >12 months, median OS (95% CI) was 66.3 months (52.1–79.7) in the PAL+LET arm (n=179) and 47.4 months (37.7–57.0) in the PBO+LET arm (n=93); hazard ratio, 0.728 (95% CI, 0.528-1.005). No new safety findings were observed. Conclusions: PALOMA-2 met its primary endpoint of improving PFS but not the secondary endpoint of OS. Pts receiving PAL+LET had numerically longer OS compared to PBO+LET, but the results were not statistically significant. Funding: Pfizer Inc (NCT01740427) Clinical trial information: NCT01740427.

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Authors
Finn, R. S., Rugo, H. S., Dieras, V. C., Harbeck, N., Im, S.-A., Gelmon, K. A., Walshe, J. M., Martin, M., Chavez Mac Gregor, M., Bananis, E., Gauthier, E. R., Lu, D. R., Kim, S., & Slamon, D. J.
Affiliations
  • University of California, Los Angeles (US)
  • University of California, San Francisco (US)
  • Centre Eugène Marquis (FR)
  • LMU Klinikum (DE)
  • Seoul National University (KR)
  • BC Cancer Agency (CA)
  • Cancer Trials Ireland (IE)
  • Instituto de Investigación Sanitaria Gregorio Marañón, CIBERONC, Universidad Complutense de Madrid, GEICAM Breast Cancer Group, Madrid, Spain;
  • The University of Texas MD Anderson Cancer Center, Houston, TX;
  • Pfizer (United States) (US)
ORCID
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2022-06-10
Volume
40
Issue
17_suppl
Pages
LBA1003-LBA1003
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2022.40.17_suppl.lba1003
OpenAlex
W4293083647
Cited by
169
References
0
Citations by year
2026: 9 · 2025: 19 · 2024: 52 · 2023: 79 · 2022: 10
Type
conference abstract
Language
en
Open access
closed
Locations
Journal of Clinical Oncology (publishedVersion)
Funders
Pfizer Inc.
Topics
  • Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
  • Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
Keywords
palbociclib, letrozole, CDK4/6 inhibitors, estrogen receptor-positive breast cancer, HER2-negative breast cancer, advanced breast cancer, first-line therapy, overall survival, PALOMA-2, progression-free survival, aromatase inhibitors, postmenopausal women, endocrine therapy, hazard ratio, statistical power

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