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Overall Survival with Palbociclib and Fulvestrant in Women with HR+/HER2− ABC: Updated Exploratory Analyses of PALOMA-3, a Double-blind, Phase III Randomized Study
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Abstract
Purpose: To conduct an updated exploratory analysis of overall survival (OS) with a longer median follow-up of 73.3 months and evaluate the prognostic value of molecular analysis by circulating tumor DNA (ctDNA). Patients and Methods: Patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2−) advanced breast cancer (ABC) were randomized 2:1 to receive palbociclib (125 mg orally/day; 3/1 week schedule) and fulvestrant (500 mg intramuscularly) or placebo and fulvestrant. This OS analysis was performed when 75% of enrolled patients died (393 events in 521 randomized patients). ctDNA analysis was performed among patients who provided consent. Results: At the data cutoff (August 17, 2020), 258 and 135 deaths occurred in the palbociclib and placebo groups, respectively. The median OS [95% confidence interval (CI)] was 34.8 months (28.8–39.9) in the palbociclib group and 28.0 months (23.5–33.8) in the placebo group (stratified hazard ratio, 0.81; 95% CI, 0.65–0.99). The 6-year OS rate (95% CI) was 19.1% (14.9–23.7) and 12.9% (8.0–19.1) in the palbociclib and placebo groups, respectively. Favorable OS with palbociclib plus fulvestrant compared with placebo plus fulvestrant was observed in most subgroups, particularly in patients with endocrine-sensitive disease, no prior chemotherapy for ABC and low circulating tumor fraction and regardless of ESR1, PIK3CA, or TP53 mutation status. No new safety signals were identified. Conclusions: The clinically meaningful improvement in OS associated with palbociclib plus fulvestrant was maintained with >6 years of follow-up in patients with HR+/HER2− ABC, supporting palbociclib plus fulvestrant as a standard of care in these patients.
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Palbociclib + fulvestrant failed to demonstrate a statistically significant overall survival benefit in the final prespecified or extended follow-up analysis of PALOMA-3.
“In PALOMA-3, palbociclib + fulvestrant failed to demonstrate a statistically significant OS benefit in the final prespecified (HR 0.81; 95% CI 0.64–1.03; P = 0.09) or extended follow-up analysis (HR 0.81; 95% CI 0.65–0.99) [11, 12].”
From Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant. (2023) · cites this paper as [12]
The Introduction states that the final protocol-specified OS analysis was not statistically significant (HR 0.81; 95% CI 0.64–1.03). For the extended follow-up, the Discussion reports HR 0.81 with a 95% CI of 0.65–0.99, which excludes 1; the Methods call that analysis unplanned and exploratory. The paper therefore supports the claim about the prespecified analysis, but not the unqualified assertion that the extended analysis also failed to show a statistically significant benefit. (LLM, conf=0.88)
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Sledge, G. W., Toi, M., Neven, P., Sohn, J., Inoue, K., Pivot, X., Burdaeva, O., Okera, M., Masuda, N., Kaufman, P. A., et al. (2020) · JAMA Oncology · doi:10.1001/jamaoncol.2019.4782 · Cited by 991
Self-citationSlamon, D. J., Neven, P., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S., Petrakova, K., Valeria Bianchi, G., Martín, M., Nusch, A., et al. (2021) · Annals of Oncology · doi:10.1016/j.annonc.2021.05.353 · Cited by 281
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Neven, P., Fasching, P. A., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S.-A., Petrakova, K., Bianchi, G. V., Martín, M., Nusch, A., et al. (2023) · Breast Cancer Research · doi:10.1186/s13058-023-01701-9 · Cited by 83
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Metadata
- Authors
- Cristofanilli, M., Rugo, H. S., Im, S.-A., Slamon, D. J., Harbeck, N., Bondarenko, I., Masuda, N., Colleoni, M., DeMichele, A., Loi, S., Iwata, H., O'Leary, B., André, F., Loibl, S., Bananis, E., Liu, Y., Huang, X., Kim, S., Lechuga Frean, M. J., & Turner, N. C.
- Affiliations
- Weill Cornell Medicine (US)
- UCSF Helen Diller Family Comprehensive Cancer Center (US)
- Seoul National University (KR)
- University of California, Los Angeles (US)
- LMU Klinikum (DE)
- Dnipro State Medical University (UA)
- Nagoya University (JP)
- European Institute of Oncology (IT)
- Abramson Cancer Center (US)
- The University of Melbourne (AU)
- Aichi Cancer Center (JP)
- 12Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom.
- Institut Gustave Roussy (FR)
- German Breast Group (DE)
- Pfizer (United States) (US)
- 16Pfizer Inc, San Diego, California.
- Institute of Cancer Research (GB)
- Corresponding author
- Cristofanilli, Massimo
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2022-05-12
- Volume
- 28
- Issue
- 16
- Pages
- 3433-3442
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC9662922
- OpenAlex
- W4280523559
- Cited by
- 207
- References
- 2
- Citations by year
- 2026: 32 · 2025: 60 · 2024: 62 · 2023: 45 · 2022: 8
- FWCI
- 28.23
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Cancer Research (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc-nd)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- Pfizer
- Topics
- Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Keywords
- palbociclib, fulvestrant, HR+/HER2- advanced breast cancer, overall survival, PALOMA-3, circulating tumor DNA, prognostic factors, endocrine therapy, ESR1 mutations, PIK3CA mutation, TP53 mutation, CDK4/6 inhibitors, long-term follow-up
- MeSH terms
- Fulvestrant, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Double-Blind Method, Female, Humans, Piperazines, Pyridines, Receptor, ErbB-2, Erb-b2 Receptor Tyrosine Kinases
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