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Alpelisib for PIK3CA -Mutated, Hormone Receptor–Positive Advanced Breast Cancer
Open accessAbstract
BACKGROUND: mutations occur in approximately 40% of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The PI3Kα-specific inhibitor alpelisib has shown antitumor activity in early studies. METHODS: -mutated cancer. Secondary end points included overall response and safety. RESULTS: -mutated cancer was greater with alpelisib-fulvestrant than with placebo-fulvestrant (26.6% vs. 12.8%); among patients with measurable disease in this cohort, the percentages were 35.7% and 16.2%, respectively. In the overall population, the most frequent adverse events of grade 3 or 4 were hyperglycemia (36.6% in the alpelisib-fulvestrant group vs. 0.7% in the placebo-fulvestrant group) and rash (9.9% vs. 0.3%). Diarrhea of grade 3 occurred in 6.7% of patients in the alpelisib-fulvestrant group, as compared with 0.3% of those in the placebo-fulvestrant group; no diarrhea of grade 4 was reported. The percentages of patients who discontinued alpelisib and placebo owing to adverse events were 25.0% and 4.2%, respectively. CONCLUSIONS: -mutated, HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously. (Funded by Novartis Pharmaceuticals; SOLAR-1 ClinicalTrials.gov number, NCT02437318.).
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“Only 20 patients (6%) in SOLAR-1 had been previously exposed to a CDK4/6 inhibitor.”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [58]
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“the use of which as a single-agent is now suboptimal in the second line”
From Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. (2024) · cites this paper as [24]
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“Hyperglycemia occurs early during therapy (median time of onset of about 2 weeks from initiation of alpelisib) with an incidence of $60% overall and typically resolves upon treatment cessation (220-222).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [220]
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“In the PIK3CA-mutated cohort, alpelisib provided a PFS benefit of 11.0 months versus 5.7 months [hazard ratio (HR) for progression or death: 0.65; 95% confidence interval (CI) 0.50-0.85, P < 0.001].”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [58]
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“Toxicity was substantially increased in the alpelisib arm, especially hyperglycaemia, rash, gastrointestinal (GI) complaints (nausea, vomiting, loss of appetite, mucositis, diarrhoea) and fatigue, which lead to dose reductions/interruptions in around 70% of patients and discontinuations in 25%.”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [58]
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- Juric D, Janku F, Rodón J, et al. Alpelisib plus fulvestrant in PIK3CA-altered and PIK3CA-wild-type estrogen receptor-positive advanced breast cancer: a phase 1b clinical trial. JAMA Oncol 2018 December 13 (Epub ahead of print).30543347
- Juric D Ciruelos E Rubovszky G et al. Alpelisib + fulvestrant for advanced breast cancer: subgroup analyses from the phase III SOLAR-1 trial. Presented at the San Antonio Breast Cancer Symposium San Antonio TX December 4–8 2018. abstract.
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Metadata
- Authors
- André, F., Ciruelos, E., Rubovszky, G., Campone, M., Loibl, S., Rugo, H. S., Iwata, H., Conte, P., Mayer, I. A., Kaufman, B., Yamashita, T., Lu, Y.-S., Inoue, K., Takahashi, M., Pápai, Z., Longin, A.-S., Mills, D., Wilke, C., Hirawat, S., & Juric, D.
- Affiliations
- Université Paris-Sud (FR)
- From Institut Gustave Roussy, INSERM Unité 981, Université Paris-Sud, Villejuif (F.A.), Institut de Cancérologie de l’Ouest, St. Herblain (M.C.), and Novartis Pharma, Paris (A.-S.L.) — all in France; Hospital Universitario 12 de Octubre, Madrid (E.C.); National Institute of Oncology (G.R.) and Duna Medical Center (Z.P.), Budapest, Hungary; German Breast Group, Neu-Isenburg, and Center for Hematology and Oncology Bethanien, Frankfurt — both in Germany (S.L.); UCSF Helen Diller Family Comprehensive...
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-05-16
- Volume
- 380
- Issue
- 20
- Pages
- 1929-1940
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2945564879
- Cited by
- 2,622
- References
- 25
- Citations by year
- 2026: 314 · 2025: 356 · 2024: 370 · 2023: 329 · 2022: 375 · 2021: 450 · 2020: 345 · 2019: 81
- FWCI
- 231.43
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Hispana (publishedVersion)
- Padua Research Archive (University of Padova) (submittedVersion, other-oa)
- Funders
- Pharmaceuticals Corporation
- Topics
- Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › PI3K/AKT/mTOR signaling in cancer
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Keywords
- alpelisib, PIK3CA mutation, hormone receptor-positive breast cancer, HER2-negative breast cancer, advanced breast cancer, PI3Kα inhibitor, fulvestrant, endocrine therapy, hyperglycemia, diarrhea, adverse events
- MeSH terms
- Fulvestrant, Progression-Free Survival, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Diarrhea, Female, Humans, Middle Aged, Mutation, Receptors, Estrogen, Receptors, Progesterone, Thiazoles, Erb-b2 Receptor Tyrosine Kinases, Antineoplastic Agents, Hormonal, Class I Phosphatidylinositol 3-Kinases
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