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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In SOLAR-1, only 20 patients (6%) had prior CDK4/6 inhibitor exposure.
“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]
Table 1 (Characteristics of the Patients at Baseline) reports prior CDK4/6 inhibitor treatment in 9 and 11 patients in the two PIK3CA-mutated groups: 20 of 341 patients, or about 6%. The claim omits that cohort restriction; across all four SOLAR-1 groups, the table reports 35 previously treated patients. (LLM, conf=0.88)
Experimental — accuracy not yet measuredUse of fulvestrant as a single agent is now suboptimal in the second line.
“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]
The efficacy results (page unavailable) show longer progression-free survival with alpelisib plus fulvestrant than with placebo plus fulvestrant in patients with PIK3CA-mutated cancer. The Discussion also reports an apparent benefit among patients receiving second-line therapy. This supports the narrower point that fulvestrant alone was less effective than that combination in this trial, but not the unqualified claim that single-agent fulvestrant is now suboptimal for all second-line use. (LLM, conf=0.85)
Experimental — accuracy not yet measuredHyperglycemia occurs early during alpelisib therapy, with a median time of onset of about 2 weeks from initiation, an incidence of ≥60% overall, and typically resolves upon treatment cessation.
“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]
The Safety section (page not available in our copy) reports hyperglycemia in 63.7% of alpelisib-treated patients, supporting the incidence claim. The End Points section describes early glucose monitoring but gives no median time to onset. The Discussion says adverse events were generally reversible, but does not establish that hyperglycemia typically resolves upon treatment cessation. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the PIK3CA-mutated cohort of SOLAR-1, alpelisib plus fulvestrant improved PFS to 11.0 months versus 5.7 months (HR 0.65; 95% CI 0.50-0.85; P<0.001).
“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]
Alpelisib plus fulvestrant caused substantially more toxicity, including hyperglycaemia, rash, GI complaints, and fatigue, with dose reductions/interruptions in about 70% and discontinuations in 25%.
“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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Self-citationVepdegestrant, a PROTAC Estrogen Receptor Degrader, in Advanced Breast Cancer
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- 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 › Pulmonary and Respiratory Medicine › 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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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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