The DOI matches its Crossref record; 24 of the 25 references it cites were found in a registry or an index.
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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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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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Cites
Comprehensive molecular portraits of human breast tumours
The Cancer Genome Atlas Network (2012) · Nature · doi:10.1038/nature11412 · Cited by 12,129
3rd ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3)
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Self-citationUS Incidence of Breast Cancer Subtypes Defined by Joint Hormone Receptor and HER2 Status
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4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)
Cardoso, F., Senkus, E., Costa, A., Papadopoulos, E., Aapro, M., André, F., Harbeck, N., Lopez, B. A., Barrios, C. H., Bergh, J. C. S., et al. (2018) · Annals of Oncology · doi:10.1093/annonc/mdy192 · Cited by 1,194
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Self-citationConvergent loss of PTEN leads to clinical resistance to a PI(3)Kα inhibitor
Juric, D., Castel, P., Griffith, M., Griffith, O. L., Won, H. H., Ellis, H., Ebbesen, S. H., Ainscough, B. J., Ramu, A., Iyer, G., et al. (2015) · Nature · doi:10.1038/nature13948 · Cited by 588
Self-citationMiller, T. W., Hennessy, B. T., Gonzalez-Angulo, A. M., Fox, E. M., Mills, G. B., Chen, H., Higham, C., Garcı́a-Echeverrı́a, C., Shyr, Y., & Arteaga, C. L. (2010) · Journal of Clinical Investigation · doi:10.1172/jci41680 · Cited by 555
Baselga, J. M., Im, S., Iwata, H., Cortés, J., Laurentiis, M. D., Jiang, Z., Arteaga, C. L., Jonat, W., Clemons, M. J., Ito, Y., et al. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30376-5 · Cited by 538
Self-citationFritsch, C. M., Huang, A., Chatenay‐Rivauday, C., Schnell, C., Reddy, A., Liu, M., Kauffmann, A., Guthy, D. A., Erdmann, D., Pover, A. D., et al. (2014) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-13-0865 · Cited by 504
Flagged first, then by citations
1 of the 25 references couldn’t be matched to a known paper.
Research works printed but not linked: 2
- 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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Eisenhardt, A. E., Schmid, A., Esser, J., Brugger, Z., Lausch, U., Kiefer, J., Braig, M., Runkel, A., Wehrle, J., Claus, R., et al. (2022) · Molecular Cancer · doi:10.1186/s12943-022-01523-x · Cited by 10
Lim, A. R., Kim, B., Kim, J. H., Hyun, M. H., Park, K. H., Kim, Y. H., & Lee, S. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1390452 · Cited by 10
Jongbloed, E. M., Jansen, M. P. H. M., de Weerd, V., Helmijr, J. A., Beaufort, C. M., Reinders, M. J. T., van Marion, R., van IJcken, W. F. J., Sonke, G. S., Konings, I. R., et al. (2023) · Scientific Reports · doi:10.1038/s41598-023-37409-1 · Cited by 6
Treatments on the Horizon: Breast Cancer Patients with Central Nervous System Metastases
Kaplan, A., Li, M. J., & Malani, R. (2022) · Current Oncology Reports · doi:10.1007/s11912-022-01206-2 · Cited by 4
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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