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Cited by 62Advanced Breast Cancer TherapiesPI3K/AKT/mTOR signaling in cancerBreast Cancer Treatment Studies

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Abstract GS3-08: Alpelisib + fulvestrant for advanced breast cancer: Subgroup analyses from the phase III SOLAR-1 trial

Juric, D, Ciruelos, E, Rubovszky, G, Campone, M, Loibl, S, Rugo, HS, Iwata, H, Conte, P, Mayer, IA, Kaufman, B, Yamashita, T, Lu, Y-S, Inoue, K, Takahashi, M, Pápai, Z, Longin, A-S, Mills, D, Wilke, C, Sellami, D, Andre, F·2019·Cancer Research
DOI 10.1158/1538-7445.sabcs18-gs3-08
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Abstract

Background: Hyperactivation of the phosphatidylinositol-3-kinase (PI3K) pathway can occur due to PIK3CA mutations, present in ~40% of patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2—) ABC. SOLAR-1, a Phase 3 randomized, double-blind trial (NCT02437318), investigated efficacy and safety of ALP (α-specific PI3K inhibitor) + FUL in pts with HR+, HER2— ABC. ALP+FUL met the primary endpoint by significantly extending progression-free survival (PFS) vs placebo (PBO) + FUL in the PIK3CA-mutant cohort (hazard ratio [HR] 0.65; 95% CI 0.50—0.85; p=0.00065; median 11.0 vs 5.7 months). Here we report overall survival (OS), subgroup data and safety in the PIK3CA-mutant cohort, and PFS by circulating tumor (ct)DNA PIK3CA mutation status in the total population. Methods: Enrollment was open to men/postmenopausal women with PIK3CA-mutant HR+, HER2— ABC and 1 prior line of endocrine therapy. Pts were randomized (1:1) to ALP (300mg/day) + FUL (500mg every 28 days and Cycle 1 Day 15) or PBO+FUL. OS was the key secondary endpoint. PFS was analyzed by PIK3CA mutant status in ctDNA, and in important prognostic subgroups, including line of treatment in ABC and prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) use. Safety was analyzed in the PIK3CA-mutant cohort. Results: 341 pts in the PIK3CA-mutant cohort received ALP+FUL (n=169) or PBO+FUL (n=172). Median follow-up from randomization to data cut-off was 20.0 months. At data cut-off,…

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Crossref · 10.1158/1538-7445.sabcs18-gs3-08

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  • Three sub-analyses of SOLAR-1 showed that the benefit seen with alpelisib was independent of the type of PIK3CA test (tissue primary or metastasis, liquid or tissue biopsy, NGS or targeted PCR test).

    “There were three sub-analyses of the SOLAR-1 trial58 which showed that the benefit seen with alpelisib was independent of the type of PIK3CA test, i.e. tissue biopsy from the primary or the metastasis, liquid or tissue biopsy, NGS or targeted PCR test.84, 85, 86”

    From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [86]

  • Three sub-analyses of SOLAR-1 showed that the benefit seen with alpelisib was independent of the type of PIK3CA test (tissue primary or metastasis, liquid or tissue biopsy, NGS or targeted PCR test).

    “There were three sub-analyses of the SOLAR-1 trial58 which showed that the benefit seen with alpelisib was independent of the type of PIK3CA test, i.e. tissue biopsy from the primary or the metastasis, liquid or tissue biopsy, NGS or targeted PCR test.84, 85, 86”

    From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [85]

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Authors
Juric, D., Ciruelos, E., Rubovszky, G., Campone, M., Loibl, S., Rugo, H., Iwata, H., Conte, P., Mayer, I., Kaufman, B., Yamashita, T., Lu, Y.-S., Inoue, K., Takahashi, M., Pápai, Z., Longin, A.-S., Mills, D., Wilke, C., Sellami, D., & Andre, F.
Affiliations
  • Université Paris-Sud (FR)
  • Massachusetts General Hospital, Boston, MA; Hospital Universitario 12 de Octubre, Madrid, Spain; National Institute of Oncology, Budapest, Hungary; Institut de Cancérologie de l'Ouest, St. Herblain, France; German Breast Group, Neu-Isenburg, Germany; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; Aichi Cancer Center, Nagoya, Japan; Istituto Oncologico Veneto, Padua, Italy; Vanderbilt University, Nashville, TN; Chaim Sheba Medical Center, Tel Hashomer, Israel; Kanagawa Cancer Center, Yokohama, Japan; National Taiwan University Hospital, Taipei, Taiwan; Saitama Cancer Center, Saitama, Japan; NHO Hokkaido Cancer Center, Sapporo, Japan; Duna Medical Center, Budapest, Hungary; Novartis Pharma S.A.S, Paris, France; Novartis Pharma AG, Basel, Switzerland; Novartis Pharmaceuticals Corporation, East Hanover, NJ; Gustave Roussy, Université Paris-Sud, Villejuif, France
ORCID
Venue
Cancer Research
Publisher
American Association for Cancer Research (AACR)
Published
2019-02-15
Volume
79
Issue
4_Supplement
Pages
GS3-08-GS3-08
ISSN
  • 0008-5472 (ISSN-L)
  • 1538-7445
DOI
10.1158/1538-7445.sabcs18-gs3-08
OpenAlex
W2943586565
Cited by
62
References
0
Citations by year
2025: 2 · 2024: 6 · 2023: 7 · 2022: 8 · 2021: 13 · 2020: 12 · 2019: 14
Type
conference abstract
Language
en
Open access
closed
Locations
Cancer Research (publishedVersion)
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, fulvestrant, PIK3CA mutation, PI3K signaling, hormone receptor-positive breast cancer, HER2-negative breast cancer, advanced breast cancer, circulating tumor DNA, overall survival, progression-free survival, CDK4/6 inhibitors, subgroup analysis, drug safety, endocrine therapy, prognostic subgroups

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