Addition of PI3K/AKT/mTOR inhibitors to fulvestrant for advanced HR+/HER2- breast cancer: a systematic review and meta-analysis

References

• Yang XR , Chang-ClaudeJ, GoodeELet al. Associations of breast cancer risk factors with tumor subtypes: a pooled analysis from the Breast Cancer Association Consortium studies. J. Natl. Cancer Inst.103(3), 250–263 (2011).
   PubMed Web of Science ®Google Scholar
• Lloyd MR , WanderSA, HamiltonEet al. Next-generation selective estrogen receptor degraders and other novel endocrine therapies for management of metastatic hormone receptor-positive breast cancer: current and emerging role. Ther. Adv. Med. Oncol.14, 17588359221113694 (2022).
   Web of Science ®Google Scholar
• Blackburn SA , ParksRM, CheungKLet al. Fulvestrant for the treatment of advanced breast cancer. Exp. Rev. Anticancer Ther.18(7), 619–628 (2018).
   PubMed Web of Science ®Google Scholar
• Cardoso F , CostaA, SenkusEet al. 3rd ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 3). Ann. Oncol.28(1), 16–33 (2017).
   PubMed Web of Science ®Google Scholar
• Szostakowska M , Trębińska-StryjewskaA, GrzybowskaEAet al. Resistance to endocrine therapy in breast cancer: molecular mechanisms and future goals. Breast Cancer Res. Treat.173(3), 489–497 (2019).
   PubMed Web of Science ®Google Scholar
• Vasan N , ToskaE, ScaltritiMet al. Overview of the relevance of PI3K pathway in HR-positive breast cancer. Ann. Oncol.30(Suppl. 10), x3–x11 (2019).
   PubMedGoogle Scholar
• Hanker AB , SudhanDR, ArteagaCL. Overcoming endocrine resistance in breast cancer. Cancer Cell.37(4), 496–513 (2020).
   PubMed Web of Science ®Google Scholar
• Araki K , MiyoshiY. Mechanism of resistance to endocrine therapy in breast cancer: the important role of PI3K/AKT/mTOR in estrogen receptor-positive, HER2-negative breast cancer. Breast Cancer (Tokyo, Japan).25(4), 392–401 (2018).
   PubMed Web of Science ®Google Scholar
• Fan W , ChangJ, FuP. Endocrine therapy resistance in breast cancer: current status, possible mechanisms and overcoming strategies. Future Med. Chem.7(12), 1511–9 (2015).
   PubMed Web of Science ®Google Scholar
• Miricescu D , TotanA, Stanescu-Spinuet al. PI3K/AKT/mTOR signaling pathway in breast cancer: From molecular landscape to clinical aspects. Int. J. Mol. Sci.22(1), 173 (2020).
   PubMed Web of Science ®Google Scholar
• Cristofanilli M , TurnerNCet al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. The Lancet Oncol.17(4), 425–439 (2016).
   PubMed Web of Science ®Google Scholar
• Gu G , DustinD, FuquaSAet al. Targeted therapy for breast cancer and molecular mechanisms of resistance to treatment. Curr. Opin. Pharmacol.31, 97–103 (2016).
   PubMed Web of Science ®Google Scholar
• Gao HF , LinYY, ZhuTet al. Adjuvant CDK4/6 inhibitors combined with endocrine therapy in HR-positive, HER2-negative early breast cancer: a meta-analysis of randomized clinical trials. Breast (Edinburgh, Scotland).59, 165–175 (2021).
   PubMed Web of Science ®Google Scholar
• Shah M , NunesMR, StearnsV. CDK4/6 inhibitors: game changers in the management of hormone receptor–positive advanced breast cancer?Oncology.32, 216–22 (2018).
   PubMed Web of Science ®Google Scholar
• Spring LM , WanderSA, ZangardiMet al. CDK 4/6 inhibitors in breast cancer: current controversies and future directions. Curr. Oncol. Rep.21(3), 25 (2019).
   PubMed Web of Science ®Google Scholar
• Pandey K , AnHJ, KimSKet al. Molecular mechanisms of resistance to CDK4/6 inhibitors in breast cancer: a review. Int. J. Cancer.145, 1179–88 (2019).
   PubMed Web of Science ®Google Scholar
• O’Brien NA , McDermottMSJ, ConklinDet al. Targeting activated PI3K/mTOR signaling overcomes acquired resistance to CDK4/6-based therapies in preclinical models of hormone receptor-positive breast cancer. Breast Cancer Res.22, 89 (2020).
   PubMed Web of Science ®Google Scholar
• Liu L , MengT, ZhengXet al. Transgelin 2 promotes paclitaxel resistance, migration, and invasion of breast cancer by directly interacting with PTEN and activating PI3K/AKT/GSK-3β pathway. Mol. Cancer Ther.18(12), 2457–2468 (2019).
   PubMed Web of Science ®Google Scholar
• Li Y , ZhaiZ, LiHet al. Guajadial reverses multidrug resistance by inhibiting ABC transporter expression and suppressing the PI3K/AKT pathway in drug-resistant breast cancer cells. Chem. Biol. Interact.305, 98–104 (2019).
   PubMed Web of Science ®Google Scholar
• Jerusalem G , BachelotT, BarriosCet al. A new era of improving progression-free survival with dual blockade in postmenopausal HR(+), HER2(-) advanced breast cancer. Cancer Treat. Rev.41(2), 94–104 (2015).
   PubMed Web of Science ®Google Scholar
• Verret B , CortesJ, BachelotTet al. Efficacy of PI3K inhibitors in advanced breast cancer. Ann. Oncol.30(Suppl. 10), x12–x20 (2019).
   PubMedGoogle Scholar
• Barchiesi G , MazzottaM, KrasniqiEet al. Neoadjuvant endocrine therapy in breast cancer: current knowledge and future perspectives. Int. J. Mol. Sci.21(10), 3528 (2019).
   Web of Science ®Google Scholar
• Higgins JPT , ThomasJ, ChandlerJet al.et al. ( Eds). Cochrane Handbook for Systematic Reviews of Interventions (2nd Edition).John Wiley & Sons, Chichester, UK (2019).
   Google Scholar
• Moher D , LiberatiA, TetzlaffJet al. for the PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med.6(7), e1000097 (2009).
   PubMed Web of Science ®Google Scholar
• Higgins JP , ThompsonSG, DeeksJJet al. Measuring inconsistency in meta-analyses. BMJ.327(7414), 557–60 (2003).
   PubMed Web of Science ®Google Scholar
• Deeks JJ , AltmanDG, BradburnMJet al. Systematic Reviews in Health Care: Meta-Analysis in Context John Wiley & Sons, NJ, USA (2008).
   Google Scholar
• Higgins J , GreenS. Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0The Cochrane Collaboration, London, UK (2011).
   Google Scholar
• Kanters S . Fixed- and random-effects models. Methods Mol. Biol.2345, 41–65 (2022).
   PubMedGoogle Scholar
• Begg CB , MazumdarM. Operating characteristics of a rank correlation test for publication bias. Biometrics.50(4), 1088–1101 (1994).
   PubMed Web of Science ®Google Scholar
• Egger M , DaveySmith G, SchneiderMet al. Bias in meta-analysis detected by a simple, graphical test. BMJ315(7109), 629–634 (1994).
   Google Scholar
• Baselga J , ImSA, IwataH, CamponeMet al. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncol.18(7), 904–916 (2017).
   PubMed Web of Science ®Google Scholar
• Di Leo A , JohnstonS, LeeKSet al. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncol.19(1), 87–100 (2018).
   PubMed Web of Science ®Google Scholar
• Jones RH , CasbardA, CarucciMet al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): a multicentre, randomised, controlled, phase 2 trial. The Lancet Oncol.21(3), 345–357 (2020).
   PubMed Web of Science ®Google Scholar
• Krop IE , MayerIA, GanjuV, SchmidPet al. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet Oncol.17(6), 811–821 (2016).
   PubMed Web of Science ®Google Scholar
• Schmid P , ZaissM, Harper-WynneCet al. Fulvestrant plus vistusertib vs fulvestrant plus everolimus vs fulvestrant alone for women with hormone receptor-positive metastatic breast cancer: the MANTA phase 2 randomized clinical trial. JAMA oncology.5(11), 1556–1564 (2019).
   PubMed Web of Science ®Google Scholar
• Kornblum N , ZhaoF, ManolaJet al. Randomized phase II trial of fulvestrant plus everolimus or placebo in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer resistant to aromatase inhibitor therapy: results of PrE0102. J. Clin. Oncol.36(16), 1556–1563 (2018).
   PubMed Web of Science ®Google Scholar
• Dent S , CortésJ, ImYHet al. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. Ann. Oncol.32(2), 197–207 (2021).
   PubMed Web of Science ®Google Scholar
• García-Sáenz JÁ , Martínez-JáñezN, CubedoRet al. Sapanisertib plus fulvestrant in postmenopausal women with estrogen receptor-positive/HER2-negative advanced breast cancer after progression on aromatase inhibitor. Clin. Cancer Res.28(6), 1107–1116 (2022).
   PubMed Web of Science ®Google Scholar
• André F , CiruelosE, RubovszkyGet al. SOLAR-1 Study Group . Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. New Engl. J. Med.380(20), 1929–1940 (2019).
   PubMed Web of Science ®Google Scholar
• Araki K , MiyoshiY. Mechanism of resistance to endocrine therapy in breast cancer: the important role of PI3K/AKT/mTOR in estrogen receptor-positive, HER2-negative breast cancer. Breast Cancer (Tokyo, Japan).25(4), 392–401 (2018).
   PubMed Web of Science ®Google Scholar
• Sirohi B , RastogiS, DawoodS. Buparlisib in breast cancer. Future Oncol. (London, England).11(10), 1463–1470 (2015).
   PubMed Web of Science ®Google Scholar
• Owonikoko TK , HarveyRD, CarthonBet al. A phase I study of safety, pharmacokinetics, and pharmacodynamics of concurrent everolimus and buparlisib treatment in advanced solid tumors. Clin. Cancer Res.26, 2497–2505 (2020).
   PubMed Web of Science ®Google Scholar
• Di Leo A , SeokLee K, CiruelosEet al. Abstract S4–07: BELLE-3: a phase III study of buparlisib + fulvestrant in postmenopausal women with HR+, HER2−, aromatase inhibitor-treated, locally advanced or metastatic breast cancer, who progressed on or after mTOR inhibitor-based treatment. Cancer Res.77, S4–07 (2017).
   Web of Science ®Google Scholar
• André F , CiruelosE, RubovszkyGet al. Alpelisib for PIK3CA-mutated, hormone receptor–positive advanced breast cancer. N. Engl. J. Med.380, 1929–1940 (2019).
   PubMed Web of Science ®Google Scholar
• Zumsteg ZS , MorseN, KrigsfeldGet al. Taselisib (GDC-0032), a potent β-sparing small molecule inhibitor of PI3K, radiosensitizes head and neck squamous carcinomas containing activating PIK3CA alterations. Clin. Cancer Res.22, 2009–2019 (2016).
   PubMed Web of Science ®Google Scholar
• Olivero AG , HeffronTP, BaumgardnerMet al. Discovery of GDC-0032: a beta-sparing PI3K inhibitor active against PIK3CA mutant tumors. Cancer Res.73, DDT02–01 (2016).
   Google Scholar
• André F , CiruelosE, RubovszkyGet al. Alpelisib for PIK3CA-mutated, hormone receptor–positive advanced breast cancer. N. Engl. J. Med.380, 1929–1940 (2019).
   PubMed Web of Science ®Google Scholar
• O’Brien NA , McDermottMSJ, ConklinDet al. Targeting activated PI3K/mTOR signaling overcomes acquired resistance to CDK4/6-based therapies in preclinical models of hormone receptor-positive breast cancer. Breast cancer research: BCR.22(1), 89 (2020).
   PubMed Web of Science ®Google Scholar
• Bian L , XuFR, JiangZF. Endocrine therapy combined with targeted therapy in hormone receptor-positive metastatic breast cancer. Chinese medical journal.133(19), 2338–2345 (2020).
   PubMed Web of Science ®Google Scholar
• Johnston SRD , HarbeckN, HeggRet al. monarchE Committee Members and Investigators . Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). Journal of clinical oncology: official journal of the American Society of Clinical Oncology.38(34), 3987–3998 (2020).
   PubMed Web of Science ®Google Scholar
• Bartsch R . ESMO 2020: highlights in breast cancer. Memo.14(2), 184–187 (2021).
   PubMedGoogle Scholar
• Shah M , NunesMR, StearnsV. CDK4/6 inhibitors: game changers in the management of hormone receptor–positive advanced breast cancer?Oncology.32, 216–22 (2018).
   PubMed Web of Science ®Google Scholar
• Cai Z , WangJ, LiYet al. Overexpressed Cyclin D1 and CDK4 proteins are responsible for the resistance to CDK4/6 inhibitor in breast cancer that can be reversed by PI3K/mTOR inhibitors. Sci. China Life Sci.66, 94–109 (2023).
   PubMed Web of Science ®Google Scholar
• Cancer Discovery . American Associationfor CancerResearch. Capivasertib doubles PFS in some breast cancers. 13(2), 250 (2023).
   Google Scholar
• Burstein HJ , SomerfieldMR, BartonDLet al. Endocrine treatment and targeted therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: ASCO guideline update. J. Clin. Oncol.39(35), 3959–3977 (2021).
   PubMed Web of Science ®Google Scholar
• Schmid P , AbrahamJ, ChanSet al. Capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer: the PAKT trial. J. Clin. Oncol.38(5), 423–433 (2020).
   PubMed Web of Science ®Google Scholar
• Kim SB , DentR, ImSAet al. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial [published correction appears in Lancet Oncol. 2018 Dec;19(12):e667]. Lancet Oncol.18(10), 1360–1372 (2017).
   PubMed Web of Science ®Google Scholar