Checkpoint inhibition for early-stage hormone receptor-positive breast cancer

References

• Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014 Apr 28;106(5). doi: 10.1093/jnci/dju055
   PubMedGoogle Scholar
• DeSantis C, Siegel R, Bandi P, et al. Breast cancer statistics, 2011. CA. Cancer J Clinicians. 2011;61(6):408–418. doi: 10.3322/caac.20134
   Web of Science ®Google Scholar
• Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12–49. doi: 10.3322/caac.21820
   PubMed Web of Science ®Google Scholar
• Mariotto A, Feuer EJ, Harlan LC, et al. Trends in use of adjuvant multi-agent chemotherapy and tamoxifen for breast cancer in the United States: 1975-1999. J Natl Cancer Inst. 2002 Nov 6;94(21):1626–1634. doi: 10.1093/jnci/94.21.1626
   PubMedGoogle Scholar
• Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379(2):111–121. doi: 10.1056/NEJMoa1804710
   PubMed Web of Science ®Google Scholar
• Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385(25):2336–2347. doi: 10.1056/NEJMoa2108873
   PubMed Web of Science ®Google Scholar
• Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006 Aug 10;24(23):3726–3734. doi: 10.1200/JCO.2005.04.7985
   PubMed Web of Science ®Google Scholar
• Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2−, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987–3998. doi: 10.1200/JCO.20.02514
   PubMed Web of Science ®Google Scholar
• Loi S, Curigliano G, Salgado RF, et al. LBA20 a randomized, double-blind trial of nivolumab (NIVO) vs placebo (PBO) with neoadjuvant chemotherapy (NACT) followed by adjuvant endocrine therapy (ET) ± NIVO in patients (pts) with high-risk, ER+ HER2− primary breast cancer (BC). Ann Oncol. 2023;34(2):S1259–S1260. doi: 10.1016/j.annonc.2023.10.010
   Google Scholar
• Loi S, Curigliano G, Salgado R, et al. Abstract GS01-01: Biomarker Results in High-risk Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Primary Breast Cancer Following Neoadjuvant Chemotherapy ± Nivolumab: an Exploratory Analysis of CheckMate 7FL. Cancer Res. 2024 May 1;84(9_Supplement):GS01–01. doi: 10.1158/1538-7445.SABCS23-GS01-01
   Google Scholar
• Cardoso F, McArthur HL, Schmid P, et al. LBA21 - KEYNOTE-756: Phase III study of neoadjuvant pembrolizumab (pembro) or placebo (pbo) + chemotherapy (chemo), followed by adjuvant pembro or pbo + endocrine therapy (ET) for early-stage high-risk ER+/HER2– breast cancer. Ann Oncol. 2023;34(suppl_2):S1254–S1335. doi: 10.1016/j.annonc.2023.10.011
   Google Scholar
• Cardoso F, O’Shaughnessy J, McArthur H, et al. Abstract GS01-02: Phase 3 study of neoadjuvant pembrolizumab or placebo plus chemotherapy, followed by adjuvant pembrolizumab or placebo plus endocrine therapy for early-stage high-risk ER+/HER2− breast cancer: KEYNOTE-756. Cancer Res. 2024 May 1;84(9_Supplement): GS01–02. doi: 10.1158/1538-7445.SABCS23-GS01-02
   Google Scholar
• Nanda R, Liu MC, Yau C, et al. Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: an analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol. 2020;6(5):676–684. doi: 10.1001/jamaoncol.2019.6650
   PubMed Web of Science ®Google Scholar
• Harbeck N, Rastogi P, O’Shaughnessy J, et al. LBA17 adjuvant abemaciclib plus endocrine therapy for HR+, HER2-, high-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. Anna Oncol. 2023;34:S1256. doi: 10.1016/j.annonc.2023.10.007
   Web of Science ®Google Scholar
• Slamon DJ, Stroyakovskiy D, Yardley DA, et al. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer: primary results from the phase III NATALEE trial. J Clin Oncol. 2023;41(17_suppl):LBA500–LBA500. doi: 10.1200/JCO.2023.41.17_suppl.LBA500
   Web of Science ®Google Scholar
• Tutt ANJ, Garber JE, Kaufman B, et al. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384(25):2394–2405. doi: 10.1056/NEJMoa2105215
   PubMed Web of Science ®Google Scholar
• Ye F, Dewanjee S, Li Y, et al. Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer. Mol Cancer. 2023 Jul 06;22(1):105. doi: 10.1186/s12943-023-01805-y
   PubMed Web of Science ®Google Scholar
• Geyer CE Jr., Garber JE, Gelber RD, et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022 Dec;33(12):1250–1268. doi: 10.1016/j.annonc.2022.09.159
   PubMed Web of Science ®Google Scholar
• Tolaney SM, Barroso-Sousa R, Keenan T, et al. Effect of eribulin with or without pembrolizumab on progression-free survival for patients with hormone receptor–positive, ERBB2-negative metastatic breast cancer: a randomized clinical trial. JAMA Oncol. 2020;6(10):1598–1605. doi: 10.1001/jamaoncol.2020.3524
   PubMed Web of Science ®Google Scholar
• Rugo HS, Delord JP, Im SA, et al. Safety and antitumor activity of pembrolizumab in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. Clin Cancer Res. 2018 Jun 15;24(12):2804–2811. doi: 10.1158/1078-0432.CCR-17-3452
   PubMed Web of Science ®Google Scholar
• Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372(26):2521–2532. doi: 10.1056/NEJMoa1503093
   PubMed Web of Science ®Google Scholar
• Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer. N Engl J Med. 2018;378(22):2078–2092. doi: 10.1056/NEJMoa1801005
   PubMed Web of Science ®Google Scholar
• Winer EP, Lipatov O, Im SA, et al. Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):499–511. doi: 10.1016/S1470-2045(20)30754-3
   PubMed Web of Science ®Google Scholar
• Dirix LY, Takacs I, Jerusalem G, et al. Avelumab, an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase 1b JAVELIN solid tumor study. Breast Cancer Res Treat. 2018 Feb;167(3):671–686. doi: 10.1007/s10549-017-4537-5
   PubMed Web of Science ®Google Scholar
• Schmid P, Adams S, Rugo HS, et al. Atezolizumab and Nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med. 2018 Nov 29;379(22):2108–2121. doi: 10.1056/NEJMoa1809615
   PubMed Web of Science ®Google Scholar
• Emens LA, Adams S, Barrios CH, et al. First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis. Ann Oncol. 2021 Aug;32(8):983–993. doi: 10.1016/j.annonc.2021.05.355
   PubMed Web of Science ®Google Scholar
• Miles D, Gligorov J, André F, et al. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021 Aug;32(8):994–1004. doi: 10.1016/j.annonc.2021.05.801
   PubMed Web of Science ®Google Scholar
• Cortes J, Rugo HS, Cescon DW, et al. Pembrolizumab plus chemotherapy in advanced triple-negative breast cancer. N Engl J Med. 2022;387(3):217–226. doi: 10.1056/NEJMoa2202809
   PubMed Web of Science ®Google Scholar
• Song F, Tarantino P, Garrido-Castro A, et al. Immunotherapy for early-stage triple negative breast cancer: is earlier better? Curr Oncol Rep. 2024 Jan;26(1):21–33. doi: 10.1007/s11912-023-01487-1
   PubMed Web of Science ®Google Scholar
• Schmid P, Cortes J, Pusztai L, et al. Pembrolizumab for early triple-negative breast cancer. N Engl J Med. 2020;382(9):810–821. doi: 10.1056/NEJMoa1910549
   PubMed Web of Science ®Google Scholar
• Schmid P, Cortes J, Dent R, et al. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386(6):556–567. doi: 10.1056/NEJMoa2112651
   PubMed Web of Science ®Google Scholar
• Schmid P, Cortes J, Dent R, et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for early-stage triple-negative breast cancer: updated event-free survival results from the phase 3 KEYNOTE-522 study. In: 2023 San Antonio Breast Cancer Symposium; San Antonio, TX. Abstract LBO1-01. cited 2023 Dec 5.
   Google Scholar
• Patel SP, Othus M, Chen Y, et al. Neoadjuvant–adjuvant or adjuvant-only pembrolizumab in advanced melanoma. N Engl J Med. 2023;388(9):813–823. doi: 10.1056/NEJMoa2211437
   PubMed Web of Science ®Google Scholar
• Masuda N, Lee SJ, Ohtani S, et al. Adjuvant capecitabine for breast cancer after preoperative chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147–2159. doi: 10.1056/NEJMoa1612645
   PubMed Web of Science ®Google Scholar
• Cortes J, Cescon DW, Rugo HS, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020 Dec 5;396(10265):1817–1828. doi: 10.1016/S0140-6736(20)32531-9
   PubMed Web of Science ®Google Scholar
• Goel S, DeCristo MJ, Watt AC, et al. CDK4/6 inhibition triggers anti-tumour immunity. Nature. 2017 Aug 01;548(7668):471–475. doi: 10.1038/nature23465
   PubMed Web of Science ®Google Scholar
• Rugo HS, Kabos P, Beck JT, et al. Abemaciclib in combination with pembrolizumab for HR+, HER2− metastatic breast cancer: phase 1b study. NPJ Breast Cancer. 2022 Nov 05;8(1):118. doi: 10.1038/s41523-022-00482-2
   PubMed Web of Science ®Google Scholar
• Li J, Wu J, Han J. Analysis of tumor microenvironment heterogeneity among breast cancer subtypes to identify subtype-specific signatures. Genes (Basel). 2022 Dec 23;14(1):44. doi: 10.3390/genes14010044
   PubMed Web of Science ®Google Scholar
• Denkert C, von Minckwitz G, Darb-Esfahani S, et al. Tumour-infiltrating lymphocytes and prognosis in different subtypes of breast cancer: a pooled analysis of 3771 patients treated with neoadjuvant therapy. Lancet Oncol. 2018;19(1):40–50. doi: 10.1016/S1470-2045(17)30904-X
   PubMed Web of Science ®Google Scholar
• Griguolo G, Dieci MV, Paré L, et al. Immune microenvironment and intrinsic subtyping in hormone receptor-positive/HER2-negative breast cancer. NPJ Breast Cancer. 2021 Feb 12;7(1):12. doi: 10.1038/s41523-021-00223-x
   PubMed Web of Science ®Google Scholar
• Zhao X, Qu J, Sun Y, et al. Prognostic significance of tumor-associated macrophages in breast cancer: a meta-analysis of the literature. Oncotarget. 2017 May 2;8(18):30576–30586. doi: 10.18632/oncotarget.15736
   PubMedGoogle Scholar
• Waks AG, Stover DG, Guerriero JL, et al. The immune microenvironment in hormone receptor–positive breast cancer before and after preoperative chemotherapy. Clin Cancer Res. 2019;25(15):4644–4655. doi: 10.1158/1078-0432.CCR-19-0173
   PubMed Web of Science ®Google Scholar
• Krishnamurti U, Wetherilt CS, Yang J, et al. Tumor-infiltrating lymphocytes are significantly associated with better overall survival and disease-free survival in triple-negative but not estrogen receptor-positive breast cancers. Hum Pathol. 2017 Jun;64:7–12. doi: 10.1016/j.humpath.2017.01.004
   PubMed Web of Science ®Google Scholar
• Kolberg-Liedtke C, Gluz O, Heinisch F, et al. Association of TILs with clinical parameters, Recurrence Score® results, and prognosis in patients with early HER2-negative breast cancer (BC)—a translational analysis of the prospective WSG PlanB trial. Breast Cancer Res. 2020 May 14;22(1):47. doi: 10.1186/s13058-020-01283-w
   PubMed Web of Science ®Google Scholar
• Onkar S, Cui J, Zou J, et al. Immune landscape in invasive ductal and lobular breast cancer reveals a divergent macrophage-driven microenvironment. Nat Cancer. 2023 Apr 1;4(4):516–534. doi: 10.1038/s43018-023-00527-w
   PubMedGoogle Scholar
• Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164–172. doi: 10.1016/S0140-6736(13)62422-8
   PubMed Web of Science ®Google Scholar
• Loibl S, Schneeweiss A, Huober J, et al. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response. Ann Oncol. 2022 Nov;33(11):1149–1158. doi: 10.1016/j.annonc.2022.07.1940
   PubMed Web of Science ®Google Scholar
• Paakkola NM, Karakatsanis A, Mauri D, et al. The prognostic and predictive impact of low estrogen receptor expression in early breast cancer: a systematic review and meta-analysis. ESMO Open. 2021 Dec;6(6):100289. doi: 10.1016/j.esmoop.2021.100289
   PubMed Web of Science ®Google Scholar
• Blum JL, Flynn PJ, Yothers G, et al. Anthracyclines in early breast cancer: the ABC trials-USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 (NRG Oncology). J Clin Oncol. 2017 Aug 10;35(23):2647–2655. doi: 10.1200/JCO.2016.71.4147
   PubMed Web of Science ®Google Scholar
• Mittempergher L, Kuilman MM, Barcaru A, et al. The ImPrint immune signature to identify patients with high-risk early breast cancer who may benefit from PD1 checkpoint inhibition in I-SPY2. J Clin Oncol. 2022;40(16_suppl):514–514. doi: 10.1200/JCO.2022.40.16_suppl.514
   Web of Science ®Google Scholar
• Higgins T, Kantor O, Harrison B, et al. Defining the biology of estrogen receptor-low-positive breast cancer. Ann Surg Oncol. 2024 Apr;31(4):2244–2252. doi: 10.1245/s10434-023-14835-z
   PubMedGoogle Scholar
• Alves CP, Dey-Guha I, Kabraji S, et al. AKT1(low) quiescent cancer cells promote solid tumor growth. Mol Cancer Ther. 2018 Jan;17(1):254–263. doi: 10.1158/1535-7163.MCT-16-0868
   PubMed Web of Science ®Google Scholar
• Conforti F, Pala L, Bagnardi V, et al. Cancer immunotherapy efficacy and patients’ sex: a systematic review and meta-analysis. Lancet Oncol. 2018 Jun;19(6):737–746. doi: 10.1016/S1470-2045(18)30261-4
   PubMed Web of Science ®Google Scholar
• Gaglia G, Kabraji S, Rammos D, et al. Temporal and spatial topography of cell proliferation in cancer. Nat Cell Biol. 2022 Mar;24(3):316–326. doi: 10.1038/s41556-022-00860-9
   PubMed Web of Science ®Google Scholar
• Kabraji S, Sole X, Huang Y, et al. AKT1(low) quiescent cancer cells in ductal carcinoma in situ of the breast. NPJ Breast Cancer. 2019;5(1):10. doi: 10.1038/s41523-019-0105-y
   PubMedGoogle Scholar
• Sammut SJ, Crispin-Ortuzar M, Chin SF, et al. Multi-omic machine learning predictor of breast cancer therapy response. Nature. 2022 Jan;601(7894):623–629. doi: 10.1038/s41586-021-04278-5
   PubMed Web of Science ®Google Scholar
• Spencer KR, Wang J, Silk AW, et al. Biomarkers for immunotherapy: current developments and challenges. Am Soc Clin Oncol Educ Book. 2016;35(36):e493–503. doi: 10.1200/EDBK_160766
   PubMedGoogle Scholar
• Virassamy B, Caramia F, Savas P, et al. Intratumoral CD8(+) T cells with a tissue-resident memory phenotype mediate local immunity and immune checkpoint responses in breast cancer. Cancer Cell. 2023 Mar 13;41(3):585–601 e8. doi: 10.1016/j.ccell.2023.01.004
   PubMed Web of Science ®Google Scholar
• Wang C, Zheng X, Zhang J, et al. CD300ld on neutrophils is required for tumour-driven immune suppression. Nature. 2023 Sep;621(7980):830–839. doi: 10.1038/s41586-023-06511-9
   PubMed Web of Science ®Google Scholar
• Masuda J, Sakai H, Tsurutani J, et al. Efficacy, safety, and biomarker analysis of nivolumab in combination with abemaciclib plus endocrine therapy in patients with HR-positive HER2-negative metastatic breast cancer: a phase II study (WJOG11418B NEWFLAME trial). J Immunother Cancer. 2023 Sep;11(9):e007126. doi: 10.1136/jitc-2023-007126
   PubMed Web of Science ®Google Scholar
• Fanucci K, Pilat MJ, Shyr D, et al. Multicenter phase II trial of the PARP inhibitor olaparib in recurrent IDH1- and IDH2-mutant glioma. Cancer Res Commun. 2023 Feb;3(2):192–201. doi: 10.1158/2767-9764.CRC-22-0436
   PubMedGoogle Scholar