Academic Journal
Axillary Management and Outcomes After Neoadjuvant Endocrine Therapy in the Randomized PELOPS Trial.
| Τίτλος: | Axillary Management and Outcomes After Neoadjuvant Endocrine Therapy in the Randomized PELOPS Trial. |
|---|---|
| Συγγραφείς: | Weiss A; Division of Surgical Oncology, Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA. Anna_weiss@urmc.rochester.edu.; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA. Anna_weiss@urmc.rochester.edu.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA. Anna_weiss@urmc.rochester.edu.; Harvard Medical School, Boston, MA, USA. Anna_weiss@urmc.rochester.edu., Jin Q; Department of Data Science, Dana-Farber Cancer Institute, Boston, MA, USA., Tayob N; Department of Data Science, Dana-Farber Cancer Institute, Boston, MA, USA., Wrabel E; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA., DeMeo M; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA., Carter J; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA., Constantine M; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA.; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Faggen M; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA.; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Block C; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA.; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Fenton MA; Division of Oncology, Lifespan Cancer Institute, Providence, RI, USA., Lo KMS; Division of Medical Oncology, Stamford Health, Stamford, CT, USA., Openshaw T; Eastern Maine Medical Center, Bangor, ME, USA., Yardley D; Department of Medical Oncology, Sarah Cannon Research Institute, Nashville, TN, USA., Kennedy L; Division of Medical Oncology, Vanderbilt University Medical Center, Nashville, TN, USA., Bedrosian I; Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Mittendorf EA; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA., Jeselsohn R; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA.; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Metzger Filho O; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA.; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., King TA; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA.; Winship Cancer Institute of Emory University, Atlanta, GA, USA. |
| Πηγή: | Annals of surgical oncology [Ann Surg Oncol] 2026 Mar; Vol. 33 (3), pp. 2275-2283. Date of Electronic Publication: 2025 Nov 23. |
| Τύπος έκδοσης: | Journal Article; Randomized Controlled Trial |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Springer Country of Publication: United States NLM ID: 9420840 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1534-4681 (Electronic) Linking ISSN: 10689265 NLM ISO Abbreviation: Ann Surg Oncol Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2005- : New York, NY : Springer Original Publication: New York, NY : Raven Press, c1994- |
| Ιατρικοί όροι (MeSH): | Neoadjuvant Therapy*/mortality , Breast Neoplasms*/pathology , Breast Neoplasms*/drug therapy , Breast Neoplasms*/surgery , Carcinoma, Lobular*/pathology , Carcinoma, Lobular*/drug therapy , Antineoplastic Combined Chemotherapy Protocols*/therapeutic use , Lymph Node Excision*/mortality , Neoplasm Recurrence, Local*/pathology, Pyridines/administration & dosage ; Piperazines/administration & dosage ; Piperazines/therapeutic use ; Antineoplastic Agents, Hormonal/therapeutic use ; Receptors, Estrogen/metabolism ; Humans ; Female ; Middle Aged ; Aged ; Axilla ; Survival Rate ; Follow-Up Studies ; Prognosis ; Sentinel Lymph Node Biopsy |
| Περίληψη: | Background: Data to inform surgical management of the axilla after neoadjuvant endocrine therapy (NET) are limited. Here we report nodal status, surgical procedure, and outcomes among patients enrolled between 2016 and 2020 in the Palbociclib and Endocrine therapy for LObular breast cancer Preoperative Study (NCT02764541). Methods: Women with hormone receptor-positive, HER2-negative tumors > 1.5 cm, any cN, were randomized 2:1 to NET ± palbociclib for 24 weeks. Axillary surgery (sentinel lymph node biopsy [SLNB] ± axillary dissection [ALND]) and nodal evaluation (H&E ± IHC) were not specified in the protocol. Pathologic node-positive (ypN+) rates, local-regional recurrence-free interval (LRRFI), and breast cancer-specific survival (BCSS), compared by univariate Cox proportional hazards, were prespecified exploratory endpoints. Results: A total of 188 patients were analyzed (128 treated with NET + palbociclib, 60 NET), median age 56.5 years (interquartile range [IQR] 50-66). 82 (43.6%) had lobular histology, 99 (52.7%) were cN0, 84 (44.7%) cN+, and 5 (2.6%) cN unknown. Of cN+ patients with known ypN, nodal pathologic complete response rates were 10.9% (6/55) after NET + palbociclib and 13.6% (3/22) after NET. Among 108 ypN+ patients, 26 (24.1%) underwent SLNB, 82 (75.9%) ALND, and 99 (91.7%) radiation. At 4.65 years (IQR 3.66-5.56) median follow-up, 3-year LRRFI for ypN+ patients treated with SLNB only was 96% (88.6%, 100%) and ALND was 97.4% (93.9%, 100.0%), p = 0.6; 3-year BCSS for SLNB was 96.0% (88.6%, 100.0%) and ALND was 100.0% (100%, 100%), p = 0.9. Conclusions: The addition of palbociclib to NET did not impact pathologic nodal outcomes. Among those with ypN+ disease, neither LRRFI nor BCSS appears to be impacted by performance of ALND. Trial Registration: clinicaltrials.gov, NCT02764541. (© 2025. Society of Surgical Oncology.) |
| Competing Interests: | Disclosure: AW reports paid advisory board participation for Abbvie, Merck, and Myriad. She has received honoraria from OncLive (MJH Lifesciences), Empire State Hematology & Oncology Society, Society of Breast Imaging. EAM reports compensated service on scientific advisory boards for AstraZeneca, BioNTech, Merck and Moderna; uncompensated service on steering committees for Bristol Myers Squibb and Roche/Genentech; speakers honoraria and travel support from Merck Sharp & Dohme; and institutional research support from Roche/Genentech (via SU2C grant) and Gilead. EAM also reports research funding from Susan Komen for the Cure for which she serves as a Scientific Advisor, and uncompensated participation as a member of the American Society of Clinical Oncology Board of Directors. OM-F reports research support from Pfizer to institution. TAK reports speaker honoraria for Exact Sciences, compensated service on the FES Steering Committee for GE Healthcare, compensated service for advisory board role for Veracyte, and compensated service as faculty for PrecisCa cancer information service. RJ reports funding from Pfizer for the PELOPS clinical trial; consulting fees from Pfizer, Novartis, Astra Zeneca, Lilly, Carrick Therapeutics; and research funding from Novartis, Lilly, Recursion and Pfizer (institutional funding). |
| References: | 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):111–21. https://doi.org/10.1056/NEJMoa1804710 . (PMID: 10.1056/NEJMoa1804710298609176172658) 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):2336–47. https://doi.org/10.1056/NEJMoa2108873 . (PMID: 10.1056/NEJMoa2108873349143399096864) Spring LM, Gupta A, Reynolds KL, et al. Neoadjuvant endocrine therapy for estrogen receptor-positive breast cancer: a systematic review and meta-analysis. JAMA Oncol. 2016;2(11):1477–86. https://doi.org/10.1001/jamaoncol.2016.1897 . (PMID: 10.1001/jamaoncol.2016.1897273675835738656) Cataliotti L, Buzdar AU, Noguchi S, et al. Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative “Arimidex” Compared to Tamoxifen (PROACT) trial. Cancer. 2006;106(10):2095–103. https://doi.org/10.1002/cncr.21872 . (PMID: 10.1002/cncr.2187216598749) Ellis MJ, Suman VJ, Hoog J, et al. Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype–ACOSOG Z1031. J Clin Oncol. 2011;29(17):2342–9. https://doi.org/10.1200/jco.2010.31.6950 . (PMID: 10.1200/jco.2010.31.6950215556893107749) Boughey JC, Suman VJ, Mittendorf EA, et al. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013;310(14):1455–61. https://doi.org/10.1001/jama.2013.278932 . (PMID: 10.1001/jama.2013.278932241011694075763) Kuehn T, Bauerfeind I, Fehm T, et al. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013;14(7):609–18. https://doi.org/10.1016/S1470-2045(13)70166-9 . (PMID: 10.1016/S1470-2045(13)70166-923683750) Boileau JF, Poirier B, Basik M, et al. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol. 2015;33(3):258–64. https://doi.org/10.1200/JCO.2014.55.7827 . (PMID: 10.1200/JCO.2014.55.782725452445) Classe JM, Loaec C, Gimbergues P, et al. Sentinel lymph node biopsy without axillary lymphadenectomy after neoadjuvant chemotherapy is accurate and safe for selected patients: the GANEA 2 study. Breast Cancer Res Treat. 2019;173(2):343–52. https://doi.org/10.1007/s10549-018-5004-7 . (PMID: 10.1007/s10549-018-5004-730343457) Weiss A, Wong S, Golshan M, et al. Patterns of axillary management in stages 2 and 3 hormone receptor-positive breast cancer by initial treatment approach. Ann Surg Oncol. 2019;26(13):4326–36. https://doi.org/10.1245/s10434-019-07785-y . (PMID: 10.1245/s10434-019-07785-y31562601) Montagna G, Sevilimedu V, Fornier M, et al. How effective is neoadjuvant endocrine therapy (NET) in downstaging the axilla and achieving breast-conserving surgery? Ann Surg Oncol. 2020;27(12):4702–10. https://doi.org/10.1245/s10434-020-08888-7 . (PMID: 10.1245/s10434-020-08888-7328399007554166) Moo TA, Edelweiss M, Hajiyeva S, et al. Is low-volume disease in the sentinel node after neoadjuvant chemotherapy an indication for axillary dissection? Ann Surg Oncol. 2018;25(6):1488–94. https://doi.org/10.1245/s10434-018-6429-2 . (PMID: 10.1245/s10434-018-6429-2295727055930130) Wong SM, Almana N, Choi J, et al. Prognostic significance of residual axillary nodal micrometastases and isolated tumor cells after neoadjuvant chemotherapy for breast cancer. Ann Surg Oncol. 2019;26(11):3502–9. https://doi.org/10.1245/s10434-019-07517-2 . (PMID: 10.1245/s10434-019-07517-231228134) Jeselsohn R, Russo D, Jin Q, et al. PS18-06: primary results and the transcriptomic analysis of PELOPS, a randomized phase II study of neoadjuvant palbociclib with or without endocrine therapy for breast cancer patients with invasive lobular carcinoma or invasive ductal carcinoma [abstract]. 2024 San Antonio Breast Cancer Symposium. December 2024. Park KU, Gregory M, Bazan J, et al. Neoadjuvant endocrine therapy use in early stage breast cancer during the covid-19 pandemic. Breast Cancer Res Treat. 2021;188(1):249–58. https://doi.org/10.1007/s10549-021-06153-3 . (PMID: 10.1007/s10549-021-06153-3336512717921279) Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017;318(10):918–26. https://doi.org/10.1001/jama.2017.11470 . (PMID: 10.1001/jama.2017.11470288983795672806) Bartels SAL, Donker M, Poncet C, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981–22023 AMAROS trial. J Clin Oncol. 2023;41(12):2159–65. https://doi.org/10.1200/JCO.22.01565 . (PMID: 10.1200/JCO.22.0156536383926) Kantor O, Wakeman M, Weiss A, et al. Axillary management after neoadjuvant endocrine therapy for hormone receptor-positive breast cancer. Ann Surg Oncol. 2021;28(3):1358–67. https://doi.org/10.1245/s10434-020-09073-6 . (PMID: 10.1245/s10434-020-09073-632869154) Kantor O, Wong S, Weiss A, et al. Prognostic significance of residual nodal disease after neoadjuvant endocrine therapy for hormone receptor-positive breast cancer. NPJ Breast Cancer. 2020;6:35. https://doi.org/10.1038/s41523-020-00177-6 . (PMID: 10.1038/s41523-020-00177-6328218037426953) Murphy BM, Hoskin TL, Degnim AC, Boughey JC, Hieken TJ. Surgical management of axilla following neoadjuvant endocrine therapy. Ann Surg Oncol. 2021;28(13):8729–39. https://doi.org/10.1245/s10434-021-10385-4 . (PMID: 10.1245/s10434-021-10385-4342750428286162) An SJ, Thai C, Ismail S, et al. Nodal response and survival after neoadjuvant endocrine therapy in hormone receptor-positive breast cancer: 20-year experience from a single institution. Ann Surg Oncol. 2024;31(13):8786–94. https://doi.org/10.1245/s10434-024-16059-1 . (PMID: 10.1245/s10434-024-16059-13915415311560637) Johnston S, Puhalla S, Wheatley D, et al. Randomized phase II study evaluating palbociclib in addition to letrozole as neoadjuvant therapy in estrogen receptor-positive early breast cancer: PALLET trial. J Clin Oncol. 2019;37(3):178–89. https://doi.org/10.1200/JCO.18.01624 . (PMID: 10.1200/JCO.18.0162430523750) Corso G, Shen S, Criscitiello C, et al. Invasive lobular carcinoma: Strategies and perspectives from the lobular breast cancer research group. Cancer Treat Rev. 2025;140:103001. https://doi.org/10.1016/j.ctrv.2025.103001 . (PMID: 10.1016/j.ctrv.2025.10300140815983) Giuliano AE, Hunt KK, Ballman KV, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011;305(6):569–75. https://doi.org/10.1001/jama.2011.90 . (PMID: 10.1001/jama.2011.90213040825389857) Boughey JC, Ballman KV, Le-Petross HT, et al. Identification and resection of clipped node decreases the false-negative rate of sentinel lymph node surgery in patients presenting with node-positive breast cancer (T0–T4, N1–N2) who receive neoadjuvant chemotherapy: results from ACOSOG Z1071 (Alliance). Ann Surg. 2016;263(4):802–7. https://doi.org/10.1097/SLA.0000000000001375 . (PMID: 10.1097/SLA.0000000000001375266495894777661) Goldhaber NH, O’Keefe T, Kang J, Douglas S, Blair SL. Is Choosing Wisely wise for lobular carcinoma in patients over 70 years of age? A National Cancer Database analysis of sentinel node practice patterns. Ann Surg Oncol. 2023;30(10):6024–32. https://doi.org/10.1245/s10434-023-13886-6 . (PMID: 10.1245/s10434-023-13886-63749016310495516) Poodt IGM, Spronk PER, Vugts G, et al. Trends on axillary surgery in nondistant metastatic breast cancer patients treated between 2011 and 2015: a Dutch population-based study in the ACOSOG-Z0011 and AMAROS era. Ann Surg. 2018;268(6):1084–90. https://doi.org/10.1097/SLA.0000000000002440 . (PMID: 10.1097/SLA.000000000000244028742702) Mamtani A, Zabor EC, Stempel M, Morrow M. Lobular histology does not predict the need for axillary dissection among ACOSOG Z0011-eligible breast cancers. Ann Surg Oncol. 2019;26(10):3269–74. https://doi.org/10.1245/s10434-019-07536-z . (PMID: 10.1245/s10434-019-07536-z313423636669889) Morrow M, Van Zee KJ, Patil S, et al. Axillary dissection and nodal irradiation can be avoided for most node-positive Z0011-eligible breast cancers: a prospective validation study of 793 patients. Ann Surg. 2017;266(3):457–62. https://doi.org/10.1097/SLA.0000000000002354 . (PMID: 10.1097/SLA.0000000000002354286503555649371) |
| Contributed Indexing: | Keywords: Axillary lymph node dissection; Axillary management; Axillary surgery; Breast cancer; Clinical trial; Neoadjuvant endocrine therapy; Outcomes |
| Molecular Sequence: | ClinicalTrials.gov NCT02764541 |
| Substance Nomenclature: | G9ZF61LE7G (palbociclib) 0 (Pyridines) 0 (Piperazines) 0 (Antineoplastic Agents, Hormonal) 0 (Receptors, Estrogen) |
| Entry Date(s): | Date Created: 20251123 Date Completed: 20260213 Latest Revision: 20260213 |
| Update Code: | 20260213 |
| DOI: | 10.1245/s10434-025-18697-5 |
| PMID: | 41276768 |
| Βάση Δεδομένων: | MEDLINE |
καταχωρήστε σχόλιο πρώτοι!