Academic Journal
Axillary Nodal Response to Neoadjuvant T-DM1 Combined with Pertuzumab in a Prospective Phase II Multi-Institution Clinical Trial.
| Τίτλος: | Axillary Nodal Response to Neoadjuvant T-DM1 Combined with Pertuzumab in a Prospective Phase II Multi-Institution Clinical Trial. |
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| Συγγραφείς: | Weiss A; From the Division of Surgical Oncology, Department of Surgery, University of Rochester, Rochester, NY (Weiss)., Jin Q; Department of Data Science (Jin, Tayob), Dana-Farber Cancer Institute Boston, MA., Waks AG; Division of Medical Oncology (Waks, Metzger-Filho), Dana-Farber Cancer Institute Boston, MA.; Harvard Medical School, Boston, MA (Waks, Tayob, King, Metzger-Filho).; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA (Waks, Wrabel, King, Metzger-Filho)., Yardley D; Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN (Yardley)., Spring LM; Massachusetts General Hospital, Boston, MA (Spring)., Wrabel E; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA (Waks, Wrabel, King, Metzger-Filho)., Tayob N; Department of Data Science (Jin, Tayob), Dana-Farber Cancer Institute Boston, MA.; Harvard Medical School, Boston, MA (Waks, Tayob, King, Metzger-Filho)., Viale G; Division of Pathology, European Institute of Oncology, IRCCS and University of Milan, Milan, Italy (Viale)., Krop IE; Yale Cancer Center, New Haven, CT (Krop)., King TA; Harvard Medical School, Boston, MA (Waks, Tayob, King, Metzger-Filho).; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA (Waks, Wrabel, King, Metzger-Filho).; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA (King)., Metzger-Filho O; Division of Medical Oncology (Waks, Metzger-Filho), Dana-Farber Cancer Institute Boston, MA.; Harvard Medical School, Boston, MA (Waks, Tayob, King, Metzger-Filho).; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA (Waks, Wrabel, King, Metzger-Filho). |
| Πηγή: | Journal of the American College of Surgeons [J Am Coll Surg] 2024 Mar 01; Vol. 238 (3), pp. 303-311. Date of Electronic Publication: 2023 Dec 04. |
| Τύπος έκδοσης: | Clinical Trial, Phase II; Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Lippincott Williams & Wilkins, Inc Country of Publication: United States NLM ID: 9431305 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-1190 (Electronic) Linking ISSN: 10727515 NLM ISO Abbreviation: J Am Coll Surg Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2022- : [Baltimore, MD] : Lippincott Williams & Wilkins, Inc. Original Publication: Chicago, Ill. : The College, c1994- |
| Ιατρικοί όροι (MeSH): | Breast Neoplasms*/drug therapy , Breast Neoplasms*/surgery , Breast Neoplasms*/pathology , Neoadjuvant Therapy* , Antibodies, Monoclonal, Humanized*, Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Erb-b2 Receptor Tyrosine Kinases/therapeutic use ; Ado-Trastuzumab Emtansine/therapeutic use ; Humans ; Female ; Prospective Studies |
| Περίληψη: | Background: Patients with ERBB2 (HER2)-positive breast cancer experience high pathologic complete response (pCR) rates after standard neoadjuvant anti-HER2 systemic therapy. We examined axillary pathologic nodal response to neoadjuvant dual HER2-targeted therapy alone, based on breast pathologic response, in a multi-institution clinical trial. Study Design: Patients with HER2-positive breast cancer were enrolled to a phase II single-arm trial, which administered 6 cycles of neoadjuvant trastuzumab emtansine (T-DM1) plus pertuzumab. Rates of pathologic nodal disease (ypN) in patients who were clinically node-negative (cN0) and node-positive (cN1) were analyzed, by residual breast disease (pCR and residual cancer burden [RCB] I to III). Results: One hundred fifty-eight patients completed preoperative treatment and proceeded to surgery. Of 92 patients who were cN0, 48 (52.2%) and 10 (10.9%) experienced breast pCR and RCB I, respectively. Of these, 100% were ypN0. Of 34 with RCB II to III, 26 (76.5%) were ypN0. Of 30 patients who were cN1 with breast pCR, 100% were ypN0; of the 12 patients who were cN1 with RCB I, 66.7% were ypN0; and of the 24 patients who were cN1 with RCB II to III, 25% were ypN0. ypN0 rates were significantly different between patients who did and did not experience a pCR, in both cN0 (p = 0.002) and cN1 (p < 0.001) subgroups. Conclusions: Patients with HER2-positive breast cancer treated with dual HER2-targeted therapy who experienced a breast pCR or RCB I response were frequently ypN0. These findings support future trials considering omission of axillary surgical staging for patients with HER2-positive breast cancer in neoadjuvant trials of active HER2-targeted regimens, particularly if they experience breast pCR or RCB I. (Copyright © 2023 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.) |
| References: | Al-Hilli Z, Hoskin TL, Day CN, et al. Impact of neoadjuvant chemotherapy on nodal disease and nodal surgery by tumor subtype. Ann Surg Oncol. 2018;25:482–493. Mamtani A, Barrio AV, King TA, et al. How often does neoadjuvant chemotherapy avoid axillary dissection in patients with histologically confirmed nodal metastases? Results of a prospective study. Ann Surg Oncol. 2016;23:3467–3474. Weiss A, King C, Vincuilla J, et al. Rates of pathologic nodal disease among cN0 and cN1 patients undergoing routine axillary ultrasound and neoadjuvant chemotherapy. Breast Cancer Res Treat. 2022;195:181–189. Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367:1783–1791. von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380:617–628. Hurvitz SA, Martin M, Symmans WF, et al. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018;19:115–126. Hurvitz SA, Martin M, Jung KH, et al. Neoadjuvant trastuzumab emtansine and pertuzumab in human epidermal growth factor receptor 2-positive breast cancer: three-year outcomes from the phase III KRISTINE study. J Clin Oncol. 2019;37:2206–2216. Masuda N, Ohtani S, Takano T, et al. A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast cancer. Breast Cancer Res Treat. 2020;180:135–146. Clark AS, Yau C, Wolf DM, et al. Neoadjuvant T-DM1/pertuzumab and paclitaxel/trastuzumab/pertuzumab for HER2(+) breast cancer in the adaptively randomized I-SPY2 trial. Nat Commun. 2021;12:6428. Filho OM, Viale G, Stein S, et al. Impact of HER2 heterogeneity on treatment response of early-stage HER2-Positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab. Cancer Discov. 2021;11:2474–2487. Gianni L, Eiermann W, Semiglazov V, et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010;375:377–384. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25–32. Ollila DW, Cirrincione CT, Berry DA, et al. Axillary management of stage II/III breast cancer in patients treated with neoadjuvant systemic therapy: results of CALGB 40601 (HER2-positive) and CALGB 40603 (triple-negative). J Am Coll Surg. 2017;224:688–694. 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;310:1455–1461. Lucci A, McCall LM, Beitsch PD, et al. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011. J Clin Oncol. 2007;25:3657–3663. Appelgren M, Sackey H, Wengstrom Y, et al. Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial. Breast. 2022;63:16–23. Verbelen H, Gebruers N, Eeckhout FM, et al. Shoulder and arm morbidity in sentinel node-negative breast cancer patients: a systematic review. Breast Cancer Res Treat. 2014;144:21–31. Reimer T, Stachs A, Veselinovic K, et al. Patient-reported outcomes for the Intergroup Sentinel Mamma study (INSEMA): a randomised trial with persistent impact of axillary surgery on arm and breast symptoms in patients with early breast cancer. EClinicalMedicine. 2023;55:101756. Weiss A, Campbell J, Ballman KV, et al. Factors associated with nodal pathologic complete response among breast cancer patients treated with neoadjuvant chemotherapy: results of CALGB 40601 (HER2+) and 40603 (triple-negative) (alliance). Ann Surg Oncol. 2021;28:5960–5971. Shi Z, Wang X, Qiu P, et al. Predictive factors of pathologically node-negative disease for HER2 positive and triple-negative breast cancer after neoadjuvant therapy. Gland Surg. 2021;10:166–174. Ryu JM, Choi HJ, Park EH, et al. Relationship between breast and axillary pathologic complete response according to clinical nodal stage: a nationwide study from Korean Breast Cancer Society. J Breast Cancer. 2022;25:94–105. |
| Substance Nomenclature: | EC 2.7.10.1 (Erb-b2 Receptor Tyrosine Kinases) SE2KH7T06F (Ado-Trastuzumab Emtansine) 0 (Antibodies, Monoclonal, Humanized) K16AIQ8CTM (pertuzumab) |
| Entry Date(s): | Date Created: 20231204 Date Completed: 20240216 Latest Revision: 20260127 |
| Update Code: | 20260130 |
| DOI: | 10.1097/XCS.0000000000000916 |
| PMID: | 38047578 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1879-1190 |
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| DOI: | 10.1097/XCS.0000000000000916 |