The effectiveness and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early-stage human epidermal growth factor receptor 2-positive breast cancer: Turkish Oncology Group study.

Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols / adverse effects Biomarkers, Tumor / metabolism Breast Neoplasms / pathology Carcinoma, Intraductal, Noninfiltrating / drug therapy Docetaxel / therapeutic use Female Humans Middle Aged Neoadjuvant Therapy / methods Receptor, ErbB-2 / metabolism Trastuzumab / adverse effects

Journal

Anti-cancer drugs

ISSN: 1473-5741

Titre abrégé: Anticancer Drugs

Pays: England

ID NLM: 9100823

Informations de publication

Date de publication:
01 08 2022

Historique:

pubmed: 16 6 2022

medline: 16 7 2022

entrez: 15 6 2022

Statut: ppublish

Résumé

In our study, we aimed to evaluate the pathological response rates and side effect profile of adding pertuzumab to the treatment of HER2+ locally advanced, inflammatory, or early-stage breast cancer. This study was conducted by the Turkish Oncology Group (TOG) with data collected from 32 centers. Our study was multicentric, and a total of 364 patients were included. The median age of the patients was 49 years (18-85 years). Two hundred fifteen (60%) of the cases were hormone receptor/HER2+ positive(ER+ or PR+, or both), and 149 (40%) of them were HER2-rich (ER and PR negative). The number of complete responses was 124 (54%) in the docetaxel+trastuzumab+pertuzumab arm and 102 (45%) in the paclitaxel+trastuzumab+pertuzumab arm, and there was no difference between the groups in terms of complete response. In 226 (62%) patients with complete response, a significant correlation was found with DCIS, tumor focality, removed lymph node, and ER status P < 0.05. Anemia, nausea, vomiting, myalgia, alopecia, and mucosal inflammation were significantly higher in the docetaxel arm, P < 0.05. In our study, no statistical difference was found between the before-after echocardiography values. DCIS positivity in biopsy before neoadjuvant chemotherapy, tumor focality; the number of lymph nodes removed and ER status were found to be associated with pCR. In conclusion, we think that studies evaluating pCR-related clinicopathological variables and radiological imaging features will play a critical role in the development of nonsurgical treatment approaches.

Identifiants

DOI: 10.1097/CAD.0000000000001310 PMID: 35703239

pubmed: 35703239

doi: 10.1097/CAD.0000000000001310

pii: 00001813-202208000-00007

doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0

Biomarkers, Tumor 0

Docetaxel 15H5577CQD

ERBB2 protein, human EC 2.7.10.1

Receptor, ErbB-2 EC 2.7.10.1

pertuzumab K16AIQ8CTM

Trastuzumab P188ANX8CK

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

663-670

Informations de copyright

Références

Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, et al. Preoperative chemotherapy: updates of National surgical adjuvant breast and bowel project protocols B-18 and B-27. J Clin Oncol 2008; 26:778–785.

Esserman LJ, Berry DA, DeMichele A, Carey L, Davis SE, Buxton M, et al. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL–CALGB 150007/150012, ACRIN 6657. J Clin Oncol 2012; 30:3242–3249.

Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, et al. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res 2007; 13:2329–2334.

Rouzier R, Perou CM, Symmans WF, Ibrahim N, Cristofanilli M, Anderson K, et al. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res 2005; 11:5678–5685.

Dawood S, Broglio K, Buzdar AU, Hortobagyi GN, Giordano SH. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review. J Clin Oncol 2010; 28:92–98.

Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortobagyi GN. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist 2009; 14:320–368.

Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344:783–792.

Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, 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.

Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet 2014; 384:164–172.

van la Parra RF, Kuerer HM. Selective elimination of breast cancer surgery in exceptional responders: historical perspective and current trials. Breast Cancer Res 2016; 18:28.

Kuerer HM, Rauch GM, Krishnamurthy S, Adrada BE, Caudle AS, DeSnyder SM, et al. A clinical feasibility trial for identification of exceptional responders in whom breast cancer surgery can be eliminated following neoadjuvant systemic therapy. Ann Surg 2018; 267:946–951.

Mazouni C, Peintinger F, Wan-Kau S, Andre F, Gonzalez-Angulo AM, Symmans WF, et al. Residual ductal carcinoma in situ in patients with complete eradication of invasive breast cancer after neoadjuvant chemotherapy does not adversely affect patient outcome. J Clin Oncol 2007; 25:2650–2655.

von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol 2012; 30:1796–1804.

Buzatto IP, Ribeiro-Silva A, Andrade JM, Carrara HH, Silveira WA, Tiezzi DG. Neoadjuvant chemotherapy with trastuzumab in HER2-positive breast cancer: pathologic complete response rate, predictive and prognostic factors. Braz J Med Biol Res 2017; 50:e5674.

Seidman A, Hudis C, Pierri MK, Shak S, Paton V, Ashby M, et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002;20:1215–1221.

Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, et al.; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol 2013; 31:3997–4013.

Broglio KR, Quintana M, Foster M, Olinger M, McGlothlin A, Berry SM, et al. Association of pathologic complete response to neoadjuvant therapy in HER2-positive breast cancer with long-term outcomes: a meta-analysis. JAMA Oncol 2016; 2:751–760.

Buzdar AU, Suman VJ, Meric-Bernstam F, Leitch AM, Ellis MJ, Boughey JC, et al.; American College of Surgeons Oncology Group Investigators. Fluorouracil, epirubicin, and cyclophosphamide (FEC-75) followed by paclitaxel plus trastuzumab versus paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab as neoadjuvant treatment for patients with HER2-positive breast cancer (Z1041): a randomised, controlled, phase 3 trial. Lancet Oncol 2013; 14:1317–1325.

Robidoux A, Tang G, Rastogi P, Geyer CE Jr, Azar CA, Atkins JN, et al. Lapatinib as a component of neoadjuvant therapy for HER2-positive operable breast cancer (NSABP protocol B-41): an open-label, randomised phase 3 trial. Lancet Oncol 2013; 14:1183–1192.

Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, 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.

Gianni L, Pienkowski T, Im YH, Tseng LM, Liu MC, Lluch A, et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol 2016; 17:791–800.

Jones RL, Lakhani SR, Ring AE, Ashley S, Walsh G, Smith IE. Pathological complete response and residual DCIS following neoadjuvant chemotherapy for breast carcinoma. Br J Cancer 2006; 94:358–362.

Boughey JC, Gonzalez RJ, Bonner E, Kuerer HM. Current treatment and clinical trial developments for ductal carcinoma in situ of the breast. Oncologist 2007;12:1276–1287.

Goodwin A, Parker S, Ghersi D, Wilcken N. Post-operative radiotherapy for ductal carcinoma in situ of the breast. Cochran Database Syst Rev 2009; 21:CD000563.

Robinson EK, Hunt KK. Noninvasive breast cancer. In: Feig BW, Berger DH, Fuhrman GM, editors. The MD Anderson surgical oncology handbook. 3rd ed. 2003; Lippincot William Wilkins, pp. 1–12.

Wu W, Kamma H, Ueno E, Fujiwara M, Satoh H, Hara H, et al. The intraductal component of breast cancer is poorly responsive to neo-adjuvant chemotherapy. Oncol Rep 2002; 9:1027–1031.

Goldberg H, Zandbank J, Kent V, Leonov-Polak M, Livoff A, Chernihovsky A, et al. Chemotherapy may eradicate ductal carcinoma in situ (DCIS) but not the associated microcalcifications. Eur J Surg Oncol 2017; 43:1415–1420.

Von Minckwitz G, Darb-Esfahani S, Loibl S, Huober J, Tesch H, Solbach C, Holms F, et al. Responsiveness of adjacent ductal carcinoma in situ and changes in HER2 status after neoadjuvant chemotherapy/trastuzumab treatment in early breast cancer—results from the GeparQuattro study (GBG 40). Breast Cancer Res Treat 2012; 132:863–870.

Doebar SC, van den Broek EC, Koppert LB, Jager A, Baaijens MHA, Obdeijn IAM, van Deurzen CHM. Extent of ductal carcinoma in situ according to breast cancer subtypes: a population-based cohort study. Breast Cancer Res Treat 2016; 158:179–187.

Labrosse J, Morel C, Lam T, Laas E, Feron J-G, Coussy F, et al. The presence of an in situ component on pre-treatment biopsy is not associated with response to neoadjuvant chemotherapy for breast cancer. Cancers 2021; 13:235.

Volders JH, Negenborn VL, Spronk PE, Krekel NMA, Schoonmade LJ, Meijer S, et al. Breast-conserving surgery following neoadjuvant therapy-a systematic review on surgical outcomes. Breast Cancer Res Treat 2018; 168:1–12.

Petruolo O, Sevilimedu V, Montagna G, Le T, Morrow M, Barrio AV. How often does modern neoadjuvant chemotherapy downstage patients to breast-conserving surgery? Ann Surg Oncol 2021; 28:287–294.

Ataseven B, Lederer B, Blohmer JU, Denkert C, Gerber B, Heil J, et al. Impact of multifocal or multicentric disease on surgery and locoregional, distant and overall survival of 6,134 breast cancer patients treated with neoadjuvant chemotherapy. Ann Surg Oncol 2015; 22:1118–1127.

Levine MN. Trastuzumab cardiac side effects: only time will tell. J Clin Oncol 2005; 23:7775–7776.

Perik PJ, de Vries EG, Gietema JA, van der Graaf WT, Smilde TD, Sleijfer DT, van Veldhuisen DJ. Serum HER2 levels are increased in patients with chronic heart failure. Eur J Heart Fail 2007; 9:173–177.

Alhussein MM, Mokbel A, Cosman T, Aghel N, Yang EH, et al. Pertuzumab cardiotoxicity in patients with HER2-positive cancer: a systematic review and meta-analysis. CJC 2021; 1–11.