171
Views
3
CrossRef citations to date
0
Altmetric
Perspective

A clinical perspective on escalating or de-escalating adjuvant therapy in HER2+ breast cancer

, , &
Pages 9-16 | Received 24 Sep 2018, Accepted 20 Nov 2018, Published online: 04 Dec 2018

References

  • Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244:707–712.
  • Sjogren S, Inganäs M, Lindgren A, et al. Prognostic and predictive value of c-erbB-2 overexpression in primary breast cancer, alone and in combination with other prognostic markers. J Clin Oncol. 1998;16:462–469.
  • Gabos Z, Sinha R, Hanson J, et al. Prognostic significance of human epidermal growth factor receptor positivity for the development of brain metastasis after newly diagnosed breast cancer. J Clin Oncol. 2006;24:5658–5663.
  • Dawood S, Broglio K, Buzdar AU, et al. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review. J Clin Oncol. 2010;28:92–98.
  • Musolino A, Ciccolallo L, Panebianco M, et al. Multifactorial central nervous system recurrence susceptibility in patients with HER2- positive breast cancer: epidemiological and clinical data from a population-based cancer registry study. Cancer. 2011;117:1837–1846.
  • Gianni L, Eiermann W, Semiglazov V, et al. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol. 2014;15:640–647.
  • von Minckwitz G, Rezai M, Fasching PA, et al. Survival after adding capecitabine and trastuzumab to neoadjuvant anthracycline taxane- based chemotherapy for primary breast cancer (GBG 40– geparQuattro). Ann Oncol. 2014;25:81–89.
  • Joensuu H, Bono P, Kataja V, et al. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer Trial. J Clin Oncol. 2009;27:5685–5692.
  • Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365:1273–1283.
  • Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353:1673–1684.
  • Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353:1659–1672.
  • Pinto AC, Ades F, de Azambuja E, et al. Trastuzumab for patients with HER2 positive breast cancer: delivery, duration and combination therapies. Breast. 2013;22(Suppl. 2):S152–5.
  • Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32:3744–3752.
  • Slamon DJ, Eiermann W, Robert NJ, et al. Ten year follow-up of BCIRG-006 comparing doxorubicin plus cyclophosphamide followed by docetaxel (AC→T) with doxorubicin plus cyclophosphamide followed by docetaxel and trastuzumab (AC→TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2+ early breast cancer. Cancer Res. 2015;76(suppl):abstr S5–04.
  • Jackisch C, Piccart MJ, Gelber RD, et al. HERA TRIAL: 10-year follow up of trastuzumab after adjuvant chemotherapy in HER2 positive breast cancer — final analysis. Cancer Res. 2015;76(suppl):abstr PD5–01.
  • Cameron D, Piccart-Gebhart MJ, Gelber RD, et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin adjuvant (HERA) trial. Lancet. 2017;389:1195–2105.
  • Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 2006;354:809–820.
  • Schneider BP, O’Neill A, Shen F, et al. Pilot trial of paclitaxel-trastuzumab adjuvant therapy for early stage breast cancer: a trial of the ECOG-ACRIN cancer research group (E2198). Br J Cancer. 2015;113:1651–1657.
  • Joensuu H, Fraser J, Wildiers H, et al. Effect of adjuvant trastuzumab for a duration of 9 weeks vs 1 year with concomitant chemotherapy for early human epidermal growth factor receptor 2-positive breast cancer: the SOLD randomized clinical trial. JAMA Oncol. 2018;4(9):1199–1206.
  • Guarneri V, Frassoldati A, Bruzzi P, et al. Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2-positive breast cancer (Short-HER Trial;NCT00629278). Clin Breast Cancer. 2008;8:453–456.
  • Mavroudis D, Saloustros E, Malamos N, et al. Six versus 12 months of adjuvant trastuzumab in combination with dose-dense chemotherapy for women with HER2-positive breast cancer: a multicenter randomized study by the Hellenic Oncology Research Group (HORG). Ann Oncol. 2015;26:1333–1340.
  • Pivot X, Romieu G, Debled M, et al. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013;14:741–748.
  • Pivot X, Suter T, Nabholtz JM, et al. Cardiac toxicity events in the PHARE trial, an adjuvant trastuzumab randomised phase III study. Eur J Cancer. 2015;51:1660–1666.
  • Earl HM, Cameron DA, Miles D, et al. The PERSEPHONE trial: duration of Trastuzumab with Chemotherapy in women with HER-2 positive early breast cancer. J Clin Oncol. 2012;30(suppl):abstrTPS660. http://meetinglibrary.asco.org/content/97920-114
  • Earl HM, Hiller L, Vallier AL, et al. PERSEPHONE: 6 versus 12 months (m) of adjuvant trastuzumab in patients (pts) with HER2 positive (+) early breast cancer (EBC): randomised phase 3 non-inferiority trial with definitive 4-year (yr) disease-free survival (DFS) results. J Clin Oncol. 2018;36(suppl):abstr 506.
  • Conte PF, Bisagni G, Frassoldati A, et al. 9 weeks vs 1 year adjuvant trastuzumab in combination with chemotherapy: results of the phase III multicentric Italian study Short-HER. J Clin Oncol. 2017;35(suppl):abstr 501.
  • O’Sullivan CC, Bradbury I, Campbell C, et al. Efficacy of adjuvant trastuzumab for patients with human epidermal growth factor receptor 2-positive early breast cancer and tumors ≤ 2 cm: a meta-analysis of the randomized trastuzumab trials. J Clin Oncol. 2015;33:2600–2608.
  • Tolaney SM, Barry WT, Dang CT, et al. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med. 2015;372:134–141.
  • van Ramshorst MS, van der Heijden-van der Loo M, Dackus GMHE, et al. The effect of trastuzumab-based therapy on overall survival in small, node-negative HER2-positive breast cancer: to treat or not to treat? Breast Cancer Res Treat. 2016;158(2):361–371.
  • T-DM1 vs paclitaxel/trastuzumab for breast (ATEMPT Trial). ClinicalTrial.gov. NCT01853748.
  • Trastuzumab emtansine in treating older patients with human epidermal growth factor receptor 2-positive stage I-III breast cancer. ClinicalTrial.gov. NCT02414646.
  • Dahabreh IJ, Linardou H, Siannis F, et al. Trastuzumab in the adjuvant treatment of early-stage breast cancer: a systematic review and meta-analysis of randomized controlled trials. Oncologist. 2008;13:620–630.
  • Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, et al. Herceptin Adjuvant (HERA) trial study team. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013;382:1021–1028.
  • Chan A, Delaloge S, Holmes FA, et al. ExteNET study group. neratinib after trastuzumab-based adjuvant therapy in patients with HER2- positive breast cancer (ExteNET): a multicentre, randomised, double- blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016;17:367–377.
  • Martin M, Holmes FA, Eilertsen B, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):1688–1700.
  • Hurvitz S, Chan A, Iannotti N, et al. Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients with HER2+ early-stage breast cancer: the CONTROL trial [abstract]. Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9 San Antonio, TX. Philadelphia (PA): AACR Cancer Res 2018; 78(4Suppl):Abstract nr P3-14-01
  • http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004030/WC500244282.pdf
  • Goss PE, Smith IE, O’Shaughnessy J, et al. Adjuvant lapatinib for women with early-stage HER2- positive breast cancer: a randomised, controlled, phase 3 trial. Lancet Oncol. 2013;14:88–96.
  • Piccart-Gebhart MJ, Holmes AP, Baselga J, et al. First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T→L), or their combination (T+L) in the adjuvant treatment of HER2-positive early breast cancer (EBC). J Clin Oncol. 2014;32(suppl):abstr LBA4.
  • Piccart-Gebhart M, Holmes E, Baselga J, et al. adjuvant lapatinib and trastuzumab for early human epidermal growth factor receptor 2-positive breast cancer: results from the randomized phase III adjuvant lapatinib and/or trastuzumab treatment optimization trial. J Clin Oncol. 2016;34:1034–1042.
  • Slamon DJ, Swain SM, Buyse M, et al. Primary results from BETH, a phase 3 controlled study of adjuvant chemotherapy and trastuzumab ± bevacizumab in patients with HER2-positive, node-positive or high-risk node-negative breast cancer. 2013 San Antonio Breast Cancer Symposium; December 11, 2013; San Antonio, TX.
  • von Minckwitz G, Procter M, de Azambuja E, et al. Adjuvant pertuzumab and trastuzumab in Early HER2-positive breast cancer. N Engl J Med. 2017;377(2):122–131.
  • A study of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor in the breast or axillary lymph nodes following preoperative therapy (KATHERINE). ClinicalTrial.gov. NCT01772472.
  • A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer. ClinicalTrial.gov. NCT01966471.
  • Loibl S, Majewski I, Guarneri V, et al. PIK3CA mutations are associated with reduced pathological complete response rates in primary HER2-positive breast cancer: pooled analysis of 967 patients from five prospective trials investigating lapatinib and trastuzumab. Ann Oncol. 2016;27:1519–1525.
  • Denkert C, von Minckwitz G, Darb-Esfahani S, et al. Evaluation of tumor-infiltrating lymphocytes (TILs) as predictive and prognostic biomarkers in different subtypes of breast cancer treated with neoadjuvant therapy—a meta-analysis of 3771 patients. Cancer Res. 2017;77(suppl):abstr S1–09.
  • Perez EA, Ballman KV, Tenner KS, et al. Association of stromal tumor infiltrating lymphocytes with recurrence-free survival in the n9831 adjuvant trial in patients with early-stage HER2-positive breast cancer. JAMA Oncol. 2016;2:56–64.
  • 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;384:164–172.
  • Gianni L, Pienkowski T, Im YH, 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.
  • Schneeweiss A, Chia S, Hickish T, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline containing and anthracycline-free chemotherapy regimens in patients with HER2- positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013;24:2278–2284.
  • Untch M, Jackisch C, Schneeweiss A, et al. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016;17:345–356.
  • Llombart-Cussac A, Cortés J, Paré L, et al. HER2-enriched subtype as a predictor of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancer (PAMELA): an open-label, single-group, multicentre, phase 2 trial. Lancet Oncol. 2017;18:545–554.
  • Rimawi MF, Mayer IA, Forero A, et al. Multicenter phase II study of neoadjuvant lapatinib and trastuzumab with hormonal therapy and without chemotherapy in patients with human epidermal growth factor receptor 2-overexpressing breast cancer: TBCRC 006. J Clin Oncol. 2013;31:1726–1731.
  • Rimawi MF, Niravath PA, Wang T, et al. TBCRC023: A randomized multicenter phase II neoadjuvant trial of lapatinib plus trastuzumab, with endcorine therapy and without chemotherapy, for 12 vs. 24 weeks in patients with HER2 overexpressing breast cancer. Cancer Res. 2015;75(9S):S602(SABCS).
  • Nitz UA, Gluz O, Christgen M, et al. De-escalation strategies in HER2-positive early breast cancer (EBC): final analysis of the WSG-ADAPT HER2+/HR- phase II trial: efficacy, safety, and predictive markers for 12 weeks of neoadjuvant dual blockade with trastuzumab and pertuzumab ± weekly paclitaxel. Ann Oncol. 2017;28:2768–2772.
  • 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.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.