Macau Society of Clinical Oncology

Adjuvant Treatment in HER2+ eBC

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Q1. APHINITY trial met its primary endpoint by reducing risk of invasive disease–free survival (IDFS) events with pertuzumab + trastuzumab + chemotherapy in the intent-to-treat (ITT) population. According to the 6-year follow up, which group of patients have the most IDFS benefit?

At a median follow-up of 74 months,IDFS was significantly improved with pertuzumab, and node-positive patients continued to derive the greatest benefit with the addition of pertuzumab; the benefit of pertuzumab for IDFS was seen regardless of hormone receptor status.


Ref: 1) Piccart M, et al: Interim overall survival analysis of APHINITY (BIG 4-11): A randomized, multicenter, double-blind, placebo-controlled trial comparing chemotherapy plus trastuzumab plus pertuzumab vs chemotherapy plus trastuzumab plus placebo as adjuvant therapy in patients with operable HER2-positive early breast cancer. 2019 San Antonio Breast Cancer Symposium. Abstract GS1-04. Presented December 11, 2019. 2) https://ascopost.com/issues/january-25-2020/six-year-aphinity-trial-update/ (accessed 3 Dec 2020)

Q2. Approximately how many % of patients with cN- disease may be pN+ upon pathological evaluation?

The rate of false-negative lymph node diagnosis is approximately 10-30%, highlighting the need to base adjuvant treatment decisions on pathological evaluations to avoid under-treating patients with cN- disease who may be pN+


Ref: 1) Kane G, et al. False-negative rate of ultrasound-guided fine-needle aspiration cytology for identifying axillary lymph node metastasis in breast cancer patients. Breast J

. 2019 Sep;25(5):848-852; 2) Qun L, et al. Preoperative assessment of axillary lymph node status in breast cancer patients by ultrasonography combined with mammography. Medicine (Baltimore). 2018 Jul; 97(30): e11441; 3) Krag DN,et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):927-33.

Q3. According to international guidelines, which HER2-positive eBC patients may consider adjuvant APT (weekly paclitaxel and trastuzumab) regimen?

NCCN: Adjuvant chemotherapy with weekly paclitaxel and trastuzumab can be considered for T1 N0 M0 HER2-positive cancers.

AGO Recommendations: In HER2-positive node-negative early breast cancer with a maximum diameter of 2 cm, trastuzumab might be combined with weekly paclitaxel (AGO+).


*In the eBC setting, trastuzumab is approved for the adjuvant treatment of patients with HER2-positive eBC, following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; or in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. Guideline recommendations for the adjuvant use of trastuzumab with paclitaxel alone represent off-label use in this setting.



Ref: 1) NCCN Breast Cancer Guidelines v4.2020; 2) AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2019. Breast Care 2019;14:224–245.

Q4. Which adjuvant treatment regimen should be offered if a HER2-positive eBC patient achieved a pCR (pathological complete response) after neoadjuvant therapy?

Patients who achieve a pCR are still at risk of relapse, therefore guidelines recommend continuation of trastuzumab +/- pertuzumab to complete 18 cycles in the adjuvant setting for patients with a pCR.


Ref: 1) NCCN Breast Cancer Guidelines v4.2020; 2) Early Breast Cancer: ESMO Clinical Practice Guidelines. Ann Oncol (2019); 30: 1194-1220.; 3) AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2019. Breast Care 2019;14:224–245.; 4) Burstein HJ, et al. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Annals of Oncol. Special Articles Editor’s Choice, Vol 30, Issue 10, P1541-1557, Oct 01, 2019.

Q5. Which adjuvant treatment regimen should be offered if a HER2-positive eBC patient had residual invasive disease present after neoadjuvant therapy?

International guidelines including NCCN, ESMO, AGO, and St. Gallen all recommend T-DM1 for patients with residual invasive disease after neoadjuvant therapy.


Ref: 1) NCCN Breast Cancer Guidelines v4.2020; 2) Early Breast Cancer: ESMO Clinical Practice Guidelines. Ann Oncol (2019); 30: 1194-1220.; 3) AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2019. Breast Care 2019;14:224–245.; 4) Burstein HJ, et al. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Annals of Oncol. Special Articles Editor’s Choice, Vol 30, Issue 10, P1541-1557, Oct 01, 2019.