Preoperative Systemic Therapy vs Upfront Surgery in HER2 Positive Early Breast Cancer
Preoperative Systemic Therapy vs Upfront Surgery in HER2 Positive Early Breast Cancer
Preoperative systemic treatment can make patients getting more opportunity for
 breast-conserving surgery, down-staging and new drugs developing. It is particularly common
 in human epidermal growth factor receptor 2 (HER2)-over expressing subtype for as high as
 40%~60% pCR rate of such a population. Even though, in NSABP B18/27 trials, it had been
 proved that PST could not improve either disease-free survival (DFS) or overall survival (OS)
 comparing with postoperatively systemic treatment in total population. We designed a
 real-world study to investigate the prognosis of anti-HER2 treatment combined with
 chemotherapy preoperatively versus postoperatively in HER2-positive early breast cancer
Patients with a diagnosis of HER2 positive early invasive breast cancer (cT1-3N0-1M0), from
 January 2012 to December 2014 were identified and enrolled continuously. The conditions of
 HER2-positive expression of primary breast cancer were defined as follows: HER2 3+ by
 immunohistochemical (IHC) method or HER2 2+ by IHC with a further positive result by
 fluorescence in situ hybridization (FISH). According to the real upfront treatment, all
 eligible patients were classified as PST group and surgery group. All the patients accepted
 standard one-year trastuzumab as anti-HER2 treatment combined with chemotherapy. In the PST
 group, the effect was evaluated according to RECIST1.1 every two cycles, the patients with
 clinical complete response (cCR) or partial response (PR) would receive the whole course of
 chemotherapy, those with stable disease (SD) or progressive disease (PD) would receive
 surgery promptly. After surgery, all patients underwent irradiation and endocrine therapies
 if necessary. The pCR was defined as the absence of infiltrating residual invasive disease in
 the breast and axillary nodes. For those non-pCR patients after PST, intensive adjuvant
 chemotherapy was not routine treatment except patients with progressive disease.The primary
 endpoint was DFS defined as the time from enrollment to local, regional, or distant
 recurrences; the occurrence of contralateral breast cancer; or death without evidence of
 breast cancer. Patients suffered disease progress becoming inoperable before surgery were
 counted as local treatment failures. The second endpoint was OS defined as the time from
 study entry to death from any cause. All the endpoints were compared between PST group and
 upfront surgery group, also further analysis according to pathological response status
 stratified in PST group.
Inclusion Criteria:

 1. HER2 positive

 2. early invasive breast cancer (cT1-3N0-1M0)

 3. using one-year trastuzumab as anti-HER2 treatment

 Exclusion Criteria:

 1. Exclude metastasis and recurrent breast cancer

 2. using trastuzumab less than a year