Added text to state that for patients undergoing partial mastectomy, margins may be positive after primary surgery, often leading to re-excision. Added that a clinical trial of 235 patients with stage 0 to III breast cancer, who underwent partial mastectomy, with or without resection of selective margins, randomly assigned patients to have additional cavity shave margins resected or not; patients in the shave group had a significantly lower rate of positive margins than those in the no-shave group and a lower rate of second surgery for clearing margins (cited Chagpar et al. as reference 21 and level of evidence 1iiDiv).
Revised text to state that a meta-analysis of dose-dense treatment versus standard dosing included data from eight trials that included 17,188 patients (cited Petrelli et al. as reference 94). Also added that the patients who received dose-dense chemotherapy had better overall survival (OS) and disease-free survival than those on the conventional schedule; a statistically significant OS benefit was observed in patients with estrogen receptor (ER)-negative tumors but not in those with ER-positive breast cancer.
Added text to state that pathologic complete response (pCR) has been utilized as a surrogate endpoint for long-term outcomes in preoperative clinical trials in breast cancer. Also added that a pooled analysis of 11 preoperative randomized trials determined that pCR provided a better association with improved outcomes compared with eradication of invasive tumor from the breast alone; pCR could not be validated in this study as a surrogate endpoint for improved event-free survival (EFS) and OS (cited Cortazar et al. as reference 163 and level of evidence 3iiiD). Added that on the basis of a strong association of pCR with substantially improved outcomes in individual patients with more aggressive subtypes of breast cancer, the U.S. Food and Drug Administration has supported the use of pCR as an endpoint in preoperative clinical trials for patients with high-risk, early-stage breast cancer.
Added text to state findings from the phase III GeparSepto trial that investigated an alternative taxane in patients with untreated primary breast cancer, including the pCR rates in two arms (cited Untch et al. as reference 176 and level of evidence 1iiDiv).
Added text to state that CALGB 40601 was a phase III trial that randomly assigned patients with stage II and III HER2-positive breast cancer to receive either paclitaxel plus trastuzumab or paclitaxel plus trastuzumab plus lapatinib; the primary endpoint of the study was pCR in the breast (cited Carey et al. as reference 191 and level of evidence 1iiDiv). Also added that pCR in patients who received paclitaxel plus trastuzumab arm 46%, and pCR in patients who received paclitaxel plus trastuzumab plus lapatinib was 56%, indicating no benefit for the addition of lapatinib.
Revised text to state that the NeoALTTO phase III trial randomly assigned 455 women with HER2-positive early-stage breast cancer to receive preoperative lapatinib, or preoperative trastuzumab, or preoperative lapatinib plus trastuzumab. Also added that an updated analysis for the prespecified secondary endpoints of EFS and OS indicated no difference between the groups (cited de Azambuja et al. as reference 192).
Added text to state that findings from a meta-analysis of randomized trials evaluated the administration of anti-HER2 monotherapy versus dual anti-HER2 therapy (cited Valachis et al. as reference 194 and level of evidence 3iiiD), including findings about left ventricular ejection fraction decline and symptomatic heart failure.
Revised text to state that the standard chemotherapy regimen for initial treatment is the same as that used in the adjuvant setting, although trials done solely in patients with locally advanced disease have not shown a statistically significant advantage to dose-dense chemotherapy (cited Petrelli et al. as reference 1).
Revised text to state that in a retrospective series, 70 patients with locally advanced breast cancer and supraclavicular metastases received preoperative chemotherapy. Added that these results have been confirmed in a separate series of patients treated in British Columbia (cited Olivotto et al. as reference 4).
Added text to state that subsequent trials have confirmed that patients with locally advanced and inflammatory breast cancer can experience long-term disease-free survival when treated with initial chemotherapy.
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