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BackgroundThe MF07-01 trial is a multicenter, phase III, randomized, controlled study comparing locoregional treatment (LRT) followed by systemic therapy (ST) with ST alone for treatment-naïve stage IV breast cancer (BC) patients.MethodsAt initial diagnosis, patients were randomized 1:1 to either the LRT or ST group. All the patients were given ST either immediately after randomization or after surgical resection of the intact primary tumor.ResultsThe trial enrolled 274 patients: 138 in the LRT group and 136 in the ST group. Hazard of death was 34% lower in the LRT group than in the ST group (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.49–0.88; p = 0.005). Unplanned subgroup analyses showed that the risk of death was statistically lower in the LRT group than in the ST group with respect to estrogen receptor (ER)/progesterone receptor (PR)(+) (HR 0.64; 95% CI 0.46–0.91; p = 0.01), human epidermal growth factor 2 (HER2)/neu(–) (HR 0.64; 95% CI 0.45–0.91; p = 0.01), patients younger than 55 years (HR 0.57; 95% CI 0.38–0.86; p = 0.007), and patients with solitary bone-only metastases (HR 0.47; 95% CI 0.23–0.98; p = 0.04).ConclusionIn the current trial, improvement in 36-month survival was not observed with upfront surgery for stage IV breast cancer patients. However, a longer follow-up study (median, 40 months) showed statistically significant improvement in median survival. When locoregional treatment in de novo stage IV BC is discussed with the patient as an option, practitioners must consider age, performance status, comorbidities, tumor type, and metastatic disease burden.

BackgroundThis study aimed to compare the impact of postmastectomy radiation therapy (PMRT) on outcomes after prepectoral versus subpectoral implant-based breast reconstruction with local deepithelialized dermal flap and acellular dermal matrix (ADM).MethodsFrom 2010 to 2017, 274 patients (426 breasts) underwent prepectoral reconstruction. In this group, 241 patients (370 breasts) were not exposed to PMRT, whereas 45 patients (56 breasts) were exposed to PMRT. Of 100 patients (163 breasts) who underwent partial subpectoral reconstruction, 87 (140 breasts) were not exposed to PMRT, whereas 21 patients (23 breasts) were exposed. The outcomes were assessed by comparing complication rates between the pre- and subpectoral groups.ResultsA higher rate of capsular contracture was found for the prepectoral patients with PMRT than for those without PMRT (16.1 vs 3.5%; p = 0.0008) and for the subpectoral patients with PMRT than for those without PMRT (52.2 vs 2.9%; p = 0.0001). The contracture rate was three times higher for the subpectoral patients with PMRT than for the prepectoral patients with PMRT (52.2 vs 16.1%; p = 0.0018). In addition, 10 (83.3%) of 12 cases with capsular contracture in the subpectoral cohort that received PMRT were Baker grades 3 or 4 compared with only 2 (22.2%) of 9 cases of the prepectoral group with PMRT (p = 0.0092).ConclusionsThe patients undergoing subpectoral breast reconstruction who received PMRT had a capsular contracture rate three times greater with more severe contractures (Baker grade 3 or 4) than the patients receiving PMRT who underwent prepectoral breast reconstruction.

BackgroundThere have been conflicting studies reporting on survival advantages between breast-conserving surgery with radiotherapy (BCS) in comparison with mastectomy. Our aim was to compare the efficacy of BCS and mastectomy in terms of overall survival (OS) comparing all past published studies.MethodsWe performed a comprehensive review of literature through October 2021 in PubMed, Scopus, and EMBASE. The studies included were randomized controlled trials (RCTs) and cohorts that compare BCS versus mastectomy. We excluded studies that included male sex, stage 0, distant metastasis at diagnosis, bilateral synchronous cancer, neoadjuvant radiation/chemotherapy, and articles with incomplete data. We performed a meta-analysis following the random-effect model with the inverse variance method.ResultsFrom 18,997 publications, a total of 30 studies were included in the final analysis: 6 studies were randomized trials, and 24 were retrospective cohorts. A total of 1,802,128 patients with a follow-up ranging from 4 to 20 years were included, and 1,075,563 and 744,565 underwent BCS and mastectomy, respectively. Among the population, BCS is associated with improved OS compared with mastectomy [relative risk (RR) 0.64, 95% confidence interval (CI) 0.55–0.74]. This effect was similar when analysis was performed in cohorts and multi-institutional databases (RR 0.57, 95% CI 0.49–0.67). Furthermore, the benefit of BCS was stronger in patients who had less than 10 years of follow-up (RR 0.54, 95% CI 0.46–0.64).ConclusionsPatients who underwent BCS had better OS compared with mastectomy. Such results depicting survival advantage, especially using such a large sample of patients, may need to be included in the shared surgical decision making when discussing breast cancer treatment with patients.

BackgroundImplant-based breast reconstruction (IBBR) remains the standard and most popular option for women undergoing breast reconstruction after mastectomy worldwide. Recently, prepectoral IBBR has resurged in popularity, despite limited data comparing prepectoral with subpectoral IBBR.MethodsA systematic search of PubMed and Cochrane Library from January 1, 2011 to December 31, 2021, was performed following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) reporting guidelines, data were extracted by independent reviewers. Studies that compared prepectoral with subpectoral IBBR for breast cancer were included.ResultsOverall, 15 studies with 3,101 patients were included in this meta-analysis. Our results showed that patients receiving prepectoral IBBR experienced fewer capsular contractures (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.32–0.92; P = 0.02), animation deformity (OR, 0.02; 95% CI, 0.00–0.25; P = 0.002), and prosthesis failure (OR, 0.58; 95% CI, 0.42–0.80; P = 0.001). There was no significant difference between prepectoral and subpectoral IBBR in overall complications (OR, 0.83; 95% CI, 0.64–1.09; P = 0.19), seroma (OR, 1.21; 95% CI, 0.59-2.51; P = 0.60), hematoma (OR, 0.76; 95% CI, 0.49–1.18; P = 0.22), infection (OR, 0.87; 95% CI, 0.63–1.20; P = 0.39), skin flap necrosis (OR, 0.70; 95% CI, 0.45–1.08; P = 0.11), and recurrence (OR, 1.31; 95% CI, 0.52–3.39; P = 0.55). Similarly, no significant difference was found in Breast-Q scores between the prepectoral and subpectoral IBBR groups.ConclusionsThe results of our systematic review and meta-analysis demonstrated that prepectoral, implant-based, breast reconstruction is a safe modality and has similar outcomes with significantly lower rates of capsular contracture, prosthesis failure, and animation deformity compared with subpectoral, implant-based, breast reconstruction.

BackgroundThe SINODAR-ONE trial is a prospective noninferiority multicenter randomized study aimed at assessing the role of axillary lymph node dissection (ALND) in patients undergoing either breast-conserving surgery or mastectomy for T1–2 breast cancer (BC) and presenting one or two macrometastatic sentinel lymph nodes (SLNs). The endpoints were to evaluate whether SLN biopsy (SLNB) only was associated with worsening of the prognosis compared with ALND in terms of overall survival (OS) and relapse.MethodsPatients were randomly assigned (1:1 ratio) to either removal of ≥ 10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm).ResultsThe trial started in April 2015 and ceased in April 2020, involving 889 patients. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB-only arm, respectively (p = 0.936).ConclusionsThe 3-year survival and relapse rates of T1–2 BC patients with one or two macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND.

BackgroundThe added value of surgery in breast cancer patients with pathological complete response (pCR) after neoadjuvant systemic therapy (NST) is uncertain. The accuracy of imaging identifying pCR for omission of surgery, however, is insufficient. We investigated the accuracy of ultrasound-guided biopsies identifying breast pCR (ypT0) after NST in patients with radiological partial (rPR) or complete response (rCR) on MRI.MethodsWe performed a multicenter, prospective single-arm study in three Dutch hospitals. Patients with T1–4(N0 or N +) breast cancer with MRI rPR and enhancement ≤ 2.0 cm or MRI rCR after NST were enrolled. Eight ultrasound-guided 14-G core biopsies were obtained in the operating room before surgery close to the marker placed centrally in the tumor area at diagnosis (no attempt was made to remove the marker), and compared with the surgical specimen of the breast. Primary outcome was the false-negative rate (FNR).ResultsBetween April 2016 and June 2019, 202 patients fulfilled eligibility criteria. Pre-surgical biopsies were obtained in 167 patients, of whom 136 had rCR and 31 had rPR on MRI. Forty-three (26%) tumors were hormone receptor (HR)-positive/HER2-negative, 64 (38%) were HER2-positive, and 60 (36%) were triple-negative. Eighty-nine patients had pCR (53%; 95% CI 45–61) and 78 had residual disease. Biopsies were false-negative in 29 (37%; 95% CI 27–49) of 78 patients. The multivariable associated with false-negative biopsies was rCR (FNR 47%; OR 9.81, 95% CI 1.72–55.89; p = 0.01); a trend was observed for HR-negative tumors (FNR 71% in HER2-positive and 55% in triple-negative tumors; OR 4.55, 95% CI 0.95–21.73; p = 0.058) and smaller pathological lesions (6 mm vs 15 mm; OR 0.93, 95% CI 0.87–1.00; p = 0.051).ConclusionThe MICRA trial showed that ultrasound-guided core biopsies are not accurate enough to identify breast pCR in patients with good response on MRI after NST. Therefore, breast surgery cannot safely be omitted relying on the results of core biopsies in these patients.