Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial

The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor–positive tumors that may recur later in the disease course (the ACOSOG is now part of the Alliance for Clinical Trials in Oncology)

Chemosensitivity Predicted by BluePrint 80-Gene Functional Subtype and MammaPrint in the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST).

PURPOSE: The purpose of the NBRST study is to compare a multigene classifier to conventional immunohistochemistry (IHC)/fluorescence in situ hybridization (FISH) subtyping to predict chemosensitivity as defined by pathological complete response (pCR) or endocrine sensitivity as defined by partial response. METHODS: The study includes women with histologically proven breast cancer, who will receive neoadjuvant chemotherapy (NCT) or neoadjuvant endocrine therapy. BluePrint in combination with MammaPrint classifies patients into four molecular subgroups: Luminal A, Luminal B, HER2, and Basal. RESULTS: A total of 426 patients had definitive surgery. Thirty-seven of 211 (18 %) IHC/FISH hormone receptor (HR)+/HER2- patients were reclassified by Blueprint as Basal (n = 35) or HER2 (n = 2). Fifty-three of 123 (43 %) IHC/FISH HER2+ patients were reclassified as Luminal (n = 36) or Basal (n = 17). Four of 92 (4 %) IHC/FISH triple-negative (TN) patients were reclassified as Luminal (n = 2) or HER2 (n = 2). NCT pCR rates were 2 % in Luminal A and 7 % Luminal B patients versus 10 % pCR in IHC/FISH HR+/HER2- patients. The NCT pCR rate was 53 % in BluePrint HER2 patients. This is significantly superior (p = 0.047) to the pCR rate in IHC/FISH HER2+ patients (38 %). The pCR rate of 36 of 75 IHC/FISH HER2+/HR+ patients reclassified as BPLuminal is 3 %. NCT pCR for BluePrint Basal patients was 49 of 140 (35 %), comparable to the 34 of 92 pCR rate (37 %) in IHC/FISH TN patients. CONCLUSIONS: BluePrint molecular subtyping reclassifies 22 % (94/426) of tumors, reassigning more responsive patients to the HER2 and Basal categories while reassigning less responsive patients to the Luminal category. These findings suggest that compared with IHC/FISH, BluePrint more accurately identifies patients likely to respond (or not respond) to NCT

Factors associated with optimal cosmetic results at 36 months in patients treated with accelerated partial breast irradiation (APBI) on the American Society of Breast Surgeons (ASBrS) MammoSite® Breast Brachytherapy registry trial

Purpose: To evaluate factors associated with optimal cosmetic results at 36 months for early-stage breast cancer patients enrolled on the American Society of Breast Surgeons (ASBrS) MammoSite® Breast Brachytherapy registry trial. Materials and Methods: 1,440 patients (1,449 cases) with early-stage breast cancer undergoing breast-conserving therapy were treated with the MammoSite® radiation therapy system (RTS) brachytherapy catheter to deliver adjuvant accelerated partial breast irradiation (APBI) (34 Gy in 3.4-Gy fractions). Cosmetic outcome was evaluated at each follow-up visit and dichotomized as excellent/good or fair/poor. Median follow-up for surviving patients was 43.0 months (range 0-73.0 months). Results: The percentage of patients with good/excellent cosmetic results at 12, 24, 36, and 48 months were as follows: 94.5% (n = 950/1,005), 93.8% (n = 781/833), 93.1% (n = 683/734), and 90.4% (n = 520/575), respectively. Three-year absolute rates of good/excellent cosmesis were as follows: breast-related wound infection (BWI) (83.3%) versus no BWI (94%), \u3c7 mm skin spacing (87.5%) versus ≥7 mm skin spacing (93.6%). Using multiple regression analysis, factors predictive of worse cosmetic outcome at 36 months included smaller skin spacing [odds ratio (OR) 1.06, confidence interval (CI) 1.01-1.12] and BWI (OR 0.33, CI 0.16-0.70). A predictive model developed showed that presence of a BWI, use of chemotherapy, and skin spacing had the most effect on cosmetic outcomes. However, in patients that did not develop a breast infection, skin spacing and use of chemotherapy had the most effect on cosmesis. Conclusion: APBI delivered by MammoSite® brachytherapy lead to good/excellent cosmesis in 93% of patients with 3-year follow-up. Breast wound infection, use of chemotherapy, and skin spacing were found to be the three most important predictors of cosmesis at 36 months in our cohort of patients. © 2009 Society of Surgical Oncology

Factors associated with optimal long-term cosmetic results in patients treated with accelerated partial breast irradiation using balloon-based brachytherapy

Purpose: To evaluate factors associated with optimal cosmetic results at 72 months for early-stage breast cancer patients treated with Mammosite balloon-based accelerated partial breast irradiation (APBI). Methods and Materials: A total of 1,440 patients (1,449 cases) with early-stage breast cancer undergoing breast-conserving therapy were treated with balloon-based brachytherapy to deliver APBI (34 Gy in 3.4-Gy fractions). Cosmetic outcome was evaluated at each follow-up visit and dichotomized as excellent/good (E/G) or fair/poor (F/P). Follow-up was evaluated at 36 and 72 months to establish long-term cosmesis, stability of cosmesis, and factors associated with optimal results. Results: The percentage of evaluable patients with excellent/good (E/G) cosmetic results at 36 months and more than 72 months were 93.3% (n = 708/759) and 90.4% (n = 235/260). Factors associated with optimal cosmetic results at 72 months included: larger skin spacing (p = 0.04) and T1 tumors (p = 0.02). Using multiple regression analysis, the only factors predictive of worse cosmetic outcome at 72 months were smaller skin spacing (odds ratio [OR], 0.89; confidence interval [CI], 0.80-0.99) and tumors greater than 2 cm (OR, 4.96, CI, 1.53-16.07). In all, 227 patients had both a 36-month and a 72-month cosmetic evaluation. The number of patients with E/G cosmetic results decreased only slightly from 93.4% at 3 years to 90.8% (p = 0.13) at 6 years, respectively. Conclusions: APBI delivered with balloon-based brachytherapy produced E/G cosmetic results in 90.4% of cases at 6 years. Larger tumors (T2) and smaller skin spacing were found to be the two most important independent predictors of cosmesis. © 2012 Elsevier Inc. All rights reserved