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Purpose: Lymphedema is a potential complication of breast cancer treatment. This longitudinal substudy aimed to prospectively assess arm measurements and symptoms following neoadjuvant chemotherapy and axillary dissection in the ACOSOG/Alliance Z1071 trial to characterize the optimal approach to define lymphedema., Methods: Z1071 enrolled patients with cT0-4, N1-2, M0 disease treated with neoadjuvant chemotherapy. All patients underwent axillary dissection. Bilateral limb volumes, circumferences, and related symptoms were assessed pre-surgery, 1-2 weeks post-surgery, and semiannually for 36 months. Lymphedema definitions included volume increase ≥ 10% or limb circumference increase ≥ 2 cm. Symptoms were assessed by the Lymphedema Breast Cancer Questionnaire., Results: In 488 evaluable patients, lymphedema incidence at 3 years by ≥ 10%-volume-increase was 60.3% (95% CI 55.0-66.2%) and by ≥ 2 cm-circumference increase was 75.4% (95% CI 70.8-80.2%). Symptoms of arm swelling and heaviness decreased from post-surgery for the first 18 months and then were relatively stable. The 3-year cumulative incidence of arm swelling and heaviness was 26.0% (95% CI 21.7-31.1%) and 30.9% (95% CI 26.3-36.3%), respectively. There was limited agreement between the two measurements (kappa 0.27) and between symptoms and measurements (kappa coefficients ranging from 0.05-0.09)., Conclusions: Lymphedema incidence by limb volume and circumference gradually increased over 36 months post-surgery, whereas lymphedema symptoms were much lower. These findings underscore the importance of prospective surveillance and evaluation of both limb measurements and symptom assessment. Lymphedema incidence rates varied by definition. We recommend that ≥ 10% volume change criterion be used for lymphedema evaluation for referral for specialist care., Trial Registration: NCT00881361.

Objective: The purpose of this study is to determine lymph node features on axillary ultrasound (US) images obtained after neoadjuvant chemotherapy that are associated with residual nodal disease in patients with initial biopsy-proven node-positive breast cancer., Subjects and Methods: All patients had axillary US performed after neoadjuvant chemotherapy. Axillary US images were centrally reviewed for lymph node size, cortical thickness, and cortical morphologic findings (type I indicated no visible cortex; type II, a hypoechoic cortex ≤ 3 mm; type III, a hypoechoic cortex > 3 mm; type IV, a generalized lobulated hypoechoic cortex; type V, focal hypoechoic cortical lobulation; and type VI, a totally hypoechoic node with no hilum). Lymph node characteristics were compared with final surgical pathologic findings., Results: Axillary US images obtained after neoadjuvant chemotherapy and surgical pathologic findings were available for 611 patients. Residual nodal disease was present in 373 patients (61.0%), and 238 (39.0%) had a complete nodal pathologic response. Increased cortical thickness (mean, 3.5 mm for node-positive disease vs 2.5 mm for node-negative disease) was associated with residual nodal disease. Lymph node short-axis and long-axis diameters were significantly associated with pathologic findings. Patients with nodal morphologic type I or II had the lowest rate of residual nodal disease (51 of 91 patients [56.0%] and 138 of 246 patients (56.1%), respectively), whereas those with nodal morphologic type VI had the highest rate (44 of 55 patients [80.0%]) (p = 0.004). The presence of fatty hilum was significantly associated with node-negative disease (p = 0.0013)., Conclusion: Axillary US performed after neoadjuvant chemotherapy is useful for nodal response assessment, with longer short-axis diameter, longer long-axis diameter, increased cortical thickness, and absence of fatty hilum significantly associated with residual nodal disease after neoadjuvant chemotherapy.

Background: American College of Surgeons Oncology Group Z0010 is a prospective multicenter trial designed to evaluate the prognostic significance of micrometastases in the sentinel lymph nodes and bone marrow aspirates of women with early-stage breast cancer. Surgical complications associated with the sentinel lymph node biopsy surgical procedure are reported., Methods: Eligible patients included women with clinical T1/2N0M0 breast cancer. Surgical outcomes were available at 30 days and 6 months after surgery for 5327 patients. Patients who had a failed sentinel node mapping (n=71, 1.4%) or a completion lymph node dissection (n=814, 15%) were excluded. Univariate and multivariate analyses were performed to identify predictors for the measured surgical complications., Results: In patients who received isosulfan blue dye alone (n=783) or a combination of blue dye and radiocolloid (n=4192), anaphylaxis was reported in .1% of subjects (5 of 4975). Other complications included axillary wound infection in 1.0%, axillary seroma in 7.1%, and axillary hematoma in 1.4% of subjects. Only increasing age and an increasing number of sentinel lymph nodes removed were significantly associated with an increasing incidence of axillary seroma. At 6 months, 8.6% of patients reported axillary paresthesias, 3.8% had a decreased upper extremity range of motion, and 6.9% demonstrated proximal upper extremity lymphedema (change from baseline arm circumference of >2 cm). Significant predictors for surgical complications at 6 months were a decreasing age for axillary paresthesias and increasing body mass index and increasing age for upper extremity lymphedema., Conclusions: This study provides a prospective assessment of the sentinel lymph node biopsy procedure, as performed by a wide range of surgeons, demonstrating a low complication rate.

Purpose: Use of adjuvant radiation therapy (RT) after neoadjuvant chemotherapy (NAC) in node-positive breast cancer (BC) is highly variable. In ACOSOG Z1071, RT after NAC was used at the discretion of treating physicians. Herein, we report the impact of RT and pathologic response on locoregional recurrence (LRR) after NAC.Methods and Materials: ACOSOG Z1071 enrolled women with cT0-4N1-2 BC treated with NAC from 2009 to 2011. Patients underwent sentinel node surgery and completion axillary lymph node dissection. The RT was at the discretion of the treating physicians. Patient outcomes were analyzed as a function of clinical-pathologic factors and use of RT.Results: Of 701 eligible patients, mastectomy was performed in 423 (59.6%) and breast-conserving surgery in 277 (40.4%). After NAC, residual disease was observed in 506 (72.2%), and 195 (27.8%) had a pathologic complete response. Of the patients, 591 (85.3%) received adjuvant RT and 102 (14.7%) did not. Median follow-up was 5.9 years. Forty-three patients (6.1%) experienced LRR, 145 (20.7%) experienced distant metastasis, and 142 (20.4%) died. Patients with pathologic complete response had the best LRR-relapse-free survival (hazard ratio [HR], 0.32; 95% confidence interval, 0.12-0.81; P = .016), distant metastasis-free survival (HR, 0.31; 95% CI, 0.19-0.52; P < .0001), BC-specific survival (HR, 0.34; 95% CI, 0.19-0.59; P = .0001) and overall survival (HR, 0.39; 95% CI, 0.240-0.63; P = .001) compared to patients with residual disease after NAC. Patients with triple-negative BC had a higher LRR rate compared to those with hormone receptor-positive BC (HR, 5.91; 95% CI, 2.80-12.49). There was a trend toward lower LRR with the use of postmastectomy and regional nodal RT, but there was no impact on overall, disease-free, or BC-specific survival.Conclusion: In the ACOSOG Z1071 trial, in which the use of RT after NAC was at the discretion of the treating physicians, RT was associated with a trend toward decreased LRR. There was no association of RT with overall survival, BC-specific survival, or Disease Specific Survival. Triple-negative BC was associated with higher locoregional relapse rates. [ABSTRACT FROM AUTHOR]

Importance: 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).Objective: To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection.Design, Setting, and Participants: The ACOSOG Z0011 phase 3 randomized clinical trial enrolled patients from May 1999 to December 2004 at 115 sites (both academic and community medical centers). The last date of follow-up was September 29, 2015, in the ACOSOG Z0011 (Alliance) trial. Eligible patients were women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases.Interventions: All patients had planned lumpectomy, planned tangential whole-breast irradiation, and adjuvant systemic therapy. Third-field radiation was prohibited.Main Outcomes and Measures: The primary outcome was overall survival with a noninferiority hazard ratio (HR) margin of 1.3. The secondary outcome was disease-free survival.Results: Among 891 women who were randomized (median age, 55 years), 856 (96%) completed the trial (446 in the SLND alone group and 445 in the ALND group). At a median follow-up of 9.3 years (interquartile range, 6.93-10.34 years), the 10-year overall survival was 86.3% in the SLND alone group and 83.6% in the ALND group (HR, 0.85 [1-sided 95% CI, 0-1.16]; noninferiority P = .02). The 10-year disease-free survival was 80.2% in the SLND alone group and 78.2% in the ALND group (HR, 0.85 [95% CI, 0.62-1.17]; P = .32). Between year 5 and year 10, 1 regional recurrence was seen in the SLND alone group vs none in the ALND group. Ten-year regional recurrence did not differ significantly between the 2 groups.Conclusions and Relevance: Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, 10-year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection. These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes.Trial Registration: clinicaltrials.gov Identifier: NCT00003855. [ABSTRACT FROM AUTHOR]

Purpose: American College of Surgeons Oncology Group Z1071 was a prospective trial evaluating the false negative rate of sentinel lymph node (SLN) surgery after neoadjuvant chemotherapy (NAC) in breast cancer patients with initial node-positive disease. Radiation therapy (RT) decisions were made at the discretion of treating physicians, providing an opportunity to evaluate variability in practice patterns following NAC.Methods and Materials: Of 756 patients enrolled from July 2009 to June 2011, 685 met all eligibility requirements. Surgical approach, RT, and radiation field design were analyzed based on presenting clinical and pathologic factors.Results: Of 401 node-positive patients, mastectomy was performed in 148 (36.9%), mastectomy with immediate reconstruction in 107 (26.7%), and breast-conserving surgery (BCS) in 146 patients (36.4%). Of the 284 pathologically node-negative patients, mastectomy was performed in 84 (29.6%), mastectomy with immediate reconstruction in 69 (24.3%), and BCS in 131 patients (46.1%). Bilateral mastectomy rates were higher in women undergoing reconstruction than in those without (66.5% vs 32.2%, respectively, P<.0001). Use of internal mammary RT was low (7.8%-11.2%) and did not differ between surgical approaches. Supraclavicular RT rate ranged from 46.6% to 52.2% and did not differ between surgical approaches but was omitted in 193 or 408 node-positive patients (47.3%). Rate of axillary RT was more frequent in patients who remained node-positive (P=.002). However, 22% of patients who converted to node-negative still received axillary RT. Post-mastectomy RT was more frequently omitted after reconstruction than mastectomy (23.9% vs 12.1%, respectively, P=.002) and was omitted in 19 of 107 patients (17.8%) with residual node-positive disease in the reconstruction group.Conclusions: Most clinically node-positive patients treated with NAC undergoing mastectomy receive RT. RT is less common in patients undergoing reconstruction. There is wide variability in RT fields. These practice patterns conflict with expert recommendations and ongoing trial guidelines. There is a significant need for greater uniformity and guidelines regarding RT following NAC. [ABSTRACT FROM AUTHOR]