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Impact of Radiation on Locoregional Control in Women with Node-Positive Breast Cancer Treated with Neoadjuvant Chemotherapy and Axillary Lymph Node Dissection: Results from ACOSOG Z1071 Clinical Trial.

ABSTRACT: 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.

SUBMITTER: Haffty BG

PROVIDER: S-EPMC6699883 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Impact of Radiation on Locoregional Control in Women with Node-Positive Breast Cancer Treated with Neoadjuvant Chemotherapy and Axillary Lymph Node Dissection: Results from ACOSOG Z1071 Clinical Trial.

Haffty Bruce G BG McCall Linda M LM Ballman Karla V KV Buchholz Thomas A TA Hunt Kelly K KK Boughey Judy C JC

International journal of radiation oncology, biology, physics 20190511 1

<h4>Purpose</h4>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.<h4>Methods and materials</h4>ACOSOG Z1071 enrolled women with cT0-4N1-2 BC treated with NAC from 2009 to 2011. Patients underwent sentinel node surgery and completion a ...[more]

PMID: 31085287

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Project description:Sentinel lymph node (SLN) surgery provides reliable nodal staging information with less morbidity than axillary lymph node dissection (ALND) for patients with clinically node-negative (cN0) breast cancer. The application of SLN surgery for staging the axilla following chemotherapy for women who initially had node-positive cN1 breast cancer is unclear because of high false-negative results reported in previous studies.To determine the false-negative rate (FNR) for SLN surgery following chemotherapy in women initially presenting with biopsy-proven cN1 breast cancer.The American College of Surgeons Oncology Group (ACOSOG) Z1071 trial enrolled women from 136 institutions from July 2009 to June 2011 who had clinical T0 through T4, N1 through N2, M0 breast cancer and received neoadjuvant chemotherapy. Following chemotherapy, patients underwent both SLN surgery and ALND. Sentinel lymph node surgery using both blue dye (isosulfan blue or methylene blue) and a radiolabeled colloid mapping agent was encouraged.The primary end point was the FNR of SLN surgery after chemotherapy in women who presented with cN1 disease. We evaluated the likelihood that the FNR in patients with 2 or more SLNs examined was greater than 10%, the rate expected for women undergoing SLN surgery who present with cN0 disease.Seven hundred fifty-six women were enrolled in the study. Of 663 evaluable patients with cN1 disease, 649 underwent chemotherapy followed by both SLN surgery and ALND. An SLN could not be identified in 46 patients (7.1%). Only 1 SLN was excised in 78 patients (12.0%). Of the remaining 525 patients with 2 or more SLNs removed, no cancer was identified in the axillary lymph nodes of 215 patients, yielding a pathological complete nodal response of 41.0% (95% CI, 36.7%-45.3%). In 39 patients, cancer was not identified in the SLNs but was found in lymph nodes obtained with ALND, resulting in an FNR of 12.6% (90% Bayesian credible interval, 9.85%-16.05%).Among women with cN1 breast cancer receiving neoadjuvant chemotherapy who had 2 or more SLNs examined, the FNR was not found to be 10% or less. Given this FNR threshold, changes in approach and patient selection that result in greater sensitivity would be necessary to support the use of SLN surgery as an alternative to ALND.clinicaltrials.gov Identifier: NCT00881361.

Project description:PurposeSentinel lymph node biopsy (SLNB) alone following neoadjuvant chemotherapy (NAC) remains controversial in patients with breast cancer who are initially lymph node-positive. The present study aimed to evaluate the impact of SLNB and axillary lymph node dissection (ALND) on breast cancer recurrence and survival in patients who converted from lymph node-positive to pathological node-negative (ypN0) after NAC.MethodsThis single-center retrospective study included 223 patients who converted to axillary lymph node-negative status after NAC and underwent breast and axillary surgery between January 2006 and December 2015. This study compared the overall survival (OS), disease-free survival (DFS), ipsilateral axillary lymph node recurrence rates and incidence of postoperative complications, especially, arm lymphedema and shoulder stiffness between SLNB and ALND.ResultsThis study included 223 patients with axillary pathological complete response (pCR) after NAC and surgery. The SLNB and ALND groups included 94 and 129 patients, respectively. The median follow-up time was 57 (range, 6-155) in the SLNB group and 99 (range 2-159) months in the ALND group. The corresponding 5-year OS and DFS rates were 96.3% and 94.2% (p = 0.392), and 89.2% and 86.4% (p = 0.671), respectively. Four patients (4.3%) in the SLNB group and nine (7.0%) in the ALND group developed locoregional recurrences. Ipsilateral axillary lymph node recurrence and distant metastasis were observed in one (1.1%) and three (2.3%) patients, and in 10 (10.6%) and 11 (8.5%) patients, respectively. Patients in the ALND group were more likely than their SLNB counterparts to experience complications, such as shoulder stiffness (9 [7.0%] vs. 4 [4.3%] patients, p = 0.57). The rate of lymphedema in the ALND group was three times that in the SLNB group (35 [27.1%] vs. 8 [8.5%] patients, p < 0.001).ConclusionAs an alternative to ALND, SLNB has oncological safety in patients with axillary pathological complete response after NAC.

Project description:In this study, we aimed to evaluate axillary lymph node dissection (ALND) rates and prognosis in neoadjuvant chemotherapy (NCT) compare with neoadjuvant endocrine therapy (NET) in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), lymph node (LN)-positive, premenopausal breast cancer patients (NCT01622361). The multicenter, phase 3, randomized clinical trial enrolled 187 women from July 5, 2012, to May 30, 2017. The patients were randomly assigned (1:1) to either 24 weeks of NCT including adriamycin plus cyclophosphamide followed by intravenous docetaxel, or NET involving goserelin acetate and daily tamoxifen. ALND was performed based on the surgeon’s decision. The primary endpoint was ALND rate and surgical outcome after preoperative treatment. The secondary endpoint was long-term survival. Among the 187 randomized patients, pre- and post- neoadjuvant systemic therapy (NST) assessments were available for 170 patients. After NST, 49.4% of NCT patients and 55.4% of NET patients underwent mastectomy after treatment completion. The rate of ALND was significantly lower in the NCT group than in the NET group (55.2% vs. 69.9%, P=.046). Following surgery, the NET group showed a significantly higher mean number of removed LNs (14.96 vs. 11.74, P=.003) and positive LNs (4.84 vs. 2.92, P=.000) than the NCT group. The axillary pathologic complete response (pCR) rate was significantly higher in the NCT group (13.8% vs. 4.8%, P=.045) than in the NET group. During a median follow-up of 67.3 months, 19 patients in the NCT group and 12 patients in the NET group reported recurrence. The 5-year ARFS (97.5%vs. 100%, P=.077), DFS (77.2% vs. 84.8%, P=.166), and OS (97.5% vs. 94.7%, P=.304) rates did not differ significantly between the groups. In conclusion, although survival did not differ significantly, more NCT patients might able to avoid ALND, with fewer LNs removed with lower LN positivity. Clinical Trial Registration https://clinicaltrials.gov/ct2/show/NCT01622361, identifier NCT01622361.

Project description:IntroductionBreast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects.Methods and analysesThis multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival.DiscussionThis study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity.Ethics and disseminationThe Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results.Trial registrationClinicalTrials.gov, identifier number NCT04889924.

Dataset Information

Impact of Radiation on Locoregional Control in Women with Node-Positive Breast Cancer Treated with Neoadjuvant Chemotherapy and Axillary Lymph Node Dissection: Results from ACOSOG Z1071 Clinical Trial.

Publications

Impact of Radiation on Locoregional Control in Women with Node-Positive Breast Cancer Treated with Neoadjuvant Chemotherapy and Axillary Lymph Node Dissection: Results from ACOSOG Z1071 Clinical Trial.

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