Denise A Yardley1,2,3, Nancy Peacock4,5, Brooke Daniel4,6, Betrand Anz4,6, David C Molthrop7, Sonalee K Shroff7, Robyn Young8, Aleksander Jankov9, Amy Vander Woude10, Mythili Shastry4, Johanna Pasek4, Laura M DeBusk4, John D Hainsworth4,5. 1. Sarah Cannon Research Institute, Nashville, TN, USA. dyardley@tnonc.com. 2. Tennessee Oncology, PLLC, Nashville, TN, USA. dyardley@tnonc.com. 3. Sarah Cannon Research Institute, 250 25th Avenue North, Suite 100, Nashville, TN, 37203, USA. dyardley@tnonc.com. 4. Sarah Cannon Research Institute, Nashville, TN, USA. 5. Tennessee Oncology, PLLC, Nashville, TN, USA. 6. Tennessee Oncology, PLLC, Chattanooga, TN, USA. 7. Florida Hospital Cancer Institute, Orlando, FL, USA. 8. The Center for Cancer and Blood Disorders, Fort Worth, TX, USA. 9. Family Cancer Center, Memphis, TN, USA. 10. Cancer Research Consortium of West Michigan, Grand Rapids, MI, USA.
Abstract
PURPOSE: Women with residual invasive breast cancer at the primary site or axillary lymph nodes following neoadjuvant chemotherapy have a high risk of recurrence. Eribulin improves survival in patients with metastatic breast cancer who progress after anthracycline and taxane therapy. This phase 2 trial assessed the efficacy of postoperative eribulin in breast cancer patients who did not achieve a pCR following standard neoadjuvant chemotherapy. METHODS: Women with localized breast cancer who had residual invasive cancer following ≥ 4 cycles of standard anthracycline and/or taxane-containing neoadjuvant chemotherapy received adjuvant eribulin treatment. HER2-positive patients also received trastuzumab for 1 year. Adjuvant hormonal therapy and locoregional radiotherapy were administered as per institutional guidelines. Primary endpoint was the 2-year DFS rate. Three patient cohorts were analyzed: TNBC (Cohort A), HR+/HER2- (Cohort B), and HER2+ (Cohort C). RESULTS: One hundred twenty-six patients (Cohort A-53, Cohort B-42, and Cohort C-31) were enrolled. Neoadjuvant chemotherapy included a taxane and an anthracycline in 70%. Eribulin was well tolerated; 84% of patients received the planned 6 cycles. After a median follow-up of 28 months, the 24-month DFS rates were 56% (95% CI 42, 69), 83% (95% CI 67, 91), and 73% (95% CI 53, 86) for Cohorts A, B, and C, respectively. The most common grade 3/4 treatment-related adverse events were neutropenia (26%), leukopenia (13%), and neuropathy (7%). CONCLUSION: Administration of adjuvant eribulin after neoadjuvant chemotherapy was feasible and well tolerated. The 24-month DFS rate did not reach the study target levels in any of the cohorts and was similar to DFS previously described in these cohorts following neoadjuvant chemotherapy alone.
PURPOSE:Women with residual invasive breast cancer at the primary site or axillary lymph nodes following neoadjuvant chemotherapy have a high risk of recurrence. Eribulin improves survival in patients with metastatic breast cancer who progress after anthracycline and taxane therapy. This phase 2 trial assessed the efficacy of postoperative eribulin in breast cancerpatients who did not achieve a pCR following standard neoadjuvant chemotherapy. METHODS:Women with localized breast cancer who had residual invasive cancer following ≥ 4 cycles of standard anthracycline and/or taxane-containing neoadjuvant chemotherapy received adjuvant eribulin treatment. HER2-positive patients also received trastuzumab for 1 year. Adjuvant hormonal therapy and locoregional radiotherapy were administered as per institutional guidelines. Primary endpoint was the 2-year DFS rate. Three patient cohorts were analyzed: TNBC (Cohort A), HR+/HER2- (Cohort B), and HER2+ (Cohort C). RESULTS: One hundred twenty-six patients (Cohort A-53, Cohort B-42, and Cohort C-31) were enrolled. Neoadjuvant chemotherapy included a taxane and an anthracycline in 70%. Eribulin was well tolerated; 84% of patients received the planned 6 cycles. After a median follow-up of 28 months, the 24-month DFS rates were 56% (95% CI 42, 69), 83% (95% CI 67, 91), and 73% (95% CI 53, 86) for Cohorts A, B, and C, respectively. The most common grade 3/4 treatment-related adverse events were neutropenia (26%), leukopenia (13%), and neuropathy (7%). CONCLUSION: Administration of adjuvant eribulin after neoadjuvant chemotherapy was feasible and well tolerated. The 24-month DFS rate did not reach the study target levels in any of the cohorts and was similar to DFS previously described in these cohorts following neoadjuvant chemotherapy alone.
Authors: Tomás Pascual; Mafalda Oliveira; Patricia Villagrasa; Vanesa Ortega; Laia Paré; Begoña Bermejo; Serafín Morales; Kepa Amillano; Rafael López; Patricia Galván; Jordi Canes; Fernando Salvador; Paolo Nuciforo; Isabel T Rubio; Antonio Llombart-Cussac; Serena Di Cosimo; José Baselga; Nadia Harbeck; Aleix Prat; Javier Cortés Journal: NPJ Breast Cancer Date: 2021-11-25