Phase II trial of eribulin in patients who do not achieve pathologic complete response (pCR) following neoadjuvant chemotherapy

Autor: David C. Molthrop, John D. Hainsworth, Denise A. Yardley, Aleksander Jankov, Sonalee K. Shroff, Robyn R. Young, N. W. Peacock, Mythili Shastry, Amy Vander Woude, Brooke R. Daniel, Johanna Pasek, Laura M. DeBusk, Betrand Anz
Rok vydání: 2019
Předmět:
0301 basic medicine
Oncology
Cancer Research
Non-Randomized Controlled Trials as Topic
Receptor
ErbB-2
medicine.medical_treatment
Cohort Studies
chemistry.chemical_compound
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
Anthracyclines
skin and connective tissue diseases
Neoadjuvant therapy
Ketones
Middle Aged
Prognosis
Metastatic breast cancer
Neoadjuvant Therapy
Survival Rate
Receptors
Estrogen
Chemotherapy
Adjuvant
030220 oncology & carcinogenesis
Hormonal therapy
Female
Taxoids
Receptors
Progesterone
Eribulin
Adult
Bridged-Ring Compounds
medicine.medical_specialty
Anthracycline
Breast Neoplasms
03 medical and health sciences
Breast cancer
Internal medicine
medicine
Adjuvant therapy
Biomarkers
Tumor
Humans
Furans
Aged
business.industry
Trastuzumab
medicine.disease
Radiation therapy
030104 developmental biology
chemistry
Drug Resistance
Neoplasm
business
Follow-Up Studies
Zdroj: Breast cancer research and treatment. 180(3)
ISSN: 1573-7217
Popis: 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. 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). 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%). 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.
Databáze: OpenAIRE
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