1 The Tolerance of CREATE-X Capecitabine Dosing in a United States TNBC Patient Population

Publication
Article
Miami Breast Cancer Conference® Abstracts Supplement38th Annual Miami Breast Cancer Conference® - Abstracts
Volume 35
Issue suppl 1
Pages: 11

Alaina J. Kessler, MD, MPH1; Natalie S. Berger, MD1; Lauren K. Margetich, MD1; Erin L. Moshier, MS2; and Paula Klein, MD1,2

1Icahn School of Medicine at Mount Sinai, New York, NY.

2The Mount Sinai Hospital, New York, NY.

Background

Capecitabine has been shown to prolong overall survival in patients with triple-negative breast cancer (TNBC) with residual disease after neoadjuvant chemotherapy based on the CREATE-X study (UMIN000000843). The starting dose of capecitabine in CREATE-X was 1250 mg/m2 twice per day on days 1 through 14 every 3 weeks. Fluoropyrimidine toxicity is higher in the United States compared with East Asia. The goal of this study was to evaluate the tolerance of capecitabine at a US urban clinic treating predominantly non-Asian patients.

Materials and Methods

We performed a retrospective chart review of patients with TNBC with residual disease from June 1, 2017, to June 1, 2020. Distributions of categorical variables were compared between capecitabine dosing groups using the χ2/Fisher’s exact test, as appropriate. All statistical analyses were conducted using SAS version 9.4 (SAS Institute).

Results

A total of 32 patients who met criteria were included (average [SD] age, 52.5 [9.6] years). Eight patients (25%) were Hispanic/Latinx, 11 (34.4%) were White, 10 (31.3%) were African American, and 2 (6.3%) were Asian. At diagnosis, 4 patients (12.5%) had clinical stage I disease, 16 (50.0%) had stage II disease, and 12 (37.5%) had stage III disease. Of the 16 patients (50.0%) prescribed capecitabine 1250 mg/m2, 5 patients (31.3%) completed 8 cycles, all requiring dose reductions. Of the 283 patients in the CREATE-X study treated with this dose, 37.8% completed capecitabine treatment with the planned dose compared with 0% of patients in our cohort; 36.7% completed treatment with dose reduction compared with 31.3% in our cohort; and 25.4% discontinued treatment compared with 25.0% in our cohort. Of the 14 patients (43.8%) in our cohort prescribed the US standard dosing of 1000 mg/m2, 4 patients (28.6%) completed 8 cycles with 1 patient requiring dose reductions. Four of the 14 patients (28.6%) discontinued capecitabine due to intolerance. The most common adverse events were hand-foot syndrome (62.5%), nausea (46.9%), and diarrhea (34.4%).

Conclusions

When compared with the study population in CREATE-X, no patients in our cohort tolerated 8 cycles of capecitabine 1250 mg/m2 whereas 3 of 4 (75%) patients tolerated 8 cycles of capecitabine at 1000 mg/m2. This treatment dose was not studied in CREATE-X. Trials in metastatic disease comparing these 2 doses demonstrated similar efficacy with less toxicity. Further studies are warranted in this curative-intent population.

Articles in this issue

1 The Tolerance of CREATE-X Capecitabine Dosing in a United States TNBC Patient Population
1 The Tolerance of CREATE-X Capecitabine Dosing in a United States TNBC Patient Population
6 Survival Benefit of Eribulin, But Not Capecitabine, for Metastatic Breast Cancer Is Associated With Baseline Absolute Lymphocyte Count in Peripheral Blood
6 Survival Benefit of Eribulin, But Not Capecitabine, for Metastatic Breast Cancer Is Associated With Baseline Absolute Lymphocyte Count in Peripheral Blood
7 Evaluation of the 21-Gene Recurrence Score (RS) Assay Results Following Successful Intraoperative Radiation Therapy (IORT) Treatment of Patients With Early-Stage Breast Cancer
7 Evaluation of the 21-Gene Recurrence Score (RS) Assay Results Following Successful Intraoperative Radiation Therapy (IORT) Treatment of Patients With Early-Stage Breast Cancer
8 Concordance of Tumor Response with Eribulin Use in Real-World Clinical Practice
8 Concordance of Tumor Response with Eribulin Use in Real-World Clinical Practice
13 Real-world Treatment Patterns and Tumor Response of Palbociclib Plus an Aromatase Inhibitor for Metastatic Breast Cancer: Flatiron Database Analysis
13 Real-world Treatment Patterns and Tumor Response of Palbociclib Plus an Aromatase Inhibitor for Metastatic Breast Cancer: Flatiron Database Analysis
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25 A Retrospective Cohort Study of Demographic, Clinical, and Treatment Characteristics of Patients With Metastatic Breast Cancer Who Have Received PARP Inhibitors
25 A Retrospective Cohort Study of Demographic, Clinical, and Treatment Characteristics of Patients With Metastatic Breast Cancer Who Have Received PARP Inhibitors
28 Primary Outcome Analysis of Invasive Disease-Free Survival for monarchE: Abemaciclib Plus Adjuvant Endocrine Therapy for High-Risk Early Breast Cancer
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30 Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Early- Stage Breast Cancer (ESBC) Receiving Docetaxel and Cyclophosphamide
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35 Decreased Epithelial Mesenchymal Transition Process After AGTR-1 Gene Edition By Crispr/Cas9, Losartan, and PARP Inhibitor Treatment In Breast Cancer Cell Line
37 Treatment Outcomes Using Neoadjuvant Chemotherapy for HER2-Positive Breast Cancer in African American and Hispanic Women
37 Treatment Outcomes Using Neoadjuvant Chemotherapy for HER2-Positive Breast Cancer in African American and Hispanic Women
42 The United States Retrospective Claims Database Analysis of Demographic, Clinical, and Treatment Characteristics of Metastatic Breast Cancer Patients receiving Olaparib
42 The United States Retrospective Claims Database Analysis of Demographic, Clinical, and Treatment Characteristics of Metastatic Breast Cancer Patients receiving Olaparib
43 Lobular Cancer Responsiveness to Chemotherapy Is Equivalent to That of Ductal Cancer With Similar Genomic Profiles: An NCDB Analysis
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44 Drivers of Oncologist Treatment Selection in HR+/HER2- Metastatic Breast Cancer
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