LATE-BREAKING RESEARCH: Clinical/Translational Research
Abstract #LB04

Safety and Tolerability of an Alternative Capecitabine Dosing Schedule in Patients with Colorectal Cancer

JHOP - March 2023 Vol 13 Special Feature - HOPA Abstracts

Presenter: Mei Ka Fong, PharmD, BCOP, Levine Cancer Institute, Atrium Health, Charlotte, NC

Co-Authors: Sarah L. Hanson, PharmD, BCOP, Levine Cancer Institute, Atrium Health, Charlotte, NC; Madison Kuch, MHA, Levine Cancer Institute, Atrium Health, Charlotte, NC; Erin Donohue, PhD, Levine Cancer Institute, Atrium Health, Charlotte, NC; Jimmy Hwang, MD, Levine Cancer Institute, Atrium Health, Charlotte, NC; Mohamed E. Salem, MD, Levine Cancer Institute, Atrium Health, Charlotte, NC

BACKGROUND: Capecitabine at FDA-approved doses as a single agent, or in combination, is difficult to tolerate for many patients. Since its approval, alternative doses and schedules have been proposed and evaluated.1,2 For example, capecitabine at 825 mg/m2 orally twice daily on days 1 through 5 and on day 8 through every 14 days provides an earlier rest period after 5 days instead of 14 days, which may help improve tolerability, but also a higher dose intensity than the original schedule. This schedule has been employed at our institution.

OBJECTIVES: To summarize the frequency of dose modifications and the adverse events (AEs) in patients with colorectal cancer who received this alternative dosing regimen, and to evaluate the tolerability of the alternative dosing, as defined by the frequency of AEs and dose modifications.

METHOD: We analyzed adult patients with colorectal cancer who received capecitabine dosed twice daily on days 1 through 5 and days 8 through 12, every 14 days, between January 1, 2018, and July 31, 2020. Patients were excluded if they had received capecitabine with radiation, in combination with irinotecan, or if their creatinine clearance was <30 mL/min. The type of adverse event and the frequency of dose modifications, which were defined as either a dose reduction, delay, and/or treatment discontinuation, were collected.

RESULTS: A total of 48 patients who received the alternative dosing were reviewed. In all, 28 patients received a combination of capecitabine and oxaliplatin, and 20 patients received single-agent capecitabine. Of the 48 patients, 47 had at least 1 AE, including myelosuppression, palmar-plantar erythrodysesthesia, stomatitis, fatigue, nausea, vomiting, diarrhea, or constipation. A total of 27 (56.3%) patients had a dose modification, with dose reductions in 13 (27.1%) patients and a dose hold or delay in 14 (29.2%) patients. Capecitabine was eventually discontinued as a result of AEs in 7 (14.6%) patients, with 6 of these patients receiving the combination of capecitabine and oxaliplatin. The most common AE was fatigue (68.8%), followed by diarrhea (60.4%). Palmar-plantar erythrodysesthesia was reported in 14 (29.2%) patients. A total of 5 (10.4%) patients had documented myelosuppression.

CONCLUSION: This small, retrospective study provides insight into the potential tolerability of using an alternative dosing regimen for patients with colorectal cancer. Further studies are warranted to determine how the frequency of AEs with the alternative regimen compares with the historical dosing. Larger prospective studies would also help determine the potential survival impact of this alternative dosing regimen in patients with metastatic and nonmetastatic colorectal cancer.

  1. Bryson E, Sakach E, Patel U, et al. Safety and efficacy of 7 days on/7 days off versus 14 days on/7 days off schedules of capecitabine in patients with metastatic colorectal cancer: a retrospective review. Clin Colorectal Cancer. 2021;20:153-160.
  2. Rossi D, Alessandroni P, Catalano V, et al. Safety profile and activity of lower capecitabine dose in patients with metastatic breast cancer. Clin Breast Cancer. 2007;7:857-860.
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