A phase II study evaluating the preventive effect of topical hydrocortisone for capecitabine-induced hand-foot syndrome in patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine plus oxaliplatin (T-CRACC study)
Abstract
Background: Topical steroids may help prevent capecitabine-induced hand-foot syndrome in patients with colorectal cancer, as inflammation is involved in anti-tumor agent-induced hand-foot syndrome development. We assessed the preventive efficacy of medium-class topical corticosteroids for capecitabine-induced hand-foot syndrome in patients receiving adjuvant chemotherapy for colorectal cancer.
Methods: This open-label, single-arm, single-center phase II study included patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine + oxaliplatin. Prophylactic topical hydrocortisone butyrate (0.1%) was applied to the palms and soles from day 1 of adjuvant chemotherapy. The primary endpoint was grade ≥ 2 hand-foot syndrome incidence within four cycles. Secondary endpoints were the time to onset and incidence of each hand-foot syndrome grade, dose reduction, schedule delay, hand-foot syndrome-induced discontinuation, and other adverse events.
Results: Fifty patients were enrolled; three were excluded. Among the 47 included (median age = 54.5 years), 100% had Eastern Cooperative Oncology Group performance status 0, 36.1% were male, and 95.7% had pathological stage III disease. Hand-foot syndrome induced dose reduction, schedule delay, and discontinuation were required in 0, 2, and 0 patients, respectively, with a median relative capecitabine dose intensity of 100% within four cycles. Grade ≥ 2 hand-foot syndrome incidence during the cycles was 6.4%. Time to…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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