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• W4361944753 abstract "<div>Abstract<p><b>Purpose:</b> Mucosal melanoma is rare and associated with extremely poor prognosis. However, standard adjuvant therapy for mucosal melanoma has not been established. We conducted a randomized phase II clinical trial in patients with resected mucosal melanoma to compare the efficacy and safety of high-dose IFN-α2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy.</p><p><b>Experimental Design:</b> Patients with mucosal melanoma in stage II/III after surgery were randomized into three groups: observation group (group A, surgery alone), HDI group (group B, treated with 15 × 10⁶ U/m²/d IFN-α2b, followed by 9 × 10⁶ U IFN-α2b), and temozolomide (200 mg/m²/d) plus cisplatin (75 mg/m²) group (group C). The endpoints were relapse-free survival (RFS), overall survival (OS), and toxicities.</p><p><b>Results:</b> One hundred and eighty-nine patients were enrolled and finally analyzed. With a median follow-up of 26.8 months, the median RFS was 5.4, 9.4, and 20.8 months for group A, B, and C, respectively. Estimated median OS for group A, B, and C was 21.2, 40.4, and 48.7 months, respectively. Patients treated with temozolomide plus cisplatin showed significant improvements in RFS (<i>P</i> < 0.001) and OS (<i>P</i> < 0.01) than those treated with either HDI or surgery alone. Toxicities were generally mild to moderate.</p><p><b>Conclusion:</b> Both temozolomide-based chemotherapy and HDI are effective and safe as adjuvant therapies for resected mucosal melanoma as compared with observation alone. However, HDI tends to be less effective than temozolomide-based chemotherapy for patients with resected mucosal melanoma in respect to RFS. The temozolomide plus cisplatin regimen might be a better choice for patients with resected mucosal melanoma. <i>Clin Cancer Res; 19(16); 4488–98. ©2013 AACR</i>.</p></div>" @default.
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• W4361944753 date "2023-03-31" @default.
• W4361944753 modified "2023-09-27" @default.
• W4361944753 title "Data from Phase II Randomized Trial Comparing High-Dose IFN-α2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma" @default.
• W4361944753 doi "https://doi.org/10.1158/1078-0432.c.6521468" @default.
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