Low-Dose Total Skin Electron Beam Radiotherapy in Stage IB-IIB Mycosis Fungoides: Results From the Prospective S-MISR Study

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PURPOSE Low-dose radiation demonstrates efficacy in treating primary cutaneous T-cell lymphomas. This study evaluated the safety and efficacy of low-dose total skin electron beam therapy (TSEBT) regimens in patients with mycosis fungoides (MF). MATERIALS AND METHODS Patients with stage IB to IIB MF received low-dose TSEBT. The primary end point assessed was the overall response rate (ORR). The secondary end points included time to next treatment (TTNT), progression-free survival (PFS), and toxicity. Exploratory patient-reported outcome measures and potential soluble biomarkers were investigated. RESULTS In a study of 118 patients, 38 were in stage IB to IIA and 80 were in stage IIB according to International Society for Cutaneous Lymphomas /European Organisation for Research and Treatment of Cancer (EORTC) TNM classification. Patients had received a median of four previous treatments and were treated with either 12 Gy in eight fractions (65 patients) or 8 Gy in two fractions (53 patients). The ORR was 92% at 3 months. After a median follow-up of 45 months (95% CI, 36 to 54), the median TTNT was 16 months (95% CI, 8 to 24) and the median PFS was 11 months (95% CI, 8 to 14). There was no significant difference in outcome between the radiation regimens. Only 17% reported grade 2 toxicities, and the rate of grade 3 or higher toxicity was 4%. There were no significant differences in toxicity based on radiation dose or fractionation. Participants reported meaningful improvements, including reduced itching and skin disease burden, along with better scores on Skindex-29 and EORTC core quality of life questionnaire assessments. The study identified several prognostic factors and potential biomarkers in a multivariate analysis. CONCLUSION Low-dose TSEBT delivered with 8 Gy or 12 Gy provides significant clinical benefits and shows minimal toxicity. In a multivariate analysis, we identified several prognostic factors and potential biomarkers which could support patient selection.

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