NTCT-02A COMMON AND LONG-LASTING PERIPHERAL NEUROPATHY IS ASSOCIATED WITH BRENTUXIMAB VEDOTIN TREATMENT OF MYCOSIS FUNGOIDES AND SÉZARY SYNDROME

BACKGROUND: Brentuximab vedotin (BV) is an antibody-drug conjugate with a CD30 antibody linked to the microtubule inhibitor monomethyl auristatin E. The use of BV is being explored in Mycosis fungoides (MF) and Sezary syndrome (SS). In studies of BV treatment in other lymphomas, peripheral neuropathy was reported in 36% and 52% of patients, with resolution or improvement in 63% and 54%, respectively. METHODS: Patients were adults with good performance status in a phase II study of BV for MF/SS. A neurologist evaluated the patients at pre-defined intervals, and we employed the Total Neuropathy Score - clinical (TNSc) in a subset of the patients. Spearmanu0027s coefficient was used to measure correlations between CTCAE grade and TNSc scores. Logistic regression was used to evaluate the relationship between neuropathy grade and baseline neuropathy risk factors along with BV dose. RESULTS: Twenty-one (66%) of 32 patients developed worsening neuropathy, 9 (28%) CTCAE grade 1, 11 (34%) grade 2, and 1 (3%) grade 4. Seven (58%) of the patients with grades 2 or 4 progressed after the last dose of BV. Thirteen (62%) of patients showed improvement or resolution of the neuropathy. Risk factors of age, diabetes, alcoholism, and prior chemotherapy did not predict neuropathy. Total dose of BV predicted neuropathy (p u003c 0.0001). CTCAE grade correlated with TNSc (ρ = 0.75, p u003c 0.001), and grade 2 neuropathy occurred around a TNSc of 6 to 8. CONCLUSIONS: Our study reveals that a larger proportion of MF/SS patients treated with BV developed a long-lasting neuropathy than expected. The neuropathy has the pattern of a large fiber, sensory predominant syndrome, with generally negative symptoms. The TNSc provides a reliable measure of neuropathy with greater granularity. The ability to more clearly and objectively monitor such side effects is of paramount importance in the MF/SS population, given the chronic nature of their diagnosis.