PF325 REAL ‐ LIFE DATA ON ROMIDEPSIN TREATMENT FOR RELAPSED AND REFRACTORY PERIPHERAL AND CUTANEOUS T‐CELL LYMPHOMA ‐ A MULTICENTER NATIONAL OBSERVATIONAL STUDY
Authors: S. Shimony, N. Horowitz, E. Ribakovsky, U. Rozovski, A. Avigdor, K. Zloto, T. Berger, I. Avivi, C. Perry, U. Abadi, P. Raanani, A. Gafter‐Gvili, R. Gurion
Journal: HemaSphere (2019)

Background: Peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL) are uncommon subsets of non‐Hodgkin lymphomas (NHLs), comprising less than 15% of all NHLs. The rate of refractory and relapsed (R/R) disease remains high both in PTCL and in advanced CTCL. Romidepsin is a class I selective histone deacetylase (HDAC) inhibitor approved by the FDA for R/R CTCL and PTCL patients treated with at least one prior systemic therapy. As for now, there is no real‐life data on the efficacy and safety of romidepsin in T cell lymphomas. Aims: To evaluate real‐life data concerning the efficacy and saftey of romidepsin treatment for R/R CTCL and PTCL. Methods: We conducted a multicenter retrospective study between the years 2013–2018. Demographic, clinical, laboratory and pathological data regarding PTCL and CTCL patients aged 18 years or more treated with romidepsin for R/R disease were extracted. Primary outcomes were: overall survival (OS) and event free survival (EFS). Secondary outcomes were progression free survival (PFS), response rates, duration of response (DOR) and adverse events. Efficacy outcomes were analyzed separately for PTCL and CTCL. Results: We reviewed the medical records of 53 patients with R/R PTCL (n = 42, 79.2%) or CTCL (n = 11, 20.8%) who received romidepsin between 2013 and 2018 in five medical centers nationwide. The median age was 66.2 (range 26–82) years and 64% of patients were males. The vast majority of patients had good performance status ‐ ECOG 1 or less (86%), with advanced stage (71% with stage IV disease) and multiple previous lines of treatment (median 2, range 1–5). CTCL : While the Overall response rate (ORR) was 25% and none experienced complete response (CR), the DOR was 13.8 months, (95% CI: 9.2 to 18.4) and the median OS was not reached. The median PFS and EFS were 4.7 (95% CI: 0.5–8.9) and 4.0 (95% CI: 0.4–7.5), respectively. For PTCL : The ORR was 33% (n = 13) and 12.5% (n = 5) experienced CR. The OS was 7.1 months (95% CI: 3.5 to 10.7), PFS 2.2 months (95%CI: 0.5 to 3.9) and EFS 1.9 months (95% CI: 1.2 to 2.6). In responders, the DOR was 13.4 months (95%CI: 10.0 to 16.8). In a univariate analysis for EFS, response to therapy, number of previous lines and PTCL subclass predicted for longer EFS, whereas in multivariate analysis treatment response was the only significant predictor (OR 12.67 CI 95% 3.35–47.91, p &lt; 0.0001). In a univariate and multivariate analysis for OS, treatment response was the only predictor (figure 1; OR 4.48, CI 95% 1.57–12.79, p = 0.005). Most grade 3–4 adverse events were hematological, including neutropenia (35%), thrombocytopenia (31%) and anemia (23%). Four patients (7.7%) had febrile neutropenia and a third of all patients required hospitalization due to infection. The most common non‐hematological adverse events, except for infections, were nausea/vomiting (36%) and electrolyte disturbances (low magnesium and potassium levels in 27.5% and 19.2% of the patients, respectively). Summary/Conclusion: This real‐life experience with romidepsin confirms the results of the pivotal phase II trials. Unlike those trials, PTCL subtypes and the number of previous lines of therapy did have an impact on patient's outcomes. In addition, patients who had good response to romidepsin benefited most in terms of both EFS and OS. image