Plitidepsin is active in peripheral T-cell lymphoma: a subset analysis from an ongoing multicenter phase II trial

C Ferme; MV Mateos; S Szyldergemajn; E Zucca; S Extremera; J Briones; G Alessandro; V Ribrag

doi:10.4081/hmr.v3i1.531

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Background. Peripheral T-cell lymphomas (PTCL) represent a small (<10%) yet a particularly aggressive subset of NHL. Up to 75% of those patients (pts) eventually become relapsed/refractory, with no effective options available. Thus, a prospective open label, multicenter phase II study to evaluate the activity of plitidepsin (Aplidin®) in adult pts with relapsed/refractory aggressive lymphomas was planned and is currently ongoing. We report the preliminary results from a cohort of non-cutaneous PTCL. Patients and methods. As of December 2008, 19 pts were treated with plitidepsin 3.2 mg/m2 i.v. infusion over a 1-h on days 1, 8 and 15 q4wk. Sixteen pts have been evaluated, one is too early and two were non-evaluable as per protocol criteria: one had a hypersensitivity reaction and one had cutaneous involvement exclusively. Pts had a median of 3 (1-6) previous regimens, including 4 pts (33%) with prior autologous transplantation. Lymphoma histology: 11 PTCL-nos, 3 anaplastic large-cell, 3 angioimmunoblastic and 2 NK/T nasal type. Ten pts were male, median age was 56 y (35-74), with performance status 0 in 6 pts, 1 in 5 pts and 2 in 3 pts. Results. Two CR (1 unconfirmed) and 2 PR were observed for a 25% objective response rate (95% CI: 11%-70%). Median duration of response was 4 months (range: 1+ - 12+). Median overall survival was 11 months (range 1+- 24+). Plitidepsin was tolerable in this heavily pre-treated population, particularly with low hematologic toxicity. Of 2 cases of grade (G) 4 neutropenia, 1 was already present at baseline and only 1 pt developed G3 thrombocytopenia during treatment. Transient and reversible G3 ALT/AST elevations occurred in 7 patients. Clinical toxicities mainly consisted of mild to moderate muscular weakness, myalgia and cramps, plus G1-2 fatigue and nausea in 1/3 of the patients. Conclusion. Plitidepsin (Aplidin®) shows promising activity and an acceptable safety profile in this difficult-to-treat subset of patients. Remarkably, no significant hematologic toxicity was seen in this heavily pretreated cohort. To confirm these preliminary data an expansion of the cohort is currently ongoing. Updated

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Ferme, C., Mateos, M., Szyldergemajn, S., Zucca, E., Extremera, S., Briones, J., Alessandro, G., & Ribrag, V. (2009). Plitidepsin is active in peripheral T-cell lymphoma: a subset analysis from an ongoing multicenter phase II trial. Hematology Meeting Reports (formerly Haematologica Reports), 3(1). https://doi.org/10.4081/hmr.v3i1.531

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