Abstract Published online before print October 12, 2012 .
Background. This phase II clinical trial evaluated the efficacy, safety and pharmacokinetics of plitidepsin 3.2 mg/m2 administered as a 1-hour intravenous infusion weekly on Days 1, 8 and 15 every 4 weeks in 67 adult patients with relapsed/refractory aggressive non-Hodgkin's lymphoma.
Design and Methods. Patients were divided into 2 cohorts: non-cutaneous peripheral T-cell lymphoma (n=34) and other lymphomas (n=33). Efficacy was evaluated using the International Working Group criteria (1999).
Results. Response occurred in 6 of 29 evaluable patients with non-cutaneous peripheral T-cell lymphoma (overall response rate 20.7%; 95% confidence interval, 8.0%-39.7%), including 2 complete responses and 4 partial responses. No responses occurred in 30 evaluable patients with other lymphomas (including 27 B-cell lymphomas).
Conclusions. Plitidepsin monotherapy has clinical activity in relapsed/refractory T -cell lymphomas. Combinations of plitidepsin with other chemotherapeutic drugs deserve further evaluation in non-cutaneous peripheral T-cell lymphoma.
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http://www.haematologica.org/content/early/2012/09/14/haematol.2012.069757.full.pdf+html