17 octubre 2012

Aplidin ( PharmaMar ) . Multicenter Phase II Study of plitidepsin in Patients With Relapsed / Refractory Non-Hodgkin's Lymphoma. .

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.

...   http://www.haematologica.org/content/early/2012/09/14/haematol.2012.069757.full.pdf+html