https://doi.org/10.4081/hmr.v3i1.531

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

Vol. 3 No. 1: 2006...2009: Now we know T-cell lymphomas better, Bologna, Italy, 16-18 March 2009
Published: June 11, 2009
Abstract Views: 196
PDF: 192
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Authors

C Ferme
support@pagepress.org
MV Mateos
S Szyldergemajn
E Zucca
S Extremera
J Briones
G Alessandro
V Ribrag
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

Dimensions

Altmetric

PlumX Metrics

Downloads

Citations

Crossref
Scopus
Google Scholar
Europe PMC

Supporting Agencies

How to Cite

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
Authors who publish with this journal agree to the following terms: Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).