Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma.

Abstract

BACKGROUND:

To evaluate neoadjuvant trabectedin (1.5 mg/m(2) 24-h i.v. infusion every 3 weeks; three to six cycles) in patients with locally advanced myoxid liposarcoma (ML) previously untreated with chemotherapy or radiation.

PATIENTS AND METHODS:

Primary efficacy end point was pathological complete response (pCR) or tumoral regression rate. Objective response according to RECIST (v.1.0) was a secondary end point.

RESULTS:

Three of 23 assessable patients had pCR [13%; 95% confidence interval (CI), 3% to 34%]. Furthermore, very good and moderate histological responses were observed in another 2 and 10 patients, respectively. Histological decrement in the cellular and vascular tumor component and maturation of tumor cells to lipoblasts were observed in both myoxid and myoxid/round cell variants. Seven patients had partial response according to RECIST (objective response rate of 24%; 95% CI, 10% to 44%). No disease progression was reported. Neoadjuvant trabectedin was usually well tolerated, with a safety profile similar to that described in patients with soft tissue sarcoma or other tumor types.

CONCLUSION:

Trabectedin 1.5 mg/m(2) given as a 24-h i.v. infusion every 3 weeks is a therapeutic option in the neoadjuvant setting of ML.

• Authors: A Gronchi, B N Bui, S Bonvalot, S Pilotti, S Ferrari, P Hohenberger, R J Hohl, G D Demetri, A Le Cesne, P Lardelli, I Pérez, A Nieto, J C Tercero, V Alfaro, E Tamborini, J Y Blay
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 23 Issue 3 Pg. 771-776 (Mar 2012) ISSN: 1569-8041 [Electronic] England
• PMID: 21642514 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Alkylating
• Dioxoles
• Tetrahydroisoquinolines
• Trabectedin

Topics

• Adult
• Aged
• Antineoplastic Agents, Alkylating (therapeutic use)
• Dioxoles (therapeutic use)
• Female
• Humans
• Liposarcoma, Myxoid (drug therapy)
• Male
• Middle Aged
• Neoadjuvant Therapy
• Tetrahydroisoquinolines (therapeutic use)
• Trabectedin
• Young Adult