Journal
ANNALS OF ONCOLOGY
Volume 23, Issue 3, Pages 771-776Publisher
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mdr265
Keywords
chemotherapy; liposarcoma; neoadjuvant; soft tissue sarcoma; surgery
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Funding
- PharmaMar S.A., Sociedad Unipersonal [NCT00579501]
- Novartis
- Pfizer
- Roche
- PharmaMar
- Amgen
- Ariad
- Daiichi-Sankyo
- Infinity Pharmaceuticals
- Johnson Johnson
- PhamaMar
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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.
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