A Gronchi1, B N Bui2, S Bonvalot3, S Pilotti4, S Ferrari5, P Hohenberger6, R J Hohl7, G D Demetri8, A Le Cesne3, P Lardelli9, I Pérez9, A Nieto9, J C Tercero9, V Alfaro9, E Tamborini4, J Y Blay10. 1. Department of Surgery, National Cancer Institute, Milano, Italy. Electronic address: alessandro.gronchi@istitutotumori.mi.it. 2. Department of Medical Oncology, Institute Bergonié, Bourdaux. 3. Departments of Surgery; Medical Oncology, Institute Gustave Roussy, Paris, France. 4. Department of Surgery, National Cancer Institute, Milano, Italy. 5. Department of Chemotherapy, Orthopedic Institute Rizzoli, Bologna, Italy. 6. Division of Surgical Oncology and Thoracic Surgery, Mannheim University Medical Center, University of Heidelberg, Germany. 7. Department of Internal Medicine, Carver College of Medicine, Division of Hematology, Oncology and Blood and Marrow Transplantation, Iowa. 8. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA. 9. Department of Clinical R&D, PharmaMar, Colmenar Viejo, Madrid, Spain. 10. Department of Medical Oncology; Léon Bérard Cancer Center, Lyon, France.
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.
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: Jörg Thomas Hartmann; M Horger; T Kluba; A Königsrainer; P de Zwart; C Hann von Weyhern; F Eckert; W Budach; C Bokemeyer Journal: Invest New Drugs Date: 2013-10-04 Impact factor: 3.850
Authors: Eelco de Bree; Alexander Karatzanis; Jennifer L Hunt; Primož Strojan; Alessandra Rinaldo; Robert P Takes; Alfio Ferlito; Remco de Bree Journal: Eur Arch Otorhinolaryngol Date: 2014-05-07 Impact factor: 2.503