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Sarcoma
Volume 2006 (2006), Article ID 26986, 8 pages
http://dx.doi.org/10.1155/SRCM/2006/26986
Clinical Study

Phase II Trial of Doxorubicin Plus Escalated High-Dose Ifosfamide in Patients With Advanced Soft Tissue Sarcomas of the Adult: A Study of the Spanish Group for Research on Sarcomas (GEIS)

A. López-Pousa,1 J. Martín,2 J. Montalar,3 R. de las Peñas,4 J. García del Muro,5 J. Cruz,6 J. Maurel,7 P. Escudero,8 A. Casado,9 J. M. Buesa,10 and the Spanish Group for Research on Sarcomas (GEIS)1

1Medical Oncology Department, Hospital Sant Pau, Barcelona 08025, Spain
2Medical Oncology Department, Hospital Son Dureta, Palma de Mallorca 07014, Spain
3Medical Oncology Department, Hospital Clínico La Fe, Valencia 46009, Spain
4Medical Oncology Department, Hospital Provincial, Castellón 12002, Spain
5Medical Oncology Department, Instituto Catalán de Oncología, Barcelona 08907, Spain
6Medical Oncology Department, Hospital Universitario de Canarias, Tenerife 38320, Spain
7Medical Oncology Department, Hospital Clínic, Barcelona 08036, Spain
8Medical Oncology Department, Hospital Clínico, Zaragoza 50009, Spain
9Medical Oncology Department, Hospital Clínico San Carlos, Madrid 28040, Spain
10Medical Oncology Department, Hospital Central de Asturias, Instituto Universitario de Oncología del Principado de Asturias (IUOPA), Oviedo 33006, Spain

Received 27 December 2005; Revised 22 May 2006; Accepted 6 June 2006

Copyright © 2006 A. López-Pousa et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. To explore the tolerance and the activity of high-dose ifosfamide (IFOS) combined with doxorubicin (DXR) at 50 mg/m2 every 4 weeks in patients with soft tissue sarcomas. Methods. DXR was given IV bolus and IFOS by continuous infusion at 2 g/m2/day. Initial IFOS dose (12 g/m2) was adjusted to 10, 13, or 14 g/m2 according to toxicity. Results. Seventy patients received 277 cycles (median 3 cycles, range 1–10), 34% with IFOS dose increased, 30% decreased, and 48% delivered at 12 g/m2. Toxicity grade 4 occurred on granulocytes (67% of patients) or platelets (19%), 54% had febrile neutropenia, 31% grade 3/4 asthenia, and 26% abandoned the study due to toxicity. Three toxic deaths occurred. In 57 non-GIST patients objective activity was 45.6% (95% CI, 32 to 58%). Conclusion. At least 4 cycles were tolerated by 71% of patients, most receiving DXR 50 mg/m2 plus IFOS 10–12 g/m2, with substantial toxicity.