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)

López-Pousa, A.; Martín, J.; Montalar, J.; de las Peñas, R.; del Muro, J. García; Cruz, J.; Maurel, J.; Escudero, P.; Casado, A.; Buesa, J. M.; the Spanish Group for Research on Sarcomas (GEIS), undefined

doi:https://doi.org/10.1155/SRCM/2006/26986

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Clinical Study | Open Access

Volume 2006 | Article ID 026986 | https://doi.org/10.1155/SRCM/2006/26986

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

Received27 Dec 2005

Revised22 May 2006

Accepted06 Jun 2006

Published19 Sept 2006

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.

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Copyright

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.

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