Originally published as JCO Early Release 10.1200/JCO.2008.19.2930 on March 9 2009

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Efficacy of Sequential High-Dose Doxorubicin and Ifosfamide Compared With Standard-Dose Doxorubicin in Patients With Advanced Soft Tissue Sarcoma: An Open-Label Randomized Phase II Study of the Spanish Group for Research on Sarcomas

Joan Maurel, Antonio López-Pousa, Ramón de las Peñas, Joaquín Fra, Javier Martín, Josefina Cruz, Antonio Casado, Andrés Poveda, Javier Martínez-Trufero, Carmen Balañá, María Auxiliadora Gómez, Ricardo Cubedo, Oscar Gallego, Belen Rubio-Viqueira, Jordi Rubió, Raquel Andrés, Isabel Sevilla, Juan Jose de la Cruz, Xavier García del Muro, Jose María Buesa

From the Medical Oncology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS); Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas; Hospital Clínic Barcelona, University of Barcelona; Hospital Sant Pau, Barcelona; Hospital Provincial Castellón; Hospital Central Asturias; Hospital Universitario Canarias; Hospital Son Dureta, Mallorca; Hospital Clínico Madrid; Instituto Valenciano de Oncologia; Hospital Miguel Servet, Zaragoza; Hospital Germans Trias i Pujol, Badalona; Hospital Reina Sofía, Cordoba; Hospital Puerta de Hierro; Madrid Hospital 12 de Octubre, Madrid; Institut Català d'Oncologia, Girona; Hospital Clínico Zaragoza; Hospital Clínico Malaga; Medicina Preventiva, Universidad Autónoma de Madrid; Institut Català Oncologia, Hospitalet, Spain.

Corresponding author: Joan Maurel, MD, Medical Oncology Department, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Hospital Clínic, Villarroel 170, 08036 Barcelona, Spain; e-mail: jmaurel{at}clinic.ub.es.

Purpose To assess the progression-free survival (PFS) and antitumor response to standard-dose doxorubicin compared with sequential dose-dense doxorubicin and ifosfamide in first-line treatment of advanced soft tissue sarcoma.

Patients and Methods Patients with measurable advanced soft tissue sarcoma, Eastern Cooperative Oncology Group (ECOG) performance status (PS) < 2, between the ages 18 and 65 years, and with adequate bone marrow, liver, and renal function were entered in the study. The stratifications were: ECOG PS (0 v 1), location of metastases, and potentially resectable disease. Patients were randomly assigned to either doxorubicin 75 mg/m² given as a bolus injection every 3 weeks for 6 cycles (arm A) or doxorubicin at 30 mg/m² per day for 3 consecutive days once every 2 weeks for 3 cycles followed by ifosfamide at 12.5 g/m² delivered by continuous infusion over 5 days once every 3 weeks for 3 cycles with filgastrim or pegfilgastrim support (arm B).

Results Between December 2003 and September 2007, 132 patients were entered onto the study. Febrile neutropenia, asthenia, and mucositis were more frequent in the arm B. The interim preplanned analysis for futility allowed the premature closure. Objective responses were observed in 23.4% of assessable patients in arm A and 24.1% in arm B. PFS was 26 weeks in the arm A and 24 weeks in arm B (P = .88). Overall survival did not differ between the two therapeutic arms (P = .14).

Conclusion Single-agent doxorubicin remains the standard treatment in fit patients with advanced soft tissue sarcoma.

Deceased.

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas is supported by Instituto de Salud Carlos III.

Written on behalf of Grupo Español de Investigación en Sarcomas.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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