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,
J. Martín,
J. Montalar,
R. de las Peñas,
J. García del Muro,
J. Cruz,
J. Maurel,
P. Escudero,
A. Casado,
J. M. Buesa,
the Spanish Group for Research on Sarcomas (GEIS)
Affiliations
A. López-Pousa
Medical Oncology Department, Hospital Sant Pau, Barcelona 08025, Spain
J. Martín
Medical Oncology Department, Hospital Son Dureta, Palma de Mallorca 07014, Spain
J. Montalar
Medical Oncology Department, Hospital Clínico La Fe, Valencia 46009, Spain
R. de las Peñas
Medical Oncology Department, Hospital Provincial, Castellón 12002, Spain
J. García del Muro
Medical Oncology Department, Instituto Catalán de Oncología, Barcelona 08907, Spain
J. Cruz
Medical Oncology Department, Hospital Universitario de Canarias, Tenerife 38320, Spain
J. Maurel
Medical Oncology Department, Hospital Clínic, Barcelona 08036, Spain
P. Escudero
Medical Oncology Department, Hospital Clínico, Zaragoza 50009, Spain
A. Casado
Medical Oncology Department, Hospital Clínico San Carlos, Madrid 28040, Spain
J. M. Buesa
Medical Oncology Department, Hospital Central de Asturias, Instituto Universitario de Oncología del Principado de Asturias (IUOPA), Oviedo 33006, Spain
the Spanish Group for Research on Sarcomas (GEIS)
Medical Oncology Department, Hospital Sant Pau, Barcelona 08025, Spain
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.
