title: 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).
abstract: Background. To explore the tolerance and the activity of high-dose ifosfamide (IFOS) combined with doxorubicin (DXR) at 50 mg/m(2) every 4 weeks in patients with soft tissue sarcomas. Methods. DXR was given IV bolus and IFOS by continuous infusion at 2 g/m(2)/day. Initial IFOS dose (12 g/m(2)) was adjusted to 10, 13, or 14 g/m(2) 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/m(2). 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/m(2) plus IFOS 10-12 g/m(2), with substantial toxicity.
authors.affiliation: Medical Oncology Department, Hospital Sant Pau, 08025 Barcelona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: López-Pousa
authors.forename: J
authors.initials: J
authors.lastname: Martín
authors.forename: J
authors.initials: J
authors.lastname: Montalar
authors.forename: R
authors.initials: R
authors.lastname: de Las Peñas
authors.forename: J
authors.initials: J
authors.lastname: García Del Muro
authors.forename: J
authors.initials: J
authors.lastname: Cruz
authors.forename: J
authors.initials: J
authors.lastname: Maurel
authors.forename: P
authors.initials: P
authors.lastname: Escudero
authors.forename: A
authors.initials: A
authors.lastname: Casado
authors.forename: J M
authors.initials: JM
authors.lastname: Buesa