Doxorubicin (DXR) and prolonged infusion gemcitabine (GMC) as first-line treatment in advanced soft tissue sarcomas (STS). A phase II trial of the Spanish Group for Research in Sarcomas (GEIS)

9033 Background: Results from a previous phase I trial (ASCO 2003, abst.3317) demonstrated MTD for GMC 800 mg/m2 by 10 mg/m2/min perfusion associated to DXR 60 mg/m2 Methods: April'02 to December'03 36 patients were included in a phase II trial of first-line treatment in advanced STS with DX at 60 mg/m2 (d 1), followed by GMC 800 mgr/m2 administered in 80 minutes (d 1,8) every 3 weeks. Results: 36 patients ECOG 0–2, metastatic/unresectable STS entered the trial. Results from 23 patients: male/ female 13/10; ECOG 0 = 5 pts, 1 = 15 pts, 2 = 3 pts. Median age 56 (23–76)y. Histology: Lipos. 6, MFH 4, Leiomio 2, other 11. Primary tumor: extremities 8, retroperitoneal 7, uterine 2, truncal 2, other 4. A median of 6 (1–9) and a total of 93 cycles (cy) were administered. Toxicity by patient (23): neutropenia grade(G)IV 7 (30%), GIII 9 (39%); anemia GIII 4 (17%), GII 7 (30%); thrombocytopenia GIV 2 (8%), GIII 3 (13%), GII 4 (17%) pts. Neutropenic fever in 5 (21%) pts. Grade III/IV mucositis in 14 (60%) pts. Toxici...