Background: Dose intensive chemotherapy has not been tested prospectively for the treatment of gynecologic sarcomas. We investigated the antitumor activity and toxicity of high-dose ifosfamide and doxorubicin, in the context of a multidisciplinary strategy for the treatment of advanced and metastatic, not pretreated, gynecologic sarcomas. Patients and methods: Thirty-nine patients were enrolled onto a phase I-II multicenter trial of ifosfamide, 10 g/m(2) as a continuous infusion over 5 days, plus doxorubicin intravenously, 25 mg/m(2)/day for 3 days with Mesna and granulocyte-colony-stimulating factor every 21 days. Salvage therapy was allowed after chemotherapy. Results: Among the 37 evaluable patients, the tumor was locally advanced (n = 11), with concomitant distant metastases (n = 5) or with distant metastases only (n = 21). After a median of three (range 1-7) chemotherapy cycles, six patients experienced a complete response and 12 a partial response for an overall response rate of 49% (95% CI 32% to 66%). The response rate was higher in poorly differentiated tumors (62%) compared with moderately well differentiated ones (18%), but was not different according to histology subtypes. Eleven patients had salvage therapy, either immediately following chemotherapy (n = 7) or at time of progression (n = 4). With a median follow-up time of 5 years, the median overall survival was 30.5 months. Hematological toxicity was as expected neutropenia, thrombopenia and anemia >= grade 3 at 50%, 34% and 33% of cycles respectively. No toxic death occurred. Conclusions: High-dose ifosfamide plus doxorubicin is an active regimen for all subtypes of gynecological sarcomas. Its toxicity was manageable in a multicentric setting. The prolonged survival might be due to the multidisciplinary strategy that was possible in one-third of the patients.
Leyvraz, S., Zweifel, M., Jundt, G., Lissoni, A.A., Cerny, T., Sessa, C., et al. (2006). Long-term results of a multicenter SAKK trial on high-dose ifosfamide and doxorubicin in advanced or metastatic gynecologic sarcomas. ANNALS OF ONCOLOGY, 17(4), 646-651 [10.1093/annonc/mdl020].
Citazione: | Leyvraz, S., Zweifel, M., Jundt, G., Lissoni, A.A., Cerny, T., Sessa, C., et al. (2006). Long-term results of a multicenter SAKK trial on high-dose ifosfamide and doxorubicin in advanced or metastatic gynecologic sarcomas. ANNALS OF ONCOLOGY, 17(4), 646-651 [10.1093/annonc/mdl020]. | |
Tipo: | Articolo in rivista - Articolo scientifico | |
Carattere della pubblicazione: | Scientifica | |
Titolo: | Long-term results of a multicenter SAKK trial on high-dose ifosfamide and doxorubicin in advanced or metastatic gynecologic sarcomas | |
Autori: | Leyvraz, S; Zweifel, M; Jundt, G; Lissoni, AA; Cerny, T; Sessa, C; Fey, M; Dietrich, D; Honegger, HP | |
Autori: | ||
Data di pubblicazione: | apr-2006 | |
Lingua: | English | |
Rivista: | ANNALS OF ONCOLOGY | |
Digital Object Identifier (DOI): | http://dx.doi.org/10.1093/annonc/mdl020 | |
Appare nelle tipologie: | 01 - Articolo su rivista |