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Media type:
E-Article
Title:
Preoperative chemoradiation therapy for localized retroperitoneal sarcoma (RPS): Final results of a phase II study from the Italian Sarcoma Group
Contributor:
Gronchi, Alessandro;
De Paoli, Antonino;
Dani, Carla;
Merlo, Domenico Franco;
Quagliuolo, Vittorio;
Grignani, Giovanni;
Bertola, Giulio;
Navarria, Piera;
Sangalli, Claudia;
Dei Tos, Angelo Paolo;
Fiore, Marco;
Casali, Paolo Giovanni
imprint:
American Society of Clinical Oncology (ASCO), 2013
Description:
<jats:p> 10519 </jats:p><jats:p> Background: To study the feasibility, safety and activity of the combination of high dose long-infusion Ifosfamide (HLI) and radiation therapy (RT) as preoperative treatment for resectable localized RPS. Methods: Patients received 3 cycles of HLI (14 g/m<jats:sup>2</jats:sup>). RT was started in combination with the onset of the 2<jats:sup>nd</jats:sup> <jats:sup> </jats:sup>cycle and administered up to a total dose of 50.4 Gy. Surgery was scheduled 4-6 weeks after the end of RT. Primary end-point was 3-yr relapse free survival (RFS). The expected 3-yr RFS in the study population treated with surgery alone was 40%. The experimental treatment was aimed at achieving a relative reduction in relapses of at least 1/3, corresponding to a 3-yrs RFS of 55%. With 60 enrolled patients, the study would have had a 90% power to discriminate between the hypotheses of 3-yrs RFS of 40% (H0) and 55% (H1), using a 1-sided 10% level of significance. Results: Between December 2003 and 2010, 86 patients were recruited. 3 patients were ineligible after central pathological review. 63 were affected by primary tumor and 20 by local recurrence. The 3 main histological subtypes were well differentiated liposarcoma (19/83, 23%), dedifferentiated liposarcoma (26/83, 31%) and leiomyosarcoma (14/83, 17%). Median tumor size was 120 mm (IQ range= 82-160). The overall preoperative treatment was completed in 60 patients. CT was completed in 65 patients, while RT in 73. Five patients had progression before surgery (3 distant and 2 local) and were not operated. 78 patients underwent surgery. At a median follow-up of 4.8 years (IQ range=3-6.1), 23 and 15 patients developed local recurrence (LR) and distant metastases (DM) respectively; 30 patients died of disease. 3-yr and 5-yr RFS and overall survival were 56% and 44%, and 74% and 59%, respectively. Crude cumulative incidence of LR and DM at 5 yrs were 37% and 26%, respectively. Conclusions: The combination of preoperative HLI and RT was feasible in two thirds of patients, while pre-operative RT could be completed in most (73/83). The primary endpoint of the study was met. Although a systemic coverage can be added to RT when this is felt to be appropriate, the ongoing international Phase III trial is exploring the role of RT alone. Clinical trial information: ITASARC_*II_2004_003. </jats:p>