Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Department of Radiation Oncology, Centro di Riferimento Oncologico, Aviano, Italy.
Eur J Cancer. 2014 Mar;50(4):784-92. doi: 10.1016/j.ejca.2013.11.021. Epub 2013 Dec 5.
To study feasibility, safety and activity of the combination of high-dose long-infusion ifosfamide (HLI) and radiotherapy (RT) as preoperative treatment for resectable localised retroperitoneal sarcoma (RPS).
Patients received three cycles of HLI (14 g/m2). RT was started in combination with second 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-year relapse free survival (RFS). The trial is registered with ITASARC_∗II_2004_003.
Between December 2003 and 2010, 83 patients were recruited. Main histological subtypes were well differentiated liposarcoma (19/83, 23%), dedifferentiated liposarcoma (26/83, 31%), leiomyosarcoma (14/83, 17%). Median tumour size was 120 mm (interquartile (IQ) range=82-160). The overall preoperative treatment was completed in 60 patients. Chemotherapy (CT) was completed in 65, while RT in 73. Four patients progressed before surgery and were not operated. 79 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); 30 patients died of disease. 3 and 5-year RFS and overall survival were 0.56 (90% confidence interval (CI): 0.45, 0.65) and 0.44 (90% CI: 0.27, 0.48), and 0.74 (90% CI: 0.62, 0.81) and 0.59 (90% CI: 0.33, 0.58). Crude cumulative incidence of LR and DM at 5 years were 0.37 (standard error (SE): 0.06) and 0.26 (SE: 0.06).
The combination of preoperative HLI and RT was feasible in two thirds of patients, while preoperative RT could be completed in most (73/83). 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.
This is a pure academic trial. No funding sources contributed to it.
研究高剂量长时间输注异环磷酰胺（HLI）联合放疗（RT）作为可切除局部腹膜后肉瘤（RPS）术前治疗的可行性、安全性和活性。
患者接受三个周期的 HLI（14g/m2）。第二周期开始联合 RT，总剂量达 50.4Gy。RT 结束后 4-6 周进行手术。主要终点为 3 年无复发生存率（RFS）。该试验在 ITASARC_∗II_2004_003 注册。
2003 年 12 月至 2010 年，共招募 83 例患者。主要组织学亚型为高分化脂肪肉瘤（19/83，23%）、去分化脂肪肉瘤（26/83，31%）、平滑肌肉瘤（14/83，17%）。肿瘤大小中位数为 120mm（四分位距（IQR）=82-160）。60 例患者完成了总体术前治疗。65 例完成化疗（CT），73 例完成 RT。4 例患者在手术前进展，未行手术。79 例患者接受了手术。中位随访时间为 4.8 年（IQR=3-6.1），23 例和 15 例患者发生局部复发（LR）和远处转移（DM）；30 例患者死于疾病。3 年和 5 年的 RFS 和总生存率分别为 0.56（90%可信区间（CI）：0.45，0.65）和 0.44（90%CI：0.27，0.48），0.74（90%CI：0.62，0.81）和 0.59（90%CI：0.33，0.58）。5 年时 LR 和 DM 的累积发生率分别为 0.37（标准误差（SE）：0.06）和 0.26（SE：0.06）。
三分之二的患者可进行术前 HLI 和 RT 联合治疗，而大多数（73/83）患者可完成术前 RT。尽管当认为合适时，可以向 RT 中添加全身覆盖，但正在进行的国际 III 期试验正在探索单独 RT 的作用。
这是一项纯学术试验。没有资金来源为其提供支持。
