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Abstract：
BACKGROUND: To report the final results of a prospective, one-armed, single-center phase I/II trial (NCT01566123).
METHODS: Between 2007 and 2017, 37 patients with primary or recurrent (N = 6) retroperitoneal sarcomas were enrolled. Treatment included preoperative IMRT of 45-50 Gy with a simultaneous integrated boost of 50-56 Gy, surgery and IORT. The primary endpoint was local control (LC) at 5 years. The most common histology was dedifferentiated liposarcoma (51%), followed by leiomyosarcoma (24%) and well-differentiated liposarcoma (14%). The majority of lesions were high-grade (FNCLCC G1: 30%, G2: 38%, G3: 27%, two missing). Five patients were excluded from LC analysis per protocol.
RESULTS: The minimum follow-up of the survivors was 62 months (median: 109; maximum 162). IORT was performed for 27 patients. Thirty-five patients underwent gross total resection; the pathological resection margin was mostly R+ (80%) and, less often, R0 (20%). We observed 10 local recurrences. The 5-year LC of the whole cohort was 59.6%. Eleven patients received a dose > 50 Gy plus IORT boost; LC was 64.8%; the difference, however, was not significant (p = 0.588). Of 37 patients, 15 were alive and 22 deceased at the time of final analysis. The 5-year OS was 59.5% (68.8% per protocol).
CONCLUSIONS: The primary endpoint of a 5-year LC of 70% was not met. This might be explained by the inclusion of recurrent disease and the high rate of G3 lesions and leiomyosarcoma, which have been shown to profit less from radiotherapy. Stratification by grading and histology should be considered for future studies.
METHODS: Between 2007 and 2017, 37 patients with primary or recurrent (N = 6) retroperitoneal sarcomas were enrolled. Treatment included preoperative IMRT of 45-50 Gy with a simultaneous integrated boost of 50-56 Gy, surgery and IORT. The primary endpoint was local control (LC) at 5 years. The most common histology was dedifferentiated liposarcoma (51%), followed by leiomyosarcoma (24%) and well-differentiated liposarcoma (14%). The majority of lesions were high-grade (FNCLCC G1: 30%, G2: 38%, G3: 27%, two missing). Five patients were excluded from LC analysis per protocol.
RESULTS: The minimum follow-up of the survivors was 62 months (median: 109; maximum 162). IORT was performed for 27 patients. Thirty-five patients underwent gross total resection; the pathological resection margin was mostly R+ (80%) and, less often, R0 (20%). We observed 10 local recurrences. The 5-year LC of the whole cohort was 59.6%. Eleven patients received a dose > 50 Gy plus IORT boost; LC was 64.8%; the difference, however, was not significant (p = 0.588). Of 37 patients, 15 were alive and 22 deceased at the time of final analysis. The 5-year OS was 59.5% (68.8% per protocol).
CONCLUSIONS: The primary endpoint of a 5-year LC of 70% was not met. This might be explained by the inclusion of recurrent disease and the high rate of G3 lesions and leiomyosarcoma, which have been shown to profit less from radiotherapy. Stratification by grading and histology should be considered for future studies.
摘要：
背景：为了报告前瞻性的最终结果，单臂,单中心I/II期试验（NCT01566123）。
方法：在2007年至2017年之间，纳入了37例原发性或复发性（N=6）腹膜后肉瘤患者。治疗包括术前IMRT为45-50Gy，同时整合增强50-56Gy，手术和IORT。主要终点是5年的局部控制（LC）。最常见的组织学是去分化脂肪肉瘤（51%），其次是平滑肌肉瘤（24％）和高分化脂肪肉瘤（14％）。大多数病变是高级别（FNCLCCG1：30％，G2:38%,G3:27%,两个失踪）。根据方案从LC分析中排除5名患者。
结果：幸存者的最小随访时间为62个月（中位数：109；最大值162）。对27例患者进行了IORT。35例患者行大体全切除；病理切除边缘大多为R+(80%)，很少，R0（20%）。我们观察到10次局部复发。整个队列的5年LC为59.6%。11例患者接受剂量>50Gy加IORT加强；LC为64.8%；差异，然而,不显著(p=0.588)。37名患者中,在最终分析时，15人还活着，22人死亡。5年OS为59.5%（每个方案为68.8%）。
结论：未达到5年LC70%的主要终点。这可以解释为包括复发性疾病和G3病变和平滑肌肉瘤的高发率，已被证明从放射治疗中获利较少。未来的研究应考虑通过分级和组织学进行分层。
方法：在2007年至2017年之间，纳入了37例原发性或复发性（N=6）腹膜后肉瘤患者。治疗包括术前IMRT为45-50Gy，同时整合增强50-56Gy，手术和IORT。主要终点是5年的局部控制（LC）。最常见的组织学是去分化脂肪肉瘤（51%），其次是平滑肌肉瘤（24％）和高分化脂肪肉瘤（14％）。大多数病变是高级别（FNCLCCG1：30％，G2:38%,G3:27%,两个失踪）。根据方案从LC分析中排除5名患者。
结果：幸存者的最小随访时间为62个月（中位数：109；最大值162）。对27例患者进行了IORT。35例患者行大体全切除；病理切除边缘大多为R+(80%)，很少，R0（20%）。我们观察到10次局部复发。整个队列的5年LC为59.6%。11例患者接受剂量>50Gy加IORT加强；LC为64.8%；差异，然而,不显著(p=0.588)。37名患者中,在最终分析时，15人还活着，22人死亡。5年OS为59.5%（每个方案为68.8%）。
结论：未达到5年LC70%的主要终点。这可以解释为包括复发性疾病和G3病变和平滑肌肉瘤的高发率，已被证明从放射治疗中获利较少。未来的研究应考虑通过分级和组织学进行分层。
