原发性腹膜后肉瘤患者的术前放疗：EORTC-62092 试验（STRASS）与非试验（STREXIT）结果。
Preoperative Radiotherapy in Patients With Primary Retroperitoneal Sarcoma: EORTC-62092 Trial (STRASS) Versus Off-trial (STREXIT) Results.
机构信息
Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Department of Surgery, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
出版信息
Ann Surg. 2023 Jul 1;278(1):127-134. doi: 10.1097/SLA.0000000000005492. Epub 2022 Jul 14.
OBJECTIVE
The aim of the present study was to compare the effect of radiotherapy (RT) on abdominal recurrence-free survival (ARFS) in patients with primary retroperitoneal sarcoma treated in the EORTC-STBSG-62092 (STRASS) phase 3 randomized controlled trial (STRASS cohort) and off-trial (STREXIT cohort) and to pool STRASS and STREXIT data to test the hypothesis that RT improves ARFS in patients with liposarcoma.
BACKGROUND
The STRASS trial did not show any difference in ARFS between patients treated with preoperative radiotherapy+surgery (RT+S) versus surgery alone (S).
METHODS
All consecutive adult patients not enrolled in STRASS and underwent curative-intent surgery for a primary retroperitoneal sarcoma with or without preoperative RT between 2012 and 2017 (STRASS recruiting period) among ten STRASS-recruiting centres formed the STREXIT cohort. The effect of RT in STREXIT was explored with a propensity score (PS)-matching analysis. Primary endpoint was ARFS defined as macroscopically incomplete resection or abdominal recurrence or death of any cause, whichever occurred first.
RESULTS
STRASS included 266 patients, STREXIT included 831 patients (727 after excluding patients who received preoperative chemotherapy, 202 after 1:1 PS-matching). The effect of RT on ARFS in STRASS and 1:1 PS-matched STREXIT cohorts, overall and in patients with liposarcoma, was similar. In the pooled cohort analysis, RT administration was associated with better ARFS in patients with liposarcoma [N=321, hazard ratio (HR), 0.61; 95% confidence interval (CI), 0.42-0.89]. In particular, patients with well-differentiated liposarcoma and G1-2 dedifferentiated liposarcoma (G1-2 DDLPS, n=266) treated with RT+S had better ARFS (HR, 0.63; 95% CI, 0.40-0.97) while patients with G3 DDLPS and leiomyosarcoma had not. At the current follow-up, there was no association between RT and overall survival or distant metastases-free survival.
CONCLUSIONS
In this study, preoperative RT was associated with better ARFS in patients with primary well-differentiated liposarcoma and G1-2 DDLPS.
目的
本研究旨在比较放射治疗（RT）对 EORTC-STBSG-62092（STRASS）三期随机对照试验（STRASS 队列）和非试验（STREXIT 队列）中接受原发性腹膜后肉瘤治疗的患者的腹部无复发生存（ARFS）的影响，并将 STRASS 和 STREXIT 数据汇总，以检验 RT 改善脂肪肉瘤患者 ARFS 的假设。
背景
STRASS 试验表明，接受术前放疗+手术（RT+S）与单纯手术（S）治疗的患者在 ARFS 方面无差异。
方法
2012 年至 2017 年期间，10 个 STRASS 招募中心中有 727 名患者在 STRASS 招募期间接受了术前化疗，202 名患者接受了 1:1 倾向评分（PS）匹配，对这些患者进行了前瞻性收集，对未纳入 STRASS 的连续成年患者进行了根治性手术治疗。使用 PS 匹配分析探讨 RT 在 STREXIT 中的作用。主要终点为 ARFS，定义为肉眼不完全切除或腹部复发或任何原因死亡，以先发生者为准。
结果
STRASS 纳入 266 例患者，STREXIT 纳入 831 例患者（202 例经 1:1 PS 匹配）。在 STRASS 和 1:1 PS 匹配的 STREXIT 队列中，RT 对 ARFS 的影响相似，整体及脂肪肉瘤患者均如此。在汇总队列分析中，RT 治疗与脂肪肉瘤患者更好的 ARFS 相关[N=321，风险比（HR），0.61；95%置信区间（CI），0.42-0.89]。特别是，接受 RT+S 治疗的分化良好的脂肪肉瘤和 G1-2 去分化脂肪肉瘤（G1-2 DDLPS，n=266）患者 ARFS 更好（HR，0.63；95%CI，0.40-0.97），而 G3 DDLPS 和 leiomyosarcoma 患者则不然。在目前的随访中，RT 与总生存或远处无转移生存无关。
结论
本研究表明，术前 RT 与原发性分化良好的脂肪肉瘤和 G1-2 DDLPS 患者的更好的 ARFS 相关。
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