BACKGROUND:To explore correlation between the quality of surgery and outcome in high-risk soft tissue sarcoma (STS) patients treated within a phase III randomized trial. PATIENTS AND METHODS:In the trial, all patients received three cycles of preoperative chemotherapy (CT) with epirubicin 120 mg/m(2) and ifosfamide 9 g/m(2) and were randomly assigned to receive two further postoperative cycles. Radiotherapy (RT) could be delivered in the preoperative or postoperative setting. The association between surgical margins and overall survival (OS) was studied in a univariate and multivariate fashion. RESULTS:Two hundred and fifty-two patients completed the whole treatment and were operated conservatively. At a median follow-up of 60 months (IQR, 45-74 months), the 5-year OS was 0.73, even in patients with positive and negative margins. The 5-year cumulative incidence (CI) of local recurrence (LR) in patients with positive and negative microscopic margins was 0.17 (standard error, SE, 0.08) and 0.03 (SE, 0.01), respectively. In the subgroup of patients receiving combined preoperative CT-RT and with positive surgical margins, the CI of LR was 0. CONCLUSIONS:In this setting of high-risk STS treated by preoperative CT or CT-RT, the negative impact of positive margins on the outcome was limited. When close margins can be anticipated preoperative CT-RT may be a reasonable option to maximize the chance of cure.

译文

背景:探讨III期随机试验中治疗的高危软组织肉瘤(STS)患者的手术质量与预后之间的相关性。
患者与方法:在该试验中,所有患者均接受了三个周期的术前化疗(CT),其中表柔比星120 mg / m(2)和异环磷酰胺9 g / m(2),并随机分配为接受另外两个术后周期。放疗(RT)可以在术前或术后进行。以单变量和多变量的方式研究了手术切缘和总生存期(OS)之间的关联。
结果:252例患者完成了全部治疗,并保守治疗。在中位随访60个月(IQR,45-74个月)时,即使在切缘阳性和阴性的患者中,其5年OS为0.73。镜切缘阳性和阴性的患者5年局部复发(LR)的5年累积发生率(CI)分别为0.17(标准误,SE,0.08)和0.03(SE,0.01)。在接受联合术前CT-RT且手术切缘阳性的患者亚组中,LR的CI为0。
结论:在这种术前CT或CT-RT治疗高危STS的情况下,正切缘对预后的负面影响是有限的。当可以预见边缘狭窄时,术前CT-RT可能是使治愈机会最大化的合理选择。

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