病理学完全缓解(pCR)可能与软组织肉瘤(STS)患者的预后相关。我们寻求确定pCR对接受新辅助化疗放射治疗(CT-RT)(放射肿瘤学组[ RTOG] 9514)或仅接受术前图像引导放射治疗(RT，RTOG 0630)的STS患者生存结果的预后意义，并提供RTOG 0630的长期更新信息。RTOG已完成两个针对局部化STS患者的多中心非随机2期临床试验。本次研究共有来自RTOG 0630(n = 79)和RTOG 9514(n = 64)的143名符合条件的患者纳入了pCR的附属分析，同时还评估了RTOG 0630的79名患者的长期结果。试验9514中的患者接受CT与RT交替，而试验0630中的患者仅接受术前RT。采用Kaplan-Meier法估计总体和无病生存(OS和DFS)率。使用多变量Cox模型分层分析，并在可能的情况下进行分层；否则，通过分层log-rank检验计算P值。分析时间为2016年12月14日至2017年4月13日。总体而言，有42名(53.2％)男性; 68人(86.1％)是白人; 平均年龄(标准差)为59.6(14.5)岁。在RTOG 0630的中位随访6.0年时，有1个新的领域内复发和1个新的远处失败自最初报道以来。从两项研究中，有123名患者可供评估pCR：51名患者中的14名(27.5％)在试验9514中，72名患者中的14名(19.4％)在试验0630中达到了pCR。五年生存率对于pCR患者为100％，而对于试验9514和0630中没有达到pCR的患者分别为76.5％(95％CI，62.3-90.8％)和56.4％(95％CI，43.3-69.5％)。总体而言，pCR与较少pCR相比，与改善的OS(P= .01)和DFS(HR，4.91;95％CI，1.51-15.93;P= .008)有关。达到pCR的患者，5年局部失败率为0％，而在9514和0630中未达到pCR的患者分别为11.7％(95％CI，3.6-25.1％)和9.1％(95％CI，3.3-18.5％)。除平滑肌肉瘤、脂肪肉瘤和黏液纤维肉瘤外，组织学类型与较差的OS有关(HR，2.24;95％CI，1.12-4.45)。这个对两个非随机的临床试验进行的附加分析发现，pCR与STS患者的生存率有关，并且应视为未来研究的临床结果的预后因素。ClinicalTrials.gov标识符：RTOG 0630(NCT00589121)；RTOG 9514(NCT00002791)。

Pathologic complete response (pCR) may be associated with prognosis in patients with soft tissue sarcoma (STS).We sought to determine the prognostic significance of pCR on survival outcomes in STS for patients receiving neoadjuvant chemoradiotherapy (CT-RT) (Radiation Therapy Oncology Group [RTOG] 9514) or preoperative image-guided radiotherapy alone (RT, RTOG 0630) and provide a long-term update of RTOG 0630.RTOG has completed 2 multi-institutional, nonrandomized phase 2 clinical trials for patients with localized STS. One hundred forty-three eligible patients from RTOG 0630 (n = 79) and RTOG 9514 (n = 64) were included in this ancillary analysis of pCR and 79 patients from RTOG 0630 were evaluated for long-term outcomes.Patients in trial 9514 received CT interdigitated with RT, whereas those in trial 0630 received preoperative RT alone.Overall and disease-free survival (OS and DFS) rates were estimated by the Kaplan-Meier method. Hazard ratios (HRs) and P values were estimated by multivariable Cox model stratified by study, where possible; otherwise, P values were calculated by stratified log-rank test. Analysis took place between December 14, 2016, to April 13, 2017.Overall there were 42 (53.2%) men; 68 (86.1%) were white; with a mean (SD) age of 59.6 (14.5) years. For RTOG 0630, at median follow-up of 6.0 years, there was 1 new in-field recurrence and 1 new distant failure since the initial report. From both studies, 123 patients were evaluable for pCR: 14 of 51 (27.5%) in trial 9514 and 14 of 72 (19.4%) in trial 0630 had pCR. Five-year OS was 100% for patients with pCR vs 76.5% (95% CI, 62.3%-90.8%) and 56.4% (95% CI, 43.3%-69.5%) for patients with less than pCR in trials 9514 and 0630, respectively. Overall, pCR was associated with improved OS (P = .01) and DFS (HR, 4.91; 95% CI, 1.51-15.93; P = .008) relative to less than pCR. Five-year local failure rate was 0% in patients with pCR vs 11.7% (95% CI, 3.6%-25.1%) and 9.1% (95% CI, 3.3%-18.5%) for patients with less than pCR in 9514 and 0630, respectively. Histologic types other than leiomyosarcoma, liposarcoma, and myxofibrosarcoma were associated with worse OS (HR, 2.24; 95% CI, 1.12-4.45).This ancillary analysis of 2 nonrandomized clinical trials found that pCR was associated with improved survival in patients with STS and should be considered as a prognostic factor of clinical outcomes for future studies.ClinicalTrials.gov Identifiers: RTOG 0630 (NCT00589121); RTOG 9514 (NCT00002791).