Feasibility and Activity of Concurrent Neoadjuvant Chemotherapy and Radiotherapy in Patients with High-risk Soft-Tissue Sarcoma.

The trial also included a cohort of patients not randomized but just registered and treated with EI.

该试验还包括了一组未随机分配但仅注册并接受EI治疗的患者。

In this study, we analyzed the tolerability and activity of concurrent EI and radiotherapy (RT) in the ISG-STS 1001 trial.

在本研究中，我们分析了ISG-STS 1001试验中同时接受EI和放射治疗（RT）的耐受性和活性。

patients_and_methods

EI consisted of epirubicin 120 mg/m2 plus ifosfamide 9 g/m2 per cycle.

EI包括每周期表柔比星120 mg/m2加上异环磷酰胺9 g/m2。

RT was delivered at a dose of 44 to 50 Gy preoperatively or 60 to 66 Gy postoperatively.

放射治疗（RT）的剂量为术前44至50 Gy或术后60至66 Gy。

ChT dose intensity (DI), grade ≥3 hematologic toxicities, acute RT-related toxicities, postoperative local complications, and radiologic response by RECIST were compared between the group of patients receiving concurrent preoperative ChT and RT (ChT/RT group) and the group receiving preoperative ChT alone (ChT group).

比较了接受同时术前化疗和放疗（ChT/RT组）与仅接受术前化疗（ChT组）的患者群体在化疗剂量强度（DI）、≥3级血液毒性、急性放疗相关毒性、术后局部并发症以及根据RECIST标准的影像学反应。

Results

Among the 548 patients enrolled in the ISG-STS 1001 trial, 287 were included in the current analysis (146 received preoperative RT).

在ISG-STS 1001试验中，共有548名患者入组，其中287名患者纳入了当前的分析（146名接受了术前放疗）。

The median ChT DI was >90% in both groups.

两组患者的中位化疗剂量强度（DI）均>90%。

Hematologic toxicities were comparable between the 2 groups.

两组之间的血液毒性相当。

With regard to postoperative complications, a higher number of wound dehiscence (9% vs. 3.5%, respectively; P = 0.06) and seroma (10.4% vs. 2.8%, respectively; P = 0.01) were observed in the ChT/RT group compared with the ChT group.

关于术后并发症，与化疗组相比，化疗/放疗组观察到更多的伤口裂开（分别为9%对3.5%，P=0.06）和血清肿（分别为10.4%对2.8%，P=0.01）。

A statistically significant association between RECIST response and preoperative RT was found (20.3% and 9.8% in the ChT/RT and ChT groups, respectively; P = 0.02).

发现RECIST反应与术前放疗之间存在统计学上显著的关联（化疗/放疗组和化疗组分别为20.3%和9.8%；P=0.02）。

Conclusions

Concurrent EI and RT is feasible and safe, resulting in an increased proportion of dimensional responses.

同时进行EI和RT是可行且安全的，导致尺寸反应比例增加。