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软组织肉瘤患者放化疗与单纯放疗的配对队列研究。

A matched cohort study of radio-chemotherapy versus radiotherapy alone in soft tissue sarcoma patients.

机构信息

Department of Radiation Oncology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Largo Brambilla 3, 50141, Florence, Italy.

Department of Orthopaedic Oncology and Reconstructive Surgery, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.

出版信息

Radiol Med. 2019 Apr;124(4):301-308. doi: 10.1007/s11547-018-0939-7. Epub 2018 Sep 12.

DOI:10.1007/s11547-018-0939-7
PMID:30209796
Abstract

PURPOSE

Adjuvant radiotherapy is the standard postoperative treatment after conservative surgery in high risk soft tissue sarcoma. The role of adjuvant chemotherapy is still debated. Therefore, a matched cohort analysis was performed in high risk soft tissue patients to analyse differences in terms of clinical outcome and toxicity between patients treated with concomitant radio-chemotherapy (RTCT) and radiotherapy (RT) alone.

MATERIALS AND METHODS

For each patient in RT group was selected a patient in the RTCT group matching for age, T stage and grading. Acute and late toxicity were recorded, overall survival, recurrence free survival and distant metastases free survival were analysed and compared between the two groups.

RESULTS

Ninety patients were selected, half of patients underwent radio-chemotherapy and half received radiotherapy alone. During the treatment Grade 3 dermatitis was recorded in 15 (16.7%) patients, 6 (6.7%) patients associated chemotherapy and during follow up 12 (13.3%) patients developed grade 2 late fibrosis, 3 (3.3%) joint stiffness and 1 (1.1%) patient experienced a bone fracture. There were no differences in the rate of acute and late toxicity between RTCT and RT alone group. Nineteen (21.1%) patients developed local recurrence, overall 5-year local relapse free survival was 83%. There were no differences between the two groups. 29 patients developed distant metastases, 14 (15.6%) patients in the RTCT group and 15 (16.7%) patients in the RT group. The 5-year distant metastases free survival was 67%. Age > 65 years was the only independent factor affecting distant recurrence (HR = 5.7, 95% CI 2.7-11.9; p = 0.001). At the time of analysis 15 (16.7%) patients were dead, 6 (6.7%) patients in the RTCT group and 9 (10%) patients in the RT group. 5-years overall survival was: 88%. At multivariate analysis age > 65 years was an independent prognostic factor of overall survival (HR = 3.7, 95% CI 1.2-12.1, p = 0.037).

CONCLUSIONS

Prospective randomized studies with large size population and with subgroup analysis for histological subtypes are necessary to clarify the role of adjuvant chemotherapy in soft tissue sarcoma patients. Tailored treatment has to be considered in elderly soft tissue patients to guarantee a better outcome in this high risk and fragile population.

摘要

目的

在高危软组织肉瘤患者中,辅助放疗是保肢手术后的标准治疗方法。辅助化疗的作用仍存在争议。因此,对高危软组织肉瘤患者进行了一项匹配队列分析,以分析接受同期放化疗(RTCT)和单纯放疗(RT)治疗的患者在临床结局和毒性方面的差异。

材料和方法

为 RT 组中的每位患者选择了一位在年龄、T 分期和分级方面相匹配的 RTCT 组患者。记录急性和迟发性毒性,分析并比较两组患者的总生存、无复发生存和无远处转移生存。

结果

共选择了 90 例患者,其中一半患者接受了放化疗,另一半患者仅接受了放疗。在治疗过程中,15 例(16.7%)患者出现 3 级皮炎,其中 6 例(6.7%)患者接受了化疗,在随访期间,12 例(13.3%)患者出现 2 级迟发性纤维化,3 例(3.3%)出现关节僵硬,1 例(1.1%)出现骨折。RTCT 组和 RT 组之间的急性和迟发性毒性发生率无差异。19 例(21.1%)患者发生局部复发,5 年局部无复发生存率为 83%。两组间无差异。29 例患者发生远处转移,其中 RTCT 组 14 例(15.6%),RT 组 15 例(16.7%)。5 年无远处转移生存率为 67%。年龄>65 岁是影响远处复发的唯一独立因素(HR=5.7,95%CI 2.7-11.9;p=0.001)。分析时,15 例(16.7%)患者死亡,其中 RTCT 组 6 例(6.7%),RT 组 9 例(10%)。5 年总生存率为 88%。多因素分析显示,年龄>65 岁是总生存的独立预后因素(HR=3.7,95%CI 1.2-12.1,p=0.037)。

结论

有必要进行前瞻性随机研究,以确定辅助化疗在软组织肉瘤患者中的作用,研究人群需足够大,并进行组织学亚型的亚组分析。对于老年软组织患者,必须考虑个体化治疗,以保证这一高危和脆弱人群获得更好的结局。

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