Department of Oncology, Oslo University Hospital, Oslo, Norway.
Department of Pathology, Oslo University Hospital, Oslo, Norway.
Acta Oncol. 2022 Jul;61(7):793-800. doi: 10.1080/0284186X.2022.2082259. Epub 2022 Jun 13.
Data from the real-world setting on perioperative chemotherapy in high-risk, localized soft tissue sarcoma (STS) is limited. Real-world data (RWD) includes data derived from patients treated outside clinical trials and often captures long-term follow-up not recorded in clinical trials. The aim of this study was to provide population-based, real-world evidence on perioperative chemotherapy in localized STS.
Adult patients with localized STS in the extremities or trunk wall treated at Oslo University Hospital, Oslo, Norway from 1998 to 2017 were included in the study. Data were extracted from a prospectively maintained database, supplemented by retrospective review of medical records.
The total study cohort included 806 patients, of whom 154 (19%) received perioperative chemotherapy. A regimen with anthracycline and ifosfamide was given in 141 of 154 cases (92%). During long-term follow-up two patients developed secondary malignancies, cardiac toxicity was registered in 11 patients (7%) and renal toxicity in 12 patients (8%). Seventy-one of 154 patients (46%) were treated outside of clinical trials and constituted the RWD cohort. The median age at surgery was slightly lower and there were more synovial sarcomas and fewer myxofibrosarcomas in the RWD cohort. No difference in chemotherapy dose intensity was observed. The estimated 5-year metastasis-free survival (MFS) in all patients receiving perioperative chemotherapy was 58%. In the RWD cohort 5-year MFS was 53% and in the clinical study cohort 61% (HR 1.24; 95% CI 0.77-2.00).
Long-term outcome after perioperative chemotherapy was comparable for patients treated in routine clinical practice to those in clinical trials. Secondary malignancy and cardiac toxicity were observed. The risk of serious late side effects should be included in the decision process on perioperative chemotherapy.
关于高风险局限性软组织肉瘤（STS）围手术期化疗的真实世界数据有限。真实世界数据（RWD）包括从临床试验之外治疗的患者中获得的数据，并且通常可获取临床试验中未记录的长期随访信息。本研究旨在提供局限性 STS 围手术期化疗的基于人群的真实世界证据。
纳入 2017 年于挪威奥斯陆大学医院接受治疗的局限性 STS 成人患者，肿瘤位于四肢或躯干壁。从一个前瞻性维护的数据库中提取数据，并通过回顾病历进行补充。
该研究的总队列包括 806 例患者，其中 154 例（19%）接受了围手术期化疗。在 154 例病例中，有 141 例（92%）使用了含蒽环类药物和异环磷酰胺的方案。在长期随访期间，有 2 例患者发生继发性恶性肿瘤，11 例（7%）患者出现心脏毒性，12 例（8%）患者出现肾毒性。在 154 例患者中有 71 例（46%）接受了临床试验以外的治疗，构成了 RWD 队列。手术时的中位年龄略低，RWD 队列中滑膜肉瘤更多，黏液纤维肉瘤更少。未观察到化疗剂量强度的差异。接受围手术期化疗的所有患者的估计 5 年无转移生存率（MFS）为 58%。在 RWD 队列中，5 年 MFS 为 53%，在临床研究队列中为 61%（HR 1.24；95%CI 0.77-2.00）。
在常规临床实践中接受围手术期化疗的患者与临床试验中的患者的长期预后相当。观察到继发性恶性肿瘤和心脏毒性。在决定是否进行围手术期化疗时，应考虑严重晚期副作用的风险。
