Department of Sarcoma, Peritoneal and Rare Tumours (SPRinT), Division of Surgery and Surgical Oncology, National Cancer Centre Singapore, Singapore, Singapore.
Department of Sarcoma, Peritoneal and Rare Tumours (SPRinT), Division of Surgery and Surgical Oncology, Singapore General Hospital, Singapore, Singapore.
PLoS One. 2024 Apr 4;19(4):e0300594. doi: 10.1371/journal.pone.0300594. eCollection 2024.
Peritoneal sarcomatosis (PS) is a difficult entity to treat with limited options and guarded prognosis. We aimed to determine if the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) could offer superior local recurrence-free survival in patients with retroperitoneal sarcoma at high risk of developing PS as opposed to extended resection alone.
This is a single arm, phase II intervention study where all patients with recurrent localized retroperitoneal sarcoma considered at high risk of developing PS were considered for enrolment (ClinicalTrials.gov identifier: NCT03792867). Upon enrolment, patients underwent vigorous preoperative testing to ensure fitness for the procedure. During surgery, patients underwent extended resection and HIPEC with doxorubicin. Patients were followed-up every 2 weeks (± 10 days) for the first month and subsequently every three months (± 1 month) up to a year post-surgery, and were assessed for potential chemotherapy toxicity and post-treatment complications. After a year from resection and HIPEC, patients were followed-up either during routine clinic review or contacted via telephone every year (± 1 month) for 3 years.
Six patients were recruited but one patient dropped out due to adverse and unexpected intraoperative events. The remaining patients completed the procedure uneventfully. Post-HIPEC, all patients recurred with a disease-free interval ranging from six to 24 months. Three patients died due to complications from recurrent disease whereas the remaining three patients are alive as of their last visit. The overall survival at time at reporting ranged between 22 to 56 months.
The procedure is feasible with no major morbidity to patients. However, we are unable to recommend for it to be implemented as a routine procedure at this current stage due to lack of improved survival outcomes. Further multi-institutional studies may be conducted to yield better results.
腹膜肉瘤病(PS)是一种难以治疗的实体瘤,治疗选择有限,预后不佳。我们旨在确定与单纯扩大切除术相比,腹腔内热灌注化疗(HIPEC)的加入是否能为腹膜后肉瘤高危发生 PS 的患者提供更好的局部无复发生存率。
这是一项单臂、二期干预研究,所有考虑局部复发性腹膜后肉瘤且有发生 PS 高危的患者均被纳入研究(临床试验注册号:NCT03792867)。入组后,患者接受了强化的术前检查,以确保手术的适宜性。在手术过程中,患者接受了扩大切除术和多柔比星 HIPEC。患者在术后第 1 个月每 2 周(±10 天)进行随访,随后每 3 个月(±1 个月)随访至术后 1 年,评估潜在的化疗毒性和治疗后并发症。切除和 HIPEC 后 1 年,患者通过常规门诊复查或每年(±1 个月)通过电话随访 3 年。
共招募了 6 名患者,但有 1 名患者因术中不良和意外事件而退出。其余患者均顺利完成了手术。HIPEC 后,所有患者均复发,无疾病间隔时间为 6 至 24 个月。3 名患者因复发疾病并发症死亡,其余 3 名患者截至最后一次就诊时仍存活。报告时的总生存率在 22 至 56 个月之间。
该手术对患者无明显的发病率,是可行的。然而,由于没有改善的生存结果,我们目前无法推荐将其作为常规手术实施。可能需要进行进一步的多机构研究以获得更好的结果。