Department of Gynecology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands.
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
Eur J Surg Oncol. 2021 Jan;47(1):101-107. doi: 10.1016/j.ejso.2019.05.006. Epub 2019 May 13.
The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improves recurrence-free (RFS) and overall survival (OS) in patients with FIGO stage III ovarian cancer. We evaluated the effect of HIPEC on patient's health-related quality of life (HRQoL) in the OVHIPEC trial.
OVHIPEC was a multicentre, open-label, randomized phase III trial for patients with stage III ovarian cancer. Patients were randomly assigned (1:1) to receive interval CRS with or without HIPEC with cisplatin. HRQoL was assessed using the EORTC QLQ-C30, and the ovarian (QLQ-OV28) and colorectal cancer (QLQ-CR38) modules. HRQoL questionnaires were administered at baseline, after surgery, after end of treatment, and every three months thereafter. HRQoL was a secondary endpoint, with the prespecified focus on the QLQ-C30 summary score and symptom scores on fatigue, neuropathy and gastro-intestinal symptoms. HRQoL was analysed using linear and non-linear mixed effect models.
In total, 245 patients were randomized. One-hundred-ninety-seven patients (80%) completed at least one questionnaire. No significant difference over time in the QLQ-C30 summary scores was observed between the study arms (p-values for linear and non-linear growth: p > 0.133). The pattern over time for fatigue, neuropathy and gastro-intestinal symptoms did not significantly differ between treatment arms.
The addition of HIPEC to interval CRS does not negatively impact HRQoL in patients with stage III ovarian cancer who are treated with interval CRS due to the extent of disease. These HRQoL results, together with the improvement in RFS and OS, support the viability of HIPEC as an important treatment option in this patient population. CLINICALTRIALS.
NCT00426257.
2006-003466-34.
在间隔细胞减灭术（CRS）的基础上加入腹腔热灌注化疗（HIPEC）可提高 FIGO 分期 III 期卵巢癌患者的无复发生存率（RFS）和总生存率（OS）。我们在 OVHIPEC 试验中评估了 HIPEC 对患者健康相关生活质量（HRQoL）的影响。
OVHIPEC 是一项多中心、开放标签、随机 III 期临床试验，纳入了 III 期卵巢癌患者。患者按 1:1 比例随机分配接受含顺铂的 HIPEC 联合或不联合 HIPEC 的间隔 CRS。使用 EORTC QLQ-C30 问卷和卵巢（QLQ-OV28）和结直肠癌（QLQ-CR38）模块评估 HRQoL。在基线、手术后、治疗结束时以及此后每三个月进行 HRQoL 问卷调查。HRQoL 是次要终点，预设重点是 QLQ-C30 总评分和疲劳、神经病变和胃肠道症状的症状评分。使用线性和非线性混合效应模型进行 HRQoL 分析。
共 245 例患者被随机分组。197 例（80%）患者至少完成了一份问卷。研究组之间 QLQ-C30 总评分的时间变化无显著差异（线性和非线性增长的 p 值：p 值>0.133）。治疗组之间的疲劳、神经病变和胃肠道症状的时间变化模式无显著差异。
对于因疾病程度而接受间隔 CRS 治疗的 III 期卵巢癌患者，在间隔 CRS 的基础上加用 HIPEC 不会对 HRQoL 产生负面影响。这些 HRQoL 结果，加上 RFS 和 OS 的改善，支持 HIPEC 作为该患者人群的重要治疗选择的可行性。临床试验。
NCT00426257。
EudraCT 编号：2006-003466-34。
