a Division of Obstetrics and Gynecology, Department of Women's and Children's Health , Karolinska Institutet , Stockholm , Sweden.
b Theme Cancer , Karolinska University Hospital , Stockholm , Sweden.
Acta Oncol. 2018 Dec;57(12):1671-1676. doi: 10.1080/0284186X.2018.1521987. Epub 2018 Oct 5.
The health-related quality of life (HRQoL) outcomes after comprehensive surgical staging including infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer (EC) are unknown. Our aim was to investigate the long-term HRQoL between robot-assisted laparoscopic surgery (RALS) and laparotomy (LT).
A total of 120 women with high-risk stage I-II EC were randomised to RALS or LT for hysterectomy, bilateral salpingoophorectomy, pelvic and infrarenal paraaortic lymphadenectomy in the previously reported Robot-Assisted Surgery for High-Risk Endometrial Cancer trial. The HRQoL was measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-30) and its supplementary questionnaire module for endometrial cancer (QLQ-EN24) questionnaire. Women were assessed before and 12 months after surgery. In addition, the EuroQol Eq5D non-disease specific questionnaire was used for descriptive analysis.
There was no difference in the functional scales (including global health status) in the intention to treat analysis, though LT conferred a small clinically important difference (CID) over RALS in 'cognitive functioning' albeit not statistically significant -6 (95% CI-14 to 0, p = .06). LT conferred a significantly better outcome for the 'nausea and vomiting' item though it did not reach a CID, 4 (95% CI 1 to 7, p = .01). In the EORTC-QLQ/QLQ-EN24, no significant differences were observed. Eq5D-3L questionnaire demonstrated a higher proportion of women reporting any extent of mobility impairment 12 months after surgery in the LT arm (p = .03).
Overall, laparotomy and robot-assisted surgery conferred similar HRQoL 12 months after comprehensive staging for high-risk EC.
在高危子宫内膜癌（EC）患者中进行包括肾下主动脉旁淋巴结清扫术在内的综合外科分期后，健康相关生活质量（HRQoL）的结果尚不清楚。我们的目的是调查机器人辅助腹腔镜手术（RALS）与剖腹手术（LT）之间的长期 HRQoL。
共有 120 名高危 I-II 期 EC 患者随机分为 RALS 或 LT 组，行子宫切除术、双侧输卵管卵巢切除术、盆腔和肾下主动脉旁淋巴结清扫术，此前报道的机器人辅助手术治疗高危子宫内膜癌试验中。使用欧洲癌症研究与治疗组织生活质量问卷核心 30 项（EORTC-QLQ-30）及其子宫内膜癌补充问卷模块（QLQ-EN24）来测量 HRQoL。在手术前和手术后 12 个月对女性进行评估。此外，还使用 EuroQol Eq5D 非疾病特定问卷进行描述性分析。
在意向治疗分析中，功能量表（包括总体健康状况）没有差异，但 LT 在“认知功能”方面较 RALS 具有较小的临床重要差异（CID），尽管无统计学意义-6（95%CI-14 至 0，p=0.06）。LT 在“恶心和呕吐”项目上的结果明显更好，但未达到 CID，4（95%CI 1 至 7，p=0.01）。在 EORTC-QLQ/QLQ-EN24 中，未观察到显著差异。Eq5D-3L 问卷显示，手术后 12 个月 LT 组报告任何程度活动能力受损的女性比例更高（p=0.03）。
总体而言，在高危 EC 患者的综合分期后，剖腹手术和机器人辅助手术在 12 个月后均具有相似的 HRQoL。
