Academic Department of Gynaecological Oncology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK
School of Biosciences and Medicine, University of Surrey, Guildford, UK.
Int J Gynecol Cancer. 2024 Jun 3;34(6):886-897. doi: 10.1136/ijgc-2024-005265.
To establish the feasibility and safety of robotic interval debulking surgery following the MIRRORS protocol (robot-assisted laparoscopic assessment prior to robotic or open surgery) in women with advanced-stage ovarian cancer. MIRRORS is the first of three planned trials: MIRRORS, MIRRORS-RCT (pilot), and MIRRORS-RCT.
The participants were patients with stage IIIc-IVb epithelial ovarian cancer undergoing neo-adjuvant chemotherapy, suitable for interval debulking surgery with a pelvic mass ≤8 cm. The intervention was robot-assisted laparoscopic assessment prior to robotic or open interval debulking surgery (MIRRORS protocol). The primary outcome was feasibility of recruitment, and the secondary outcomes were quality of life (EORTC QLQC30/OV28, HADS questionnaires), pain, surgical complications, complete cytoreduction rate (%), conversion to open surgery (%), and overall and progression-free survival at 1 year.
Overall, 95.8% (23/24) of patients who were eligible were recruited. Median age was 68 years (range 53-83). All patients had high grade serous histology and were BRCA negative. In total, 56.5% were stage IV, 43.5% were stage III, 87.0% had a partial response, while 13.0% had stable disease by RECIST 1.1. Median peritoneal cancer index was 24 (range 6-38). Following MIRRORS protocol, 87.0% (20/23) underwent robotic interval debulking surgery, and 13.0% (3/23) had open surgery. All patients achieved R<1 (robotic R0=47.4%, open R0=0%). No patients had conversion to open. Median estimated blood loss was 50 mL for robotic (range 20-500 mL), 2026 mL for open (range 2000-2800 mL) (p=0.001). Median intensive care length of stay was 0 days for robotic (range 0-8) and 3 days (range 3-13) for MIRRORS Open (p=0.012). The median length of stay was 1.5 days for robotic (range 1-17), 6 days for open (range 5-41) (p=0.012). The time to chemotherapy was as follows 18.5 days for robotic (range 13-28), 25 days for open (range 22-28) (p=0.139).
Robotic interval debulking surgery appears safe and feasible for experienced robotic surgeons in patients with a pelvic mass ≤8 cm. A randomized controlled trial (MIRRORS-RCT) will determine whether MIRRORS protocol has non-inferior survival (overall and progression-free) compared with open interval debulking surgery.
在接受新辅助化疗的 IIIc-IVb 期上皮性卵巢癌患者中，评估 MIRRORS 方案（机器人辅助腹腔镜评估前行机器人或开放手术）行间隔肿瘤减灭术的可行性和安全性。MIRRORS 是三个计划试验中的第一个：MIRRORS、MIRRORS-RCT（先导）和 MIRRORS-RCT。
参与者为接受新辅助化疗的 IIIc-IVb 期上皮性卵巢癌患者，适合行间隔肿瘤减灭术，盆腔肿块≤8cm。干预措施为机器人辅助腹腔镜评估前行机器人或开放间隔肿瘤减灭术（MIRRORS 方案）。主要结局是招募的可行性，次要结局是生活质量（EORTC QLQ30/OV28、HADS 问卷）、疼痛、手术并发症、完全肿瘤细胞减灭率（%）、中转开腹率（%）以及 1 年的总生存率和无进展生存率。
共有 95.8%（23/24）符合条件的患者入组。中位年龄为 68 岁（范围 53-83 岁）。所有患者均为高级别浆液性组织学且均为 BRCA 阴性。56.5%的患者为 IV 期，43.5%为 III 期，87.0%患者按 RECIST 1.1 标准有部分缓解，13.0%患者疾病稳定。腹膜癌指数中位数为 24（范围 6-38）。根据 MIRRORS 方案，87.0%（20/23）患者行机器人间隔肿瘤减灭术，13.0%（3/23）患者行开腹手术。所有患者均达到 R<1（机器人 RO=47.4%，开腹 RO=0%）。无患者中转开腹。机器人组中位估计出血量为 50ml（范围 20-500ml），开腹组为 2026ml（范围 2000-2800ml）（p=0.001）。机器人组中位 ICU 住院时间为 0 天（范围 0-8 天），开腹组为 3 天（范围 3-13 天）（p=0.012）。机器人组中位住院时间为 1.5 天（范围 1-17 天），开腹组为 6 天（范围 5-41 天）（p=0.012）。化疗时间如下：机器人组为 18.5 天（范围 13-28 天），开腹组为 25 天（范围 22-28 天）（p=0.139）。
对于经验丰富的机器人外科医生，机器人间隔肿瘤减灭术在盆腔肿块≤8cm 的患者中似乎是安全可行的。一项随机对照试验（MIRRORS-RCT）将确定 MIRRORS 方案与开腹间隔肿瘤减灭术相比是否具有非劣效的总生存率和无进展生存率。
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