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Abstract
Objective 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.
Methods 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.
Results 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).
Conclusions 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.
- Ovarian Cancer
- Cytoreduction surgical procedures
- Surgical Oncology
- Fallopian Tube Neoplasms
- Quality of Life (PRO)/Palliative Care
Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The datasets generated from this current study will be available upon request from Christina Uwins (Christina.Uwins@nhs.net) as raw anonymized data for up to 5 years following completion of the study. Participants have given their consent for the information collected from this study to be used to support other research in the future and to be shared anonymously with other researchers.
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- Ovarian Cancer
- Cytoreduction surgical procedures
- Surgical Oncology
- Fallopian Tube Neoplasms
- Quality of Life (PRO)/Palliative Care
Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The datasets generated from this current study will be available upon request from Christina Uwins (Christina.Uwins@nhs.net) as raw anonymized data for up to 5 years following completion of the study. Participants have given their consent for the information collected from this study to be used to support other research in the future and to be shared anonymously with other researchers.
Footnotes
Twitter @christinauwins, @ssskene, @AgnMichael
Contributors Conceptualization: CU and SB-M. Study design: CU, SB-M, SSS, and AM. Data collection: CU, HA, JR, JC, JCh, PE, and SB-M. Data interpretation: CU, KB, AT, JC, JCh, PE, SS, AM, and SB-M. Drafting and/or editing manuscript: CU, HA, KB, JR, AT, JC, JCh, PE, SSS, AM, and SB-M. All authors approve and agree to be accountable for all aspects of the work. CU and SB-M are the guarantors and accept full responsibility for the finished work and the conduct of the study.
Funding MIRRORS was funded following open competition by both GRACE Charity (Gynae-oncology Research and Clinical Excellence) Registered Charity No. 1189729 https://grace-charity.org.uk/ and NIHR Applied Research Collaborations (ARC) Kent Surrey & Sussex (KSS) Greenshoots award. MIRRORS was also adopted on to the National Institute for Health Research (NIHR) portfolio. The NIHR portfolio consists of clinical research studies that are eligible for support from the NIHR clinical research network in England. The funders have played no role in conducting the research or the writing of this paper.
Competing interests CU is Vice President of the The Young European Advocates of Robotic Surgery (YEARS) which is part of the Society of European Robotic Gynaecological Surgery (SERGS) HA: none, KB: none, JR: none, AT: none, JC: none. JC is a proctor for Intuitive Surgical Ltd, the manufacturers of Da VinciTM surgical robots. As such, he has received payment and travel expenses within the past three years for surgical proctoring on robotic gynecological surgery at other hospitals around the UK, as he is an acknowledged expert in this field. He also occasionally gives paid lectures on behalf of pharmaceutical companies. PE: none, SSS: none, AM: Consulting or Advisory Role (EISA Pharma, GlaxoSmithKline, Ipsen) Research Funding (Merck) Travel, Accommodations, Expenses (Merck). SB-M is a proctor for Intuitive Surgical Ltd, the manufacturers of Da VinciTM surgical robots. As such, he has received payment and travel expenses within the past three years for surgical proctoring on robotic gynaecological surgery at other hospitals around the UK and in the EU, as he is an acknowledged expert in this field. SB-M has recently been appointed Vice President (President Elect) of the British and Irish Association of Robotic Gynaecological Surgeons (BIARGS).
Provenance and peer review Not commissioned; externally peer reviewed.
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