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Abstract
Objective The aim of this study was to explore the feasibility and safety of the laparoscopic approach after neoadjuvant chemotherapy among selected chemosensitive patients with advanced ovarian cancer.
Methods The CILOVE study was a phase II prospective non-randomized multicenter study. It aimed to enroll 47 women with unresectable disease at the time of initial diagnosis (International Federation of Gynecology and Obstetrics (FIGO) stage IV and/or diffuse extensive carcinomatosis for advanced FIGO stage IIIC or patients unfit to withstand radical primary surgery), in response to chemotherapy and fit to undergo laparoscopy.
Results Among the 48 patients enrolled in the trial, 44 (92%) patients underwent exploratory staging laparoscopy and, as a result, 41 patients were eligible for cytoreductive surgery. Among them, 32 were intended to be managed by laparoscopy and nine patients were managed by laparotomy. The conversion rate to laparotomy was 9.4% (3/32) and the reasons were multiple surgical adhesions (n=1), miliary carcinomatosis and adhesion to the intraperitoneal mesh (n=1), and poor laparoscopic evaluation of transverse colon involvement (n=1). All except one patient had optimal cytoreduction (97% complete cytoreduction, 3% incomplete cytoreduction (residual tumor <2.5 mm)). The median operative time was 267 min (range 146–415) and the median estimated blood loss was 150 mL (range 0–500). Two patients had intra-operative complications: one diaphragm rupture that was repaired during laparoscopy and one bradycardia. Six patients experienced early post-operative complications (<1 month), but there were no grade 3 and 4 complications (3 infections, 1 lymphoedema, 2 hemorrhage). After cytoreductive laparoscopy, the percentage of patients without progression at 12 months was 87.5%.
Conclusions Interval ovarian cytoreduction by a laparoscopic approach is safe and feasible for patients with a favorable response to chemotherapy. With the widespread use of neoadjuvant chemotherapy in the management of advanced ovarian cancer, a minimally invasive approach may be a potential option.
- Laparotomy
- Gynecologic Surgical Procedures
- Ovarian Cancer
- Laparoscopes
- Operative Time
Data availability statement
Data are available upon reasonable request. Data will be provided for the reproducibility of this study in other centers if such is requested.
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Data availability statement
Data are available upon reasonable request. Data will be provided for the reproducibility of this study in other centers if such is requested.
Footnotes
Contributors CP, ET and MC contributed to the study concept and design. CP, CA, EL, RR, GF, FL, JC, VF, NP, MB, MC contributed to the recruitment of patients. All authors contributed to the acquisition of data. CP, ET and MB carried out the analysis and interpretation. All authors contributed significantly to writing the manuscript, the critical review of the manuscript, and the final approval of the manuscript. CP is responsible for the overall content as guarantor.
Funding This work was supported by (1) the Ligue contre le Cancer (the departmental committees of Puy-de Dôme and Haute Loire, France), (2) the PARCC-ARA (Plateforme Rhône-Alpes d'aide à la Recherche Clinique en Cancérologie), and (3) KARL STORZ Company.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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