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Laparoscopic management of advanced epithelial ovarian cancer after neoadjuvant chemotherapy: a phase II prospective multicenter non-randomized trial (the CILOVE study)
  1. Christophe Pomel1,2,
  2. Cherrif Akladios3,
  3. Eric Lambaudie4,
  4. Roman Rouzier5,
  5. Gwennael Ferron6,
  6. Fabrice Lecuru7,
  7. Jean-Marc Classe8,
  8. Virginie Fourchotte5,
  9. Nicolas Paillocher9,
  10. Arnaud Wattiez3,
  11. Pierre-Francois Montoriol10,
  12. Emilie Thivat2,11,
  13. Marie Beguinot1 and
  14. Michel Canis12
  1. 1Department of Surgical Oncology, Centre Jean Perrin, Clermont-Ferrand, France
  2. 2INSERM U1240 IMOST, Clermont-Ferrand, France
  3. 3Department of Surgical Oncology, Hôpital de Hautepierre, Strasbourg, France
  4. 4Department of Surgical Oncology, Institut Paoli-Calmettes, Marseille, France
  5. 5Department of Surgical Oncology, Institut Curie, Paris, France
  6. 6Department of Surgical Oncology, Institut Claudius Regaud, Toulouse, France
  7. 7Hôpital Georges-Pompidou, Paris, France
  8. 8Department of Surgical Oncology, Institut de Cancérologie de l'Ouest Site René Gauducheau, Saint Herblain, France
  9. 9Department of Surgical Oncology, Institut de Cancérologie de l'Ouest Site Paul Papin, Angers, France
  10. 10Department of Radiology, Centre Jean Perrin, Clermont-Ferrand, France
  11. 11Division de Recherche Clinique, Centre Jean Perrin, Clermont-Ferrand, France
  12. 12Department of Obstetrics and Gynaecology, CHU Estaing, Clermont-Ferrand, France
  1. Correspondence to Professor Christophe Pomel, Surgical Oncology, Centre Jean Perrin, Clermont-Ferrand, 63011 Auvergne-Rhône-Alpes, France; Christophe.POMEL{at}clermont.unicancer.fr

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.

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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.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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