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  • br L M Randall et al Gynecologic Oncology xxx xxxx

    2019-11-05


    6 L.M. Randall et al. / Gynecologic Oncology xxx (xxxx) xxx
    thus, could be missed by standard staging techniques. Second, intraop-erative imaging could identify more disease during cytoreductive sur-gery and contribute to the strongly prognostic outcome of complete tumor resection. In a study by Eskander et al., women deemed to have completely resected disease were found to have measurable disease on CT scan performed one month postoperatively for clinical trial en-rollment [17]. This may be due to underestimation of residual disease volume, aggressive disease biology, or progression of occult surgical le-sions. Third, the proportion of women receiving neoadjuvant chemo-therapy (NACT) prior to surgery has significantly increased from 8.6% to 22.6% between the years of 2004 and 2013 (p b 0.001), and adoption of this Amiloride HCL treatment modality occurred primarily after 2007 (95%CI 2006–2009; p = 0.001) [11], following the publication of EORTC 55971 [3]. Despite improved rates of complete disease resection post-NACT, complete resection in the interval debulking setting has not translated into a similar magnitude of benefit as that observed with pri-mary debulking. Since NACT reduces tumor burden to a microscopic level in many cases, the risk of leaving behind disease not recognized by usual means of visual inspection and palpation is increased. More-over, pathologic complete response (pCR) following NACT is highly prognostic in the breast cancer population, but there is a need to better define this for multi-focal diseases like ovarian cancer. Therefore, image-guided surgery might be particularly beneficial in this increas-ingly common treatment group. Finally, the controversial benefit of sec-ondary cytoreductive surgery for women with ovarian cancer recurrence is the objective of two prospective clinical trials, GOG 213 (NCT00565851) and DESKTOP III (NCT01166737). Should the data be positive in this setting, removal of all existing disease will be important in order to achieve the maximum benefit of surgery.
    In conclusion, with the application of OTL38 and NIR imaging at the time of cytoreductive surgery, we propose a more accurate method to increase the rate of complete tumor resection and moving this hypoth-esis in a phase III clinical trial.
    Declaration of Competing Interest
    The institutions of LMR, RMW, SCD, and JLT all received funding to conduct the clinical trial. None of the investigators received funding out-side of this mechanism. PSL is the Founder and Chief Scientific Officer of OnTarget Laboratories. He was involved in the scientific concept and study design from the perspective of optimization of the drug reconsti-tution and timing of administration, but evolutionary tree did not participate in the clinical trial. He only reviewed the manuscript from a scientific perspec-tive, and did not author or edit any of the clinical findings.
    Acknowledgements
    The authors thank the patients, clinical investigators and site per-sonnel who participated in this study. The funding source was OnTarget Laboratories, the manufacturer of OTL38, who did not influence the con-tent or conclusions of the manuscript. Additional funding was received by Dr. Randall from the Queen of Hearts Foundation, United States of America for salary support to author the manuscript.
    Author contribution
    LMR, RMW, SCD, and JLT all enrolled and treated patients per study protocol and wrote and edited the manuscript. PSL advised the study on
    scientific aspects of OTL38 drug preparation. The manuscript was writ-ten and edited independent from the study sponsor.
    References
    [3] I. Vergote, C.G. Tropé, F. Amant, G.B. Kristensen, T. Ehlen, N. Johnson, R.H.M. Verheijen, M.E.L. van der Burg, A.J. Lacave, P.B. Panici, G.G. Kenter, A. Casado, C. Mendiola, C. Coens, L. Verleye, G.C.E. Stuart, S. Pecorelli, Reed NS for the European Organization for Research, Treatment of Cancer–Gynaecological Cancer Group, NCIC Clinical Trials Group — a Gynecologic Cancer Intergroup Collaboration, Neoad-juvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer, N. Engl. J. Med. 363 (2010) 943–953.