Résumé
Abstract
Aim: There is an important literature supporting the role of staging laparoscopy to predict the chances of optimal cytoreduction but its role to screen patient for inclusion in neoadjuvant therapy clinical trial is unknown. We report here the results of screening by laparoscopy for inclusion in a clinical trial testing the efficacy of bevacizumab in the neoadjuvant settting (Anthalya: A Randomized, Open-label, Phase II Study Assessing the Efficacy and the Safety of Bevacizumab in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Adenocarcinoma, Initially Unresectable. NCT01739218).
Methods: We are currently conducting a clinical trial to evaluate the efficacy of neoadjuvant bevacizumab and chemotherapy measured by the rate of complete resection, defined as the removal of all macroscopic residual tumour at interval debulking surgery (IDS). Secondary objectives are: safety, Objective Response Rate for the neoadjuvant period and after all courses of treatment and monitoring of CA 125. Before randomization, patients with suspicion of stage IIIC-IV ovarian cancer had a laparoscopy to have a histological assessment of the tumor, to document the FIGO stage and to evaluate resectability for inclusion. Standard pictures and scoring are performed during this laparoscopy and during IDS. We report here the results of screening by laparoscopy.
Results: This multicenter study is conducted in 14 centers. Over a 16 month period, 182 and 82 patients have been screened and randomized, respectively. The proportion of screening/inclusion in the paticipating centers ranged from 16% to 100% (mean: 46%). Reasons for non inclusion were resectable tumor (60%), non ovarian/tubal/peritoneal adenocarcinoma histology or contra-indication to carboplatin/taxol/bevacizumab (29%), patient refusal (1%). The screening success was not statistically related to the specialty of the PI in each center (medical oncologist vs surgical oncologist, p = 0.09) or to the volume of patients screened (p = 0.09).
Conclusions: In patients with suspicion of ovarian cancer (based on imaging, CA125 and clinical data), screening by laparoscopy resulted in eligibility of 46% of patients for inclusion in a neoadjuvant therapy clinical trial. Resectable tumors was the first reason for non inclusion in this neoadjuvant therapy trial.
Disclosure: R. Rouzier: membership on an advisory board; V. Menguy: Employee;
Y. Ghazi: Employee;. All other authors have declared no conflicts of interest.