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AGO-OVAR OP.2 (AGO DESKTOP OVAR II) Validation of a score of predictive factors for complete resection in platinum-sensitive recurrent ovarian cancer A project of the AGO Kommission OVAR and AGO Study Group Ovarian Cancer (AGO-OVAR) An open-label prospective multicenter-trial Objectives of the DESKTOP-series Phase I: - Identification of surgical aim - Creation of a predictive score for resectability Phase II: - Validation of this score Phase III: - Prospective randomized trial © P. Harter 2006 DESKTOP- OVAR I: Results • what is the surgical endpoint ? 1 0,9 survival probability 0,8 no residuals median OS 45.2 mos. 0,7 0,6 0,5 0,4 0,3 0 vs. 1-10 mm: 0,2 HR: 4.17 (CI 2,42 - 7,16); p < 0.001 0,1 0 vs. 10+ mm: HR: 3.31 (CI 1,86 - 5,88); p < 0.001 residuals > 10 mm median OS 19.7 mos. residuals 1 - 10 mm median OS 19.6 mos. 0 0 DESKTOP 12 24 36 48 months Harter P, du Bois A, Hahmann M et al. Ann Surg Oncol (in press) © P. Harter 2006 DESKTOP- OVAR I • who benefits ? multivariate analysis (survival) Variable OR (95% CI) p-value Residual after surgery (0 vs. > 0 mm) 2.94 (1.68-5.17) < 0.001 Ascites (cut-off 500 ml) 2.30 (1.31-4.04) 0.004 Pt-based chx after surgery (yes vs. no) 1.84 (1.13-3.01) 0.015 Not an independent prognostic factor for survival after surgery for recurrence are: • Localization of recurrence (pelvic vs. others) • PS (ECOG 0 vs. > 0) • Residuals after 1st surgery ( 0 vs. > 0 mm) • TFI (< 6 vs. > 6-12 vs. > 12 months), but small no. of pts with TFI < 6 months • FIGO-stage at primary diagnosis (I/II vs. III/IV) © P. Harter 2006 DESKTOP-OVAR I • Predictors of successful surgery ( = complete resection) multivariate analysis pre-OP variable OR (95%CI) p-value PS (ECOG 0 vs. > 0) 2.65 (1.56-4.52) < 0.001 Residual disease 1st. Surgery ( 0 vs. > 0) 2.46 (1.45-4.20) < 0.001 or: initial FIGO-stage (I/II vs. III/IV) 1.87 (1.04-3.37) 0.036 Ascites (cut-off 500 ml)* 5.08 (1.97-13.16) < 0.001 * exclusively CA 125 (Correlation with ascites) Not significant for complete resection in multivariate model (multivariate Model with all significant pre-OP variables) • Localization of Recurrent disease (Pelvic vs. others) • Treatment-free-interval © P. Harter 2006 AGO-DESKTOP II: Prospective Validation of a Predictive Score for Resectability in Platinum-Sensitive ROC (PFS > 6 mos) • PS ECOG = 0 • no residuals after primary surgery (or, if unknown: initially FIGO I/II) • absence of ascites > 500 ml Surgery is planned ? Yes (basic collective 2) No (basic collective 1) predictive score positive (all items) ? Yes (CRR 79%) = study collective Laparotomy calculated numbers No (CRR 43%) (1st endpoint): 122 pts. with positive score and a complete resection rate (CRR) of at least only descriptive analysis of further therapy 75% will show with 95% probability that a positive score can predict CR in >2 of 3 pts. Platinum-based combination chemotherapy * CRR: Results from DESKTOP-OVAR I © P. Harter 2006 DESKTOP II Primary objective: With which frequency can macroscopically complete tumour resections be achieved in platinum-sensitive recurrent ovarian-, fallopian tube- or peritoneal cancer when applying the AGO-score? (frequency = positive predictive factor; PPF) Secondary objectives: 1. Description of the collective which underwent surgery despite absence of at least one of the three items (AGO-score negative), and analysis according to the score. Sub-score for patients who only meet parts of the items of the score – negative predictive factor (NPF) for this selected collective. 3. Feasibility and complications in surgery in relapsed ovarian cancer in a multicentre setting (descriptive analysis) © P. Harter 2006 DESKTOP II Study collectives 1. Basic collective 1: All pts. with relapsed platinum-sensitive ovarian-, fallopian tube- or peritoneal cancer who present to participating centres will be included in the documentation. For this basic collective, baseline documentation of patient- and disease characteristics will be carried out. 2. Basic collective 2 consists of patients from basic collective 1 who will have surgery for recurrence. For these patients, an additional documentation of surgery will be carried out. 3. Primary study collective: patients from basic collective 2 with positive AGO-score © P. Harter 2006 Recruitment AGO-OVAR OP.2/ DESKTOP II (10.05.2007) 100 80 60 40 20 0 10 MAY 2007 sugery (score positive) score negative screening only Ad oggi:… Numero di centri MITO partecipanti 11 Numero di centri che hanno ottenuto l’approvazione da parte del C.E. 5 (UCSC-CB, UCSC-RM, Ospedale Fatebenefratelli-RM, INT-Napoli, Ospedale Fatebenefratelli-BN) Centri che hanno arruolato 2 (UCSC-CB 4 pts, UCSC-RM 5 pts)