The MITO-16/MANGO-OV2 Project: 8th Progress Report

Presentazione sul tema: "The MITO-16/MANGO-OV2 Project: 8th Progress Report"— Transcript della presentazione:

1 The MITO-16/MANGO-OV2 Project: 8th Progress Report
XXVIII^ Riunione Nazionale MITO Mesagne 19 Gennaio 2017 The MITO-16/MANGO-OV2 Project: th Progress Report

2 The MITO 16/MANGO OV2 project
PHASE IV prospective study of first-line bevacizumab plus chemotherapy in advanced ovarian cancer patients (IIIB-IV) with translational objectives and conducted only in Italy PHASE III randomised controlled trial on the efficacy of the addition of bevacizumab to second line chemotherapy following first-line treatment including bevacizumab in platinum-sensitive advanced ovarian cancer patients. To be conducted internationally (France, Greece and Switzerland).

3 MITO 16/MANGO OV2 (a) Phase IV trial
Figures End of the enrollment: March 2014 400 patients enrolled Number of events (to 15/06/2017): 282 (280 required) Patients without events: 117 Patients with last FU visit > 6 months: 237 (85 without an event) Patients with last FU visit > 12 months:59 without an event

4 MITO 16/MANGO OV2 (a) Phase IV trial
Timeline July-September 2017: database cleaning and first (descriptive) set of analyses. Samples testing asap Results to be disclosed by end 2017 Important: Translational Research project…

5 MITO 16/MANGO OV2 project: the Phase III trial
Ovarian Ca Platinum-sensitive Previous Bevacizumab ECOG 0-2 Availability of samples for translational res. No Beva contraindications R CBDCA AUC5 + PAC 175 mg/m2 q3w or CBDCA AUC4, d1 + GEM 1000mg /m2, d1&8 q3w CBDCA AUC5+PLD 30mg/m2 q4w Plus bevacizumab** 15mg/kg q3w Plus bevacizumab 15mg/kg q3w Plus bevacizumab 10mg/kg q2w ARM 1: 6 cycles ARM 2*: 6 cycles n=400 pts International (MITO, MANGO, ENGOT) *Patients without PD after 6 cycles of combined treatment will receive Bevacizumab maintenance until PD **Bevacizumab will be provided by Roche ltd

6 MITO 16/MANGO OV2 project: the Phase III trial
Primary objective: To test whether the addition of bevacizumab to second-line chemotherapy can prolong progression-free survival (PFS) of platinum sensitive ovarian cancer patients progressing or recurring after a first-line treatment including bevacizumab

7 MITO 16/MANGO OV2 (b) Phase III trial
Figures End of the enrollment: 11 november 2016 406 patients enrolled (405 effective) Number of events (to 15/06/2017): 182 (265 required) Patients without events: 223 See next slide….

8 Patients follow-up details - 1
Follow-up age Pts Alive Pts Event Free 2014 3 Jan-Jun 2015 5 Jul-Dec 2015 33 23 Jan-Jun 2016 58 42 Jul-Dec 2016 94 75 Jan-Mar 2017 61 29 not in FU since March Apr-Jun 2017 88 44 33 not in FU

9 Patients follow-up details – 2 Last eCRF: Registrazione (27)
Pt Id Centre Id Date 118 603 12/06/2015 119 147 10/08/2015 153 396 31/08/2015 155 47 09/09/2015 168 24/09/2015 222 353 14/01/2016 252 212 24/02/2016 258 04/03/2016 262 11/03/2016 275 11/04/2016 278 320 14/04/2016 280 15/04/2016 296 11/05/2016 310 03/06/2016 337 145 18/07/2016 339 21/07/2016 344 01/08/2016 357 30/08/2016 362 625 05/09/2016 368 560 19/09/2016 372 28/09/2016 385 13/10/2016 389 18/10/2016 395 24/10/2016 399 28/10/2016 403 03/11/2016 Codice Centro Istituzione Pazienti ferme a registrazione Pazienti arruolate 47 Fed II Napoli 3 5 145 Gemelli 2 30 147 S.Vincenzo (Taormina) 212 S.Maria delle Croci (Ravenna) 1 320 INT Milano 61 353 A.O.Policlinico Modena 368 IEO 4 27 396 Garibaldi Nesima (Catania) 6 560 Sondrio 603 A.O. Universitaria Pisa 7 625 Leon Bernard, Lyon

10 The Phase III trial: Enrollment vs Events
# events for final analysis:265

11 Enrollment by Group

12 Arruolamento per braccio di trattamento
Chemo BackBone: CBDCA+ ITALY Rest of Europe - Beva +Beva Paclitaxel 16 15 5 6 PLD 69 30 29 Gemcitabina 52 56 83

13 Stato dei Campioni (ITALY) n:63
Istituzione Pts arruolati Campioni attesi* Campioni raccolti Da Raccogliere U. O. di Ginecologia Oncologica Dip. di Gin. ed Ostetricia Policlinico Universitario Gemelli Università  Cattolica del Sacro Cuore, Roma 30 21 Istituto Nazionale Tumori Divisione Ginecologia Oncologica, Milano 61 32 17 15 Istituto Europeo di Oncologia UO Ginecologia, Milano 27 14 Ospedale Santa Chiara UO di Ostetricia e Ginecologia ad indirizzo Oncologico Universitaria, Pisa 7 4 Istituto Oncologico Veneto IRCCS UOC Oncologia Medica II, Padova 9 2 AOU Policlinico Universitario Federico II Oncologia Medica,Napoli 5 U.O.Oncologia Medica - A.O. Vito Fazzi, Lecce Oncologia Medica IRCCS San Martino IST, Genova 6 Oncologia Medica A.O.Garibaldi Nesima, Catania 1

14 Campioni-Resto d’Europa
Country # enrol prvd tprv % CH 17 F 100 61 39 39% Gr 11 100% Totale 128 89

15 GRAZIE!!