XXIV MITO Meeting Pisa, 4 DEC 2014

Presentazione sul tema: "XXIV MITO Meeting Pisa, 4 DEC 2014"— Transcript della presentazione:

1 XXIV MITO Meeting Pisa, 4 DEC 2014 The MITO-16/MANGO-OV2 Project: th Progress Report (last update NOV 2014)

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
Design Ovarian Ca Stage IIIB-IV (FIGO) ECOG 0-2 Availability of samples for translational res. No Beva contraindications No previous treatments Bevacizumab* 15mg/kg Paclitaxel 175mg/m2 Carboplatin AUC 5 q3wks If not PD Bevacizumab* 15 mg/Kg q 3wks 6 cycles 22 cycles *Bevacizumab will be provided by Roche ltd

4 MITO 16/MANGO OV2 (a) Phase IV trial
Key inclusion criteria: FIGO stage IIIB & C or IV No previous treatment for advanced stage disease. ECOG Performance Status of 0–2. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements. Availability of tumour samples for molecular analyses (mandatory) No contraindications to bevacizumab Adequate organ function No surgery ≤ 28 days

5 MITO 16/MANGO OV2 project: the Phase IV trial Analysis Interval Debulking Surgery
Investigators are prompt to collect information about the performing of IDS and about the inceidence of adverse events in the period around the IDS.

6 MITO 16/MANGO OV2 project: the Phase IV trial Analysis Interval Debulking Surgery
The results presented hereafter are preliminary and will change based on your updating of information and answering to queries...

7 MITO 16/MANGO OV2 project: the Phase IV trial Analysis Interval Debulking Surgery
Pazienti per cui abbiamo il dato IDS 358 IDS fatta 79 Durata mediana dell’intervento in ore 3 Range interquartile 1-4.3 Durata mediana degenza in giorni 7 6-9 Ciclo a cui la IDS è stata effettuata 3-4 Intervallo tra l’ultimo ciclo di BEVA e l’IDS in giorni 37 36-44

8 MITO 16/MANGO OV2 project: the Phase IV trial Analysis Interval Debulking Surgery
Profilassi con anticoagulanti/trombotici 16 Profilassi con antibiotici 13 Complicanze: 3 Emorragia Trombosi Venosa Tromboembolia Trasfusioni RBC 2 Febbre Ascessi pelvici 1 Infezione cicatrice Deiscenza ferita Fistola

9 MITO 16/MANGO OV2 project: the Phase IV trial
The data collection 41 pts have no information about this CRF.... 10 pts have the last info in at “Registration”

10 MITO 16/MANGO OV2 project: the Phase IV trial
The data collection Cod Stato Center CRF Visit Valore 80 610 Registration 12/06/2013 129 06/08/2013 235 608 30/10/2013 275 04/12/2013 304 23/12/2013 385 27/02/2014 384 383 388 3 355 28/02/2014 386

11 MITO 16/MANGO OV2 project: the Phase IV trial
The data collection 41 pts have no information about this CRF.... 10 pts have the last info in at “Registration” Most of the patients don’t have a “regular” data input. (134/373 have the last data in by 01/09/2014)

12 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

13 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

14 the Phase III trial: Fact & Figures
Approvazione da parte del Comitato Etico del Centro coordinatore - Istituto Tumori di Napoli 19/12/2012 Stipula polizza assicurativa (Gerling) Febbraio 2013 Centri che hanno dato adesione 94 Centri con parere CEI favorevole 86 Centri autorizzati all’arruolamento delle pazienti 69

15 The Phase III trial: Enrollment

16 Arruolamento per centro e braccio di trattamento - ITALIA
Chemo Chemo Beva 109 A.O.S. Maria della Misericordia, Udine (UD) 1 222 Istituto Romagnolo per lo Studio e la Cura dei Tumori, Meldola (FC) 320 Istituto Nazionale Tumori, Milano (MI) 3 4 Dipartimento Uro-Ginecologico - Istituto Nazionale Tumori, Napoli 43 U.L.S.S. 13, Mirano (VE) 47 Università  Federico II, Napoli 172 Ospedale S. Giovanni Calibita Fatebenefratelli, Roma 368 Istituto Europeo di Oncologia, Milano (Milano) 2 587 Oncologia Medica IRCCS San Martino IST, Genova (GE)

17 Arruolamento per centro e braccio di trattamento -Europa
Chemo Chemo+Beva 499 Clinique de la Sauvegarde, LYON (nn) 1 43 U.L.S.S. 13, Mirano (VE) 294 IOSI , Bellinzona- Switzerland 459 Centre Hospitalier Intercommunal de Creteil, CRETEIL (nn) 587 Oncologia Medica IRCCS San Martino IST, Genova (GE) 624 Centre Francois Baclesse, CAEN (nn) 2 3 627 Hopital Tenon, PARIS (nn) 632 Institut de Cancerologie Gustave Roussy, VILLEJUIF (nn) 635 Institut Bergoni, Beordeaux (nn) 639 Hopital Rene Huguenin, Institut Curie, SAINT-CLOUD (nn) 648 Recherche Clinique - Oncologie, PARIS 653 Kantonsspital Luzern Medizinische Onkologie, Luzern 656 Kantonsspital Frauenfeld Frauenklinik, Frauenfeld

18 Platelet count decreased
SAEs Patient ID Description Outcome 2 Allergic reaction Resolved 3 Platelet count decreased 5 Intestinal volvulus Not Resolved Anal Fistula 18 Epistaxis 19 Bowel occlusion 22 Haematuria Death Fatal 27 Febrile neutropenia 31 Nausea, vomiting 34 39 Bowel obstruction Unknown

19 GRAZIE!!