Napoli,25 giugno 2015 XXV MITO MEETING: CONSIGLIO DIRETTIVO.

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1 Napoli,25 giugno 2015 XXV MITO MEETING: CONSIGLIO DIRETTIVO

2 Consiglio Direttivo MITO 25 Giugno Napoli Consiglio Direttivo MITO 25 Giugno Napoli Presenti Pignata Scambia Scibilia Fagotti Greggi Raspagliesi Ferrandina Mangili Invitati Breda, Lorusso, Scollo, Marchetti, Salutari

3 156 centri MITO (Ginecologie ed Oncologie, 2nuovi) 10 centri MITO (gruppo traslazionale) 467 soci (6 nuovi) Centri e soci Centri e soci

4 Nuovi soci MITO-group Nuovi soci MITO-group Sara Giovannoni–Oncologia Medica Università ”La Sapienza ” – Roma Antonio Gorio- U.O. Ostetricia e ginecologia Fondazione Poliambulanza- Brescia Giovanni Stellato- U.O. C. Ginecologia oncologica INT-Fondazione ” G. Pascale ” – Napoli Angela Maria Trujillo-U.O.C. Oncologia medica Uro-ginecologica INT-Fondazione ”G.Pascale ” – Napoli Margherita Tambaro-U.O.C. Oncologia medica Uro-ginecologica INT-Fondazione ”G.Pascale ” – Napoli Francesca Falcone-U.O. Ostetricia e ginecologia -Seconda Università degli Studi di Napoli

5 MITO Pub Second-line dovitinib (TKI258) in patients with FGFR2-mutated or FGFR2-non- mutated advanced or metastatic endometrial cancer: a non-randomised, open- label, two-group, two-stage, phase 2 study. Konecny GE, Finkler N, Garcia AA, Lorusso D, Lee PS, Rocconi RP, Fong PC, Squires M, Mishra K, Upalawanna A, Wang Y, Kristeleit R. Lancet Oncol. 2015 Jun;16(6):686-94. Pazopanib plus weekly paclitaxel versus weekly paclitaxel alone for platinum- resistant or platinum-refractory advanced ovarian cancer (MITO 11): a randomised, open-label, phase 2 trial. Pignata S, Lorusso D, Scambia G, Sambataro D, Tamberi S, Cinieri S, Mosconi AM, Orditura M, Brandes AA, Arcangeli V, Panici PB, Pisano C, Cecere SC, Di Napoli M, Raspagliesi F, Maltese G, Salutari V, Ricci C, Daniele G, Piccirillo MC, Di Maio M, Gallo C, Perrone F; MITO 11 investigators. Lancet Oncol. 2015 May;16(5):561-8. Is the endometrial evaluation routinely required in patients with adult granulosa cell tumors of the ovary? Ottolina J, Ferrandina G, Gadducci A, Scollo P, Lorusso D, Giorda G, Breda E, Savarese A, Candiani M, Zullo F, Mangili G. Gynecol Oncol. 2015 Feb;136(2):230-4.

6 MITO Pub Gynecologic Cancer InterGroup (GCIG) consensus review for mucinous ovarian carcinoma.. Ledermann JA, Luvero D, Shafer A, O'Connor D, Mangili G, Friedlander M, Pfisterer J, Mirza MR, Kim JW, Alexandre J, Oza A, Brown J. Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3):S14-9 Gynecologic Cancer InterGroup (GCIG) consensus review for high-grade undifferentiated sarcomas of the uterus. Pautier P, Nam EJ, Provencher DM, Hamilton AL, Mangili G, Siddiqui NA, Westermann AM, Reed NS, Harter P, Ray Coquard I.Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3):S73-7. Gynecologic Cancer InterGroup (GCIG) consensus review for clear cell carcinoma of the uterine corpus and cervix. Hasegawa K, Nagao S, Yasuda M, Millan D, Viswanathan AN, Glasspool RM, Devouassoux- Shisheboran M, Covens A, Lorusso D, Kurzeder C, Kim JW, Gladieff L, Bryce J, Friedlander M, Fujiwara K. Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3):S90-5.

7 MITO Pub Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in very platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial. Mahner S, Meier W, du Bois A, Brown C, Lorusso D, Dell'Anna T, Cretin J, Havsteen H, Bessette P, Zeimet AG, Vergote I, Vasey P, Pujade-Lauraine E, Gladieff L, Ferrero A. Eur J Cancer. 2015 Feb;51(3):352-8. Gynecologic Cancer InterGroup (GCIG) consensus review for carcinoid tumors of the ovary. Reed NS, Gomez-Garcia E, Gallardo-Rincon D, Barrette B, Baumann K, Friedlander M, Kichenadasse G, Kim JW, Lorusso D, Mirza MR, Ray-Coquard I. Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3):S35-41. Trophoblastic disease review for diagnosis and management: a joint report from the International Society for the Study of Trophoblastic Disease, European Organisation for the Treatment of Trophoblastic Disease, and the Gynecologic Cancer InterGroup. Mangili G, Lorusso D, Brown J, Pfisterer J, Massuger L, Vaughan M, Ngan HY, Golfier F, Sekharan PK, Charry RC, Poveda A, Kim JW, Xiang Y, Berkowtiz R, Seckl MJ. Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3):S109-16.

8 MITO Pub  Trophoblastic disease review for diagnosis and management: a joint report from the International Society for the Study of Trophoblastic Disease, European Organisation for the Treatment of Trophoblastic Disease, and the Gynecologic Cancer InterGroup. Mangili G, Lorusso D, Brown J, Pfisterer J, Massuger L, Vaughan M, Ngan HY, Golfier F, Sekharan PK, Charry RC, Poveda A, Kim JW, Xiang Y, Berkowtiz R, Seckl MJ. Int J Gynecol Cancer. 2014 Nov;24  Gynecologic Cancer InterGroup (GCIG) consensus review for ovarian and primary peritoneal low-grade serous carcinomas. Gourley C, Farley J, Provencher DM, Pignata S, Mileshkin L, Harter P, Maenpaa J, Kim JW, Pujaide-Lauraine E, Glasspool RM, Ray-Coquard I, Gershenson D. Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3): S9-13. Gynecologic Cancer InterGroup (GCIG) consensus review for ovarian and primary peritoneal low-grade serous carcinomas.  Management of bilateral malignant ovarian germ cell tumors: a MITO-9 retrospective study. Sigismondi C, Scollo P, Ferrandina G, Candiani M, Angioli R, Viganò R, Scarfone G, Mangili G. Int J Gynecol Cancer. 2015 Feb;25(2):203-7.  Gynecologic Cancer Intergroup (GCIG) consensus review for ovarian germ cell tumors. Brown J, Friedlander M, Backes FJ, Harter P, O'Connor DM, de la Motte Rouge T, Lorusso D, Maenpaa J, Kim JW, Tenney ME, Seckl MJ. Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3):S48-54.

9 MITO all’ ASCO MITO end2 2015 MITO 11 2014 MITO 7 2013 MITO 2 2010 MITO 3 2007 MITO 1 2006

10 Studi in corso e in via di attivazione… Studi in corso e in via di attivazione… PROFIT /ENGOT SOLO2(Napoli) MILO(Napoli) NOVA(Milano) TRINOVA 2 (Roma) TRINOVA 3 (Roma) Paola1 (Napoli) BGOG Farletuzumab(Napoli) Endometrial high risk (Napoli) GCIG DESKTOP III (Napoli) ANZGOG Sintomi (Napoli) ONGOING MITO 8 ENGOT OV1 (INT Napoli) TUMORI RARI MITO 9 (Bari, ISR Milano) MITO 14-borderline (FBF Roma) MITO 15 YONDELIS (Gemelli-Roma) MITO 16a- MANGO OV 2 (INT Napoli) MITO 16b- MANGO OV 2 INT Napoli) MITO 17(INT Napoli) MITO 18 Horse (Roma Gemelli) MITO 19- Meta encefaliche (Sapienza-Roma) MITO 20 Piccole cellule (Gemelli-Roma) MITO 21 - BRCA 1 and BRCA 2 mutation carriers (Mirano) MITO 22 –Sierosi di basso grado (Napoli) MITO Cerv 2 (Napoli) TOTEM-Endometrio (Mango) MITO BEVAEND 2- Bevacizumab endometrio (Roma) EXPRESSION OVAR 4 (INT Milano)

11

12 ICON9

13 AGO-OVAR 2.X A project of the AGO Study Group & Astra Zeneca

14 -Chemotherapy free treatment options -prognostic and predictive value of HRD vs Histo-Typ vs BRCA -prognostic and predictive value of calendar vs biology -platinum-free interval vs chemotherapy free interval Study population: recurrent ovarian cancer having received 1 or 2 prior therapies with at least 1 therapy containing platinum and progression free intervals being 3 months or longer after last chemo course (pts with non-platinum lines are excluded) Strata (tbd): -Center -1 vs 2 prior therapies -BRCA status -complete resection at prior surgery for this relapse -PFS 3-6 vs > 6 months

15 Primary Endpoint: PFS 1 Secondary Endpoints: PFS 2, PFS1+PFS2, OS, RR, Safety Preplanned subgroups: - histo typ by central lab network - HRD / BRCA somatic mutation / BRCA germline mutation - chemotherapy-free intervall 3-6 vs 6-12 vs 12+ months - platinum-interval extended by non-platinum or not - tumor volume non (post-OP) vs any

16 Pt-Kombi -> Olaparib Randomisation A (Standard) Pt-Kombi +/- Bev (depending on prior Bev exposure) PD – PFS 1 PD – PFS 2 B. Olaparib + Ced Design of AGO/ENGOT study Patient population - recurrent OC with1 or 2 prior platinum based lines B. Olaparib + Ced N ~ 800-1000

17 BGOG Farletuzumab Study

18 Objectives Primary: Farletuzumab has superior efficacy compared to placebo in improving progression-free survival (PFS) as determined by RECIST 1.1 when added to 1 of 2 standard chemotherapy regimens (carboplatin plus paclitaxel or carboplatin plus PLD) in subjects with platinum-sensitive ovarian cancer in first relapse who have a CA125 ≤ 3x the upper limit of normal (ULN) at study entry. Farletuzumab has superior efficacy compared to placebo in improving progression-free survival (PFS) as determined by RECIST 1.1 when added to 1 of 2 standard chemotherapy regimens (carboplatin plus paclitaxel or carboplatin plus PLD) in subjects with platinum-sensitive ovarian cancer in first relapse who have a CA125 ≤ 3x the upper limit of normal (ULN) at study entry.Secondary: Overall survival (OS) in this population Overall survival (OS) in this population To assess the effect of Farletuzumab in prolonging second platinum-free interval longer than first platinum-free interval To assess the effect of Farletuzumab in prolonging second platinum-free interval longer than first platinum-free interval To assess the effect of farletuzumab on best objective response (OR) rate, time to response (TTR) and duration of response (DR) by RECIST 1.1 criteria To assess the effect of farletuzumab on best objective response (OR) rate, time to response (TTR) and duration of response (DR) by RECIST 1.1 criteria To assess the safety and tolerability of Farletuzumab To assess the safety and tolerability of Farletuzumab To assess the pharmacokinetics and exposure-response relationships between Farletuzumab and PFS and OS To assess the pharmacokinetics and exposure-response relationships between Farletuzumab and PFS and OS

19 Consiglio Direttivo MITO Consiglio Direttivo MITO Prossima riunione MITO Roma Candidature da: Bologna Brindisi

20 MITO ma quanto ci costi? SEDE ANNO PERNOTTANTI COSTOTOTALENOTE ROMA 20097755.000 PISA 20115442.000 NAPOLI 20118864.000RIUN.D.M. + TRASL VERONA 20128058.000 MILANO 20128972.500RIUN D.M. + TRASL BARI 20136155.000 ROMA 20138573.000 RIUN D.M. + TRASL SIRACUSA 20146053.000 PISA 201478 51.000 + 11.500 62.500 RIUN D.M. + TRASL NAPOLI 20157958.000 + 11.300 69.300 RIUN.D.M.+ TRASL.+ GRANTS x REL. ESTERI

21 Programma 2013-2015 Revisione statuto per votazioni Implementare il gruppo degli anatomo-patologi (Scibilia-Losito promotori) Continuare attività del gruppo qualità Elaborazione di protocolli che possano coinvolgere i radioterapisti (Savarese-Lorusso) Streaming e nuova struttura riunione MITO Programmi specifici dei vari gruppi