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Napoli,25 giugno 2015
XXV MITO MEETING:
CONSIGLIO DIRETTIVO
Consiglio Direttivo MITO
25 Giugno Napoli
Presenti
Pignata
Scambia
Scibilia
Fagotti
Greggi
Raspagliesi
Ferrandina
Mangili
Invitati
Breda, Lorusso, Scollo,
Marchetti, Salutari
Centri e soci
 156 centri MITO (Ginecologie ed Oncologie, 2nuovi)
 10 centri MITO (gruppo traslazionale)
 467 soci (6 nuovi)
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
MITO Pub
Second-line dovitinib (TKI258) in patients with FGFR2-mutated or FGFR2-nonmutated advanced or metastatic endometrial cancer: a non-randomised, openlabel, 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 platinumresistant 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.
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, DevouassouxShisheboran 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.
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.
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.
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.
MITO all’ ASCO
MITO end2 2015
MITO 11 2014
MITO 7 2013
MITO 2 2010
MITO 3 2007
MITO 1 2006
Studi in corso
e in via di attivazione…
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)
PROFIT /ENGOT
• SOLO2(Napoli)
• MILO(Napoli)
•NOVA(Milano)
•TRINOVA 2 (Roma)
•TRINOVA 3 (Roma)
•Paola1 (Napoli)
• BGOG Farletuzumab(Napoli)
•Endometrial high risk (Napoli)
•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)
GCIG
•DESKTOP III (Napoli)
•ANZGOG Sintomi (Napoli)
ICON9
AGO-OVAR 2.X
A project of the
AGO Study Group & Astra Zeneca
-
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
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
Design of AGO/ENGOT study
Randomisation
N
~ 800-1000
A (Standard)
Pt-Kombi +/- Bev
(depending on prior
Bev exposure)
Patient population - recurrent
OC with1 or 2 prior platinum
based lines
B. Olaparib + Ced
PD – PFS 1
B. Olaparib + Ced
Pt-Kombi -> Olaparib
PD – PFS 2
BGOG Farletuzumab
Study
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.
Secondary:





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 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 pharmacokinetics and exposure-response relationships between
Farletuzumab and PFS and OS
Consiglio Direttivo MITO
Prossima riunione MITO Roma
Candidature da:
• Bologna
• Brindisi
MITO ma quanto ci costi?
SEDE
ROMA
PISA
ANNO
PERNOTTANTI
COSTO
TOTALE
2009
77
55.000
2011
54
42.000
NAPOLI
2011
88
64.000
VERONA
2012
80
58.000
MILANO
2012
89
72.500
BARI
2013
61
55.000
ROMA
2013
85
73.000
SIRACUSA
2014
60
53.000
PISA
2014
78
51.000 + 11.500 62.500
NAPOLI
2015
79 58.000 + 11.300 69.300
NOTE
RIUN.D.M. + TRASL
RIUN D.M. + TRASL
RIUN D.M. + TRASL
RIUN D.M. + TRASL
RIUN.D.M.+ TRASL.+
GRANTS x REL. ESTERI
Programma 2013-2015
•
Revisione statuto per votazioni
•
Implementare il gruppo
(Scibilia-Losito promotori)
degli
anatomo-patologi
•
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