RARE TUMOR Working Group. Thursday, May 30, 2013, 3:30 p.m. 5:30 pm. Huron Room, Doubletree Hotel, Chicago MINUTES

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1 GCIG RARE TUMOR Working Group Thursday, May 30, 2013, 3:30 p.m. 5:30 pm Huron Room, Doubletree Hotel, Chicago MINUTES I.Ray-Coquard (Chair), J.Ledermann (co-chair) Attendees: A. Jhingran (RTOG), C.Chu (COGi), C.Scott & M.Friedlander & C.Lee (ANZGOG), I.McNeish & A.Clamp & C.Gourley (MRC-NCRI), E.Gomez (GICOM), J.McAlpine (NCIC CTG), A.Okamoto (JGOG), E.Pujade-Lauraine (GINECO), D.Mezzanzanica (MITO), E.Witteveen (DGOG), J.Sehouli & A.Mustea (NOGGO), M.Mirza & H. Havsteen (NSGO), A.Oza & S.Welch (PMHC), E. Kohn & B.Greer & D.Gershenson (NCI US), M.Bookman & D. Miller (GOG), E. Shash (EORTC-GCG), R.Zang (SGOG), M.Baumann (AGO-De), R.Glasspool (SGCTG), J.Schink (ISSTD), K.Fujiwara (GOTIC), A.Zeimet (AGO-Au). WELCOME, INTRODUCTIONS, CONFLICTS OF INTEREST DISCLOSURES AGENDA Call to Order and Welcome Review of Minutes of Leiden MEETING 2012 Update on GCIG Rare Tumor Initiative (I Ray- Coquard & J Ledermann) Update of rare gynecologic cancer GCIG meeting London Nov 2013 (I Ray-Coquard & J Ledermann) New projects Other Business Adjournment

2 1 GCIG Rare Tumor statements: 20 requested: Topics leader Group Coordinator Ov & Ut carcinosarcoma GINECO D Berton Rigaud low malignant potential tumors AGO P Harter low grade serous carcinoma MRC C Gourley D Gershenson Co Coordinator Step Validated by Chairmans & 2 nd draft waited Waiting for the 1st draft for validation Sex cord tumor GINECO I Ray Coquard N Colombo All + germ Cell Tumor GOG J Brown M Seickl for validation squamous Ov carcinoma SGCTG R Glasspool Antonio Gonzales for validation Small Cell carcinoma Under review by cervix GOTIC K Fujiwara N Reed co coordinator small cell carcinoma Ovarian EORTC N Reed P Pautier Validated by Chairmans & 2 nd draft waited vulvar & vagina non squamous carcinoma US NCI M Leitao Xi Cheng All + ovarian carcinoid tumor GICOM E Gomez N Reed for validation Topics leader Group Coordinator Co Coordinator Step pseudomixoma peritonei & mucinuouscarcinoma MRC/NCRI J Ledermann D Gershenson Waitingfor the 1st draft for clear cell carcinoma Ovary JGOG A Okamoto R Glasspool validation clear cell carcinoma Cervix & Ut GOTIC K Fujiwara & Dr Hasegawa trophoblastic diseases MITO K Larusso M Seckl low grade endometrial stromal sarcoma EORTC F Amant All + HGUS GINECO P Pautier uterine papillary serous carcinoma JGOG S Sagae A Viswanathan adenosarcoma ANZGOG M Friedlander Ut & Ov leiomyosarcoma US NCI M Hensley All + glandular carcinoma of cervix GOTIC K Fujiwara for validation 2 nd draft waited Validated by Chairmans & 2 nd draft waited Validated by Chairmans & 2 nd draft waited Under review by co coordinator for validation for validation

3 SUMMARY Ov & Ut carcinosarcoma low malignant potential tumors low grade serous carcinoma Sex cord tumor germ Cell Tumor squamous Ov carcinoma Small Cell carcinoma cervix small cell carcinoma OV vulvar & vagina non suqamous carcinoma ovarian carcinoid tumor pseudomixoma peritonei & mucinuous carcinoma clear cell carcinoma Ovary clear cell carcinoma Cervix & Ut trophoblastic diseases low grade endometrial stromal sarcoma HG uterine sarcoma uterine papillary serous carcinoma adenosarcoma Ut & Ov leiomyosarcoma glandular carcinoma of cervix 20 DOCUMENTS: 18 sent at least a first draft (MEoc, BL waiting) 4 completely finalized 4 2 nd draft waiting 7 under validation by group/chairs 3 under review by co coordonator Questions & discussions Definition of the project : GCIG rare tumor consensus review Relation with other groups/societies: WSN, ISSTD, EOSTD,.. Next steps for publication: Review by national groups will be done on Sept Finalization by an editing board I R-C, JAL, M. Friedlander, K Lorusso, E Kohn, D Gershenson, A Oza for October Final version posted on GCIG website Next meeting specifically dedicated to review documents ESMO meeting (Amsterdam 2013) Definition of the project : GCIG rare tumor consensus review - As not guidelines and not always in consultation with international groups such as sarcoma/tdg etc, these should be GCIG consensus Review Group documents posted on web site - A commentary for eg IJGC demonstrating how these were written and what their function is. - Idea would be to revise group documents every year or two.

4 Next steps: - These need to be sent to individual groups for circulation within membership as groups see fit for comment. Then back to RTWG for final version that should be finally agreed by groups before being posted on the GCIG web site - Acknowledgements of authors should be on the web site as well as other societies if they have endorsed. - A review committee should be set up to manage the finalization of the group documents before posting on the GCIG web site. I R-C JAL Michael Friedlander Ketta Lorusso Elise Kohn David Gershenson Amit Oza Agreed to do this. 2. London RTwg Brainstorming Program GCIG Rare Tumors Planning Meeting London, 16 Nov 2013 Participants: GCIG groups (2-3 representatives for each group) & invited speakers / experts in the field Objectives: To define current guidelines for rare gynecologic tumors; To define control arm for present and future clinical trials involving rare cancer; To identify national & international barriers for trials dedicated to rare gynecologic cancers To summarize and prioritize key issues for research and agree new set of trial concepts to address the key issues in several rare tumors To prioritize and design 3 international initiatives in rare gynecologic cancer

5 Developing Agenda : GCIG Rare Tumors Planning Meeting London, 16 Nov 2013 Welcome, objectives Review & validation of the GCIG rare cancers documents Main statistical issues for ongoing & future trials Main harmonization/regulation issues Complexities of collecting samples across international boundaries - Example of successful story from other cancers/groups II part : 3 working groups sessions 1) relatively rare tumors 2) rare tumors 3) very rare tumors - First part should include talk about complexities of collecting samples across international boundaries. legal, IP, etc. Possible speakers include Clare Scott or Jalid Sehouli ( EUTROC experience) - 3 working sessions: These should be methodologically led, taking a tumor for each of the three sessions: 1. Eg: pap serous endo Ca or adenoca cervix as an example of a RCT. Would need biology input into this too 2. Rarer tumor type where novel design methodologies would be key (eg: adaptive design) (eg: SCT) 3. The very rare where there is no possibility of a RCT. Registry data should be decided ( work with FIGO who are developing a minimum dataset). Could be linked to Cartwheel type project to capture as many patients as possible and build knowledge iteratively. Importance of path input emphasized by David Millan- need to work on getting expert review? telepathology Workshop 1 Relatively Rare tumour Possible co-chairs: K.Fujiwara & R.Glasspool Need some definitions and perhaps a list compiled from Rare Cancer? FIGO data etc but incidence varies throughout the world

6 Workshop 2 Rare tumors Possible co-chairs: A Oza & M Parmar Workshop 3 Very rare Possible co-chairs: D. Gershenson & C. Scott or M. Friedlander Need to have biostatisticians in groups 1 & 3 to help (J Paul & M Brady) D Gershenson, A Oza, K Fujiwara, R Glasspool, M Parmar confirmed to be present; C Scott not sure yet. 3 Other Business: GCIG on going trials or potential trials Alienor (GINECO) GOG0275 (UC1005): A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-Day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia. J Schink 4 Adjourn