JGOG3020 Japanese Gynecologic Oncology Group A pha hase I III r - PowerPoint PPT Presentation

JGOG3020 Japanese Gynecologic Oncology Group A pha hase I III r rand ndom omize zed c clini nical t trial to to i inv nvestigate the he n necessity of of adjuv uvant nt che hemot othe herapy for surgical s stage I I epithelial ov ovarian c cancer JGOG Ovarian committee JGOG3020 Principal investigator Dep. OB/GYN Jikei University School of Medicine, Tokyo, Japan Hiroshi Tanabe

ＪＧＯＧ３０２０ Staging surgery: TAH,BSO,OMTX, Peritoneal washings for cytology pelvic and aortic node dissections peritoneal biopsies 230 cases TC or DC 3 ～ 6 cycle R A PTX:175mg/m 2 , CBDCA: AUC=6 Staging surgery N DTX: 70mg/m 2 , CBDCA: AUC=6 Ovarian Cancer D O FIGO stage I M I 230 cases Z Observation E Eligible ・ Stage IA: grade 2/3, clear cell ・ Stage IB: grade 2/3, clear cell Primary Endpoint ： OS ・ Stage IC1 Exclusive: Stage IC2, IC3 Non-inferiority study

EORTC-ACTION Around 11% of T1 shows lymph node metastasis Staging surgery (n=151) Non Staging surgery (n=295) There is a strong evidence that optimal surgical staging identifies patients 5y OS ： 85% have either little or nothing to gain from adjuvant chemotherapy 5y OS ： 85% Observation (n=75) (The Cochrane Collaboration). Chemotherapy (n=148) Chemotherapy (n=76) 5y OS ： 85% Observation (n=147) 5y OS ： 73% Is the adjuvant chemotherapy really necessary Overall Logrank test P=0.6535 Overall Logrank test P=0.0329 for stage I epithelial ovarian cancer with staging surgery?

ＪＧＯＧ３０２０ Staging surgery: TAH,BSO,OMTX, Peritoneal washings for cytology pelvic and aortic node dissections peritoneal biopsies 230 cases TC or DC 3 ～ 6 R cycle A PTX:175mg/m 2 , CBDCA: AUC=6 Staging surgery N DTX: 70mg/m 2 , CBDCA: AUC=6 Ovarian Cancer D O FIGO stage I GOG finally concluded, the adjuvant M chemotherapy of more than TC3 cycle I 230 cases shows to be not necessary . Z Observation E Eligible ・ Stage IA: grade 2/3, clear cell ・ Stage IB: grade 2/3, clear cell Primary Endpoint ： OS ・ Stage IC1 Exclusive: Stage IC2, IC3 Non-inferiority study

Results of JGOG Protocol Amendment and questionnaire Future 2014/11 ～ 2015/4 • Peritoneal biopsies is recommended, but it is FIGO stage I not indispensable if evaluation is enough IA/Ib G1 IC(a),(1),(2) Eligible for 3020 sub-stage • Expected number of subjects: 640 → 460 patients Recruitment period: 5 → 12 years (to June 2024) Performed Lymphadenectomy Follow-up period: 5 years Peritoneal biopsy Total study duration: 10 → 17 years Informed consent • International collaboration KGOG, TGOG Agree and entry 0 50 100 150 200 250 300 350

Economical Merit Cost of treatment per year for EOC stage I ・ Adjuvant chemotherapy group ：￥ 2,760,000 （ n=15, 2012 ） ・ Follow-up group ：￥ 1,400,000 （ n=5, 2012 ） （２ , ７６０ , ００ 0 －１ , ４０ 0,000 ） ×2000Pt.= ￥ 2,720,000,000 ($24,200,000)