: Q&A-,1995 ptimal Surgery: <1cm Suboptimal Surgery: >1cm -Paclitaxel/Carboplatin- PFS( S( n ptimal GG GG AG-GEC
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1 CRC 08/09/2005 ( 90% 5% 4% : 2005 (FG) Surgical Staging -
2 : Q&A-,1995 ptimal Surgery: <1cm Suboptimal Surgery: >1cm -Paclitaxel/Carboplatin- PFS( S( n ptimal GG GG AG-GEC Suboptimal GG zols et al. JC 21, 2003, Markman et al. JC 2001, du Bois et al PRC ASC, 2004 cm McGuire et al EJM 334, 1999 (n=426) ( micro 81 <0.5 cm ~1 cm 47 1~2 cm 31 > 2.0 cm 34 Goalo gross residual optimal 1cm 1cm Chi D, et al. SG (Miami), 2005 ( ) CPT -11
3 C-2 (1998) CBDCA C-3 (2000) EBM CPA / ADM CDDP / ADM / CPA (CAP) GG52 (1989) GGG (1987) DACVA (1987) G (1986) CDDP / CPA (CP) SWG (1992) Canada C (1992) CBDCA / CPA (CP) GG111 (1996) European-Canadian V-10 (2000) CDDP / TXL (TP) GG158 (1999 ASC) AG (1999 ASC) CBDCA / / TXL (TC) (TJ) CBDCA / TXT (DC) GG47 (1986) SCTRC (2001 ASC) GG: Gynecologic ncology Group GGG: Gruppo nteregionale Cooperativo ncologico Ginecologia DACVA: Danish varian Cancer Group G: orth West ncology Group AWG: Southwest ncology Group AG: Arbeitsgemeinschaft Gynaekologische nkologie (Germany) C:nternational Collaborative varian eoplasm SCTRC:Scottish Randomized Trial in varian Cancer EBM staging 2. TJ 175mg/m2/3h + AUC 5~6 3~6 135mg/m2/24h+ 75mg/m2 TP 75mg/m2+ AUC 5 DJ 60mg/m2 (day 1,8,15)+ 60mg/m2 (day1) c 36 1cm 6 1cm *1 Staging Laparotomy a/b and -c - (a~c) - *2 >6 2 *1 / / / ( ) *2 TJ (TXL) 175mg/m2+ (CBDCA) AUC56 (3? 6? ) ( ptimal Surgery ~V 1cm Staging laparotomy Primary debulking surgery ptimal Surgery*1 ED *2 PD persistent Second-line chemotherapy SDS *3 SD PD Second-line chemotherapy Salvage therapy -Chemotherapy -Radiotherapy 1 Suboptimal disease 2 Second-look operation PFS S CR: complete response/pr: partial response/sd: stable disease/pd: progressive disease SDS: secondary debulking surgery ED: no evidence of disease interval debulking surgery neoadjuvant chemotherapy) interval debulking surgery interval debulking surgery
4 Staging laparotomy Primary debulking surgery *2 Suboptimal *1 CR PR SD 1 Suboptimal disease SD second-line evidence CR: complete response/pr: partial response/sd: stable disease/pd: progressive disease DS: interval debulking surgery/sds: secondary debulking surgery PD 1cm 2 *3 *4 Second-line chemotherapy CR PR SD PD SDS Second-line chemotherapy Salvage therapy Chemotherapy Radiotherapy Upfront debulking surgery Platinum-based regimen x3 nterval debulking surgery (optional) Platinum-based regimen> x3 ERTC: (close:2005:704pts) Stage c/v varian, Peritoneal or Fallopian Tube Cancer CR/PR/SD eoadjuvant P> x3 PD nterval debulking surgery ut of protocol Platinum-based regimen> x3 2 TJ 175mg/m2/3h + AUC 5~6 ~ 6 135mg/m2/24h+ 75mg/m2 TP 75mg/m2+ AUC 5 DJ 60mg/m2 (day 1,8,15)+ 60mg/m2 (day1) :20~40% V:20% 50%
5 (secondary debulking surgery: SDS) (interval debulking surgery: DS) SDS 1) DS 2) PET 3) 4) DS 10cm SDS 80% DS ( ) 24 20% SDS GG 111 suboptimal Stage /V ( 1) ) 70%) ( - - : 3) The 3rd Drug 1. ew Combinations of Established Agents TEC topotecan/cbdca-tj 2. Maintenance Therapy ( 3. ntraperitoneal Drug Delivery 4. ovel Cytotoxics Cytotoxic 5. Biological Therapies TJ TJ TJ+ TJ 1. Anthracyclines Epirubicine AG/GEC (VAR-5) ASC 04 (final) SG/CC-C/ERTC ASC 04 Liposomal Doxo GG/MRC/AZGG ongoing 2. Topotecan AG/GEC (VAR-7) ASC 03 (interim) C-C/ERTC/GEC ongoing GG/MRC/AZGG ongoing 3. Gemcitabine AG/GEC/SG (VAR-9) completed 4/04 GG/MRC/AZGG (triplet) ongoing GG/MRC/AZGG (doublets) ongoing
6 GCG Trial Strata: FG B- + TU < 1 cm FG V or TU > 1 cm Center TEC vs. TC (AG-GEC: Final Analysis) R A D M Z A T Paclitaxel 175mg/m 2 3 h iv Carboplatin AUC 5 iv q 21 x 6 n=635 Epirubicin 60mg/m 2 iv Paclitaxel 175mg/m 2 3 h iv Carboplatin AUC 5 iv q 21 x 6 n=647 ASC, 2004 ew rleans ASC, 2004 ew rleans TEC versus TC : Final Results (AG-GEC) TEC TC 73.7% 70.3% p=0.515 PFS 18.4mo 17.9mo p=0.334 MST 45.8mo 41.0mo p=0.365 >G3 75.6% 55.5% p< % 1.3% p< >G3 17.3% 3.9% p< >G3 6.9% 3.3% p=0.004 >G3 6.4% 2.8% p= % 0.2% p=0.004 TC. SG/CC-C/ERTC TC AG-GEC ntergroup Trial Protocol VAR-7 Schema for GG 182 A Phase Randomized Trial of Paclitaxel and Carboplatin Versus Triplet or Sequential Doublet Combinations in Patients With Epithelial varian or Primary Peritoneal Carcinoma FG Stage B- V Residuals < 1cm > 1cm Center R A D M Z A T Paclitaxel 175mg/m 2 Carboplatin AUC 5 iv q 21 x 6 Paclitaxel 175mg/m 2 Carboplatin AUC 5 q 21 x 6 Topotecan 1.25mg/m 2 iv d1-5 q 21 x 4 Control Doublet Paclitaxel 175 mg/m 2 V (3 hr) D1 x 8 cycles (q 21 days) Carboplatin AUC 6 V D1 (Gem or Doxil) sequential Gemcitabine Triplet Paclitaxel 175 mg/m 2 V (3 hr) x 8 cycles (q 21 days) Carboplatin AUC 5 V D1 Gemcitabine 800 mg/m 2 /d V D1,8 Randomization Primary Endpoints Doxil Triplet Progression-free Survival (PF) Paclitaxel 175 mg/m 2 V (3 hr) D1 x 8 cycles (q 21 days) Carboplatin AUC 5 V D1 verall Survival (S) Doxil 30 mg/m 2 V (every other) D1 Response Rate (RR) V Topotecan Doublet (Module A) Topotecan Doublet (Module B) Carboplatin AUC 5 V D3 Paclitaxel 175 mg/m 2 V (3 hr) D1 Topotecan 1.25 mg/m 2 /d V D1-3 Carboplatin AUC 6 V D1 x 4 cycles (q21 days) x 4 cycles (q 21 days) V Gemcitabine Doublet (Module A) Gemcitabine Doublet (Module B) Carboplatin AUC 6 V D8 Paclitaxel 175 mg/m 2 V (3 hr) D1 Gemcitabine 1000 mg/m 2 /d V D1,8 Carboplatin AUC 6 V D1 x 4 cycles (q21 days) x 4 cycles (q 21 days) Show the Flag Maintenance Chemotherapy GGJ Chart Review of GG 182 GG business meeting, San Diego, Jan % 75% 40% 50%
7 GG178 R A /V D TJ (5~6 M Z E Arm 135mg/m 2 over 3 hours 28 3 Arm 135mg/m 2 over 3 hours verall Survival. SWG9701 (GG178): Maintenance Paclitaxel x3 months (n = 112) 8 events Paclitaxel x12 months (n = 110) 9 events Adjusted Cox analysis p = (one-sided) Cross-over eliminates any chance of meaningful survival data Months on Study Consolidation Strategies ot Effective Prolongs PFS Studies ngoing Prolonged CDDP ( 6 vs 12) Altretamine (SWG) F-alpha on-cross resistant (Topotecan) High Dose (GEC) Radiolabeled Ab HMFG1 P (SMART), P P32 varex (intent to treat) P Gem/CDDP (+SLL) Paclitaxel ( 6 vs 12) May Prolong PFS P CDDP(-SLL) WART MSK P consolidation varex (selected population) ACA 125 Vaccine ther Radiolabeled MoAbs ther vaccines VEGF-TRAP, Bevacizumab, PTK TXL or poly-glutamated TXL (CT-2103 ) or observation Advanced varian Cancer: Consolidation SG ndustry Symposium, Miami, % Monthly TXL For 12 mo 13% Polyglutamated TXL(Clinical trial) : weekly TXL for 6mo weekly topotecan for 6mo weekly docetaxel ip radioimmunotherapy 8% 65% GG #104 SWG #8501 Second look Laparotomy varian cancer Stage Stratify: < 0.5 cm > cm? R A D M Z E Cisplatin 100 mg/m 2 V Cyclophosphamide 600 mg/m 2 V q 21 days x 6 Cisplatin 100 mg/m 2 P Cyclophosphamide 600 mg/m 2 V q 21 days x 6
8 GG #114 varian cancer Stage < 1.0 cm R A D M Z E Cisplatin 75 mg/m 2 V Cyclophosphamide 750mg/m 2 V q 21 days x 6 Cisplatin 75 mg/m 2 V Paclitaxel 135 mg/m 2 V q 21 days x 6 Carboplatin AUC=9 x 2 V then Cisplatin 100 mg/m 2 P Paclitaxel 135 mg/m 2 V q 21 days x 6 Second look Laparotomy GG 172 varian cancer ptimal (<1cm) Stage Stratify: Gross residual Planned 2 nd look BRCA Analysis DA Banking R A D M Z E Paclitaxel 135 mg/m 2 /24h Cisplatin 75 mg/m 2 q 21 days x 6 Paclitaxel 135 mg/m 2 /24h Cisplatin 100 mg/m 2 P D2 Paclitaxel 60 mg/m 2 P D8 q 21 days x 6 Second look Laparotomy (if chosen) GG P vs V Trials Study Median PFS Median S %nc %nc V P V P V P GG P=.02 GG P=.01 P=.05 GG P=.01 P=.01 V cis V carb V cis 19.4 V carb 20.7 V cis 48.7 V carb 57.4 Proposed JGG Trial Paclitaxel 175 mg/m2 V Carboplatin AUC 6 V Q21, 6-8 Cycles c-v Randomization Primary Endpoint: PFS Secondary Endpoint: S, QL Paclitaxel 175 mg/m2 V Carboplatin AUC 6 P Q21, 6-8 Cycles P standard care C Clinical Alert YES ptimal P chemotherapy * Gynecologic ncologist 18% GG172 SG ndustry Symposium, Miami, % 21%*
9 p iv survival gain Maintenance community or? Most promising p ipconsolidation ( ip consolidation JGG Clinical Trials From Evidence-Based Medicine to Evidence-Generating Medicine Evidence Key words: JGG 3016 Phase Study Design JGG 3016: Tri-weekly TJ vs weekly TJ 2006/3/4 600 FG stage -V <1cm vs.>1cm FG stage vs. vs. V / vs. / A tri-weekly TJ B weekly TJ paclitaxel 180mg/m 2 2,, day day 1 paclitaxel 80mg/m 2 2,, day day 1,8,15 carboplatin AUC 6.0, 6.0, day day 1 carboplatin AUC 6.0, 6.0, day day 1 every days for for cycles every days for for cycles Primary endpoint: Progression-free survival
10 Clinical Trials GG - Study Chair () Web P Japanese Gynecologic ncology Group < > Primary Secondary : <nsert Committee> < > < > < > FAX < FAX > EMAL <username@maildomain> Phase PHASE: : < > 1600 < > <.> 1600 < > <.> Phase ther: JCG JGG KCG WJGG TGCU JCG KCG WJGG TGCU ntergroup Study GG USA GG Japan GCG ERTC AG GEC GEC SG etc GCG Gynecologic Cancer ntergroup
11 GG Japan: Structure Gynecologic ncology Group USA GGJ Protocol Committee GGJ GG nternational Provisional Member GG GG Application 1.Tumor Case Load From 2.nvestigator( ) Curriculum Vitae - ntent to Participate Letter - All nvestigators - Department Chairmen ( ) 3.Support Letter from RB ffice of Human Protection (HRP) Federalwide Assurance (FWA) umber C nvestigator umber GG Roster GG Web Menu Account GG: Per Capita Accrual GG Membership Requirement Study Dependent $1,500 - $ 3, Data Management Travel Expense Audit 85 GG Japan 85 JGG GG GG Data Management 2 Business Meeting nformed Consent Content Audit Form Quality Assurance Review Form University Hospital of Brooklyn GG Audit August 16, 2004 GG Audit Program
12 GG Audit August 17, 2004 GG-Japan Audit : GG-Japan GG-Japan Full Member GGJ Protocol # 171 GG Protocol Progress for GG Japan (5/30/05 7/10/05) Activated 9/28/1998 Point Per Capita Membership 17 3 Target Accrual 500+ Accrued Accrual GGJ /14/ /11/ /20/ Temporally Closed /4/ H16 6 JGG,JCG,JKTB,STB,SGSG,KCG,WJGG,TGCU 612(
13 H16 6 GG-JapanGG, GCG GG Japan P GG Japan GCG ( 2 64( 2 64( 617
14 (CP or CAP ) vs umber of Pts Response (%) CR PR C PD Response Rate (%) 27 2 (7.4) 1 (3.7) 2 (7.4) 22 (81.5) (27.5) 49 (45.0) 10 (9.2) 20 (18.3) nternational Gynecologic Cancer Society: nvited Lecture Sugiyama T, et al. Cancer 2000; 88: p < Enomoto T. et al. (ASC 2003 Chicago) TJ FG( Histology o/pts CR PR SD PD RR(%) % 19% GCG Study -Clear Cell Ca -Stage C~V Primary endpoint: PFS, S Secondary endpoint: Clinical response toxicity First-line chemotherapy RADMZAT Clear Cell Carcinoma: Phase Study TJ Paclitaxel 175 mg/m 2 (d1) Carboplatin AUC5~6 (d1) Every 3 wk x 6 -CPT-11/CDDP CPT mg/m 2 (d1, 8, 15) Cisplatin 60 mg/m 2 (d1) Every 4 wk x patients in each arm, and 450 total JGGGGC-CanadaUK ScotlandAustria Korea(KGG) Salvage Chemotherapy -
15 6 6 salvage chemotherapy Sensitive Relapse C : Design (ASC 2003) > 6mo (MRC/AG), >12mo RFM (taly) RADMSE A / varian Carcinoma C 4: verall Survival Proportion alive Hazard ratio = 0.82 (95% C ; p = 0.023) Absolute difference at 2 years = 7% (50% to 57%; 95% C 1% to 12%) Pac-Plat 0.1 Plat Patients at risk Years from randomisation Pac-Plat Plat AG VAR,CC CTG,ERTC GCG Gemcitabin/Carboplatin : Phase (ASC 2004 ew rleans) Sensitive relapse (TF>6mo) Gem/CBDCA (GC) vs CBDCA (C) GC 47.2% vs C 30.9% (p=0.0016) PFS GC 8.6mo vs C 5.8mo (p=0.0031) GC (GC 1.1%) >60%, 20+ months 6 6 salvage chemotherapy Recommendation in Japan Platinum (carboplatin)-combinations 1. Paclitaxel/Carboplatin (C 4) 2. Docetaxel/Carboplatin 3. CPT-11/Platinum 4. ther conventional platinum combination 5. Clinical Study of developing drug salvage chemotherapy ( C) 2
16 Refractory disease: Effective drugs in the World Phase : single arm study We should select one or two drugs among these drugs Topo- nhibitors rinotecan 5/29 (17%) JC 21:291, /26 (23%) ASC 2003 Topotecan 11/59 (19%) Docetaxel 43/155 (28%) EJC 33:2167, /30 (23%) JC18:2733,2000 Weekly paclitaxel 13/51 (25%) JC 20: 2365, 2002 ral etoposide 17/69 (25%) 8/25 (32%) Gemcitabine 3/22 (14%) Doxil 9/51 (18%) approval in Japan 65 San Diego) 1. Gemcitabine 9% 2. Topotecan 42% 3. Docetaxel 8% 4. Liposomal Doxorubicin 30% 5. ral etoposide 2% 6. ther 9% DoxilJGG Topotecan Doxil K211 Topotecan PR %, 8+ months Recommendation in Japan 1. Weekly CPT-11-based regimen 2. Weekly Paclitaxel 3. Docetaxel 4. Clinical Study of developing drugs (Topotecan, Liposomal Doxorubicin) Salvage Chemotherapy - - (best palliation) QL
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18 Placebo-Controlled Phase Trial of Concurrent vs Extended Bevacizumab (GG 0218) FG Stages /V, Suboptimal varian & Primary Peritoneal Carcinoma Randomization-15 Months Therapy Arm 1: TJ Arm 2: TJBV Arm 3/: TJBV BV TJ: paclitaxel 175mg/m2/CBDCA AUC=6 3 6 BV bevacizumab 15mg/kg 2 Burger RA et al, Proc ASC 2:457s [#5009],2005 / -Resistant: CPT-11 CPT mg/m2 (days 1,8,15) q 4week 26pts Median cycles 3 (1-4) Response Rate 23% (1 CR/5 PR) SD Rate 35% (9/26) RR+ SD Rate: 58% : 15 weeks Toxicity: >Grade 3: 2 (8%) > Grade 4: 1 (4%) > Grade 2: 9 (35%) > Grade 3: 3 (12%) ASC 2003 Matsumoto et al ational Cancer Center in Japan CPT-11 combination CPT-11/oral etoposide in Recurrent varian Cancer: Clinical Response CR PR SD PD Response Rate (%) * / 28 (39.3) *intent to treat (ncluding the effects by CA125) CR/PR+SD Rate (%)* 24 / 28 (82.1) GG 198 CA125 >100U/ml CPT-11 60~70 mg/m2(day 1,15)+ etoposide 50 mg/body (day 1-21) March 3, 2005 Primary endpoint: Clinical Progression (Recurrence-free survival) Toxicity Grade 4 eutropenia: 11/28 (35.7%) Grade 2~4 Diarrhea : 4/28 (14.3%) JCG <35) RADMZAT Tamoxifen 10 mg BD QD Thalidomide 200~400mg QD HS escalating weekly CA125 vs ERTC CA125 2 ERTC Data Center CA125) Randomisation by ERTC Data Center First-line Platinum-based doublet (TCDC) tripplet Sequentinal approach single doublet Consolidation Key Word: Endpoints Primary endpoint: verall survival Secondary endpoints: PFS/QL Second-line
19 Endometrial Carcinoma Chemotherapy: Active Agents (>15% RR) Agent Pts RR Doxorubicin % Epirubicin 27 26% Cisplatin 86 29% Carboplatin 52 31% Paclitaxel 47 36% GG trials ADM vs ADMCPA GG48 Endometrial Carcinoma Disease Categories Disseminated disease: chemotherapy: Advanced/Recurrent Locoregional disease Low-risk disease: surgery ntermediate-risk disease: surgery + pelvic radiation High-risk disease: surgery + chemotherapy Advanced/Recurrent Endometrial Carcinoma GG Protocol 177: Regimens Regimen (AP) Regimen (TAP) Doxorubicin 60 mg/m2 Cisplatin 50 mg/m2 Doxorubicin 45 mg/m2 d1 Cisplatin 50 mg/m2 d1 Paclitaxel 160 mg/m2/3h d2 Regimen requires G-CSF G-CSF 5mcg/kg days 3-12 Every 3 weeks Fleming GF et al. JC 22: , 2004 Advanced/Recurrent Proportion Surviving GG 177: Survival By Treatment Treatment Group Alive Dead Total AP TAP P= Months on Study
20 Advanced/Recurrent GG-209: Schema Advanced, Recurrent Endometrial Cancer Adriamycin 45 mg/m 2 day 1 Cisplatin 50 mg/m 2 day 1 Paclitaxel 160 mg/m 2 24 hour day 2 G-CSF 5 mcg/kg days 3-12 Q 21 days x 7 Planned accrual: 900 patients/795 failures 60 months HR: 1.20 for Carbo/paclitaxel arm pened: Carboplatin AUC 6 Paclitaxel 175 mg/m 2 3 hr Q 21 days x 7 Advanced/Recurrent Stage & V, Recurrent Any histology R A D M Z E GG-189 Chemotherapy Doxorubicin 45 mg/m 2 Cisplatin 50 mg/m 2 Paclitaxel (3 hr) 160 mg/m 2 G-CSF on day3, for10days Hormones Megace 80 po BD Tamoxifen 20 BD Alternating 3 wks Cross-over P R G R E S S Endometrial Carcinoma Classification of Disease Categories Locoregional disease Low-risk disease: stage A grades 1-2 ntermediate-risk disease: all other stage, stage High-risk disease: all stage and VA Disseminated disease: stage VB or recurrent TAP+G-CSF TJ Tamoxifen ) Endometrial Carcinoma Disease Categories : chemotherapy: Advanced/Recurrent Low-risk disease: surgery ntermediate-risk disease: surgery + pelvic radiation High-risk disease: surgery + chemotherapy TAP+G-CSF TJ Tamoxifen ) Advanced High risk The rate and prognosis of each group (presumed value) 24 FG annual report 2001 Report of Japan Society of b/gyn Distant meta ntermediate risk early stage Low risk early stage 17 5 year survival rate (%) Recurrence Risk: Definitions Low-risk factors for Recurrence: o myometrial invasion Grade 1 o suspicious cytology High-risk factors for Recurrence (in order): Paraortic and pelvic node involvement Adnexal involvement and/or positive cytology Statistical Hazard s model for Recurrence based on GG #33
21 ntermediate Risk: Defining the Target Author Definition GG-99: ntermediate Endometrial Cancer Aalders Fanning Piver Carey rr MacLeod Kucera Elliot Morrow (GG) Creutzberg (PRTEC) Clinical C, G3, C, G3, C, G3, C or G3 C or G3, B G2-3, C G3 B,C or G3 B,C or G3, Clinical B, G2-3, C G1-2 Surgically staged B, C all grades (occult) Surgical adequacy Randomization o Adjuvant Therapy (AT) Whole Pelvic Radiation (XRT) 5040 cgy pen: 1987 Closed: 1995 Accrual: 392 pts (evaluable) Keys, et al. Gynecol ncol 92:744, 2004 ntermediate Risk: GG-99 HR: 0.86 (90% C: ) P = Median F/U: 68 mos Endometrial Carcinoma -Low-risk disease: surgery -ntermediate-risk disease: surgery + pelvic radiation -High-risk disease: surgery + chemotherapy Va Keys Gynecol ncol 92:744, 2004 Endometrial Carcinoma High-Risk Disease: Management Stage (adnexal, serosal, vaginal or pelvic/pa node involvement or positive peritoneal cytology), stage VA (bladder/rectal mucosa) Surgery: relapse rates of >50% Management: resection of gross disease, radiation to involved areas, systemic therapy? /V 2 cm Any histology ode sampling required if not otherwise /V Scalene node sampling for PA (+) GG-122: Schema R A D M Z E :AP Doxorubicin 60 mg/m 2 x 8 (420 mg/m 2 max) Cisplatin 50 mg/m 2 x 8, q21-day cycles -pen Field AP-PA -30 Gy x 20 fractions (150 cgy/d) WAR -15 Gy x 8 fractions to pelvis PA -PA XRT if nodes positive or if not sampled Endpoints Primary: PFS (Powered to detect a 33% decrease in Hazard) Secondary: S, Toxicity, QL (not reported)
22 Proportion Surviving GG 122: Survival Treatment Group Alive Dead Total WA AP Months on Study [TAH/BS] JGG2033: WP) 45-50Gy Gy/ 5/ 910Gy/ 46 CAP 1/2 CPA 333mg/m 2 75 DXR 40mg/m 2 CDDP 50mg/m Sagae S et al, Proc ASC 23:455s [#5002],2005 JGG 2033: high risk (WP) vs (CAP) verall Survival Sagae et al. ASC ral Session, 2005 (WP) vs (CAP) 100 Progression-Free Survival of High ntermediate Risk (stage-a cytology(+)) Survival rate (%) WP vs CAP Hazard Ratio Confidence nterval Alive Failed Total 5ys rate WP % CAP % Log-Rank Test p= years Survival rate (%) Alive Failed Total 5ys rate 1WP 2CAP % 84.5% Log-Rank Test p= years ASC ral Session, 2005 Stage /V Endometrium: Current GG Study # 184 Contemporary ssues in Endometrial Cancer Care Stage /V < 2 cm Resid TAH/BS Debulking Pelvic +/- PA ode RT R A D M Z E D APx6 DXR 45mg/m2 +CDDP50mg/m2 + G-CSF 5mcg/kg days 2-11 TAPx6 DXR 45mg/m2 +CDDP50mg/m2 + TXL 160mg/m2/3hr +G-CSF 5mcg/kg days 3-12 Surgical Staging? ntermediate???
23 JGG2041 Primary Endpoint: Response Rate Secondary Endopoint: Toxicity Feasibility Progression-free Survival Advanced or Recurrent Endometrial Cancer With Measurable Lesions Randomization Stratification Previous Taxen Use Previous Radiation Therapy on Target Lesion >6 Mo Chemo >4 Wk RT ASC 2005 Poster Phase study of paclitaxel, doxorubicin and carboplatin combination therapy for endometrial cancer. DP Docetaxel 70mg/m 2 Cisplaitn 60mg/m 2 q 3wks for 6-9 cycles DJ Docetaxel 70mg/m 2 Carboplatin AUC=6 q 3wks for 6-9 cycles TJ Paclitaxel 180mg/m 2 Carboplatin AUC=6 q 3wks for 6-9 cycles T. Sugiyama, H. mi, J. Kigawa, M. Hatae, M. Suzuki, H. Tsuda; wate Medical University, Morioka, Japan; Tottori University, Yonago, Japan; Kagoshima City Hospital, Kagoshima, Japan; Jichi Medical School, Utsunomiya, Japan; saka City General Hospital, saka, Japan. TAC: Phase Study JGG Proposal Level TXL (mg/m 2 ) ADM (mg/m 2 ) CBDCA (AUC) TAH/BS+Surgical Satging ntermediate/high risk 2041 (TJ,DJ or DP) AP TAC GG LAP-2 Protocol Endometrial adenocarcinoma or uterine sarcoma Clinical stage., A Grade 1, 2, 3 R A D M Z E LAVH/BS + pelvic & para-aortic LD TAH/BS + pelvic & para-aortic LD Memorial Sloan Kettering Cancer Center: Prof Barakat
24 5 mm trocar nsufflation sites Laparoscope 10/12 mm trocar 5 mm trocar 10/12 mm trocar. CSPR: JGG: Mercer University School of Medicine, Macon, Georgia
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