Gynecology Abstracts Gynecology Abstracts Susana M. Campos, MD, MPH Susana M. Campos, MD, MPH Dana Farber Cancer Institute Dana Farber Cancer Institute Dana Farber Cancer Institute Dana Farber Cancer Institute Boston Mass Boston Mass
Gynecological Abstracts: ASCO 2009 Abstract Abstract Author Author Title Title # 1 Rustin G.J. Rustin G.J. A Randomized trial in ovarian cancer of early treatment of relapse A Randomized trial in ovarian cancer of early treatment of relapse based on CA125 level alone versus delayed treatment based on based on CA125 level alone versus delayed treatment based on y y conventional clinical indicators conventional clinical indicators 5504 5504 Karam A Karam A Influence of residual disease and extreme drug resistance assays on Influence of residual disease and extreme drug resistance assays on outcome in patients with epithelial ovarian cancer outcome in patients with epithelial ovarian cancer 5505 5505 Levenback Levenback Sentinel node biopsy in patients with vulvar cancer : a GOG study Sentinel node biopsy in patients with vulvar cancer : a GOG study CF CF 5507 5507 Duenas Duenas- - A phase II study comparing concurrent gemcitabine plus cisplatin and A phase II study comparing concurrent gemcitabine plus cisplatin and Gonzalez A Gonzalez A Gonzalez A Gonzalez A radiation followed by adjuvant Gem plus Cis vs. concurrent Cis and radiation followed by adjuvant Gem plus Cis vs. concurrent Cis and radiation followed by adjuvant Gem plus Cis vs concurrent Cis and radiation followed by adjuvant Gem plus Cis vs concurrent Cis and radiation in patients with stage IIB to IVA carcinoma of the cervix radiation in patients with stage IIB to IVA carcinoma of the cervix 5508 5508 Pignata S Pignata S Carboplatin plus paclitaxel ( CP) versus carboplatin plus CLD) in Carboplatin plus paclitaxel ( CP) versus carboplatin plus CLD) in patients with advanced ovarian cancer: MITO 2 patients with advanced ovarian cancer: MITO 2 5509 5509 Pujade Pujade- - Randomized phase III study of carboplatin and pegylated liposomal Randomized phase III study of carboplatin and pegylated liposomal Lauraine E Lauraine E doxorubicin vs. carboplatin and paclitaxel in relapsed platinum doxorubicin vs. carboplatin and paclitaxel in relapsed platinum sensitive ovarian cancer: CALYPSO study of the GCIG sensitive ovarian cancer: CALYPSO study of the GCIG 5510 5510 Herrstedt J Herrstedt J A randomized phase II study of gem A randomized phase II study of gem- p p y y g g -paclitaxel paclitaxel- p -carboplatin versus carboplatin versus p paclitaxel paclitaxel- -carboplatin as first line treatment of ovarian cancer: carboplatin as first line treatment of ovarian cancer: Survival of FIGO stage I Survival of FIGO stage I- -IIA patients IIA patients
Ovarian Ovarian Cancer Cancer
GOG111: Survival By Treatment GOG111: Survival By Treatment Ali Alive Died Di d M di Median PFS PFS R l ti Relative Treatment (N) (N) Survival (mo) Risk Cisplatin/ 28 174 13.0 – cyclophosphamide y p p Cisplatin/paclitaxel 45 138 18 0.69 Adapted with permission from McGuire WP, et al. N Engl J Med. 1996 ;334:1-6.
Role of IP Chemotherapy for Optimally Debulked Role of IP Chemotherapy for Optimally Debulked py py p p y y Advanced Advanced- -Stage Ovarian Cancer Stage Ovarian Cancer Imp Imp Improved outcome in Improved outcome in d d t t m i m i CP- CP -treated patients when treated patients when GOG GOG cisplatin administered IP cisplatin administered IP 104 1 104 (relative risk, 0.76) (relative risk, 0.76) Improved outcome in Improved outcome in TP TP- -treated patients when treated patients when GOG GOG cisplatin administered IP cisplatin administered IP 114 114 2 (relative risk, 0.78) (relative risk, 0.78) Improved outcome in Improved outcome in TP- TP -treated patients when treated patients when GOG GOG paclitaxel and cisplatin paclitaxel and cisplatin p p p p 172 172 3 172 172 administered IP administered IP (relative risk, 0.73) (relative risk, 0.73) CP =Cyclophosphamide and cisplatin; IP = Intraperitoneal; TP = Paclitaxel and cisplatin. 1 Alberts DS et al N Engl J Med 1996;335:1950 1955 1. Alberts DS, et al. N Engl J Med. 1996;335:1950-1955. 2. Markman M, et al. J Clin Oncol. 2001;19:1001-1007. 3. Armstrong DK et al. N Engl J Med. 2006;354:34-43. Reprinted with permission from Memorial Sloan-Kettering Cancer Web site. Available at: www.mskcc.org/patient_education/html/ 41495.cfm. Accessed March 9, 2006.
Carboplatin plus Paclitaxel versus Carboplatin Carboplatin plus Paclitaxel versus Carboplatin plus Stealth Liposomal Doxorubicin in patients plus Stealth Liposomal Doxorubicin in patients l l St St lth Li lth Li l D l D bi i i bi i i ti ti t t with Advanced Ovarian Cancer with Advanced Ovarian Cancer S. Pignata S. Pignata et al et al Abstract 5508 Abstract 5508
Abstract 5508 Abstract 5508 St d d si n Study design Study design St d d si n Control arm R Carboplatin AUC 5, day 1 C b l ti AUC 5 d 1 a Paclitaxel 175 mg/m 2 , day 1 n Treatment repeated every 21 days, for 6 cycles p y y y 1:1 d d o m Experimental arm Experimental arm Carboplatin AUC 5, day 1 Strata: PLD 30 mg/m 2 , day 1 • Center • PS (0-1, 2) Treatment repeated every 21 days, for 6 cycles • Stage (IC, II, III, IV) • Residual disease after surgery (absent, 1 cm, 1 cm, no surgery) ( , , , g y)
Study population/Endpoint Study population/Endpoint y p p y p p p p Inclusion criteria Inclusion criteria Cyto/histological diagnosis of ovarian cancer Cyto/histological diagnosis of ovarian cancer • FIGO Stage IC FIGO Stage IC – – II II – – III III – – IV IV • Age Age 75 75 • ECOG Performance Status 0 ECOG P ECOG P ECOG Performance Status 0-2 f f 0 0 2 • No previous chemotherapy No previous chemotherapy • Main exclusion criteria Main exclusion criteria Main exclusion criteria Main exclusion criteria ANC ANC 2000 2000/ / L, platelets , platelets 100000 100000/ / L L • Creatinine 1.25 x UNL, SGOT and SGPT Creatinine 1.25 x UNL, SGOT and SGPT 1.25 x UNL 1.25 x UNL • Life expectancy of less than 3 months Life expectancy of less than 3 months p p y y • Primary Endpoint: Primary Endpoint: Progression Progression free survival (PFS) Progression Progression-free survival (PFS) free survival (PFS) free survival (PFS)
Baseline characteristics Baseline characteristics Baseline characteristics Baseline characteristics Carbo + Paclitaxel Carbo + Paclitaxel Carbo + Paclitaxel Carbo + Paclitaxel Carbo + PLD Carbo + PLD Carbo + PLD Carbo + PLD (n = 410) (n = 410) (n=410) (n=410) 57 57 (21 (21- -77) 77) 57 57 (25 (25- -77) 77) Age Age median (range) median (range) ECOG Performance Status ECOG Performance Status 0- -1 1 398 398 (97%) (97%) 397 397 (97%) (97%) 2 12 12 (3%) (3%) 13 13 (3%) (3%) FIGO Stage FIGO Stage IC IC 38 38 (9%) (9%) 38 38 (9%) (9%) II II 40 40 (10%) (10%) 37 37 (9%) (9%) III III 243 243 (59%) (59%) 247 247 (60%) (60%) IV IV IV IV 89 89 89 89 (22%) (22%) (22%) (22%) 88 88 88 88 (22%) (22%) (22%) (22%) Residual disease after surgery Residual disease after surgery Absent Absent 152 152 (37%) (37%) 150 150 (37%) (37%) 1 cm 1 cm 1 cm 1 cm 68 68 68 68 (17%) (17%) (17%) (17%) 69 69 69 69 (19%) (19%) (19%) (19%) 1 cm 1 cm 117 117 (28%) (28%) 114 114 (28%) (28%) No surgery No surgery 73 73 (18%) (18%) 67 67 (16%) (16%)
Objective response – Objective response – RECIST RECIST W W Women with target lesions Women with target lesions i h i h l l i i Carbo Carbo Carbo Carbo Carbo Carbo Carbo Carbo p p + Paclitaxel + Paclitaxel + PLD + PLD ( 2 )* )* (n=156) (n=156) (n=134) (n=134) Obj Obj Objective response Objective response ti ti 0.70 0.70 0 70 0 70 92 (59%) 92 (59%) % 76 (57%) 76 (57%) % Complete response Complete response 24 (15%) 24 (15%) 22 (16%) 22 (16%) Partial response Partial response p 68 (44%) 68 (44%) 68 (44%) 68 (44%) 54 (40%) 54 (40%) 54 (40%) 54 (40%) No response No response 64 (41%) 64 (41%) 58 (43%) 58 (43%) Stable disease Stable disease 45 (29%) 45 (29%) 41 (31%) 41 (31%) Progressive disease Progressive disease 9 (6%) 9 (6%) 7 (5%) 7 (5%) Not evaluated Not evaluated 10 (6%) 10 (6%) 10 (7%) 10 (7%) * Objective response vs no response
Toxicity Toxicity Any grade Any grade Severe (G Severe (G 3) ) C+P C+P C+PLD C+PLD p* p* C+P C+P C+PLD C+PLD p* p* Toxic deaths Toxic deaths 0.8% 0.8% 0.5% 0.5% 1 1 Anemia Anemia 59% 59% 68% 68% 0.007 0.007 4% 4% 10% 10% 0.001 0.001 RBC transfusions RBC transfusions 2% 2% 6% 6% 0.002 0.002 Neutropenia Neutropenia p 73% 73% 80% 80% 0.04 0.04 49% 49% 43% 43% 0.09 0.09 Febrile neutropenia Febrile neutropenia 2% 2% 1% 1% 0.21 0.21 Thrombocytopenia Thrombocytopenia 19% 19% 48% 48% 0.001 0.001 2% 2% 16% 16% 0.001 0.001 Platelet transfusions Platelet transfusions Platelet transfusions Platelet transfusions 0.3% 0.3% 0.3% 0.3% 2% 2% 2% 2% 0.06 0.06 0.06 0.06 Bleeding Bleeding 0.3% 0.3% 1% 1% 0.37 0.37 - - 1% 1% 0.24 0.24 C+P: carboplatin + paclitaxel, 399 patients; C+PLD: carboplatin + PLD, 386 patients *Chi square or Fisher exact test as appropriate
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