Ovarian GOG trials Flashcards
GOG 95 Young et al. JCO 2003
Phase III randomized trial of IP P32 v IV cyclophosphamide/cisplat (C/P)
No difference is OS (but 17% lower in C/P), lower recurrence rate (28% v 35%) in C/P preferred therapy
GOG 97 Hoskins et al. Am J Obstet Gyn 1994; McGuire et al. JCO 1995
- Randomized trial of suboptimally (>1cm) debulked stage III/IV ovarian ca to determine if dose intensity (cyclophosphamide/cisplat increased dose for 4 q3wk cycles) v. standart tx (cyclophosphamide/cisplat 8 cycles) is superior.
- No improvement in RR, PFS< OS adn increased toxicity wiht dose intense chemo
- Secondary analysis showed significant improvement is OS with <2 cm residual disease
GOG 104 Alberts et al. NEJM 1996
- Phase III trial if IP cisplat/IV cyclophosphomide v. IV cisplat/cyclophosphomide in optimal (<2cm) debulked ovarian ca.
- improved OS in IP arm (49 v 41 mo) decreased tinnitus, hearing loss and myelosuppression in IP arm.
GOG 111 McGuire et al. NEJM 1996
- Phase III trial comparing cyclophosphamide/cisplat v cisplat/paclitaxel in suboptimal (>1cm) debulked stage III/IV ovarian ca.
- Paclitaxel/cisplat superior with PFS (18 v. 13 mo) and OS (38 v. 24 mo)
GOG 114 Markman et al. JCO 2001
-Phase III trial of standard cisp/paclitaxel vs. moderatly high dose carbo/paclitaxel/IP cis in opitmal (</= 2 cycles IP therapy
GOG 115 Homesley et al Gyn Onc 1999
Phase II trial of BEP as first line for stromal tumors
BEP is an active combination for first line in stromal tumors
37% were negative for residual disease at 2nd look xl
61% had grade 4 myelosuppression
GOG 116 Williams et al. Gyn Onc 2004
Phase II trial of carbo adn etoposide as adjuvant therapy for completely resected stage IB-III dysgerminoma
active regimen as an alteratnive to BEP when goal is to minimize toxicity
GOG 132 Muggia et al. JCO 2000
Phase III trial of cis v paclitaxel v cis/paclitaxed in suboptimal (>1cm) stage III/IV ovarian ca
cis monotherapy and combo were supreior to paclitaxel alone for RR, PFS but not OS
toxicity profile was better in combo arm; monotherapy discontinued in 17% cis, 20% paclitaxel, 7% combo
combo cis/paclitaxel remain preferred initial treatment option
GOG 134 Omura et al JCO 2003
Phase III trial of paclitaxel at 2 dose levels (135, 175, 250 mg/m2 over 24 hours) in platinum pre treated (presistant, recurrent, progressive) ovarian ca
higher response rate with 250 dose; no difference with PFS, OS
toxicity higher in 250 dose (despite addition of filgrastim) and 175 dose is recommended
GOG 152 Rose et al NEJM 2004
Randomized trial of secondary cytoreduction after 3 cycles of cis/paclitaxel followed by 3 more cycles vs no secondary cytoreduction in stage III ovarian cancer who had maximal attempt at primary surgery with >1cm residual remaining
No benefit in PFS or OS from secondary
GOG 157 Bell et al Gyn Onc 2006
phase III trial of 3 v 6 cycles of adjuvant carbo/taxol in early stage ovarian ca
nonsignificant 24% reduction in recurrence rate and no idfference in OS with additional toxicity of 6 cycles
GOG 158 Ozols JCO 2003
Phase III trial os cis/taxol 24 hr v carbo (AUC 7.5)/taxol 3 hr in optimal <1cm ovarian ca
carbo/taxol NOT inferior to cis/taxol adn has less toxicity and easier administration
GOG 172 Armstrong NEJM 2006
Phase III trial of taxol 24 hr/cis v taxol 24 hr/IP cis/IP taxol in optimal (<1cm) stage III ovarian ca
improved PFS 23.8 v 18.3 and OS 65.6 v 49.7 w/ IP therapy
only 42% in IP arm completed 6 cycles of assigned therapy
GOG 178 Markman JCO 2003
Phase III trial of 12 mo v 3 mo maintenance taxol in advanced stage ovarian ca afte rcomplete response to first line
interim analysis showed improved PFS with 12 mo maintenance 28 v 21 months
question of crossover in the study and no OS data because of early termination at interim analysis
GOG 182 Bookman JCO 2009
Phase III RCT 5 arm trial comparing the additoion of gem, doxil and topo to carbo/taxol v. carbo/taxol along in stage III/IV ovarian ca
no improvment in PFS or OS
