Ovarian cancer Flashcards
EORTC 44865 Aim
Establish effect on survival of SDS after induction of chemotherapy
EORTC 44865 Inclusion
Stage IIB-IV EOC, residual tumor <1cm after PDS
EORTC 44865 Arms
Arm 1: PDS –> chemo x6C, no SDS
Arm 2: PDS–> chemo x3C –> SDS –> chemo 3C
Chemo: cyclophosphamide 750mg/m2 + cis 75mg/m2
EORTC 44865 Results
n=278, SDS= 140, Chemo only=138
PFS: 18mo (SDS) vs 13mo
OS: 26mo vs 20mo
SDS significantly lengthened PFS and OS
GOG 152 Aim
To determine whether SDS improves PFS and OS in patients with advanced OC and residual tumor >1cm after primary debulking
GOG 152 Inclusion
Stage III or IV OC w/ >1cm residual tumor after PDS
GOG 152 arms
Arm 1: PDS –> chemo x6C
Arm 2: PDS –> 3C –> SDS –> 3C
Chemo: cis 75 + taxol 135
GOG 152 results
n=424
OS 33.9mo (SDS) vs 33.7mo (no SDS)
Risk of death or progression 7% higher in SDS than in CT alone
Chemo plus aggressive SDS did not improve PFS or OS compared with chemo alone
AGO DESKTOP OVAR trials- AIM
To develop and test a scoring system to determine who benefits from SDS in relapsed OC
AGO DESKTOP OVAR III inclusion
Relapsed, histologically dx EOC or relapsed dz radiologically, at least 6 months after last course of platinum based chemo
Positive AGO score
AGO score
Platinum sensitive disease
ECOG score 0
Ascites <500cc
R0 debulk at original surgery
AGO DESKTOP OVAR III Arms
Arm 1: CRS + CT (physician choice, platinum based)
Arm 2: CT alone
AGO DESKTOP OVAR III Results
n=407
R0 resection in 75.5%
Re-operation in 3.7%
OS 53.7mo (SDS) vs 46mo (CT) (SS)
PFS 18.4mo vs 14mo
OS 61.9mo (complete resection) vs 27.7mo (incomplete)
47 in each group had Bev, 20 total had PARP
CRS in addition to platinum based chemo resulted in increase in OS
Chi criteria
Offer SDS if:
- 1 site of recurrence, DFI >6mo
-Multiple sites but no carcinomatosis, DFI >12mo
-Carcinomatosis, DFI >30 mo
(retrospective study)
SOC-1
EORTC 55971 Aim
Compare PDS + chemo vs NACT+IDS
EORTC 55971 Inclusion
Stage IIIC or IV EOC
EORTC 55971 Arms
Arm 1: PDS –> 6C platinum based chemo
Arm 2: 3C PB chemo –> IDS –> 3C PB chemo
EORTC 55971 Results
n=670
residual tumor was <1cm after PDS in 41.6% vs 80.6% after IDS
OS 29mo (PDS) vs 30mo (IDS)
PFS 12 mo in both
Survival after NACT followed by IDS was non inferior and similar to PDS followed by chemo
CHORUS Aim
To test if NACT and IDS is non inferior to PDS followed by chemo
CHORUS Inclusion
clinical or imaging evidence of pelvic mass and extra-pelvic disease compatible with stage III or IV TOC
Only those assigned to primary chemo had histologic confirmation
CHORUS Arms
Arm 1: PDS + Chemo x6C
Arm 2: Chemo 3C –> IDS –> Chemo 3C
Chemo= carbo 5-6 + taxol 175 q3wk x 6C
CHORUS results
n=550
OS 31% (PDS) vs 34% (IDS)
22.6mo (PDS) vs 24.1 mo (IDS)
PFS 10.7 mos vs 12mo
R1 debulking accomplished in 41% PDS, 73% IDS
Women with stage III or IV TOC w/ high tumor burden, survival after IDS was not inferior to PDS
JCOG 0602 Aim
To confirm non inferiority of efficacy and show decrease in adverse events owing to reduced surgical invasiveness of NACT compared with PDS
JCOG 0602 inclusion
Stage III or IV TOC, no dx lap preop
JCOG 0602 arms
Arm 1: PDS + Chemo x 8C (allowed IDS if primary debulk > R1)
Arm 2: Chemo x4C –> IDS –> Chemo x4C
JCOG 0602 Results
n=297
R1 debulk in 82% (IDS) vs 37% (PDS)
OS 44.3mo (IDS) vs 49mo (PDS)
PFS 16.4mo(IDS) vs 15.1mo (PDS)
Non inferiority not confirmed. NACT may not always be a substitute for PDS
There was a high rate of IDS in the PDS group, which could have falsely elevated OS
LION Aim
To determine if systematic LND affects OS in patients with advanced OC
LION Inclusion
Stage IIB-IV EOC (mets must be confirmed to peritoneal cavity)
Complete macroscopic resection feasible and achieved
LION Arms
Arm 1: complete PPALND
Arm 2: No LND
LION results
LND=323; no LND =324
Microscopic LN mets in 55.7% of LND group
OS 65.5mo (LND) vs 69.2mo (no LND) (SI)
PFS 25.5mo in both
Patients with advanced OC who underwent macroscopic complete resection did not benefit from systematic LND
SCORPION Aim
To demonstrate that PDS is associated w/ high peri-op complications than IDS after NACT
To determine whether there is significant improvement in PFS with NACT over PDS
SCORPION Inclusion
Stage IIIC or IV EOC, chemo naive
SCORPION Arms
Arm 1: PDS w/ aim of R0–> 6C chemo. No SDS allowed
Arm 2: Chemo 3-4C –> IDS –> chemo to complete 6 C
SCORPION Results
n=171
PFS 15mo (PDS) vs 15mo (IDS) (SI)
OS 41mo (PDS) vs 43mo (IDS) (SI)
NACT and PDS have same efficacy but different toxicity profiles.
7 deaths in PDS, and 0 IDS.
Major complications 25.9% (PDS), 7.6% (IDS)
ACTION Aim
Compare platinum based adjuvant chemo with no further treatment following surgery in early stage OC
ACTION inclusion
Stages Ia-Ib, G2-3, IC-IIA clear cell, all grades IC-IIA, Surgery w/ TAH/BSO +staging
ACTION arms
Arm 1: observation
Arm 2: platinum based chemo x 4-6C (single agent cis, or combo)
ACTION results
n=448
Most people got cis/cytoxin (47%) or cis (33%)
RFS HR 0.63 (SS)
OS HR 0.69 (SS)
1/3 optimally staged, 2/3 were not
optimally staged patients had no benefit with chemo
Adjuvant CT improves RFS, but appears to be limited to those without optimal staging
ICON1 Aim
To determine if adjuvant chemo is necessary in early stage EOC after surgery
ICON1 Inclusion
Early stage EOC, physician unsure of whether to give chemo, no residual dz after complete staging
No restrictions on stage or grade
ICON1 arms
Arm 1: No chemo
Arm 2: chemo (87% got single agent carbo, other options included CAP or single agent cis)
ICON1 results
n=477
90% of patients stage 1-1C
OS 79% (tx) vs 70% (no tx) (SS)
PFS 73% vs 62% (SS)
All patients with early stage OC should be considered for platinum based CT after removal of all visible tumor
GOG 157 Aim
To compare recurrence rates following 3C or 6C of carbo/taxol in early stage EOC
GOG 157 inclusion
EOC, completely resected IAG3 (or CC), IBG3 (or CC), IC, or stage II
GOG 157 arms
Arm 1: 3 cycles
Arm 2: 6 cycles
Chemo= carbo 7.5AUC + taxol 175
GOG 157 results
n=427
recurrence rate 24% lower (6C), HR 0.761 (SI)
estimated recurrence rate in 5 yrs 25.4% (3C) vs 20.1% (6C)
6C of carbo/taxol do not alter recurrence risk in HR early stage EOC, but have more toxicity than 3C
GOG 157 exploratory analysis results
5yr RFS (serous): 82.7% (6c) vs 60.4% (3c) (SS)
5yr OS (serous): 85.6% (6c) vs 73.2% (3c) (SI)
5yr RFS (non-serous): 78.7% vs 78.6% (SI)
6C of chemo significantly increases RFS in serous histology, but not in non serous
GOG 175 findings
Adding 24 weeks of weekly taxol to standard carbo/taxol does not impact OS in patients with HR early stage EOC
ICON2 aim
To compare single agent carbo against CAP in women with advanced EOC
ICON2 inclusion
Histologically confirmed EOC, no prior malignant, chemo or RT
ICON2 arms
Arm 1: cytoxan + doxorubicin + cis q3wk x 6C
Arm 2: carboplatin AUC 5 q3 wks x 6C
ICON2 results
n=1526
PFS 17mo (CAP) vs 15.5 (carbo) (SI)
OS 60% in both groups (SI)
ICON3 aim
to compare safety and efficacy of paclitaxel + carbo with CAP or carbo alone
ICON3 inclusion
histologically confirmed EOC, no prior malignancy, chemo, or RT
ICON3 arms
Arm 1: CAP vs C/T
Arm 2: carbo vs CT
ICON3 results
No difference between any of the groups in PFS or OS
GOG 158 aim
Non inferiority study to compare efficacy and toxicity of carbo/taxol vs cis/taxol
GOG 158 inclusion
Stage 3 EOC, s/p debulkings to <1cm
GOG 158 arms
Arm 1: Cis 75 + taxol 135 (24hr infusion)
Arm 2: Carbo 7.5AUC + taxol 175 (3hr infusion)
all q3 wks x 6C
GOG 158 results
n=729
Median PFS 19.4 mo (cis) vs 20.7 mo (carbo) (SI)
OS 48.7mo (cis) vs 57.4mo (carbo) (SI)
SCOTROC Aim
compare efficacy, tolerability, and QoL outcomes of docetaxel-carbo w/ paclitaxel-carbo
SCOTROC inclusion
Confirmed TOC, stage IC-IV
SCOTROC arms
Arm 1: carbo 5AUC + taxol 175
Arm 2: Docetaxel 75 + carbo 5AUC
both q3wks, x6C
SCOTROC Results
n=1077
PFS 15mo (Doc) vs 14.8mo (Pac)
OS 64.2% (D) vs 68.9% (P) (SI)
CR 28% in both
Docetaxel-carbo appears to have a similar efficacy to paclitaxel carbo
NOVEL (JCOG 3016) Aim
to compare standard 3wk carbo/taxol to carbo q3wks + weekly taxol (dose dense)
NOVEL/JCOG 3016 inclusion
Stage II-IV epithelial TOC
NOVEL/JCOG 3016 Arms
Arm 1: Carbo 6AUC + taxol 180 q3wks x 6C
Arm 2: carbo q3wks + taxol 80 days 1, 8, 15
NOVEL/JCOG 3016 Results
n=627
PFS 28mo (DD) vs 17.2 (reg) (SS)
OS 72.1% (DD) vs 65.1% (SS)
long term PFS 28.2 vs 17.5
long term OS 100.5 vs 62.2