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Gyn Onc > Ovarian cancer > Flashcards

Ovarian cancer Flashcards

1
Q

EORTC 44865 Aim

A

Establish effect on survival of SDS after induction of chemotherapy

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2
Q

EORTC 44865 Inclusion

A

Stage IIB-IV EOC, residual tumor <1cm after PDS

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3
Q

EORTC 44865 Arms

A

Arm 1: PDS –> chemo x6C, no SDS
Arm 2: PDS–> chemo x3C –> SDS –> chemo 3C

Chemo: cyclophosphamide 750mg/m2 + cis 75mg/m2

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4
Q

EORTC 44865 Results

A

n=278, SDS= 140, Chemo only=138
PFS: 18mo (SDS) vs 13mo
OS: 26mo vs 20mo

SDS significantly lengthened PFS and OS

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5
Q

GOG 152 Aim

A

To determine whether SDS improves PFS and OS in patients with advanced OC and residual tumor >1cm after primary debulking

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6
Q

GOG 152 Inclusion

A

Stage III or IV OC w/ >1cm residual tumor after PDS

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7
Q

GOG 152 arms

A

Arm 1: PDS –> chemo x6C
Arm 2: PDS –> 3C –> SDS –> 3C

Chemo: cis 75 + taxol 135

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8
Q

GOG 152 results

A

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

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9
Q

AGO DESKTOP OVAR trials- AIM

A

To develop and test a scoring system to determine who benefits from SDS in relapsed OC

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10
Q

AGO DESKTOP OVAR III inclusion

A

Relapsed, histologically dx EOC or relapsed dz radiologically, at least 6 months after last course of platinum based chemo
Positive AGO score

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11
Q

AGO score

A

Platinum sensitive disease
ECOG score 0
Ascites <500cc
R0 debulk at original surgery

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12
Q

AGO DESKTOP OVAR III Arms

A

Arm 1: CRS + CT (physician choice, platinum based)
Arm 2: CT alone

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13
Q

AGO DESKTOP OVAR III Results

A

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

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14
Q

Chi criteria

A

Offer SDS if:
- 1 site of recurrence, DFI >6mo
-Multiple sites but no carcinomatosis, DFI >12mo
-Carcinomatosis, DFI >30 mo

(retrospective study)

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15
Q

SOC-1

A
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16
Q

EORTC 55971 Aim

A

Compare PDS + chemo vs NACT+IDS

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17
Q

EORTC 55971 Inclusion

A

Stage IIIC or IV EOC

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18
Q

EORTC 55971 Arms

A

Arm 1: PDS –> 6C platinum based chemo
Arm 2: 3C PB chemo –> IDS –> 3C PB chemo

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19
Q

EORTC 55971 Results

A

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

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20
Q

CHORUS Aim

A

To test if NACT and IDS is non inferior to PDS followed by chemo

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21
Q

CHORUS Inclusion

A

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

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22
Q

CHORUS Arms

A

Arm 1: PDS + Chemo x6C
Arm 2: Chemo 3C –> IDS –> Chemo 3C

Chemo= carbo 5-6 + taxol 175 q3wk x 6C

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23
Q

CHORUS results

A

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

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24
Q

JCOG 0602 Aim

A

To confirm non inferiority of efficacy and show decrease in adverse events owing to reduced surgical invasiveness of NACT compared with PDS

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25
Q

JCOG 0602 inclusion

A

Stage III or IV TOC, no dx lap preop

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26
Q

JCOG 0602 arms

A

Arm 1: PDS + Chemo x 8C (allowed IDS if primary debulk > R1)
Arm 2: Chemo x4C –> IDS –> Chemo x4C

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27
Q

JCOG 0602 Results

A

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

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28
Q

LION Aim

A

To determine if systematic LND affects OS in patients with advanced OC

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29
Q

LION Inclusion

A

Stage IIB-IV EOC (mets must be confirmed to peritoneal cavity)
Complete macroscopic resection feasible and achieved

30
Q

LION Arms

A

Arm 1: complete PPALND
Arm 2: No LND

31
Q

LION results

A

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

32
Q

SCORPION Aim

A

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

33
Q

SCORPION Inclusion

A

Stage IIIC or IV EOC, chemo naive

34
Q

SCORPION Arms

A

Arm 1: PDS w/ aim of R0–> 6C chemo. No SDS allowed
Arm 2: Chemo 3-4C –> IDS –> chemo to complete 6 C

35
Q

SCORPION Results

A

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)

36
Q

ACTION Aim

A

Compare platinum based adjuvant chemo with no further treatment following surgery in early stage OC

37
Q

ACTION inclusion

A

Stages Ia-Ib, G2-3, IC-IIA clear cell, all grades IC-IIA, Surgery w/ TAH/BSO +staging

38
Q

ACTION arms

A

Arm 1: observation
Arm 2: platinum based chemo x 4-6C (single agent cis, or combo)

39
Q

ACTION results

A

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

40
Q

ICON1 Aim

A

To determine if adjuvant chemo is necessary in early stage EOC after surgery

41
Q

ICON1 Inclusion

A

Early stage EOC, physician unsure of whether to give chemo, no residual dz after complete staging
No restrictions on stage or grade

42
Q

ICON1 arms

A

Arm 1: No chemo
Arm 2: chemo (87% got single agent carbo, other options included CAP or single agent cis)

43
Q

ICON1 results

A

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

44
Q

GOG 157 Aim

A

To compare recurrence rates following 3C or 6C of carbo/taxol in early stage EOC

45
Q

GOG 157 inclusion

A

EOC, completely resected IAG3 (or CC), IBG3 (or CC), IC, or stage II

46
Q

GOG 157 arms

A

Arm 1: 3 cycles
Arm 2: 6 cycles

Chemo= carbo 7.5AUC + taxol 175

47
Q

GOG 157 results

A

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

48
Q

GOG 157 exploratory analysis results

A

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

49
Q

GOG 175 findings

A

Adding 24 weeks of weekly taxol to standard carbo/taxol does not impact OS in patients with HR early stage EOC

50
Q

ICON2 aim

A

To compare single agent carbo against CAP in women with advanced EOC

51
Q

ICON2 inclusion

A

Histologically confirmed EOC, no prior malignant, chemo or RT

52
Q

ICON2 arms

A

Arm 1: cytoxan + doxorubicin + cis q3wk x 6C
Arm 2: carboplatin AUC 5 q3 wks x 6C

53
Q

ICON2 results

A

n=1526
PFS 17mo (CAP) vs 15.5 (carbo) (SI)
OS 60% in both groups (SI)

54
Q

ICON3 aim

A

to compare safety and efficacy of paclitaxel + carbo with CAP or carbo alone

55
Q

ICON3 inclusion

A

histologically confirmed EOC, no prior malignancy, chemo, or RT

56
Q

ICON3 arms

A

Arm 1: CAP vs C/T
Arm 2: carbo vs CT

57
Q

ICON3 results

A

No difference between any of the groups in PFS or OS

58
Q

GOG 158 aim

A

Non inferiority study to compare efficacy and toxicity of carbo/taxol vs cis/taxol

59
Q

GOG 158 inclusion

A

Stage 3 EOC, s/p debulkings to <1cm

60
Q

GOG 158 arms

A

Arm 1: Cis 75 + taxol 135 (24hr infusion)
Arm 2: Carbo 7.5AUC + taxol 175 (3hr infusion)

all q3 wks x 6C

61
Q

GOG 158 results

A

n=729
Median PFS 19.4 mo (cis) vs 20.7 mo (carbo) (SI)
OS 48.7mo (cis) vs 57.4mo (carbo) (SI)

62
Q

SCOTROC Aim

A

compare efficacy, tolerability, and QoL outcomes of docetaxel-carbo w/ paclitaxel-carbo

63
Q

SCOTROC inclusion

A

Confirmed TOC, stage IC-IV

64
Q

SCOTROC arms

A

Arm 1: carbo 5AUC + taxol 175
Arm 2: Docetaxel 75 + carbo 5AUC

both q3wks, x6C

65
Q

SCOTROC Results

A

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

66
Q

NOVEL (JCOG 3016) Aim

A

to compare standard 3wk carbo/taxol to carbo q3wks + weekly taxol (dose dense)

67
Q

NOVEL/JCOG 3016 inclusion

A

Stage II-IV epithelial TOC

68
Q

NOVEL/JCOG 3016 Arms

A

Arm 1: Carbo 6AUC + taxol 180 q3wks x 6C
Arm 2: carbo q3wks + taxol 80 days 1, 8, 15

69
Q

NOVEL/JCOG 3016 Results

A

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

70
Q
A

Gyn Onc (6 decks)

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