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Gyn Onc > Endometrial Cancer > Flashcards

Endometrial Cancer Flashcards

1
Q

CONSORT Aim

A

To investigate whether the addition of systematic PLND to standard surgery improved OS and DFS in pts with peri-operative stage I EC

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2
Q

CONSORT results

A

5yr DFS 81% (LND) vs 81.7% (no LND)
OS 85.9% (LND) vs 90% (no LND)

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3
Q

CONSORT conclusion

A

The addition of systematic pelvic LND to hyst/BSO did not improve DFS or OS compared to no LND (aka no therapeutic benefit of LND)

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4
Q

ASTEC aim

A

To assess therapeutic benefit of pelvic LND in EC confined to the corpus

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5
Q

ASTEC inclusion

A

LR= IA, IB, and G1, G2
Intermediate/HR=IA or IB w/ high grade (G3, serous, CC)
Advanced=spread beyond the corpus

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6
Q

ASTEC results

A

Sx only= 802, Sx+LND=701
5yr OS 81% (sx) vs 80% (sx+LND)
5yr RFS 79% vs 73%

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7
Q

ASTEC conclusion

A

There is no evidence of a benefit for systematic LND for EC in terms of OS, RFS, and cannot be recommended for therapeutic purposes

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8
Q

LAP2 aim

A

To compare perioperative morbidity and mortality between laparoscopy and laparotomy for the stating of uterine cancer

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9
Q

LAP2 Inclusion

A

Stage I to IIA uterine cancer (1988 staging)

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10
Q

LAP2 results

A

TLH= 1630, TAH=886
-25.8% converstion to TAH
-op time longer in TLH
-no differences in complications, readmit, reoperation
-1.14% difference in recurrence at 3yrs
-0.24% trocar site recurrence (3 of 4 had advanced dz)
-5yr OS 89.8% in both
-5yr recurrence 11.61% (TAH) vs 13.68% (TLH)

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11
Q

LAP2 Results

A

Laparoscopic comprehensive surgical staging for uterine cancer is feasible and has an improved safety profile compared to laparotomy

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12
Q

SENTI-ENDO aim

A

To assess detection rate and diagnostic accuracy of SLN in predicting the pathological pelvic node status in patients with early stage EC (using tech-99)

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13
Q

SENTI-ENDO inclusion

A

Stages I and II EC

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14
Q

SENTI-ENDO results

A

at least one SLN in 111/125 (88.8%)
-B/l mapping in 62%
-for hemipelvis: NPV 100%, sensitivity 100%
-for patient: NPV 97%, sensitivity 84%
-FN rate 6%
-SLN upstaged 10% of LR and 15% of IR

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15
Q

SENTI-ENDO conclusion

A

SLN biopsy could be a trade off between systematic LND and no dissection in patients at low and IR and could provide important data to tailor adjuvant therapy

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16
Q

FIRES aim

A

To estimate the sensitivity and NPV of SLN mapping using RA-fluorescence imaging of the tracer indocyanine green in detecting lymphatic mets in pts with EC

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17
Q

FIRES inclusion

A

documented EC of ANY histology from endometrial sampling, clinical stage I

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18
Q

FIRES results

A

-86% successful mapping of at least 1SLN
-b/l mapping 52%
-sensitivity 97.2%, NPV 99.6%
-FN rate 2.8%
-1pt w/ FN had serous papillary

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19
Q

FIRES conclusion

A

SLN mapping with ICG can safely replace LND.
SLN mapping will not identify 3% of patients with nodal dz, but will expose fewer patients to the morbidity of complete LND

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20
Q

SENTOR aim

A

To evaluate the performance of SLN using ICG in patients with stage 1 dz, with IR and high grade subtypes

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21
Q

SENTOR inclusion

A

Clinical stage IG2 endometrioid
High grade (G3, serous, CC, carcinosarcoma, undiff/dediff)

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22
Q

SENTOR results

A

n=156
-all had PLND, 80% had PALND
-SLN detection rate: 97.4%/pt, 87.5%/hemipelvis, 77.6% b/l
-NPV 99.1%
-sensitivity 96%, FN 4%
-2/27 had single metastatic SLN identified outside of traditional PLN boundaries

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23
Q

PORTEC-1 Aim

A

To establish the role of post operative pelvic RT in Stage 1 EC

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24
Q

PORTEC-1 inclusion

A

All cell types
Stage IG1 w/ >50% MI
G2 w/ an MI
G3 w/ <50% MI

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25
Q

PORTEC-1 results

A

5yr OS 81% (RT) vs 85% NAT
Locoregional relapse 4% (RT) vs 14% (NAT)

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26
Q

PORTEC-1 conclusion

A

Postoperative RT improves locoregional control, but not OS

Whole pelvic RT should be reserved with HR patients

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27
Q

GOG 99 Aim

A

To establish whether RT improves RFI in patients with HIR EC

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28
Q

GOG 99 inclusion

A

HIR
-At least 70yo + 1RF
-at least 50yo + 2RF
-any age + 3 RF

RF= G2 or G3, outer 1/3 involvement, LVSI

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29
Q

GOG 99 results

A

-24mo recurrence: 3% RT vs 12% NAT
-HIR 6% vs 26%
-Local recurrence: 1.6% vs 8.9%
-distant recurrence: 5.3% vs 6.4%
-4yr OS: 92% (RT) vs 86% (NAT) p=0.557

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30
Q

GOG 99 conclusion

A

Whole pelvic RT reduces risk of recurrence by 58% but does not impact OS
Tx with RT should be limited to patients who fit HIR category

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31
Q

PORTEC-2 Aim

A

Whether VBT=EBRT in reduction of vaginal recurrence of EC

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32
Q

PORTEC-2 inclusion

A

HIR

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33
Q

PORTEC-2 Results

A

5yr OS 82.1% (EBRT) vs 86.2% (VBT)
5yr DFS 80.2% vs 84.5%

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34
Q

PORTEC-2 Conclusion

A

VBT is effective in ensuring local control and OS + DFS are similar to EBRT. Should be tx of choice for HIR EC

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35
Q

GOG 249 aim

A

Whether VBT/CT vs VBT alone has better RFS in women with HR, early stage EC

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36
Q

GOG 249 inclusion

A

GOG 99 HIR
Stage II (cvx) regardless of other RF
Serous or CC stage 1-2 w/ neg peritoneal cytology

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37
Q

GOG 249 results

A

5yr RFS 76% in both
5yr OS 87% (RT) vs 85% (VBT/CT)
no difference in rate of vaginal cuff recurrences
-PALN and pelvic recurrence: 4% vs 9%
-Distant recurrence: 2.5% vs 18%

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38
Q

RTOG 9708 Aim

A

Establish the safety and toxicity of RT and CT for endometrial cancer following surgery

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39
Q

RTOG 9708 inclusion

A

No metastatic dz outside the pelvis
-G2 or 3 w/ >50% MI
-stromal invasion of cervix
-extrauterine dz confined to pelvis and/or positive peritoneal cytology

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40
Q

RTOG 9708 arms

A

One arm observational
Pelvic RT 45Gy + Cis 50 day 1 and 28
VBT– LDR 20Gy or HDR 18Gy
After RT –> cis/taxol x4C

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41
Q

RTOG9708 Results

A

4yr pelvic recurrence 2%
4yr regional recurrence 19%
OS 85%, DFS 81%
Stage 3 pts: OS 77%, DFS 72%
No recurrences for stage IC, IIA, IIB

42
Q

GOG 258 Aim

A

To evaluate the use of concurrent tumor volume directed EBRT and CT compared with CT alone

43
Q

GOG 258 inclusion

A

Stage III or IVA EC of any type, surgical stage I or II CC, serous and positive washings

44
Q

GOG 258 Arms

A

Arm 1: cis 50 w/ EBRT (45Gy, VBT PRN) followed by C/T x 4C
Arm 2: Carbo 6 AUC + taxol 175

45
Q

GOG 258 results

A

n=370 (CT), n=366 (CRT)
5yr RFS 58% vs 59%
Vag recurrence: 7% vs 2%
Node recurrence: 20% vs 11%
Distant recurrence: 21% vs 27%

46
Q

GOG 258 conclusion

A

The combined regimen of CRT is not superior to CT alone in prolonging RFS, but locoregional relapses were less frequent than with CT alone.

47
Q

PORTEC 3 Aim

A

To evaluate the benefit of CRT vs RT alone on HR endometrial cancer

48
Q

PORTEC 3 inclusion

A

Stage IAG3 w/ LVSI, IBG3, Stage II, Stage IIIA-C
Serous or CC stage IA w/ invasion, IB, II, or III

49
Q

PORTEC 3 arms

A

CRT: Cis 50 x2 + 48Gy –> C/T x4C
RT: 4860 cGy (VBT 14Gy PRN)

50
Q

PORTEC 3 results

A

5yr OS 81.8% (CRT) vs 76.7% (RT)
5yr FFS 75% vs 68.6%

51
Q

PORTEC 3 Post hoc

A

Stage 3: 5yr OS 78.5% (CRT) vs 68.5% (RT)
Serous: OS 71.4% (CRT) vs 52.8% (RT)

52
Q

PORTEC 3 conclusion

A

Combination of CT and RT does not significantly improve OS.

Should consider CRT for stage III and serous cancers, due to statistically significant increase in OS in post hoc analysis

53
Q

GOG 107 Aim

A

To compare doxorubicin as a single agent against combo of doxorubicin + cisplatin

54
Q

GOG 107 inclusion

A

Stage III, IV, or recurrent EC after surgery or RT

55
Q

GOG 107 arms

A

Singlet: Doxorubicin 60mg/m2 q3wk
Doublet: Doxo 60 + cist 50 q3wk

56
Q

GOG 107 results

A

PFS: 5.7mo (DC) vs 3.8 mo (D)
OS: 9mo vs 9.2mo
Overall response: 42% (DC) vs 25% (D)

57
Q

GOG 107 conclusion

A

Response rate and PFS is significantly improved when cis is added to doxorubicin, but OS is not improved and there is more toxicity

58
Q

GOG 163 aim

A

To determine whether 24hr paclitaxel plus doxorubicin is superior to cis/dox in patients with advanced EC

59
Q

GOG 163 inclusion

A

Stage III or IV, or recurrent EC

60
Q

GOG 163 arms

A

Standard: Doxo 60 + cis 50 x7C
Exp: Doxo 50 + taxol 150

61
Q

GOG 163 results

A

OR: 40% (DC) vs 43% (DP)
PFS: 7.2mo vs 6mo
OS: 12.6mo vs 13.6mo

62
Q

GOG 163 conclusion

A

Doxorubicin + taxol is not superior to doxorubicin + cis in advanced EC

63
Q

GOG 177 aim

A

To compare TAP (taxol, doxorubicin, cis) to AP (doxorubicin, cis) in terms of RR, PFS, and OS

64
Q

GOG 177 inclusion

A

Stage III, IV, or recurrent EC

65
Q

GOG 177 arms

A

AP: Doxo 60 + cis 50
TAP: doxo 45 + cis 50 + taxol 160
7C, q 3 weeks

66
Q

GOG 177 results

A

OR: 57% (TAP) vs 34% (AP)
PFS: 8.3mo vs 5.3mo (SS)
OS: 15.3mo vs 12.3mo (SS)

67
Q

GOG 177 conclusion

A

TAP significantly improves RR, PFS, and OS compared with AP. There is an increased risk of peripheral neuropathy

68
Q

GOG 122 aim

A

To compare WAI to doxo-cis in patients with advanced EC

69
Q

GOG 122 inclusion

A

Stage III or IV of any histology

70
Q

GOG 122 arms

A

RT: 30Gy WAI, 15Gy pelvis +/- PALN boost
CT: Doxorubicin 60 + Cis 50 q3wks x 8C

71
Q

GOG 122 results

A

5yr PFS 42% (CT) vs 38% (RT)
5yr OS 53% vs 42%
Gross residual disease associated with significantly shorter PFS but not OS

72
Q

GOG 209 aim

A

To determine if carboplatin and taxol could replace TAP as first line treatment in advanced or recurrent EC based on non-inferior efficacy

73
Q

GOG 122 conclusion

A

In advanced EC, CT significantly improves PFS and OS compared to RT, but causes more frequent and severe acute toxicity

74
Q

GOG 209 inclusion

A

Measurable and non measurable primary stage III, IV, or recurrent EC

75
Q

GOG 209 arms

A

AP: Doxo 45 + cis 50 + taxol 160
TC: carbo AUC 6 + taxol 175
both q3 wks, up to 7C

76
Q

GOG 209 results

A

TAP=656, CT+672
PFS 14mo (TAP) vs 13mo (TC)
OS 41mo vs 37mo
OR 52% for both

77
Q

GOG 209 conclusion

A

Carbo/taxol is not inferior to TAP and should be considered first line therapy for advanced or recurrent EC

78
Q

Fader et al Aim

A

To quantify the benefit conferred by adding trastuzumab to C/T in women with uterine serous whose tumors overexpress HER2/neu in primary and recurrent dz

79
Q

Fader inclusion

A

primary advanced (III or IV) or recurrent (any stage) HER2+ serous, optimal or suboptimal debulk, no more than 3 prior chemos

80
Q

Fader arms

A

Control: carbo 5AUC + taxol 175 q21d x 6C
Exp: C/T + trastuzumab 8mg/kg first dose, 6mg/kg subsequent, q21 days x 6 C w/ 6mg/kg maintenance until progression or unacceptable tox

81
Q

Fader results

A

control=28, exp= 30
-71% with advanced dz, 29% w/ recurrent
-PFS 8mo (control) vs 12.6mo (exp)
-primary tx: 9.3mo vs 17.9mo
-recurrent: 6mo vs 9.2om
-2020 update: OS 24.4mo vs 29.6mo (exp)– most notable in primary tx of III-IV dz

82
Q

Fader conclusion

A

The addition of C/T to HER2 positive uterine serous results in a 56% decrease in risk of progression relative to C/T alone

83
Q

MITO END-2 aim

A

To compare C/T to combo C/T/Bev in patients with advanced or recurrent EC

84
Q

MITO END-2 inclusion

A

Stage III, IV, or recurrent EC (endometrioid, serous, or CC), measurable disease

85
Q

MITO END-2 arms

A

Control: Carbo 5AUC+ taxol 175
Exp: C/T + bev 15mg/kg –> Q21 bev maintenance
Both arms 6-8 cyclesM

86
Q

MITO END-2 results

A

C/T= 49, Bev= 47
60% recurrent, 50% G3, 15% serous or CC
-PFS 10.5mo (CT) vs 13.7mo (CTB) (SI)
-OS 29.7mo vs 40mo (SI)

87
Q

MITO END-2 conclusion

A

Bev combined with carboplatin and taxol in advanced or recurrent EC failed to show significant increase in PFS

88
Q

Keynote 775 aim

A

To compare the efficacy and safety of len/pem with physicians choice of doxorubicin or paclitaxel chemo

89
Q

Keynote 775 inclusion

A

Advanced, recurrent, metastatic EC of any histology, dz progression after 1 prior platinum based chemo, no hx VEGF or PD1 meds, up to 2 lines prior CT, measurable dz

90
Q

Keynote 775 Arms

A

control: doxorubicin 60 mg/m2 q3wks or taxol 80mg/m2 weekly
Exp: lenvima 20mg PO QD + pembro 200mg IV q3 weeks up to 35 doses of pembro

91
Q

Keynote 775 results

A

n=827, pMMR=697, dMMR=130
pMMR–PFS 3.8mo (CT) vs 6.6 (LP)
pMMR– OS 12mo vs 17.4mo
Overall: PFS 3.8mo vs 7.2mo
Overall: OS 11.4mo vs 18.3mo
Response rate: 14.7% vs 31.9%
pMMR RR: 15.1% vs 30.3%

92
Q

Keynote 775 conclusion

A

Treatment with len/pem led to significantly longer PFS and OS in the pMMR, and overall population

93
Q

RUBY (part 1) Aim

A

To assess efficacy and safety of dostarlimab in combo with C/T in patients with primary advanced or recurrent EC

94
Q

RUBY (P1) inclusion

A

primary advanced or recurrent stage IIIA-IIIC1 EC w/ measurable dz
IIIC2-IV EC regardless of measurable dz
primary advanced IIIC1 w/ UCS, CC, USC, or mixed histology regardless of measurable dz

95
Q

RUBY (P1) arms

A

Control: C/T AUC 5 + Taxol 175 q3wk x 6C
Exp: as above + dostarlimab 500mg–> 1000mg q6wks up to 3 years maintenance

96
Q

RUBY (P1) results

A

control=249, exp=245
18% stage 3, 33% stage 4, 47.8% recurrent
54.7% endometrioid, 20.6% serous, 8.9% UCS
PFS: 61.4% (dMMR) vs 15.7% (CT)
PFS: 36.1% (overall) vs 18.1% (CT)
OS: 71.3% (drug) vs 56% (placebo)
OS: dMMR 83.3% vs 58.7%
–pMMR PFS 28.4% (D) vs 18.8% (CT)
–pMMR OS 67.7% (D) vs 55.1% (CT) (SI)

97
Q

RUBY (P1) conclusion

A

The combination of dostarlimab, carboplatin, and taxol significantly improved outcomes for patients with newly diagnosed primary advanced or recurrent EC, with substantial benefit seen in dMMR tumors

98
Q

GY018 Aim

A

To evaluate standard chemo of C/T + pembro + pembro maintenance vs placebo

99
Q

GY018 Inclusion

A

Advanced stage metastatic or recurrent endometrial of any histology (except UCS)
Stage III or IV (measurable dz)
hx RT or HT permitted

100
Q

GY018 Arms

A

Control: Carbo 5AUC + taxol 175 x6C + placebo
Exp: C/T + pembro 200mg q3wks + 400mg q6 weeks up to 20 cycles

101
Q

GY018 Results

A

dMMR: 70% lower risk of dz progression w/ pembro
pMMR: PFS 8.7mo (CT) vs 13.1mo (P)

102
Q

GY018 conclusion

A

Incorporation of immunotherapy into first line treatment of patients with advanced or recurrent EC translates into improved oncologic outcomes regardless of histology or MMR status

Gyn Onc (6 decks)

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