Final results of the international randomized PORTEC-3 trial of ... http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.5502...

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i n t e r n a t i o n a l ra n d o m i z e d EExxp
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PORTEC-3 trial of adjuvant TTrraacckk C

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c h e m o t h e ra py a n d ra d i a t i o n A
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t h e ra py ( R T ) v e r s u s R T a l o n e R
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for women with high-risk PPeerrm
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endometrial cancer.

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ARTICLE
C I TAT I O N
A b s t ra c t
DOI:
10.1200/JCO.2017.35.15_suppl.5502
5502 Journal of Clinical
Oncology 35,
B a c k g ro u n d : Women with high-risk no. 15_suppl (May
endometrial cancer (HREC) are at 2017) 5502-5502.
increased risk of distant metastasis and
endometrial cancer-related death. The W H AT ' S
randomized PORTEC-3 intergroup trial
was initiated to investigate the benefit of
POPULAR
adjuvant chemotherapy during and after
Most Read
radiotherapy (CTRT) versus pelvic

1 di 3 19/10/17, 09:53
Final results of the international randomized PORTEC-3 trial of ... http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.5502...

radiotherapy (RT) alone for women with Most Cited

HREC. M e t h o d s : Women with HREC (FIGO
stage I grade 3 with deep myometrial M
Miin
niim
maall R
Reessiid
duuaall
invasion and/or LVSI; stage II or III; or D
Diisseeaassee A
Asssseesssseed
d
serous/clear cell histology) were randomly b
byy M
Muullttiip
paarraam
meetteerr
allocated (1:1) to RT (48.6 Gy in 1.8 Gy FFlloow
wCCyyttoom
meettrryy iin
n
M
Muullttiip
pllee M
Myyeelloom
maa::
fractions) or CTRT (two cycles of cisplatin
IIm
mppaacctt oon
nOOu
uttccoom
mee
50 mg/m in week 1 and 4 of RT, followed
iin
n tth
hee M
Meed
diiccaall
by four cycles of carboplatin AUC5 and
R
Reesseeaarrcch
hCCoou
unncciill
paclitaxel 175 mg/m at 3-week intervals)
M
Myyeelloom
maa IIXX SSttu
uddyy
with stratification for participating center, Rawstron et al.
lymphadenectomy, stage, and histological
type. The co-primary endpoints were IIn
ntteeg
grraattiioon
n ooff
overall survival (OS) and failure-free PPaalllliiaattiivvee C
Caarree IIn
nttoo
SSttaan
nddaarrd
dOOn
nccoolloog
gyy
survival (FFS). The Kaplan-Meier method,
C
Caarree:: A
Ammeerriiccaan
n
log-rank test and Cox regression analysis
SSoocciieettyy ooff C
Clliin
niiccaall
were used for final analysis according to
O
Onnccoolloog
gyy C
Clliin
niiccaall
intention-to-treat. PORTEC-3 is registered
PPrraaccttiiccee G
Guuiid
deelliin
nee
with ISRCTN (ISRCTN14387080) and U
Uppd
daattee
ClinicalTrials.gov (NCT00411138). R e s u l t s : Ferrell et al.
686 women were enrolled between 2006
and 2013. 26 women were excluded; 13 U
Ussee ooff A
Addjju
uvvaan
ntt
B
Biissp
phhoossp
phhoon
naatteess
withdrew consent early and 13 were
aan
nddO
Otth
heerr B
Boon
nee--
ineligible, which left 660 patients in the
M
Mood
diiffyyiin
nggA
Aggeen
nttss iin
n
analysis, with a median follow up time of
B
Brreeaasstt C
Caan
ncceerr:: A
A
60.2 months (IQR 47.172.9): 330 CTRT and C
Caan
ncceerr C
Caarree
330 RT. Three- and five-year OS for CTRT O
Onnttaarriioo aan
ndd
vs. RT was 84.4% versus 83.9%, and 81.8% A
Ammeerriiccaan
n SSoocciieettyy ooff
versus 76.7%; overall HR 0.79 [95% CI C
Clliin
niiccaall O
Onnccoolloog
gyy
0.57-1.12, p=0.183]. Three-year FFS was C
Clliin
niiccaall PPrraaccttiiccee
79.7% (CTRT) versus 71.8% (RT), and at 5 G
Guuiid
deelliin
nee
years 75.5% versus 68.9%, overall HR for Dhesy-Thind et al.
FFS 0.77 [0.58-1.03, p=0.078]. Patients with
C
Caab
boozzaan
nttiin
niib
b
stage III EC had lower 5-year FFS and OS VVeerrssu
uss SSu
unniittiin
niib
bAAss
compared to stage I-II (FFS 63.9% vs IIn
niittiiaall TTaarrg
geetteed
d
78.9%, p<0.001, and OS 74.3% vs 83.1%, TTh
heerraap
pyy ffoorr
p=0.003). They also had greatest benefit of PPaattiieen
nttss W
Wiitth
h
CTRT: 5-year FFS for stage III was 69.3% M
Meettaassttaattiicc R
Reen
naall
for CTRT vs 58.0% for RT [95% CI 0.45-0.97, C
Ceellll C
Caarrcciin
noom
maa ooff
p=0.032], and 5-year OS for stage III was PPoooorr oorr
78.7 % vs 69.8% (p=0.114). C o n c l u s i o n s : IIn
ntteerrm
meed
diiaattee R
Riisskk::
Adjuvant chemotherapy given during and TTh
hee A
Alllliiaan
nccee
A
A003311220033 C
CAAB
BOOSSU
UNN
after pelvic radiotherapy for treatment of
TTrriiaall
HREC did not significantly improve 5-year
Choueiri et al.
FFS and OS, compared with RT alone. For
women with stage III EC FFS was however C
Clliin
niiccaall C
Caan
ncceerr
significantly improved with CTRT by 11% at A
Addvvaan
ncceess 22001177::
5 years. Follow-up will continue to A
Annn
nuuaall R
Reep
poorrtt oon
n

2 di 3 19/10/17, 09:53
Final results of the international randomized PORTEC-3 trial of ... http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.5502...

evaluate long-term outcomes. Clinical trial PPrroog

grreessss A
Aggaaiin
nsstt
information: NCT00411138. C
Caan
ncceerr FFrroom
m tth
hee
A
Ammeerriiccaan
n SSoocciieettyy ooff
C
Clliin
niiccaall O
Onnccoolloog
gyy
Burstein et al.

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