FNCA Project of Radiotherapy for Cervical Cancer Protocol ... · Protocol: Cervix-I Stage IIIB...
Transcript of FNCA Project of Radiotherapy for Cervical Cancer Protocol ... · Protocol: Cervix-I Stage IIIB...
FNCA Project of Radiotherapy for Cervical Cancer
Protocol: Cervix-I
Stage IIIB Squamous Cell Carcinoma of the Cervix
Standardized Protocol
Weeks 1 2 3 4 5 6 7
External RTWP
30Gy/15-17Fr
CS20Gy/10Fr
Intracavitary RTHDR (5-7 Gy/Fr)
(either)LDR (30-40 Gy/1-2Fr)
Summary of 210 Registered Cases(Period of patient accrual: Jan. 1995 ~ Dec. 1998)
Country
ChinaIndonesia
JapanKorea
MalaysiaThe Philippines
ThailandVietnam
Total
No. of Pts
3424332012223728
210
Tumor Size at Portio
VNMTHAPHLMYSKORJPNIDNCHN
% o
f C
ases
100
90
80
70
60
50
40
30
20
10
0
Large =>60mm
Medium 40-60mm
Small =<40mm
Cervical tumor size
Tumor Volume at Parametrium
VNMTHAPHLMYSKORJPNIDNCHN
% o
f C
ases
100
90
80
70
60
50
40
30
20
10
0
Heavy(5/5)
Large(4/5)
Medium(3/5)
Small(2/5)
Slight(1/5)
Degree of tumor infiltration into the parametrium
Whole Pelvic Dose in cGy
5500 - 6000
5000 - 5500
4500 - 5000
4000 - 4500
3500 - 4000
3000 - 3500
2500 - 3000
2000 - 2500
1500 - 2000
No. of
Cas
es
140
120
100
80
60
40
20
0
Dose of WP-EBRT(N=210)
ICRT Point-A Dose in cGy (HDR)
3100 - 3300
2700 - 2900
2300 - 2500
1900 - 2100
1500 - 1700
1100 - 1300
No. of
Cas
es
40
30
20
10
0
Point A Dose of HDR-ICBT (N=100)
ICRT Point-A Dose in cGy (LDR/MDR)
5300 - 5500
4900 - 5100
4500 - 4700
4100 - 4300
3700 - 3900
3300 - 3500
2900 - 3100
2500 - 2700
No. of
Cas
es
40
30
20
10
0
Point A Dose of MDR/LDR-ICBT (N=109)
91 -
98
84 -
91
77 -
84
70 -
77
63 -
70
56 -
63
49 -
56
42 -
49
35 -
42
28 -
35
21 -
28
14 -
21
7 - 14
0 -
7
100
80
60
40
20
0
91 -
98
84 -
91
77 -
84
70 -
77
63 -
70
56 -
63
49 -
56
42 -
49
35 -
42
28 -
35
21 -
28
14 -
21
7 - 14
0 -
7
40
30
20
10
0
Overall treatment timeN=190
N=103
Cervix-I
Cervix-II
No.
of p
ts.
No.
of p
ts.
Overall treatment time (days)
Overall treatment time (days)
Acute Radiation Morbidity
RTOG Grade 0 1 RTOG Grade 0 1 RTOG Grade 0 1 RTOG Grade 0 1 2 3 4 2 3 4 2 3 4 2 3 4
(99.5%)(99.5%)(99.5%)(99.5%)Rectum/Sigmoid colon (%) 75 22.5 2 Rectum/Sigmoid colon (%) 75 22.5 2 Rectum/Sigmoid colon (%) 75 22.5 2 Rectum/Sigmoid colon (%) 75 22.5 2 0 0.50 0.50 0.50 0.5
(98%)(98%)(98%)(98%)Urinary Bladder (%) 81.5 15 1Urinary Bladder (%) 81.5 15 1Urinary Bladder (%) 81.5 15 1Urinary Bladder (%) 81.5 15 1.5 1 1.5 1 1.5 1 1.5 1 1
(98.5%)(98.5%)(98.5%)(98.5%)Small Intestine (%) 76 21 Small Intestine (%) 76 21 Small Intestine (%) 76 21 Small Intestine (%) 76 21 1.5 0.5 11.5 0.5 11.5 0.5 11.5 0.5 1
Late Radiation Morbidity (at 5 years of follow-up)
RTOG/EORTC Grade 0 1 2 RTOG/EORTC Grade 0 1 2 RTOG/EORTC Grade 0 1 2 RTOG/EORTC Grade 0 1 2 3 43 43 43 4
(3%)(3%)(3%)(3%)Rectum/Sigmoid colon (%) 74 18 5 Rectum/Sigmoid colon (%) 74 18 5 Rectum/Sigmoid colon (%) 74 18 5 Rectum/Sigmoid colon (%) 74 18 5 3 03 03 03 0
(4%)(4%)(4%)(4%)Urinary Bladder (%) 78 13 Urinary Bladder (%) 78 13 Urinary Bladder (%) 78 13 Urinary Bladder (%) 78 13 5 2 25 2 25 2 25 2 2
(1%)(1%)(1%)(1%)Small Intestine (%) 94 4 Small Intestine (%) 94 4 Small Intestine (%) 94 4 Small Intestine (%) 94 4 1 1 01 1 01 1 01 1 0
86420
1.0
.8
.6
.4
.2
0.0
Overall survival rates for all cases%
Sur
viva
l
Years after RT
70%
53%
as of Dec. 2003
N=210
86420
1.0
.8
.6
.4
.2
0.0
% S
urvi
val
Years after RT
Overall survival rates by tumor sizeas of Dec. 2003
Large N=30
Small N=71Medium N=10860%
55%
31%
(P<0.05)
86420
1.0
.8
.6
.4
.2
0.0
Overall survival rates by HDR/LDR-ICBT%
Sur
viva
l
Years after RT
LDR N=109
HDR N=100
57.5%
50.7%
as of Dec. 2003
(n.s.)
86420
1.0
.8
.6
.4
.2
0.0
Overall survival rates by OTTas of Dec. 2003
Years after RT
% S
urvi
val
61%
37%
OTT < 50days N=132
OTT > 50days N=58
(P<0.05)
Overall survival rates by country
Country
CHNINDJPNKORMYSPHLTHAVTN
Total
2-y (%)
8242707563646672
69
5-y (%)
50-
525542596360
53
follow-up (%)
8829
10010042967336
73
86420
1.0
.8
.6
.4
.2
0.0
Local control rates for all casesas of Dec. 2003
% S
urvi
val
Years after RT
84%82% N=210
86420
1.0
.8
.6
.4
.2
0.0
Local control rates by tumor sizeas of Dec. 2003
% S
urvi
val
Years after RT
Large N=30
Small N=71
Medium N=10886%
80%
68%
(n.s.)
Summary of the study “Cervix-I”
1. The treatment of the standardized protocol was feasiblein the FNCA countries.
2. The outcome of the treatment was favorable.- acute & late radiation morbidity : acceptable- 5-year OS: 53%
3. There was a significant difference in OS between patientswith large tumors and those with small or medium-sizedtumors.
4. There was a significant difference in OS between patientstreated within 7 weeks and those treated over 7 weeks.
5. There were wide differences among countries in…- patient characteristics (age,tumor size,etc.)- treatment (rate of protocol deviation)- assessment of the efficacy and toxicity of the treatment - follow-up rate- survival rate
6. This study provided an important opportunity for cross-comparing the present status of RT in Asia.
7. The annual meeting provided the participants witha great deal of information on the current status of radiation oncology.
8. Based on the results, we are conducting some clinical trials, including AHF and ChemoRT for CCand ChemoRT for NPC.
Summary of the study “Cervix-I”
VNMTHAPHLMYSKORJPNIDNCHN
Pat
ient
Age
(M
ean
+/- S
.E.)
80
70
60
50
40
Age distribution by country
WHO Histology
VNMTHAPHLMYSKORJPNIDNCHN
% o
f C
ases
100
90
80
70
60
50
40
30
20
10
0
Sq.C.Ca., NK.Sm
Sq.C.Ca., NK.Lg
Sq.C.Ca., Kerat.
Sq.C.Ca., Diff.Unk.
Sq.C.Ca., Undiff.
Sq.C.Ca., Poor.Diff.
Sq.C.Ca., Mod.Diff.
Sq.C.Ca., Well Diff.
Histological subtype by country
Large =>60mmMedium 40-60mmSmall =<40mm
Whole
Pelv
ic D
ose
in c
Gy
(Mean
+/- S
.E.)
4000
3800
3600
3400
3200
3000
Dose of WP-EBRT according to tumor size
Center Shielded Dose in cGy
3000 - 3500
2500 - 3000
2000 - 2500
1500 - 2000
1000 - 1500
500 - 1000
0 - 500
No. of
Cas
es
120
100
80
60
40
20
0
Dose of CS-EBRT
Large =>60mmMedium 40-60mmSmall =<40mm
Cente
r Shie
lded
Dose
in c
Gy
(Mean
+/- S
.E.)
2000
1800
1600
1400
1200
1000
Dose of CS-EBRT according to tumor size
Summary of 210 Registered Cases
HDR LDRHDR LDRHDR LDRHDR LDR////MDRMDRMDRMDR
No. of patients 100 No. of patients 100 No. of patients 100 No. of patients 100 109109109109
Age 58.8 (31Age 58.8 (31Age 58.8 (31Age 58.8 (31----86) 52.5 (2786) 52.5 (2786) 52.5 (2786) 52.5 (27----79)79)79)79)
Tumor size small 37% Tumor size small 37% Tumor size small 37% Tumor size small 37% 31% 31% 31% 31% medium 52% medium 52% medium 52% medium 52% 52%52%52%52%large 11% large 11% large 11% large 11% 17% 17% 17% 17%
External RT WP 33 (18External RT WP 33 (18External RT WP 33 (18External RT WP 33 (18----60) Gy 36 (3060) Gy 36 (3060) Gy 36 (3060) Gy 36 (30----50) Gy50) Gy50) Gy50) GyCS CS CS CS 17 (017 (017 (017 (0----35) Gy35) Gy35) Gy35) Gy
Brachytherapy (point A) 25 (12Brachytherapy (point A) 25 (12Brachytherapy (point A) 25 (12Brachytherapy (point A) 25 (12----32) Gy 32.5 (2632) Gy 32.5 (2632) Gy 32.5 (2632) Gy 32.5 (26----53) Gy53) Gy53) Gy53) Gy
Whole Pelvic Dose in cGy
6000400020000
ICR
T P
oin
t-A
Dose
in c
Gy
6000
4000
2000
0
HDR
LDR/MDR
Correlation between the dose of WP-EBRT and the point A dose of ICBT
91 -
98
84 -
91
77 -
84
70 -
77
63 -
70
56 -
63
49 -
56
42 -
49
35 -
42
28 -
35
21 -
28
14 -
21
7 - 14
0 -
7
100
80
60
40
20
0
Overall treatment time
Overall treatment time (days)
No.
of p
ts.
(N=210)
Follow-up status at 5 years
Country
CHN
IDN
JPN
KOR
MYS
PHL
THA
VNM
Total
No. of Pts
34
24
33
20
12
22
37
28
210
No. of Pts followed
30 (88%)
7 (29%)
33 (100%)
20 (100%)
5 (42%)
21 (96%)
27 (73%)
10 (36%)
153 (73%)
Local control rates by country
Country
CHNINDJPNKORMYSPHLTHAVTN
Total
2-y (%)
897186
100100916683
69
5-y (%)
84-
86100100916675
82
follow-up (%)
8829
10010042967336
73
86420
1.0
.8
.6
.4
.2
0.0
OS by degree of infiltration into PM
(n.s.)
86420
1.0
.8
.6
.4
.2
0.0
LC by degree of infiltration into PM
(p<0.05)
86420
1.0
.8
.6
.4
.2
0.0
Local control rates by HDR/LDR-ICBT%
Sur
viva
l
Years after RT
LDRHDR83.0
80.3
(n.s.)
86420
1.0
.8
.6
.4
.2
0.0
LC by OTT (50d)
(n.s.)
86420
1.0
.8
.6
.4
.2
0.0
Overall survival rates by protocol (stage IIIB)
Cervix-II
Cervix-I
Years after RT
% S
urvi
val 62%
73%
(n.s.)
86420
1.0
.8
.6
.4
.2
0.0
Cervix-ICervix-II
Local control rates by protocol (stage IIIB)
Years after RT
% S
urvi
val
86%
82%
(n.s.)