Introduction
Materials and methods
Inclusion criteria
Objectives of the study
Statistical analysis
Results
Patient population
n (%)
| |
---|---|
Sex | |
Male | 50 (65.8)
|
Female |
26 (34.2)
|
Median age (range)
| 64 yrs. (29–84)
|
Performance status | |
ECOG 0–1
| 74 (97.4)
|
ECOG 2
| 2 (2.6)
|
Median tumor size (range)
| 50 mm (25–120)
|
Median tumor distance-EAS (range)
| 60 mm (10–120)
|
Tumor Stage | |
cT2 | 5 (6.5)
|
cT3 | 63 (82.9)
|
cT4 | 8 (10.6)
|
cN | |
cN0 | 12 (15.8)
|
cN1 | 39 (51.3)
|
cN2 | 25 (32.9)
|
Stage | |
IIA | 12 (15.8)
|
IIIA | 3 (3.9)
|
IIIB | 49 (64.5)
|
IIIC | 12 (15.8)
|
MRF involvement | |
Yes | 34 (44.7)
|
No | 42 (55.3)
|
IMRT-SIB dose (dose per fraction) | |
52.5 Gy (2.1Gy) | 16 (21)
|
54 Gy (2.16Gy) | 24 (31.5)
|
55 Gy (2.2Gy) | 34 (45)
|
57.5 Gy (2.5Gy) | 2 (2.5)
|
Treatment compliance and acute toxicity
Toxicity | G1-G2, n (%)
| G3-G4, n (%)
|
---|---|---|
GI | 29 (38.1)
| 5 (6.6)
|
GU | 23 (30.3)
| 0 (0)
|
Haematological | 14 (18.4)
| 2 (2.6)
|
Skin | 9 (11.8)
| 0 (0)
|
Cardiac | 3 (3.9)
| 1 (1.3)
|
Response to treatment and surgical data
Surgery (n. of patients) | Anastomotic leakage | Bleeding | Pelvic abscess | Small-bowel obstruction | Others | Total, n (%)
|
---|---|---|---|---|---|---|
LAR (53/72) | 1 | 2 | 3 | 2 | 3 | 11 (15.3)
|
APR (11/72) | 0 | 0 | 1 | 0 | 1 | 2 (2.8)
|
LE (8/72) | 0 | 0 | 0 | 0 | 0 | 0 (0)
|
Total, n (%)
| 1 (1.4)
| 2 (2.8)
| 4 (5.6)
| 2 (2.8)
| 4 (5.6)
| 13 (18.1)
|
pT0 | pT1 | pT2 | pT3 | pT4 | Total, n (%)
| |
cT2 | 2 | 0 | 1 | 0 | 0 | 3 (4.2)
|
cT3 | 17 | 8 | 17 | 19 | 0 | 61 (84.7)
|
cT4 | 1 | 0 | 2 | 4 | 1 | 8 (11.1)
|
Total, n (%)
| 20 (27.8)
| 8 (11.1)
| 20 (27.8)
| 23 (31.9)
| 1 (1.4)
| 72 (100)
|
pN0 | pN1 | pN2 | pNxa
| Total, n (%)
| ||
cN0 | 7 | 2 | 1 | 2 | 12 (16.7)
| |
cN1 | 22 | 9 | 1 | 5 | 37 (51.4)
| |
cN2 | 19 | 2 | 1 | 1 | 23 (31.9)
| |
Total, n (%)
| 48 (66.7)
| 13 (18.1)
| 3 (4.2)
| 8 (11.1)
| 72 (100)
| |
TRG1 | TRG2 | TRG3 | TRG4 | TRG5 | Total, n (%)
| |
cT2 | 2 | 1 | 0 | 0 | 0 | 3 (4.2)
|
cT3 | 17 | 21 | 21 | 2 | 0 | 61 (84.7)
|
cT4 | 1 | 4 | 3 | 0 | 0 | 8 (11.1)
|
Total, n (%)
| 20 (27.8)
| 26 (36.1)
| 24 (33.3)
| 2 (2.8)
| 0 (0)
| 72 (100)
|
TRG 1 | OR (95% CI)a
| Downstaging | OR (95% CI)a
| |||
---|---|---|---|---|---|---|
n | (%) | n | (%) | |||
Sex | ||||||
Man | 13 | (26.0) | Reference | 34 | (70.8) | Reference |
Woman | 7 | (26.9) | 1.67 (0.60–4.62) | 18 | (72.0) | 0.90 (0.21–3.88) |
Age (years) | ||||||
< 55 | 5 | (29.4) | Reference | 12 | (70.6) | Reference |
55–64 | 5 | (18.5) | 0.36 (0.10–1.27) | 14 | (56.0) | 0.37 (0.07–1.99) |
65–74 | 6 | (31.6) | 1.01 (0.26–3.85) | 16 | (84.2) | 2.93 (0.40–21.37) |
≥ 75 | 4 | (30.8) | 0.85 (0.20–3.56) | 10 | (83.3) | 2.75 (0.34–22.48) |
Distance EAS (mm) | ||||||
< 60 | 9 | (23.7) | Reference | 29 | (80.6) | Reference |
≥ 60 | 8 | (27.6) | 0.88 (0.30–2.55) | 17 | (58.6) | 0.12 (0.02–0.69) |
Unknown | 3 | (33.3) | 1.026 (0.22–7.12) | 6 | (75.0) | 0.15 (0.01–2.43) |
cT | ||||||
cT2 | 2 | (40.0) | Reference | 3 | (100.0) | - |
cT3 | 17 | (27.0) | 0.29 (0.02–4.14) | 42 | (67.7) | - |
cT4 | 1 | (12.5) | 0.29 (0.02–5.68) | 7 | (87.5) | - |
cN | ||||||
cN0 | 4 | (33.3) | Reference | 8 | (66.7) | Reference |
cN1 | 10 | (25.6) | 0.59 (0.16–2.23) | 25 | (67.6) | 0.39 (0.06–2.60) |
cN2 | 6 | (24.0) | 0.77 (0.18–3.34) | 19 | (79.2) | 1.14 (0.17–7.82) |
MRF involvment | ||||||
No | 6 | (17.7) | Reference | 31 | (79.5) | Reference |
Yes | 14 | (33.3) | 0.34 (0.11–1.01) | 21 | (61.8) | 0.29 (0.07–1.18) |
Single dose intensity | ||||||
2.1 | 3 | (18.8) | Reference | 12 | (80.0) | Reference |
2.16 | 9 | (37.5) | 1.45 (0.36–5.84) | 15 | (62.5) | 0.16 (0.02–1.47) |
≥ 2.2 | 8 | (22.2) | 1.45 (0.39–5.38) | 25 | (73.5) | 1.14 (0.14–9.25) |
Discussion
Author
(
a
Study)
| N. of patients | Stage | Radiotherapy | Compliance RT-CT | pCR | Tox ≥ 3 | Post-op morbidity |
---|---|---|---|---|---|---|---|
De Ridder et al. [24]
(Phase II)
| 24/13 | T3-T4 MRF+ | 46Gy/23fr/2
SIB 55.2Gy/23fr/2.4Gyfr | 100% -noCT | 14% | 4.2% | 8% |
Li et al. [25]
(Phase II)
| 63 | T3-T4 N+ | 41.8Gy/22fr/1.9
SIB 50.6Gy/22fr/2.3Gyfr | 100% –100% | 31% | 14% | 7% |
Hernando et al. [26]
(Retrospective)
| 74 | T2-T4 N+ | 45Gy/25fr/1.8
SIB 57.5Gy/25fr/2.3Gyfr | 99% – 99% | 31% | 17.6% | 7% |
Zhu et al. [27]
(Phase II)
| 78 | T3-T4 N0/N+ | 50Gy/25fr/2
SIB 55Gy/25fr/2.2Gyfr | 100% – 62% | 24% | 14% | 17% |
Wang et al. [28]
(Retrospective)
| 260 | T3-T4- N0/N+ | 41.8Gy/22fr/1.9
SIB 50.6Gy/22fr/2.3Gyfr | 99% – 99% | 18.5% | 6% | 23% |
bArbea et al. [29]
(Phase II)
| 100 | T3-T4 N+ | 47.5Gy/19fr/2.5 and
47.5Gy/20fr/2.4Gyfr | 97% – 80% | 13% | 25% | 7% |
Our experience | 76 | T3-T4 N0/N+ | 45 Gy/25fr/1.8
SIB 52.5–57.Gy/25fr 2.1–2.3Gyfr | 97.4% – 84% | 22% | 10.5% | 18% |