Introduction
Materials and methods
Patients
Eligibility
Ethics approval and consent to participate
Treatments
Evaluation of short-term response
Statistical analysis
Results
Patient characteristics
Item | NACT + RS (n = 24) N (%) | NACRT + RS (n = 38) N (%) | RS (n = 29) N (%) | P |
---|---|---|---|---|
Age (years) | ||||
< 47 | 17 (70.8%) | 25 (65.8%) | 19 (65.5%) | 0.899 |
≥ 47 | 7 (29.2%) | 13 (34.2%) | 10 (34.5%) | |
Tumor size (cm) | ||||
≤ 5 | 10 (41.7%) | 15 (39.5%) | 17 (58.6%) | 0.458 |
> 5 | 14 (58.3%) | 23 (60.5%) | 12 (41.4%) | |
Histological grade | ||||
Grade 1 | 9 (37.5%) | 19 (50.0%) | 8 (27.6%) | 0.413 |
Grade 2 | 11 (45.8%) | 16 (42.1%) | 16 (55.2%) | |
Grade 3 | 4 (16.7%) | 3 (7.9%) | 5 (17.2%) | |
Lymphnode metastasis | ||||
Positive | 5 (20.8%) | 10 (26.3%) | 6 (20.7%) | 0.825 |
Negative | 19 (79.2%) | 28 (73.7%) | 23 (79.3%) | |
Stage | ||||
IB2 | 15 (62.5%) | 29 (76.3%) | 26 (89.7%) | 0.062 |
IIA2 | 9 (37.5%) | 9 (23.7%) | 3 (10.3%) | |
Depth of muscular invasion | ||||
< 1/2 | 14 (58.3%) | 29 (76.3%) | 18 (62.1%) | 0.269 |
≥ 1/2 | 10 (41.7%) | 9 (23.7%) | 11 (37.9%) |
Effectiveness and toxicity of neoadjuvant therapy
Terms | CR (n) | OPR (n) | SR (n) |
---|---|---|---|
NACRT | |||
B2 | 6 | 9 | 14 |
IIA2 | 1 | 4 | 4 |
NACT | |||
IB2 | 1 | 6 | 8 |
IIA2 | 0 | 3 | 6 |
Adverse event | NACT (n = 24) | NACRT (n = 38) | ||||
---|---|---|---|---|---|---|
TC | TP | TN | TC | TP | TN | |
5 | 6 | 13 | 8 | 18 | 12 | |
Grade 3–4 myelosuppression | 0 | 1 | 0 | 1 | 1 | 0 |
Grade 3–4 creatinine | 0 | 0 | 1 | 1 | 1 | 0 |
Grade 3–4 hypohepatia | 1 | 1 | 1 | 1 | 1 | 0 |
Nausea/vomiting | 2 | 3 | 2 | 1 | 2 | 0 |
Sensory neuropathy | 1 | 1 | 1 | 1 | 1 | 1 |
Site | NACT (n = 11) | NACRT (n = 13) | RS (n = 12) |
---|---|---|---|
Proctitis | 0 | 0 | 1 |
Cystitis | 0 | 1 | 0 |
Vaginal stenosis | 1 | 2 | 0 |
Dermatitis | 1 | 0 | 0 |
Survival
Variable | Pts | 5 year DFS (%) | P value | 5 year OS (%) | P value |
---|---|---|---|---|---|
Tumor size (cm) | |||||
≤ 4 | 42 | 83.3 | 0.019 | 90.5% | 0.003 |
> 4 | 49 | 69.1 | 80.0% | ||
Lymphnode metastasis | |||||
Negative | 70 | 88.0 | 0.000 | 92.7% | 0.000 |
Positive | 21 | 37.0 | 60.8% | ||
Stage | |||||
IB2 | 70 | 80.2 | 0.082 | 91.0% | 0.010 |
IIA2 | 21 | 61.2 | 64.0% | ||
Depth of muscular invasion | |||||
< 1/2 | 61 | 81.1 | 0.005 | 87.9% | 0.018 |
≥ 1/2 | 30 | 65.4 | 79.4% | ||
Effectiveness of neoadjuvant therapy | |||||
OR | 30 | 89.7 | 0.001 | 68.5% | 0.007 |
SR | 32 | 49.8 | 88.9% | ||
Treatment | |||||
NACT | 24 | 73.7 | 0.053 | 86.8% | 0.035 |
NACRT | 38 | 68.4 | 72.9% | ||
RS | 29 | 91.8% | 100% |
Risk factors for recurrence and death
Varient | DFS | OS | ||
---|---|---|---|---|
HR (95% CI) | P | HR (95% CI) | P | |
Age (years) | 1.901 (0.465–7.774) | 0.371 | 1.881 (0.327–10.820) | 0.479 |
Tumor size (cm) | 0.915 (0.242–3.452) | 0.895 | 0.459 (0.104–2.026) | 0.304 |
Histological grade | NA | 0.135 | NA | 0.134 |
Lymphnode metastasis | 0.223 (0.060–0.827) | 0.025 | 0.088 (0.017–0.470) | 0.004 |
Stage | 0.621 (0.149–2.590) | 0.513 | 0.401 (0.073–2.191) | 0.291 |
Depth of stromal invasion | 0.885 (0.272–2.885) | 0.840 | 2.274 (0.529–9.785) | 0.270 |
Treatment | 0.385 (0.106–1.407) | 0.149 | 0.248 (0.045–1.360) | 0.108 |
Respond of neoadjuvant therapy | 3.662 (0.754–17.784) | 0.107 | 5.299(0.767–36.612) | 0.091 |