Table 1. Demographics and clinical characteristics of enrolled patients.
Characteristics | All patients | Arm A | Arm B | p-value | |||
---|---|---|---|---|---|---|---|
N = 146 | % | N = 71 | % | N = 75 | % | ||
Age | |||||||
Median | 51 | 52 | 50 | 0.78 | |||
Range | 28–75 | 30–73 | 28–75 | ||||
Histology | |||||||
SCC | 106 | 72.6 | 51 | 71.8 | 55 | 73.3 | 0.84 |
Non-SCC | 40 | 27.4 | 20 | 28.2 | 20 | 26.7 | |
FIGO stage | |||||||
IA2 | 16 | 10.9 | 6 | 8.5 | 10 | 13.1 | 0.61 |
IB | 69 | 47.2 | 36 | 50.7 | 33 | 44 | |
IIA | 43 | 29.6 | 19 | 26.8 | 24 | 32 | |
MIIB | 18 | 12.3 | 10 | 14 | 8 | 10.7 | |
Differentiation | |||||||
Well | 14 | 9.6 | 4 | 5.6 | 10 | 13.3 | 0.21 |
Moderate | 91 | 62.3 | 44 | 62 | 47 | 62.7 | |
Poor | 41 | 28.1 | 23 | 32.4 | 18 | 24 | |
Largest diameter | |||||||
Mean | 2.9 | 2.8 | 3 | 0.54 | |||
Range | 0.5–6.0 | 0.5–5.8 | 0.5–6.0 | ||||
Number of positive pelvic nodes | |||||||
0 | 27 | 18.5 | 16 | 22.5 | 11 | 14.7 | 0.29 |
1–2 | 76 | 52.1 | 36 | 50.7 | 40 | 53.3 | |
3–4 | 24 | 16.4 | 13 | 18.3 | 11 | 14.7 | |
> 4 | 19 | 13 | 6 | 8.5 | 13 | 17.3 | |
Lymphovascular invasion | |||||||
Negative | 74 | 50.7 | 39 | 54.9 | 35 | 46.7 | 0.32 |
Positive | 72 | 49.3 | 32 | 45.1 | 40 | 53.3 | |
Stromal invasion depth | |||||||
< 1/3 | 28 | 19.2 | 16 | 22.5 | 12 | 16 | 0.32 |
> 1/3 | 118 | 80.8 | 55 | 77.5 | 63 | 84 | |
Positive parametrium | |||||||
Yes | 17 | 11.6 | 9 | 12.7 | 8 | 10.7 | 0.71 |
No | 129 | 88.4 | 61 | 87.3 | 67 | 89.3 | |
Positive surgical margin | |||||||
Yes | 6 | 4.1 | 4 | 5.6 | 2 | 2.7 | 0.37 |
No | 140 | 95.9 | 67 | 94.3 | 73 | 97.3 |
Abbreviation: FIGO, International Federation of Gynecology and Obstetrics; SCC, squamous cell carcinoma; Non-SCC group consists of 20 adenosquamous cell carcinomas, 16 adenocarcinomas, and 4 mixed type.