Table 1.
Patient and tumor characteristics at trial entry, and treatment details
| Variable | sRT |
RHDVRT |
Total |
|||
|---|---|---|---|---|---|---|
| n | % | n | % | n | % | |
| Total | 108 | 100.0 | 111 | 100.0 | 219 | 100.0 |
| Chemotherapy randomization | ||||||
| Chemotherapy | 31 | 28.7 | 33 | 29.7 | 64 | 29.2 |
| No chemotherapy | 32 | 29.6 | 25 | 22.5 | 57 | 26.0 |
| Elect no chemotherapy | 45 | 41.7 | 53 | 47.7 | 98 | 44.7 |
| Sex | ||||||
| Male | 91 | 84.3 | 89 | 80.2 | 180 | 82.2 |
| Female | 17 | 15.7 | 22 | 19.8 | 39 | 17.8 |
| WHO performance Status | ||||||
| 0 | 57 | 52.8 | 56 | 50.5 | 113 | 51.6 |
| 1 | 42 | 38.9 | 45 | 40.5 | 87 | 39.7 |
| 2 | 9 | 8.3 | 10 | 9.0 | 19 | 8.7 |
| Age at randomization (y) | ||||||
| Median (IQR) | 75.0 (68.6, 79.9) | 73.1 (65.0, 78.1) | 74 (66.6, 79.0) | |||
| <60 | 10 | 9.3 | 13 | 11.7 | 23 | 10.5 |
| 60-69 | 23 | 21.3 | 28 | 25.2 | 51 | 23.3 |
| 70-79 | 49 | 45.4 | 50 | 45.0 | 99 | 45.2 |
| 80+ | 26 | 24.1 | 20 | 18.0 | 46 | 21.0 |
| Pathological stage, primary tumor | ||||||
| 2 | 94 | 87.0 | 90 | 81.1 | 184 | 84.0 |
| 3a | 5 | 4.6 | 7 | 6.3 | 12 | 5.5 |
| 3b | 5 | 4.6 | 11 | 9.9 | 16 | 7.3 |
| 4a | 3 | 2.8 | 2 | 1.8 | 5 | 2.3 |
| Unknown | 1 | 0.9 | 1 | 0.9 | 2 | 0.9 |
| Grade, primary tumor | ||||||
| 2 | 19 | 17.6 | 17 | 15.3 | 36 | 16.4 |
| 3 | 85 | 78.7 | 93 | 83.8 | 178 | 81.3 |
| Unknown | 4 | 3.7 | 1 | 0.9 | 5 | 2.3 |
| Histologic type | ||||||
| TCC | 106 | 98.1 | 109 | 98.2 | 215 | 98.2 |
| SCC | 0 | 0.0 | 1 | 0.9 | 1 | 0.5 |
| TCC and SCC | 1 | 0.9 | 0 | 0.0 | 1 | 0.5 |
| Unknown | 1 | 0.9 | 1 | 0.9 | 2 | 0.9 |
| Multiple tumors | ||||||
| Yes∗ | 5 | 4.6 | 4 | 3.6 | 9 | 4.1 |
| If yes, no. of tumors | ||||||
| Median (IQR) | 3 (3, 3) | 2.5 (2, 3) | 3 (3, 3) | |||
| Number unknown | 1 | 2 | 3 | |||
| No | 102 | 94.4 | 106 | 95.5 | 208 | 95.0 |
| Unknown | 1 | 0.9 | 1 | 0.9 | 2 | 0.9 |
| Tumor resection | ||||||
| Not resected | 3 | 2.8 | 1 | 0.9 | 4 | 1.8 |
| Biopsy | 7 | 6.5 | 9 | 8.1 | 16 | 7.3 |
| Complete resection | 56 | 51.9 | 63 | 56.8 | 119 | 54.3 |
| Incomplete resection | 39 | 36.1 | 36 | 32.4 | 75 | 34.2 |
| Resected (extent unknown) | 1 | 0.9 | 1 | 0.9 | 2 | 0.9 |
| Unknown | 2 | 1.9 | 1 | 0.9 | 3 | 1.4 |
| Residual mass after resection | ||||||
| Yes | 38 | 35.2 | 25 | 22.5 | 63 | 28.8 |
| No | 65 | 60.2 | 79 | 71.2 | 144 | 65.8 |
| Unknown | 5 | 4.6 | 7 | 6.3 | 12 | 5.5 |
| Tumor size (longest dimension, mm) | ||||||
| Median (IQR) | 38 (20, 50) | 30 (20, 40) | 30 (20, 50) | |||
| Unknown | 33 | 32 | 65 | |||
| Neoadjuvant chemotherapy planned | ||||||
| Yes | 26 | 24.1 | 25 | 22.5 | 51 | 23.3 |
| No | 82 | 75.9 | 86 | 77.5 | 168 | 76.7 |
| Planned radiation therapy schedule | ||||||
| 55 Gy/20 fx | 43 | 39.8 | 35 | 31.5 | 78 | 35.6 |
| 64 Gy/32 fx | 64 | 59.3 | 75 | 67.6 | 139 | 63.5 |
| Unknown | 1 | 0.9 | 1 | 0.9 | 2 | 0.9 |
| Radiation therapy dose received | ||||||
| Full dose | 105 | 97.2 | 106† | 95.5 | 211 | 96.3 |
| 80%-<100% | 1 | 0.9 | 1 | 0.9 | 2 | 0.9 |
| <80% | 1 | 0.9 | 1 | 0.9 | 2 | 0.9 |
| None | 1 | 0.9 | 3 | 2.7 | 4 | 1.8 |
| Radiation therapy delays | ||||||
| No delay ≥7 d | 106 | 98.1 | 107 | 96.4 | 213 | 97.3 |
| Delay ≥7 d | 2 | 1.9 | 4 | 3.6 | 6 | 2.7 |
Abbreviations: fx = fraction; IQR = interquartile range; RHDVRT = reduced high-dose volume radiation therapy; SCC = squamous cell carcinoma; sRT = standard whole-bladder radiation therapy; TCC = transitional cell carcinoma; WHO = World Health Organization.
∗
All ineligible for radiation therapy randomization except 1 patient in the sRT group with all tumors in same location.
†
Includes 13 patients randomized to RHDVRT who received sRT.