Table 3.
First 18 mo CTCAE v4.0 genitourinary toxicities (n = 165)
| First 18 mo genitourinary grade ≥ 2 toxicities | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm A | Arm B | |||||||||||
| Baseline (n = 82) | 5fx (n = 82) | W12 (n = 82) | Mo6 (n = 80) | Mo12 (n = 82) | Mo18 (n = 79) | Baseline (n = 83) | 5fx (n = 83) | W12 (n = 82) | Mo6 (n = 81) | Mo12 (n = 80) | Mo18 (n = 79) | |
| Grade 0 | ||||||||||||
| 49 (60%) | 20 (24%) | 41 (50%) | 45 (56%) | 46 (57%) | 51 (65%) | 59 (71%) | 28 (34%) | 39 (48%) | 46 (57%) | 47 (59%) | 53 (67%) | |
| Grade 1 | ||||||||||||
| Worst toxicity | 31 (38%) | 48 (59%) | 32 (39%) | 26 (33%) | 29 (36%) | 24 (30%) | 20 (24%) | 39 (47%) | 37 (45%) | 30 (37%) | 30 (37%) | 23 (29%) |
| Grade 2 | ||||||||||||
| Worst toxicity* | 2 (2%) | 14 (17%) | 9 (11%) | 9 (11%) | 7 (9%) | 3 (4%) | 4 (5%) | 16 (19%) | 5 (6%) | 5 (6%) | 3 (4%) | 3 (4%) |
| Cystitis | 8 | 1 | 3 | 2 | 3 | 1 | 6 | 1 | 1 | 1 | ||
| Bladder spasm | 1 | 1 | 2 | 2 | 1 | 1 | 3 | 1 | 2 | 1 | 3 | |
| Hematuria | 1 | 1 | 1 | 1 | ||||||||
| Incontinence | 1 | 1 | 1 | 1 | 1 | |||||||
| Obstruction | 5 | 2 | 1 | 3 | 1 | 5 | 2 | 2 | 1 | |||
| Pain | 3 | 1 | 1 | 2 | 1 | |||||||
| Retention | 1 | 2 | 1 | 1 | 1 | |||||||
| Urgency | 1 | 4 | 2 | 1 | 1 | 2 | 3 | 2 | 1 | 1 | ||
| Grade 3 | ||||||||||||
| Worst toxicity* | — | — | — | — | — | 1 (1%) | — | — | 1 (1%) | — | — | — |
| Obstruction | 1 | 1 | ||||||||||
Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events v4.0; 5fx, 5th fraction; W12, week 12.
*
Some patients presented more than 1 grade ≥ 2 toxicity.