Table 8.
Toxicity details for BT studies.
| First author (country) | Toxicity Scale | Acute GU toxicity | Acute GI toxicity | Late GU toxicity | Late GI toxicity | Erectile Dysfunction | PROMS | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade ≤ 2 | Grade ≥ 3 | Grade ≤ 2 | Grade ≥ 3 | Grade ≤ 2 | Grade ≥ 3 | Grade ≤ 2 | Grade ≥ 3 | ||||
| Kollmeier (USA) | CTCAE v4.0 | 96.0% | – | 96.0% | – | 82.0% | 9.0% | 91.0% | 2.0% | NR | Yes (IPSS) |
| Baumann (USA) | CTCAE v4.0 | 82.0% | – | 9.0% | – | 42.0% | 12.0% | 3.0% | – | NR | Yes (IPSS) |
| Wojcieszek (Poland) | CTCAE v4.0 | 87.0% | 1.0% | 6.0% | – | 72.0% | 13.0% | 6.0% | – | NR | NR |
| *Yamada (USA) | CTCAE v3.0 | 78.0% | – | NR | NR | 86.0% | 10.0% | 57.0% | – | Yes | Yes (IPSS) |
| Peters (Netherlands) | CTCAE v4.0 | 100.0% | – | 55.0% | – | 40.0% | 5.0% | 35.0% | – | Yes (80%) | Yes (RAND-36, EORTC) |
| Vargas (USA) | NR | 5.0% | 8.7% | NR | NR | 5.0% | 8.7% | 7.0% | 3.0% | NR | NR |
| Chen (USA) | CTCAE v4.0 | 98.0% | 2.0% | 100.0% | – | 98.0% | 2.0% | 100.0% | – | Yes (81%) | NR |
| Burri (USA) | CTCAE v3.0 | 35.0% | 11.0% | 5.0% | NR | 35.0% | 11.0% | NR | 3.0% | Yes (75%) | NR |
| Moman (Netherlands) | CTCAE v3.0 | 87.0% | 3.0% | 55.0% | – | 55.0% | 19.0% | 51.0% | 6.0% | NR | NR |
| Aaronson (USA) | CTCAE v3.0 | NR | NR | NR | 3.0% | 37.0% | 4.0% | NR | 4.0% | NR | Yes (IPSS, IIEF-5) |
| HK Lee (USA) | RTOG | 29.0% | – | 5.0% | – | 29.0% | – | 5.0% | – | NR | NR |
| Nguyen (USA) | RTOG | NR | NR | NR | NR | NR | 20.0% | NR | 20.0% | NR | NR |
| B Lee (USA) | CTCAE v3.0 | 86.0% | 14.0% | 14.0% | – | NR | 5.0% | – | – | Yes (95%) | NR |
| Koutrouvelis (USA) | NR | 13.0% | 13.0% | 13.0% | 19.0% | 13.0% | 13.0% | 13.0% | 19.0% | NR | NR |
| Grado (USA) | NR | NR | NR | NR | NR | 10.0% | 20.0% | 4.0% | 2.0% | NR | NR |
| Slevin (UK) | CTCAE v4.0 | 91.0% | – | 14.0% | – | 65.0% | 2.0% | 14.0% | – | NR | NR |
| Lopez (Spain) | RTOG | 33.0% | NR | NR | NR | NR | 21.3% | NR | NR | NR | NR |
| RTOG | 33.0% | NR | NR | NR | NR | 27.3% | NR | NR | NR | NR | |
| Crook (Canada) | CTCAE v3.0 | NR | 14.0% | NR | 14.0% | NR | 7.0% | NR | 4.0% | NR | Yes (IPSS) |
| Smith (USA) | CTCAE v5.0 | NR | NR | NR | NR | NR | 15.7% | NR | 2.8% | Yes (80%) | Yes (IPSS, MSEFS) |
| Kukielka (Poland) | CTCAE v4.0 | 96.0% | – | 12.0% | – | 41.0% | – | – | – | NR | Yes (IPSS) |
| Schonle (Germany) | CTCAE v4.0 | 15.8% | 6.1% | 2.4% | – | 15.8% | 6.1% | 2.4% | – | NR | NR |
| Chitmanee (UK) | NR | 90.0% | – | 32.0% | – | 72.0% | 10.0% | 30.0% | – | Yes (86%) | Yes (IPSS) |
| Henriquez (Spain) | CTCAE v3.0 | NR | NR | NR | NR | NR | 23.0% | NR | 4.0% | NR | NR |
| Peters (Netherlands) | CTCAE v4.03 | NR | NR | NR | NR | NR | 30.0% | NR | 10.0% | NR | NR |
| Jiang (Germany) | CTCAE v4.0 | 100.0% | – | 100.0% | – | 90.9% | 9.0% | 100.0% | – | NR | Yes (IPSS) |
| van Son (Netherlands) | CTCAE v4.0 | 65.0% | – | 37.0% | – | 55.0% | 2.0% | 37.0% | – | Yes (100%) | Yes (IPSS, RAND-36) |
| Lacy (USA) | RTOG | 9.6% | 9.6% | 9.6% | 9.6% | 9.6% | 9.6% | 9.6% | 9.6% | Yes (45.5%) | Yes (IPSS) |
| Lyczek (Poland) | RTOG | 29.6% | 2.6% | 7.9% | NR | 7.0% | 12.2% | 1.7% | 0.9% | NR | NR |
- , 0% reported toxicity; NR, not reported; GU, genitourinary; GI, gastrointestinal; CTCAE, Common Terminology Criteria for Adverse Events; RTOG, Radiation Therapy Oncology Group; NR, not reported; PROMS, patient recorded outcome measures; IPSS, International prostate symptom score; RAND-36, RAND-36 Health Survey; EORTC, European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; IIEF-5, International Index of Erectile Function questionnaire; MSEFS, Mount Sinai Erectile Function Score.
Yamada (USA) study cohort included in further publication Kollmeier (USA) however specific treatment characteristics and toxicity were not covered in later paper.