Table A1.
Toxicity | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|---|---|---|---|
GI | Excess bowel movements twice baseline or need for ≤ two anti diarrheals per week; slight rectal discharge or bleeding not requiring pads or medication | > Two antidiarrheals per week; ≤ two coagulations for bleeding; temporary steroids per suppositories or enema for symptoms/ulceration of ≤ 1 month; ≤ two dilatations; mucous discharge requiring < two pads per day; infrequent use of sanitary pads; non-narcotic or narcotic medication for pain once per day for < 1 month; regular non-narcotic or occasional narcotic for pain | > Two antidiarrheals per day for > 1 month; one blood transfusion or > two coagulations for bleeding; steroids per suppositories or enema for > 1 month; hyperbaric oxygen treatment for ulceration or bleeding; > two dilations; sanitary pads ≥ two per day for > 1 month; narcotic use > once per day for > 1 month | Fistula or obstruction requiring surgery; > one blood transfusion |
GU | Nocturia twice baseline or non-narcotic medication (eg, alpha blocker) once per day increase over baseline; microscopic hematuria; light mucosal atrophy and minor telangiectasia; dysuria not requiring medication; incontinence or dribbling not requiring sanitary pad (over baseline) | Frequency ≤ once every hour requiring alpha blocker > once per day increase over baseline; nocturia > 2× baseline; generalized telangiectasias; macroscopic hematuria requiring ≤ two cauterizations; dysuria requiring medication (non-narcotic > once per day or narcotic for pain ≤ once per day over baseline); ≤ two dilations; Foley or self-catheter for ≤ 2 weeks; incontinence requiring ≤ two pads (over baseline) | Frequency > once every hour or dysuria requiring narcotics > one per day; nocturia more frequent than once every hour; reduction in bladder capacity (150 cm3); ≥ one blood transfusion or > two cauterizations for bleeding; narcotic use of > once per day; hyperbaric oxygen, Foley or self-catheter for > 2 weeks; urethrotomy, TURP, or > two dilatations; incontinence requiring > two sanitary pads (over baseline | Gross hematuria requiring > one blood transfusion; severe hemorrhagic cystitis or ulceration requiring urinary diversion and/or cystectomy |
GU (revised) | Nocturia twice baseline or medication (eg, alpha blocker) increase over baseline; hematuria not requiring intervention; light mucosal atrophy and minor telangiectasia; dysuria or pain requiring occasional non-narcotic medication; incontinence or dribbling not requiring sanitary pad (over baseline) | Frequency ≤ every hour; nocturia > 2× baseline; generalized telangiectasias; hematuria requiring ≤ two cauterizations; pain requiring regular anti-inflammatory agent, anesthetic or antispasmodic, or occasional narcotic; stricture requiring ≤ two dilatations; Foley or self-catheter for ≤ 2 weeks; incontinence requiring ≤ two sanitary pads (over baseline) | Frequency or nocturia > hourly; dysuria and/or pain requiring regular narcotic use; reduction in bladder capacity (150 cm3); ≥ one blood transfusion or > two cauterizations for bleeding; hyperbaric oxygen treatment; Foley or self-catheter for > 2 weeks; urethrotomy, TURP, or > two dilatations; incontinence requiring > two sanitary pads (over baseline) or artificial sphincter | Gross hematuria requiring > one blood transfusion; severe hemorrhagic cystitis or ulceration requiring urinary diversion and/or cystectomy |
NOTE. Bold font indicates differences in GU and GU (revised) toxicity definitions. No patient had grade 4 or 5 (death) complication.
Abbreviations: GU, genitourinary; TURP, transurethral resection of prostate.