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. 2021 Nov 18;8(1):e215445. doi: 10.1001/jamaoncol.2021.5445

Table 2. Chronic Toxicity at 12 and 36 Months After Completion of Treatment.

Variable Patients, No. (%)
Toxicity at 12 mo Toxicity at 36 moa
TNT group A (n = 117) TNT group B (n = 109) TNT group A (n = 85) TNT group B (n = 66)
Grade 1-2 Grade 3-4 Grade 1-2 Grade 3-4 Grade 1-2 Grade 3-4 Grade 1-2 Grade 3-4
Total 72 (61.5) 18 (15.4) 67 (61.5) 19 (17.4) 43 (50.6) 10 (11.8) 52 (64.2) 8 (9.9)
Gastrointestinal
Anastomotic stenosis 3 (4.8) 1 (1.6) 1 (1.5) 0 2 (3.5) 0 2 (3.3) 0
Diarrhea 23 (36.5) 0 29 (43.9) 1 (1.5) 18 (31.6) 2 (3.5) 26 (42.6) 3 (4.9)
Proctitis 4 (6.3) 0 4 (6.1) 0 4 (4.7) 1 (1.8) 3 (4.9) 2 (3.3)
Rectal pain 5 (7.9) 0 1 (1.5) 0 2 (3.5) 0 1 (1.6) 0
Intestinal stoma site bleeding 0 0 0 0 0 1 (1.2) 0 0
Intestinal stoma prolapse 1 (0.9) 1 (0.9) 1 (0.9) 0 0 1 (1.2) 0 0
Genitourinary
Voiding disorder 5 (4.3) 0 5 (4.6) 1 (0.9) 3 (3.5) 0 1 (1.2) 0
Cystitis 2 (1.7) 0 5 (4.6) 0 2 (2.4) 0 1 (1.2) 0
Erectile dysfunction 6 (7.5) 2 (2.5) 12 (15.6) 2 (2.6) 5 (8.8) 2 (3.5) 11 (20.4) 1 (1.9)
Vaginal dryness 0 0 2 (6.2) 1 (3.1) 0 0 0 0
Neurologic
Sensory neuropathy 30 (25.6) 0 26 (23.9) 2 (1.8) 15 (17.6) 1 (1.2) 22 (27.2) 0
Oxaliplatin neurotoxicity (according to Wasserman score) 33 (28.2) 11 (9.4)b 24 (22.0) 10 (9.2)c 14 (16.5) 1 (1.2) 19 (23.5) 2 (2.5)
Fistula
Rectovesical 0 1 (0.9) 0 0 0 0 0 0
Rectovaginal 0 0 0 1 (3.1) 0 0 0
Other
Radiation dermatitis 3 (2.6) 0 3 (2.8) 0 2 (2.4) 0 0 0
Various 35 (29.9) 5 (4.3) 21 (19.3) 4 (3.7) 9 (10.6) 3 (3.5) 7 (8.6) 2 (2.5)

Abbreviation: TNT, total neoadjuvant therapy.

a

No grade 4 toxicity was documented in any of the 2 groups at 36 months.

b

Only 1 of the 11 patients in group A developed grade 4 neurotoxicity per Wasserman score at 12 months; the remaining patients had grade 3 neurotoxicity.

c

None of the 10 patients in group B had grade 4 neurotoxicity per Wasserman score at 12 months.