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.
No grade 4 toxicity was documented in any of the 2 groups at 36 months.
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.
None of the 10 patients in group B had grade 4 neurotoxicity per Wasserman score at 12 months.