Table 2.
Clinician-reported toxicity | |||||
---|---|---|---|---|---|
Cohort | Threshold | LENT-SOMA | % patients with toxicity | RTOG | % of patients with toxicity |
CFRT | M | rV60 and mucosal loss (P = 0.005, δM = 3.3) | 21% | rV60 and bowel frequency (P = 0.01, δM = 3.85) | 38% |
rV65 and mucosal loss (P = 0.003, δM = 4.3) | 21% | ||||
rV50 and bleeding (P = 0.04, δM = 20.25) | 22% | ||||
rV60 and sphincter control (P = 0.008, δM = 3.21) | 18% | ||||
rV65 and sphincter control (P = 0.04, δM = 4.1) | 18% | ||||
MS | rV50 and bleeding (P = 0.00004, δM = 8.5) | 8% | rV50 and rectal bleeding (P = 0.00008, δM = 7.1) | 10% | |
rV60 and mucosal loss (P = 0.003, δM = 4.95) | 6% | ||||
rV65 and mucosal loss (P = 0.007, δM = 5.54) | 6% | ||||
rV60 and bleeding (P = 0.04, δM = 5.23) | 8% | ||||
HFRT-4D | M | rV51 and mucosal loss (P = 0.04, δM = 2.83) | 22% | rV51 and rectal bleeding (P = 0.02, δM = 3.13) | 44% |
rV55 and mucosal loss (P = 0.03, δM = 3.9) | 22% | rV55 and rectal bleeding (P = 0.005, δM = 4.15) | 44% | ||
rV59 and bleeding management (P = 0.03, δM = 2.43) | 14% | ||||
MS | N/A | N/A | |||
HFRT-5D | M | rV51 and tenesmus (P = 0.01, δM = 5.91) | 39% | rV59 and proctitis (P = 0.002, δM = 2.3) | 55% |
rV55 and tenesmus (P = 0.01, δM = 3.74) | 39% | ||||
rV59 and tenesmus (P = 0.01, δM = 2.25) | 39% | ||||
rV59 and frequency (P = 0.05, δM = 1.86) | 41% | ||||
MS | rV59 and bleeding (P = 0.04, δM = 2.66) | 26% | N/A | ||
rV59 and mucosal loss (P = 0.02, δM = 3.9) | 6% |
Patient-reported toxicity | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Urgency |
Loose stools |
Distress |
Crampy pain |
Problem |
||||||
Threshold → |
M | MS | M | MS | M | MS | M | MS | M | MS |
Cohort ↓ | ||||||||||
CFRT | rV50 (P = 0 .003, δM = 4.5) | rV50 (P = 0.04, δM = 2.75) | N/A | N/A | N/A | N/A | rV50 (P = 0.03, δM = 3.2) | N/A | rV50 (P = 0.03, δM = 2.35) | N/A |
% patients with toxicity | 38% | 27% | – | – | – | – | 19% | – | 44% | – |
HFRT-4D | N/A | N/A | rV43 (P = 0.03, δM = 4.56) | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
% patients with toxicity | – | – | 43% | – | – | – | – | – | – | – |
HFRT-5D | N/A | N/A | N/A | rV59 (P = 0.04, δM = 4) | N/A | N/A | N/A | rV43 (P = 0.01, δM = 5.2) | N/A | N/A |
% patients with toxicity | – | – | – | 20% | – | – | – | 15% | – | – |
Where N/A is reported, no positive associations were found. Where P ≤ 0.01, results are in bold. Where results were significant after Holm correction, results are bold and italicized. M = mild threshold (symptomatic patients are defined as having mild or worse symptoms). MS = moderate/severe (symptomatic patients are defined as having moderate or worse symptoms). % of patients with toxicity events excludes patients where data was unavailable (for full results see supplementary Tables R1–R9).