Table 1.
Participant demographics and baseline U-TXM data. Panel A: participant characteristics and panel B: U-TXM at trial registration cohort.
| (A) | |||||
|---|---|---|---|---|---|
| Breast | Colorectal | Gastro-oesophageal | Prostate | All | |
| Number of participants | 260 | 192 | 53 | 211 | 716 |
| Gender | |||||
| Male | 1, <1% | 104, 54% | 40, 75% | 211, 100% | 356, 50% |
| Female | 259, >99% | 88, 46% | 13, 25% | 0, 0% | 360, 50% |
| Age at registration (years) | |||||
| Median (IQR) | 53 (47–62) | 61 (52–69) | 63 (58–69) | 67 (62–72) | 61 (52–68) |
| Range | 25–80 | 21–81 | 43–79 | 48–83 | 21–83 |
| Under 50 years | 88, 34% | 34, 18% | 6, 11% | 1, <1% | 129, 18% |
| 50–59 years | 94, 36% | 53, 28% | 13, 25% | 32, 15% | 192, 27% |
| 60–69 years | 58, 22% | 59, 31% | 21, 40% | 108, 51% | 246, 34% |
| 70 years or older | 20, 8% | 46, 24% | 13, 25% | 70, 33% | 149, 21% |
| BMI | |||||
| Median (Q1–Q3) | 27 (24–32) | 27 (24–31) | 25 (23–29) | 28 (25–31) | 27 (24–31) |
| Range | 18–45 | 19–47 | 16–33 | 20–45 | 16–47 |
| Missing | 21 | 13 | 7 | 11 | 52 |
| Under 25 | 79, 30% | 58, 30% | 22, 42% | 44, 21% | 203, 28% |
| 25–29.9 | 80, 31% | 71, 37% | 17, 32% | 97, 46% | 265, 37% |
| 30–34.9 | 42, 16% | 34, 18% | 7, 13% | 41, 19% | 124, 17% |
| 35 or more | 38, 15% | 16, 8% | 0, 0% | 18, 9% | 72, 10% |
| Missing | 21, 8% | 13, 7% | 7, 13% | 11, 5% | 52, 7% |
| Smoking status | |||||
| Never | 154, 59% | 93, 48% | 19, 36% | 109, 52% | 375, 52% |
| Ex-smoker | 94, 36% | 88, 46% | 30, 57% | 91, 43% | 303, 42% |
| Current smoker | 12, 5% | 11, 6% | 4, 8% | 11, 5% | 38, 5% |
| Diabetic | |||||
| No | 232, 89% | 165, 86% | 44, 83% | 189, 90% | 630, 88% |
| Yes | 5, 2% | 16, 8% | 6, 11% | 11, 5% | 38, 5% |
| Missing | 23, 9% | 11, 6% | 3, 6% | 11, 5% | 48, 7% |
| Receiving BP treatment | |||||
| No | 200, 77% | 135, 70% | 33, 62% | 124, 59% | 492, 69% |
| Yes | 38, 15% | 44, 23% | 17, 32% | 74, 35% | 173, 24% |
| Missing | 22, 8% | 13, 7% | 3, 6% | 13, 6% | 51, 7% |
| Statins taken within the last week | |||||
| No | 236, 91% | 148, 77% | 38, 72% | 144, 68% | 566, 79% |
| Yes | 11, 4% | 33, 17% | 13, 25% | 54, 26% | 111, 16% |
| Missing | 13, 5% | 11, 6% | 2, 4% | 13, 6% | 39, 5% |
| Neutrophils (109/L) | |||||
| <5.0 | 227, 87% | 159, 83% | 43, 81% | 172, 82% | 601, 84% |
| ≥5.0 | 20, 8% | 25, 13% | 8, 15% | 29, 14% | 82, 11% |
| Missing | 13, 5% | 8, 4% | 2, 4% | 10, 5% | 33, 5% |
| Total WCC (109/L) | |||||
| <8.0 | 237, 91% | 162, 84% | 42, 79% | 184, 87% | 625, 87% |
| ≥8.0 | 9, 3% | 22, 11% | 9, 17% | 16, 8% | 56, 8% |
| Missing | 14, 5% | 8, 4% | 2, 4% | 11, 5% | 35, 5% |
| Platelet count (109/L) | |||||
| <350 | 230, 88% | 173, 90% | 44, 83% | 196, 93% | 643, 90% |
| ≥350 | 13, 5% | 12, 6% | 7, 13% | 5, 2% | 37, 5% |
| Missing | 17, 7% | 7, 4% | 2, 4% | 10, 5% | 36, 5% |
| Raised LDL, total cholesterol or non-HDLa | |||||
| No | 70, 27% | 81, 42% | 31, 58% | 88, 42% | 270, 38% |
| Yes | 154, 59% | 92, 48% | 18, 34% | 98, 46% | 362, 51% |
| Missing | 36, 14% | 19, 10% | 4, 8% | 25, 12% | 84, 12% |
| CRP result (categorised) | |||||
| ≤5 | 208, 80% | 145, 76% | 41, 77% | 168, 80% | 562, 78% |
| >5 | 28, 11% | 30, 16% | 8, 15% | 23, 11% | 89, 12% |
| Missing | 24, 9% | 17, 9% | 4, 8% | 20, 9% | 65, 9% |
| Higher-risk diseaseb | |||||
| No | 183, 70% | 78, 41% | 10, 19% | 71, 34% | 342, 48% |
| Yes | 66, 25% | 111, 58% | 42, 79% | 137, 65% | 356, 50% |
| Missing | 11, 4% | 3, 2% | 1, 2% | 3, 1% | 18, 3% |
| Primary treatment details | |||||
| Surgery, no adjuvant chemo | 84, 32% | 44, 23% | 10, 19% | 112, 53% | 250, 35% |
| Surgery with adjuvant chemo | 166, 64% | 145, 76% | 39, 74% | 0, 0% | 350, 49% |
| Radical RT or CRT | 0, 0% | 0, 0% | 3, 6% | 97, 46% | 100, 14% |
| Missing details (surgery pts) | 10, 4% | 3, 2% | 1, 2% | 2, <1% | 16, 2% |
| Weeks between surgery and registration (n = 616)c | |||||
| 6–12 weeks | 12, 5% | 42, 22% | 9, 17% | 90, 43% | 153, 21% |
| >12 weeks | 233, 90% | 143, 74% | 40, 75% | 20, 9% | 436, 61% |
| Missing | 15, 6% | 7, 4% | 1, 2% | 4, 2% | 27, 4% |
| Timing of entry relative to adjuvant chemotherapy (n = 366) | |||||
| After chemo has finished | 166, 64% | 129, 67% | 38, 72% | 0, 0% | 333, 47% |
| While chemo is ongoing | 0, 0% | 16, 8% | 1, 2% | 0, 0% | 17, 2% |
| Missing | 10, 4% | 3, 2% | 1, 2% | 2, <1% | 16, 2% |
| (B) | ||||
|---|---|---|---|---|
| Baseline characteristic | n | Median | (Q1, Q3) | [Range] |
| Tumour type | ||||
| Breast | 260 | 782 | (503, 1178) | [114, 5999] |
| Colorectal | 192 | 1060 | (667, 1558) | [159, 5159] |
| Gastro-oesophageal | 53 | 1675 | (1150, 2365) | [415, 5182] |
| Prostate | 211 | 826 | (555, 1173) | [98, 3866] |
| Gender | ||||
| Male | 356 | 966 | (636, 1431) | [98, 4957] |
| Female | 360 | 839 | (530, 1314) | [114, 5999] |
| Age at registration (years) | ||||
| Under 50 years | 129 | 778 | (533, 1294) | [141, 4383] |
| 50–59 years | 192 | 911 | (572, 1342) | [114, 5999] |
| 60–69 years | 246 | 867 | (565, 1315) | [98, 4957] |
| 70 years or older | 149 | 1001 | (652, 1509) | [112, 5182] |
| BMI | ||||
| BMI < 25 | 203 | 904 | (590, 1385) | [103, 4957] |
| BMI 25–29.9 | 265 | 886 | (609, 1337) | [112, 5182] |
| BMI 30–34.9 | 124 | 813 | (528, 1352) | [98, 3526] |
| BMI > 35 | 72 | 1011 | (640, 1543) | [225, 5999] |
| Smoking status | ||||
| Never | 375 | 834 | (526, 1248) | [103, 5999] |
| Ex-smoker | 303 | 976 | (602, 1477) | [98, 5182] |
| Current smoker | 38 | 1379 | (750, 2182) | [466, 4957] |
| Diabetic | ||||
| Not diabetic | 630 | 894 | (575, 1361) | [112, 5182] |
| Diabetic | 38 | 986 | (745, 1531) | [98, 5999] |
| Receiving BP treatment | ||||
| No BP treatment | 492 | 909 | (591, 1347) | [103, 5999] |
| On BP treatment | 173 | 851 | (569, 1387) | [98, 4714] |
| Statin use in last week | ||||
| No statins | 566 | 908 | (597, 1366) | [103, 5182] |
| Statin use (within last week) | 111 | 859 | (500, 1379) | [98, 5999] |
| Neutrophils (109/L) | ||||
| Neutrophils <5.0 × 109/L | 601 | 879 | (559, 1330) | [98, 5159] |
| Neutrophils ≥5.0 × 109/L | 82 | 1134 | (735, 1761) | [239, 5999] |
| Total WCC (109/L) | ||||
| Total WCC < 8.0 × 109/L | 625 | 886 | (566, 1330) | [98, 5159] |
| Total WCC ≥ 8.0 × 109/L | 56 | 1212 | (817, 2089) | [426, 5999] |
| Platelet count (109/L) | ||||
| Platelet count <350 × 109/L | 643 | 887 | (569, 1343) | [98, 5999] |
| Platelet count ≥350 × 109/L | 37 | 1244 | (834, 1777) | [185, 4957] |
| Raised LDL, total cholesterol or non-HDL | ||||
| Normal cholesterol | 270 | 920 | (584, 1403) | [98, 5999] |
| Raised LDL, total cholesterol or non-HDLa | 362 | 898 | (568, 1342) | [114, 5182] |
| CRP result (categorised) | ||||
| CRP ≤ 5 | 562 | 875 | (573, 1354) | [98, 5999] |
| CRP > 5 | 89 | 1079 | (690, 1755) | [159, 5182] |
| Higher-risk disease | ||||
| Lower-risk disease | 342 | 842 | (531, 1342) | [114, 4957] |
| Higher-risk diseaseb | 356 | 968 | (650, 1400) | [98, 5999] |
| Primary treatment details | ||||
| Surgery, no adjuvant chemo | 250 | 828 | (525, 1194) | [103, 4957] |
| Surgery with adjuvant chemo | 350 | 1021 | (653, 1558) | [114, 5999] |
| Radical RT or CRT | 100 | 824 | (543, 1183) | [98, 2948] |
| Time between surgery and registration | ||||
| <12 weeks since surgery | 153 | 904 | (597, 1231) | [103, 4957] |
| ≥12 weeks since surgery | 436 | 934 | (599, 1484) | [114, 5999] |
| Timing of entry relative to adjuvant chemotherapy | ||||
| Surgery without adjuvant chemo | 250 | 828 | (525, 1194) | [103, 4957] |
| Surgery and adj chemo—completed | 333 | 986 | (613, 1531) | [114, 5999] |
| Surgery and adj chemo—ongoing | 17 | 1465 | (1283, 1678) | [749, 2769] |
| All patients | 716 | 898 | (572, 1366) | [98, 5999] |
(B) U-TXM at registration according to baseline factors.
aLDL > 3, total cholesterol>5 or non-HDL > 4 defined as elevated; note that participants with at least one of LDL, HDL and total cholesterol measured and in the normal range (and no raised measurements) are included in the normal group even if other measurements are missing.
bHigh-risk disease defined as breast Stage III; colorectal Stage III or IV; gastro-oesophageal Stage IIB or III; prostate high risk according to D’Amico classification.
cParticipants could not register for the trial until at least 6 weeks post-surgery.
Neutrophil, platelet and total white cell categories based on upper quartile and above.