Table 1.
Baseline characteristics of 1016 patients by quintile of predicted 25(OH)D score
| Predicted 25(OH)D Score |
|||||
|---|---|---|---|---|---|
| Quintile1 | Quintile 2 | Quintile 3 | Quintile 4 | Quintile 5 | |
| (n=207) | (n=200) | (n=204) | (n=203) | (n=202) | |
| Vitamin D score, median (range), ng/mL | 23.3 (16.0–24.7) | 25.7 (24.7–26.6) | 27.6 (26.6–28.3) | 29.2 (28.3–30.1) | 31.5 (30.1–36.4) |
| Season of questionnaire completion, No. (%) | |||||
| Summer (June, July, August) | 67 (32.4) | 62 (31.0) | 66 (32.4) | 62 (30.5) | 75 (37.1) |
| Autumn (Sept, Oct, Nov) | 25 (12.1) | 36 (18.0) | 29 (14.2) | 31 (15.3) | 31 (15.3) |
| Winter (Dec, Jan, Feb) | 42 (20.3) | 33 (16.5) | 49 (24.0) | 43 (21.2) | 37 (18.3) |
| Spring (Mar, April, May) | 73 (35.3) | 69 (34.5) | 60 (29.4) | 67 (33.0) | 59 (29.2) |
| Age, median (range), years | 59 (32–80) | 59 (21–83) | 62 (32–85) | 62 (24–85) | 60 (27–82) |
| Male, No. (%) | 79 (38.2) | 111 (55.5) | 118 (57.8) | 137 (67.5) | 127 (62.9) |
| Race, No. (%) | |||||
| White | 134 (64.7) | 184 (92.0) | 197 (96.6) | 193 (95.1) | 197 (97.5) |
| Black | 56 (27.1) | 6 (3.0) | 2 (1.0) | 1 (0.5) | 0 (0) |
| Other | 17 (8.2) | 10 (5.0) | 5 (2.5) | 9 (4.4) | 5 (2.5) |
| Residence, No. (%)a | |||||
| South | 52 (25.1) | 38 (19.0) | 61 (29.9) | 60 (29.6) | 87 (43.1) |
| Midwest/West | 70 (33.8) | 75 (37.5) | 83 (40.7) | 91 (44.8) | 85 (42.1) |
| Northeast | 85 (41.1) | 87 (43.5) | 60 (29.4) | 52 (25.6) | 30 (14.9) |
| Family history of CRC, No. (%) | |||||
| Yes | 38 (18.4) | 29 (14.5) | 38 (18.6) | 40 (19.7) | 38 (18.8) |
| No | 169 (81.6) | 171 (85.5) | 166 (81.4) | 163 (80.3) | 164 (81.2) |
| Baseline performance status, No. (%)b | |||||
| 0 | 134 (64.7) | 145 (72.5) | 157 (77.0) | 155 (76.4) | 154 (76.2) |
| 1–2 | 66 (31.9) | 47 (23.5) | 45 (22.1) | 46 (22.7) | 46 (22.8) |
| Unknown | 7 (3.4) | 8 (4.0) | 2 (1.0) | 2 (1.0) | 2 (1.0) |
| Invasion through bowel wall by T stage, No. (%)c | |||||
| T1–2 | 22 (10.6) | 24 (12.0) | 28 (13.7) | 31 (15.3) | 32 (15.8) |
| T3–4 | 175 (84.5) | 167 (83.5) | 174 (85.3) | 170 (83.7) | 169 (83.7) |
| Unknown | 10 (4.8) | 9 (4.5) | 2 (1.0) | 2 (1.0) | 1 (0.5) |
| Number of positive lymph nodes, No. (%) | |||||
| 1–3 | 131 (63.3) | 131 (65.5) | 127 (62.3) | 124 (61.1) | 126 (62.4) |
| ≥4 | 69 (33.3) | 62 (31.0) | 75 (36.8) | 77 (37.9) | 74 (36.6) |
| Unknown | 7 (3.4) | 7 (3.5) | 2 (1.0) | 2 (1.0) | 2 (1.0) |
| Grade of differentiation, No. (%) | |||||
| Well | 14 (6.8) | 16 (8.0) | 14 (6.9) | 2 (1.0) | 10 (5.0) |
| Moderate | 141 (68.1) | 131 (65.5) | 145 (71.1) | 141 (69.5) | 142 (70.3) |
| Poor/undifferentiated | 45 (21.7) | 45 (22.5) | 43 (21.1) | 56 (27.6) | 49 (24.3) |
| Unknown | 7 (3.4) | 8 (4.0) | 2 (1.0) | 4 (2.0) | 1 (0.5) |
| Clinical bowel obstruction at presentation, No. (%) | 45 (21.7) | 42 (21.0) | 41 (20.1) | 46 (22.7) | 47 (23.3) |
| Bowel perforation at presentation, No. (%) | 12 (5.8) | 6 (3.0) | 11 (5.4) | 10 (4.9) | 4 (2.0) |
| Treatment arm, No. (%) | |||||
| FU/LV | 104 (50.2) | 88 (44.0) | 109 (53.4) | 105 (51.7) | 109 (54.0) |
| IFL | 103 (49.8) | 112 (56.0) | 95 (46.6) | 98 (48.3) | 93 (46.0) |
| Body mass index, median (range), kg/m2d | 31 (19–52) | 29 (17–52) | 28 (18–42) | 27 (17–42) | 24 (17–38) |
| Physical activity, median (range), MET-h/wk4d | 1 (0–57) | 4 (0–74) | 6 (0–98) | 12 (0–103) | 24 (2–123) |
| Dietary vitamin D intake, energy-adjusted, median (range), IU/d | 100 (0–600) | 200 (0–1000) | 170 (41–530) | 197 (36–746) | 236 (48–595) |
| Vitamin D supplement intake, median (range), IU/d | 0 (0–600) | 24 (0–1100) | 200 (0–800) | 200 (0–800) | 200 (0–1200) |
| Total calcium intake, energy-adjusted, median (range), mg/d | 700 (300–2500) | 800 (400–2400) | 900 (300–3000) | 1000 (400–3400) | 1000 (300–3000) |
| KRAS mutational status | |||||
| Wildtype | 67 (64.4) | 61 (65.6) | 66 (62.3) | 79 (66.9) | 83 (70.3) |
| Mutant | 37 (35.6) | 32 (34.4) | 40 (37.7) | 39 (33.1) | 35 (29.7) |
| BRAF mutational status | |||||
| Wildtype | 84 (80.8) | 78 (84.8) | 88 (81.5) | 100 (85.5) | 107 (91.5) |
| Mutant | 20 (19.2) | 14 (15.2) | 20 (18.5) | 17 (14.5) | 10 (8.5) |
| PIK3CA mutational status | |||||
| Wildtype | 94 (91.3) | 76 (86.4) | 89 (87.3) | 97 (89.8) | 97 (85.8) |
| Mutant | 9 (8.7) | 12 (13.6) | 13 (12.7) | 11 (10.2) | 16 (14.2) |
| TP53 mutational status | |||||
| Wildtype | 47 (54.7) | 50 (59.5) | 41 (46.1) | 54 (59.3) | 51 (49.0) |
| Mutant | 39 (45.3) | 34 (40.5) | 48 (53.9) | 37 (40.7) | 53 (51.0) |
| MSI status | |||||
| MSI-high | 26 (12.6) | 24 (12.0) | 17 (8.3) | 32 (15.8) | 19 (9.4) |
| MSS/MSI-low | 181 (87.4) | 176 (88.0) | 187 (91.7) | 171 (84.2) | 183 (90.6) |
South includes OK, TX, LA, AR, MS, AL, FL, GA, SC, NC, VA, TN, KY, WV, DC, MD, DE, AZ, CA, NM, CO, UT, NV, GU, HI, PR, and VI); Midwest/West includes ND, SD, NE, KS, MN, IA, MO, WI, IL, MI, IN, OH, OR, WA, MT, ID, and WY; Northeast includes PA, NY, NJ, CT, RI, MA, NH, VT, ME, and AK.
Baseline performance status: PS 0 = fully active; PS 1 = restricted in physically strenuous activity but ambulatory and able to carry out light work; PS 2= ambulatory and capable of all self-care but unable to carry out any work activities, up and about >50% of waking hours.
T1–2 = level of invasion through the bowel wall not beyond the muscle layer; T3–4 = level of invasion through the bowel wall beyond the muscle layer.
Based on questionnaire 1.
25(OH)D, 25-hydroxyvitamin D; No., number; FU/LV, 5-fluorouracil and leucovorin; IFL, irinotecan; MET, metabolic equivalent.