Table 1.
Baseline clinical characteristics by patient BOR category
| Characteristics | Best response | P | ||||
|---|---|---|---|---|---|---|
| cPD (n = 21) | PD (n = 30) | SD (n = 29) | PR (n = 22) | CR (n = 4) | ||
| Histology cohort | ||||||
| GYN | 6 (28.6%) | 12 (40.0%) | 9 (31.0%) | 7 (31.8%) | 2 (50.0%) | 0.18 |
| NEN | 5 (23.8%) | 5 (16.7%) | 14 (48.3%) | 6 (27.3%) | 2 (50.0%) | |
| UGB | 10 (47.6%) | 13 (43.3%) | 6 (20.7%) | 9 (40.9%) | 0 (0%) | |
| No. of prior systemic therapies | ||||||
| Mean (s.d.) | 1.43 (0.811) | 1.60 (1.22) | 1.97 (1.61) | 2.00 (1.23) | 1.00 (0.82) | 0.32 |
| Median (min, max) | 1 (0, 3) | 1 (0, 5) | 2 (0, 5) | 2 (1, 5) | 1 (0, 2) | |
| Measurable tumor (mm) | ||||||
| Mean (s.d.) | 115 (82.3) | 72.6 (48.4) | 84.1 (53.8) | 90.0 (78.2) | 70.0 (19.1) | 0.49 |
| Median (min, max) | 108 (17.0, 344) | 58.0 (24.0, 219) | 77.0 (17.0, 220) | 64.0 (11.0, 325) | 77.5 (42.0, 83.0) | |
| Age (years) | ||||||
| Mean (s.d.) | 59.1 (13.9) | 56.5 (15.1) | 59.9 (14.3) | 56.3 (12.5) | 65.3 (9.29) | 0.85 |
| Median (min, max) | 65.0 (20.0, 75.0) | 62.5 (26.0, 75.0) | 60.0 (22.0, 82.0) | 53.5 (38.0, 74.0) | 64.0 (57.0, 76.0) | |
| Sex | ||||||
| Female | 9 (42.9%) | 22 (73.3%) | 17 (58.6%) | 17 (77.3%) | 4 (100%) | 0.048 |
| Male | 12 (57.1%) | 8 (26.7%) | 12 (41.4%) | 5 (22.7%) | 0 (0%) | |
| Site | ||||||
| AUS | 2 (9.5%) | 8 (26.7%) | 5 (17.2%) | 7 (31.8%) | 0 (0%) | 0.34 |
| BLA | 2 (9.5%) | 7 (23.3%) | 4 (13.8%) | 3 (13.6%) | 0 (0%) | |
| BMO | 4 (19.0%) | 1 (3.3%) | 3 (10.3%) | 1 (4.5%) | 0 (0%) | |
| MON | 8 (38.1%) | 6 (20.0%) | 11 (37.9%) | 3 (13.6%) | 2 (50.0%) | |
| PMC | 5 (23.8%) | 8 (26.7%) | 6 (20.7%) | 8 (36.4%) | 2 (50.0%) | |
| Season | ||||||
| Autumn | 9 (42.9%) | 13 (43.3%) | 12 (41.4%) | 11 (50.0%) | 1 (25.0%) | 0.8 |
| Spring | 3 (14.3%) | 2 (6.7%) | 7 (24.1%) | 2 (9.1%) | 1 (25.0%) | |
| Summer | 5 (23.8%) | 10 (33.3%) | 5 (17.2%) | 5 (22.7%) | 2 (50.0%) | |
| Winter | 4 (19.0%) | 5 (16.7%) | 5 (17.2%) | 4 (18.2%) | 0 (0%) | |
| BMI (kg m−2) | ||||||
| Mean (s.d.) | 26.1 (5.74) | 27.2 (5.30) | 28.6 (6.23) | 25.7 (5.05) | 25.6 (3.49) | 0.97 |
| Median (min, max) | 25.1 (19.1, 38.2) | 28.2 (18.6, 37.0) | 28.2 (18.9, 48.2) | 25.0 (18.8, 35.3) | 24.6 (22.8, 30.5) | |
| PPIs (<8 weeks) | ||||||
| Yes | 14 (66.7%) | 9 (30.0%) | 8 (27.6%) | 7 (31.8%) | 3 (75.0%) | 0.017 |
| No | 7 (33.3%) | 21 (70.0%) | 21 (72.4%) | 15 (68.2%) | 1 (25.0%) | |
| Antibiotics (<8 weeks) | ||||||
| Yes | 3 (14.3%) | 1 (3.3%) | 3 (10.3%) | 2 (9.1%) | 0 (0%) | 0.65 |
| No | 18 (85.7%) | 29 (96.7%) | 26 (89.7%) | 20 (90.9%) | 4 (100%) | |
| Platelets (×109 l−1) | ||||||
| Mean (s.d.) | 297 (134) | 279 (81.1) | 224 (97.8) | 287 (118) | 283 (50.1) | 0.32 |
| Median (min, max) | 302 (87.0, 603) | 273 (133, 575) | 189 (62.0, 431) | 276 (144, 559) | 300 (211, 321) | |
| Albumin (g l−1) | ||||||
| Mean (s.d.) | 30.9 (5.66) | 35.0 (5.34) | 36.2 (4.34) | 35.7 (3.47) | 37.0 (2.16) | 0.0056 |
| Median (min, max) | 32.0 (20.0, 38.0) | 36.5 (20.0, 44.0) | 37.0 (24.0, 44.0) | 36.0 (29.0, 41.0) | 36.5 (35.0, 40.0) | |
| NLR | ||||||
| Mean (s.d.) | 10.7 (15.8) | 3.33 (1.99) | 3.24 (2.18) | 3.66 (2.57) | 2.74 (0.144) | 0.0033 |
| Median (min, max) | 5.27 (2.22, 66.0) | 2.92 (0.970, 10.7) | 2.72 (1.00, 10.0) | 3.27 (0.960, 9.80) | 2.70 (2.62, 2.95) | |
| LDH (U l−1) | ||||||
| Mean (s.d.) | 380 (208) | 277 (155) | 264 (143) | 480 (696) | 283 (59.2) | 0.89 |
| Median (min, max) | 296 (149, 945) | 215 (162, 898) | 219 (128, 912) | 302 (140, 3,440) | 295 (202, 339) | |
Clinical characteristics (metadata) are reported stratified by BOR category for microbiome-evaluable participants (n = 106). Numerical metadata are summarized with both means and median values, and statistical associations with BOR (an ordinal variable increasing from cPD to CR) were computed using the Kendall τ test. Categorical metadata were analyzed using frequency tables, with statistical associations with BOR computed using the chi-squared test.
AUS, Austin Hospital (Melbourne); BLA, Blacktown Hospital (Sydney); BMO, Border Medical Oncology (Albury); MON, Monash Hospital (Melbourne); PMC, Peter MacCallum Cancer Centre (Melbourne); BMI, body mass index; PPIs, proton-pump inhibitors; LDH, lactate dehydrogenase.