Table 1.
Baseline characteristics of patients treated with ICT and separated into clinical responders (R) and non-responders (NR)
| Univariate analysis |
Multivariate analysis |
|||||
|---|---|---|---|---|---|---|
| Variables | ICT-R (n = 13) | ICT-NR (n = 7) | P-value | OR | 95% CI | P-value |
| Gender (F:M) | 8:5 | 4:3 | ||||
| Age (years) median (range) | 60 (36–78) | 60 (47–86) | ||||
| BMI (kg/m2) median (range) | 22.7 (17.7–27.0) | 20.7 (13.7–26.0) | ||||
| Hyperlipemia (n) | 0 | 0 | ||||
| Diabetes (n) | 4 | 0 | ||||
| TNM staging | ||||||
| III(n) | 3 | 0 | ||||
| IV(n) | 10 | 7 | ||||
| Primary surgery for CRC (n) | 8 | 7 | ||||
| Interval between primary surgery and the treatment (month) | 10(1.9–33) | 8(1.9–84) | ||||
| CA-199 (U/ml) median (range) | 31.1 (<2–119.9) | 111.1 (<2–3515.5) | ||||
| CA-125 (U/ml) median (range) | 26.2(2.7–994.1) | 75.8 (9.4–473.3) | ||||
| CA-153 (U/ml) median (range) | 10.1 (6.4–129.2) | 8.4 (6.7–11.8) | ||||
| CEA (ng/ml) median (range) | 8.6 (1.0–>15000) | 21.3 (2.8–898.0) | ||||
| T lymphocyte subgroup | ||||||
| CD3+ (%)median (range) | 74.5(51.7–82.6) | 71.2(61.1–80.5) | ||||
| CD3+/CD4+ (%)median (range) | 36.2(30.0–62.0) | 36.8(32.2–55.3) | ||||
| CD3+/CD8+ (%)median (range) | 28.9(15.9–50.6) | 26.7(22.0–31.4) | ||||
| CD3–/CD16+/CD56+ (%)median (range) | 14.4(9.4–30.3) | 17.2(12.9–29.3) | ||||
| CD3+/CD16+/CD56+ (%)median (range) | 3.1(1.3–11.3) | 1.6(0.9–11.6) | ||||
| CD19+ (%)median (range) | 7.4(3.3–16.3) | 9.7(4.1–10.8) | ||||
| CD4+/CD25+ (%)median (range) | 1.3(0.3–3.3) | 2.6(1.1–3.0) | ||||
| CD8+/CD28– (%)median (range) | 21.7(8.1–39.8) | 18.3(9.7–26.6) | ||||
| CD8+/CD28+ (%)median (range) | 11.3(7.6–18.1) | 10.3(6.9–15.3) | ||||
| CIK cell infused median (range), 1st-cycle | 7.9(3.3–11.1)×109 | 4.7(2.6–6.8)×109 | ||||
| CIK cell infused median (range), 2nd-cycle | 5.7(1.21–9.6)×109 | 4.7(2.2–5.4)×109 | ||||
| Quantification of total bacterial 16S DNA gene copy number (copies/ml): pre-therapy | 70930(39377–111409) | 68610(32377–91399) | ||||
| Bacterial diversity: pre-therapy | ||||||
| Chao | 354.59(189.33–537.94) | 211.50(153.20–321.67) | 0.011 | 1.019 | 1.001–1.037 | 0.042 |
| Shannon | 3.73(2.57–4.54) | 3.05(2.11–4.04) | 0.039 | |||
| Simpson | 0.07(0.03–0.26) | 0.11(0.05–0.19) | ||||
| Median for relative abundance of microbe at genus level(%) | ||||||
| Bifidobacterium | 2.76(0.19–36.68) | 0.33(0.00–1.33) | 0.014 | |||
| Lactobacillus | 2.76(0.12–7.19) | 0.37(0.09–3.34) | 0.014 | |||
| Enterococcus | 0.77(0.02–22.42) | 0.14(0.00–0.53) | 0.030 | |||
| Pseudomonas | 25.43(4.96–44.35) | 39.78(27.85–45.39) | 0.037 | |||
| The P-value is >0.05 when it is not indicated. | ||||||
| ICT: DC-CIK therapy combined with chemotherapy; R, response; NR, no-response. | ||||||
Patients treated with ICT were separated into responders (R) and non-responders (NR) according to the clinical assessment. The gender, age, BMI, number of patients with primary surgery, interval time between primary surgery and the treatment, tumor markers (CA-199, CA-125, CA-153, and CEA), proportion of T lymphocyte subgroup and total number of CIK cells infused was not significantly different between subgroups ICT-R (n = 13) and ICT-NR (n = 7). The total bacterial 16S DNA gene copy number of plasma between sub-group ICT-R and ICT-NR was also not statistically different. The bacterial diversity index (Chao and Shannon) and the relative abundance of Bifidobacterium, Lactobacillus, Enterococcus, Pseudomonas (at genus level) was statistically different before therapy. The multivariate analysis revealed that the Chao index was associated with response to ICT therapy.