Table 2.
Trial | Type of Tumor | Number of Patients | Topics | Evidences | Analyzed Parametres | Results |
---|---|---|---|---|---|---|
Beatty et al [24] | Colorectal/Melanoma | 52 | IDO1 inhibitor | Phase 1 | Toxicity Objective responses | Well tolerated. No objective responses. SD lasting ≥ 16 weeks in 7/52 patients. |
Machon et al. [25] | Head and neck | 31 | Aminoacids, vitamins, fatty acids, ribonucleic acids, antioxidants | Observational | Inflammatory/oxidative stress | Decreased hs-CRP (9.8 vs. 3.2, p = 0.002) and α-1 acid glycoprotein (1.2 vs. 1.0, p = 0.020) |
Sunpaweravong et al. [26] | Esophageal | 71 | Arginine, EPA, DHA and nucleotides | Randomized | Immune cells | Decreased CRP (p = 0.001) and TNF (p = 0.014) |
Maruyama et al. [27] | Gastric and esophageal cancer | 22 | Arginine, fatty acids and nucleotides | Randomized | Immune cells | Increased Th17 (9.0 ± 2.2 vs. 14.4 ± 3.5%) |
Talvas et al. [28] | Head and neck and esophageal | 28 | Arginine, fatty acids and glutamine | Double blind | Immune cells | Maintained LT4/LT8 counts ratio (2.47 ± 0.31 vs. 1.95 ± 0.20); Decreased PGE2 (66 ± 16 vs. 107 ± 16, p < 0.05); Increased IFNγ (10.3 ± 3.4 vs. 4.4 ± 1.4, p < 0.05), IL12/IL10 (2.39 vs. 3.4 p = 0.1) and IL2 (1.3 ± 0.42 vs. 0.6 ± 0.3) |
Derosa et al. [29] | NSCLC and RCC | 64 | Microbiome | Observational | Outcome (OS and PFS) | ATB vs. no ATB in RCC: increased risk of PD (75% versus 22%, p < 0.01), shorter PFS [median 1.9 vs. 7.4 mos, HR 3.1, 95% CI 1.4–6.9, p < 0.01], and shorter OS (median 17.3 vs. 30.6 mos, HR 3.5, 95% CI 1.1–10.8, p = 0.03). NSCLC: PD (52% versus 43%, p = 0.26) but decreased PFS (median 1.9 vs. 3.8 mos, HR 1.5, 95% CI 1.0–2.2, p = 0.03) and OS (median 7.9 vs. 24.6 mos, HR 4.4, 95% CI 2.6–7.7, p < 0.01). |
Rolleret al. [30] | Colon cancer | 37 | Microbiome | Double blind | Immune cells | Increased mean IL-2 (221 ng/L vs. 132 ng/L) and IFNγ (1071 vs. 712 ng/L) |
Botticelli et al. [31] | NSCLC | 11 | Microbiome | Observational | Immune cells | Tridecane and 2-pentanone associated to early progression (respectively p = 0.032 and p = 0.016). Fatty acids, lysine and nicotinic acids associated to long term beneficial effects of therapies (respectively p = 0.016, p = 0.032 and p = 0.016), |
Routy et al. [32] | NSCLC and RCC | 100 | Microbiome | Observational | Immune cells | Increased PFS in presence of CD4+ and CD8+ against A. muciniphila and E. Hirae (p = 0.031 and p = 0.044 respectively) |
Peters et al. [33] | Melanoma | 27 | Microbiome | Observational | Immune cells | Longer PFS (HR 95% CI) = 0.97 (0.95, 1.00), p = 0.02; number of shotgun subspecies: HR (95% CI) = 0.89 (0.79, 0.99), p = 0.03) |
Gopalakrishnan et al. [34] | Melanoma | 43 | Microbiome | Observational Prospectic | Immune cells | PFS (HR = 2.95, 95% C.I. = 1.31–7.29, p = 0.03). |
Matson et al. [35] | Melanoma | 42 | Microbiome | Observational Prospectic | Immune cells | Role of Microbial composition in R versus NR for this subset (p < 0.01) |
Chaput et al. [36] | Melanoma | 26 | Microbiome | Observational Prospectic | Immune cells | Longer PFS (p = 0.0039) and overall survival (p = 0.051 |
Frankel et al. [37] | Melanoma | 39 | Microbiome | Observational Prospectic | Immune cells | Higher ICT responder if microbiomes is enriched with B. caccae (p = 0.032) and Streptococcus parasanguinis (p = 0.048) |
Siska et al. [38] | RCC | 54 | Glycolysis | Observational | Immune cells | Higher PD-1highCD8+ T cells with hyperpolarized mitochondria and increased mitochondrial ROS and MTG staining (p < 0.05) and decreased PBMC PD-1lowCD8+ T cells cytoplasmic ROS (p < 0.05). |
Ostadrahimi et al. [39] | Breast | 30 | Beta-glucano | Randomized, double blind, placebo controlled | Immune cells | Increased Global health status/QoL (p = 0.023) |
Paixãoet al. [40] | Breast | 45 | n-3 fatty acids | Double blind randomized | Immune cells | Stable hsCRP in FG (initial median 0.1 (IQR 0.1–0.5), final median 0.3 (IQR 0.0–0.7), p = 0.510) vs. increased hsCRP in PG (initial median 0.1 (IQR 0.0–0.2), final median 0.2 (IQR 0.1–0.3), p = 0.024). |
SD = stable disease; LT4 = CD4 Lymphocyte; LT8 = CD8 Lymphocyte; PGE2 = Prostaglandin E2; PFS: progression free survival; R = responders, NR = Non-responders; IQR = Interquartile range; hsCRP = high sensitivity C-reactive protein; FG = supplemented with fatty acids; PG = placebo group; RCC = renal cell carcinoma; mos = months, CI = confidence interval; HP = hazard ratio; NSCLC = non-small cell lung cancer; PD = primary progressive disease; ATB = antibiotics.