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. 2022 Feb 23;23(4):134. doi: 10.3892/ol.2022.13254

Table I.

Characteristics and efficacy results of the eligible studies.

First author, year (trial) Phase Setting Target population Arms Primary endpoints SEPs No. of enrolled patients PFS (C vs. E) OS (C vs. E) ORR (C vs. E) (Refs.)
Mettu et al, 2019 (BACCI) 2, randomized Metastatic, refractory Not selected for MMR status C: Capecitabine + bevacizumab + placebo; E: Capecitabine + bevacizumab + atezolizumab PFS ORR, OS, safety 128 3.3 (95% CI, 2.1-6.2) vs. 4.4 (95% CI, 4.1-6.4) months; HR, 0.725 (95% CI, 0.491-1.07; P=0.051) 12-month OS: 43% (95% CI, 29–63) vs. 52% (95% CI, 42–65); HR, 0.94 (95% CI, 0.56-1.56; P=0.4) 4.35 (95% CI, 0.5-14.8) vs. 8.54% (95% CI, 3.5-16.8); P=0.5 (36)
Andre et al, 2021 (KEYNOTE-177) 3 Metastatic, 1st line dMMR/MSI-H C: SOC CT +/-bevaci zumab/cetuximab; E: Pembrolizumab PFS, OS ORR, safety 307 8.2 vs. 16.5 months; HR, 0.59 (95% CI, 0.45-0.79) 36.7 months vs. median not reached; HR, 0.74 (95% CI, 0.53-1.03; P=0.0359) 33.1 vs. 45.1% (16)
Chen et al, 2020 (CCTG CO.26) 2, randomized Metastatic, refractory Not selected for MMR status C: BSC; E: Durvalumab + tremelimumab + BSC OS PFS, ORR, AEs 180 1.9 vs. 1.8 months; HR, 1.01 (90% CI, 0.76-1.34; P=0.97) 4.1 vs. 6.6 months; HR, 0.72 (90% CI, 0.54-0.97; P=0.07) 0 vs. 0.84% (DCR: 6.6% vs. 22.7%; P=0.006) (30)
Grothey et al, 2018 (MODUL) 2, randomized, signal-seeking trial Metastatic, maintenance after 1st line BRAF wild-type C: Fluoropyrimidine + bevacizumab; E: Fluoropyrimidine + bevacizumab + atezolizumab PFS OS, AEs, ORR, DCR, TTR, DoR 445 7.39 vs. 7.2 months; HR, 0.96 (95% CI, 0.77-1.20; P=0.727) 21.91 vs. 22.05 months; HR, 0.86 (95% CI, 0.66-1.13; P=0.283) Ongoing (35)
Eng et al, 2019 (COTEZO IMblaze370) 3 Metastatic, at least two prior regimens Recruitment of patients with MSI-H was capped at 5% C: Regorafenib; E1: Atezolizumab; E2: Atezolizumab + cobimetinib OS PFS, CR, PR, DoR, QoL, AEs, plasmatic concentration of atezolizumab and cobimetinib, % of anti-atezolizumab antibodies 363 C vs. E1: 2 (95% CI, 1.87-3.61) vs. 1.94 (95% CI, 1.91-2.1) months; HR, 1.39 (95% CI, 1–1.94; P=0.05); C vs. E2: 2 (95% CI, 1.87-3.61) vs. 1.91 (95% CI, 1.87-1.97) months; HR, 1.25 (95% CI, 0.94-1.65; P=0.13) C vs. E1: 8.51 (95% CI, 6.41-10.71) vs. 7.10 (95% CI, 6.05-10.05) months; HR, 1.19 (95% CI, 0.83-1.71; P=0.34); C vs. E2: 8.51 (95% CI, 6.41-10.71) vs. 8.87 (95% CI, 7.00-10.61) months; HR, 1.00 (95% CI, 0.73-1.38; P=0.99) Ongoing (33)

AE, adverse event; BSC, best supportive care; C, control arm; CI, confidence interval; CR, complete remission; CT, chemotherapy; DCR, disease control rate; dMMR, deficient mismatch repair; DoR, duration of response; E, experimental arm; HR, hazard ratio; MMR, mismatch repair; MSI-H, high microsatellite instability; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial remission; QoL, quality of life; SEP, secondary endpoint; SOC, standard of care; TTR, time to treatment response.