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mHNSCC - 2nd line (L2), Immune checkpoint association , meta-analysis of study results

Outcome Relative effect 95%CI LoD Trt. better when I2 k (RCT/OBS) Bayesian probability Overall ROB Publication bias Degree of certainty Endpoint importance Published MA

efficacy endpoints 00

deaths (OS) 1.04 [0.85, 1.27]< 10%1 study (1/-)34.8 %NAnot evaluable crucial-
progression or deaths (PFS) 1.09 [0.90, 1.33]< 10%1 study (1/-)19.4 %NAnot evaluable important-
DCR 1.12 [0.72, 1.75]> 10%1 study (1/-)69.1 %NAnot evaluable non important-
objective responses (ORR) 1.07 [0.67, 1.70]> 10%1 study (1/-)61.2 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.80 [0.35, 1.79]< 10%1 study (1/-)70.9 %NAnot evaluable non important-
AE (grade 3-4) 1.33 [0.93, 1.90]< 10%1 study (1/-)6.0 %NAnot evaluable non important-
AE leading to death (grade 5) 1.32 [0.70, 2.46]< 10%1 study (1/-)19.5 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 1.54 [0.89, 2.68]< 10%1 study (1/-)6.1 %NAnot evaluable non important-
SAE (any grade) 1.39 [0.94, 2.06]< 10%1 study (1/-)5.2 %NAnot evaluable non important-
TRAE (any grade) 0.34 [0.22, 0.52]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.61 [0.39, 0.96]< 10%1 study (1/-)98.5 %NAnot evaluable non important-
TRAE leading to death (grade 5) 3.93 [0.18, 87.52]< 10%1 study (1/-)19.7 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.97 [0.40, 2.39]< 10%1 study (1/-)52.2 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 0.98 [0.02, 49.37]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.34 [0.11, 1.10]< 10%1 study (1/-)96.4 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 2.47 [0.47, 12.85]< 10%1 study (1/-)14.2 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.65 [0.11, 3.91]< 10%1 study (1/-)68.1 %NAnot evaluable non important-
Dermatitis acneiform TRAE (grade 3-4) 0.98 [0.02, 49.37]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.65 [0.11, 3.91]< 10%1 study (1/-)68.1 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 1.47 [0.24, 8.87]< 10%1 study (1/-)33.8 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.98 [0.02, 49.37]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.49 [0.02, 14.58]< 10%1 study (1/-)65.9 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.12 [0.01, 2.29]< 10%1 study (1/-)91.8 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.49 [0.02, 14.58]< 10%1 study (1/-)65.9 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.98 [0.02, 49.37]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.08 [0.01, 0.60]< 10%1 study (1/-)99.3 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 0.24 [0.01, 5.40]< 10%1 study (1/-)81.2 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.98 [0.02, 49.37]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.98 [0.02, 49.37]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 0.98 [0.02, 49.37]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 1.96 [0.18, 21.75]< 10%1 study (1/-)29.3 %NAnot evaluable non important-

LoD: level of statistical demonstration: Statistically conclusive: statistically significant with a strict control of overall risk of type 1 error (statistically demonstrated), does not take into account the risk of bias; suggested: nominally statistically significant but without a strict control of overall risk of type 1 error; inconclusive: not nominally statistically significant; safety concerns;
Bayesian probability: Bayesian posterior probability of treatment effect (computed with a noninformative prior); ROB: risk of bias; k: number of studies; published MA: number of published meta-analysis on the same topic; degree of certainty adapted from GRADE. Trt. better when: indicates when the relative treatment effect shows that the studied treatment is better than control.



 

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