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head and neck cancer squamous cell cancer (HNSCC), durvalumab alone , 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) 0.88 [0.72, 1.08]< 10%1 study (1/-)89.2 %NAnot evaluable crucial-
progression or deaths (PFS) 1.02 [0.84, 1.24]< 10%1 study (1/-)42.3 %NAnot evaluable important-
DCR 1.00 [0.63, 1.58]> 10%1 study (1/-)50.0 %NAnot evaluable non important-
objective responses (ORR) 1.05 [0.66, 1.68]> 10%1 study (1/-)58.1 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.45 [0.21, 0.94]< 10%1 study (1/-)98.3 %NAnot evaluable non important-
AE (grade 3-4) 0.89 [0.62, 1.28]< 10%1 study (1/-)73.3 %NAnot evaluable non important-
AE leading to death (grade 5) 1.01 [0.52, 1.97]< 10%1 study (1/-)48.4 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.97 [0.53, 1.77]< 10%1 study (1/-)54.3 %NAnot evaluable non important-
SAE (any grade) 1.21 [0.80, 1.80]< 10%1 study (1/-)18.2 %NAnot evaluable non important-
STRAE (any grade) 1.16 [0.56, 2.38]< 10%1 study (1/-)34.4 %NAnot evaluable non important-
TRAE (any grade) 0.29 [0.19, 0.45]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.35 [0.21, 0.59]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 8.22 [0.43, 156.41]< 10%1 study (1/-)8.3 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.91 [0.36, 2.28]< 10%1 study (1/-)58.2 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 1.01 [0.02, 51.25]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.04 [0.00, 0.75]< 10%1 study (1/-)98.4 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.50 [0.05, 5.60]< 10%1 study (1/-)71.0 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.17 [0.01, 3.35]< 10%1 study (1/-)87.6 %NAnot evaluable non important-
Dermatitis acneiform TRAE (grade 3-4) 1.01 [0.02, 51.25]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.17 [0.01, 3.35]< 10%1 study (1/-)87.6 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 1.01 [0.14, 7.25]< 10%1 study (1/-)49.5 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.01 [0.02, 51.25]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 1.01 [0.06, 16.29]< 10%1 study (1/-)49.6 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.12 [0.01, 2.37]< 10%1 study (1/-)91.5 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.51 [0.02, 15.13]< 10%1 study (1/-)65.1 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 2.03 [0.07, 60.79]< 10%1 study (1/-)34.4 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.04 [0.00, 0.68]< 10%1 study (1/-)98.6 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 0.50 [0.05, 5.60]< 10%1 study (1/-)71.0 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 1.01 [0.02, 51.25]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 1.01 [0.02, 51.25]< 10%1 study (1/-)49.8 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 2.03 [0.07, 60.79]< 10%1 study (1/-)34.4 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 1.01 [0.06, 16.29]< 10%1 study (1/-)49.6 %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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