All patients
Age < 65y (younger) Age > 65y BRAF mutant BRAF wild type ECOG ⩾ 1 ECOG 0 ECOG 1 Gender, female Gender, male LDH > ULN LDH ≤ULN metastasis (brain) NO metastasis (brain) YES PD-L1 < 1% PD-L1 < 5% PD-L1 > 1% PD-L1 > 5% stage III (locally advanced) stage IV (metastatic) stage M0 stage M0/M1A/M1B stage M1A stage M1B stage M1C
Top evidence (RCT only, high risk of bias excluded)
Best available evidence (possibly low or very low)
All RCTs
All studies (RCT+OBS)
studies
mML - 1st line (L1), Immune checkpoint association vs. nivolumab alone, meta-analysis of study results Outcome TE 95% CI n k I2 ROB Pub. bias deaths (OS)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.65 [0.53; 0.80]
0.65 [0.53 ; 0.80 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 630 NA not evaluable deaths (OS) (extension)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.83 [0.67; 1.03]
0.83 [0.67 ; 1.03 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 630 NA not evaluable PFS (extension)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.79 [0.65; 0.97]
0.79 [0.65 ; 0.97 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 630 NA not evaluable progression or deaths (PFS)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.74 [0.60; 0.92]
0.74 [0.60 ; 0.92 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 630 NA not evaluable objective responses (ORR)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.76 [1.28; 2.41]
1.76 [1.28 ; 2.41 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 630 NA not evaluable objective responses (ORR) (extension)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 5.96 [4.16; 8.54]
5.96 [4.16 ; 8.54 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 630 NA not evaluable TRAE (any grade)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.58 [1.88; 6.81]
3.58 [1.88 ; 6.81 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.82 [3.41; 6.80]
4.82 [3.41 ; 6.80 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable TRAE leading to death (grade 5)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.02; 50.56]
1.00 [0.02 ; 50.56 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable TRAE leading to discontinuation (any grade)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.85 [3.25; 7.24]
4.85 [3.25 ; 7.24 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable TRAE leading to discontinuation (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 5.10 [3.17; 8.19]
5.10 [3.17 ; 8.19 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Abdominal pain TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 2.00 [0.07; 59.93]
2.00 [0.07 ; 59.93 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Adrenal insufficiency TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.04 [0.61; 15.17]
3.04 [0.61 ; 15.17 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Arthralgia TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 2.01 [0.18; 22.24]
2.01 [0.18 ; 22.24 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Asthenia TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.06; 16.06]
1.00 [0.06 ; 16.06 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Colitis TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 9.36 [2.80; 31.26]
9.36 [2.80 ; 31.26 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Cough TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.25 [0.01; 5.54]
0.25 [0.01 ; 5.54 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Decreased appetite TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 8.09 [0.43; 153.69]
8.09 [0.43 ; 153.69 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Diarrhoea TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.45 [1.60; 7.41]
3.45 [1.60 ; 7.41 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Dry skin TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.02; 50.56]
1.00 [0.02 ; 50.56 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Dyspnoea TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.02 [0.31; 29.19]
3.02 [0.31 ; 29.19 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Fatigue TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.48 [1.26; 15.87]
4.48 [1.26 ; 15.87 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Headache TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.02 [0.18; 89.49]
4.02 [0.18 ; 89.49 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Hepatitis TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 10.15 [0.55; 186.51]
10.15 [0.55 ; 186.51 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Hyperthyroidism TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 6.05 [0.30; 121.25]
6.05 [0.30 ; 121.25 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Hypophysitis TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 5.06 [0.59; 43.61]
5.06 [0.59 ; 43.61 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Hypothyroidism TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 2.00 [0.07; 59.93]
2.00 [0.07 ; 59.93 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Increase AST TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 6.68 [1.96; 22.80]
6.68 [1.96 ; 22.80 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Increased ALT TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 7.29 [2.52; 21.10]
7.29 [2.52 ; 21.10 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Increased lipase level TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 2.60 [1.37; 4.95]
2.60 [1.37 ; 4.95 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Maculopapular rash TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.04 [0.61; 15.17]
3.04 [0.61 ; 15.17 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Myalgia TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.06; 16.06]
1.00 [0.06 ; 16.06 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Nausea TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 14.30 [0.81; 253.04]
14.30 [0.81 ; 253.04 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Pneumonitis TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.02 [0.31; 29.19]
3.02 [0.31 ; 29.19 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Pruritic rash TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.02; 50.56]
1.00 [0.02 ; 50.56 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Pruritus TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 6.10 [0.73; 50.95]
6.10 [0.73 ; 50.95 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Pyrexia TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.02 [0.18; 89.49]
4.02 [0.18 ; 89.49 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Rash TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 10.30 [1.31; 80.93]
10.30 [1.31 ; 80.93 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Thyroiditis TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 2.00 [0.07; 59.93]
2.00 [0.07 ; 59.93 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Vitiligo TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.50 [0.02; 14.93]
0.50 [0.02 ; 14.93 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Vomiting TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 7.14 [0.87; 58.36]
7.14 [0.87 ; 58.36 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable Weight decreased TRAE (grade 3-4)detailed results CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.02; 50.56]
1.00 [0.02 ; 50.56 ] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1 0% 626 NA not evaluable 0.0 20.0 1.0 relative treatment effect www.metaEvidence.org 2024-11-05 18:48 +01:00
TE: relative treatment effect (measured by a risk ratio, an odds ratio or an hazard ratio depending on what is reported in the papers);
k: number of studies; n: total number of patients;
ROB: risk of bias (ROB 2.0); Pub. bias: publication bias; OBS: observational studies; RCT: randomized clinical trials
studied treatment is better when TE > 1;
studied treatment is better when TE < 1;
pathologies: 285,68,127,128
- treatments: 856,634,861,416,864,769,980