All patients
Age < 65y (younger) Age > 65y BRAF mutant BRAF wild type ECOG 0 ECOG 1 Gender, female Gender, male LDH > ULN LDH ≤ULN previous systemic treatment (%) previous systemic treatment NO (%) stage IIIa stage IIIb stage IIIc stage M0 stage M0/M1A/M1B stage M1A stage M1B stage M1C stage M1C (with brain metastasis)
Top evidence (RCT only, high risk of bias excluded)
Best available evidence (possibly low or very low)
All RCTs
All studies (RCT+OBS)
studies
metastatic/adv melanoma (mML), ipilimumab based treatment vs. Immunostimulant, meta-analysis of study results Outcome TE 95% CI n k I2 ROB Pub. bias deaths (OS)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.68 [0.55; 0.85]
MDX010 Ipi vs gp100, 2010 0.66 [0.51; 0.86]
0.67 [0.57 ; 0.80 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 812 low not evaluable DORdetailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.68 [0.55; 0.85]
0.68 [0.55 ; 0.85 ] MDX010 Ipi plus gp100 vs gp100, 2010 1 0% 25 NA not evaluable objective responses (ORR)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 4.06 [0.94; 17.43]
MDX010 Ipi vs gp100, 2010 8.24 [1.85; 36.76]
5.73 [2.02 ; 16.27 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 812 low not evaluable AE (any grade)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 1.95 [0.54; 7.01]
MDX010 Ipi vs gp100, 2010 0.99 [0.24; 4.05]
1.43 [0.56 ; 3.70 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.94 [0.63; 1.40]
MDX010 Ipi vs gp100, 2010 0.95 [0.59; 1.55]
0.95 [0.70 ; 1.29 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable TRAE (any grade)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 2.17 [1.28; 3.67]
MDX010 Ipi vs gp100, 2010 1.09 [0.60; 1.98]
1.56 [0.79 ; 3.06 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 65% 775 low not evaluable TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 1.64 [0.90; 2.99]
MDX010 Ipi vs gp100, 2010 1.41 [0.69; 2.88]
1.54 [0.97 ; 2.44 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable TRAE leading to death (grade 5)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 1.36 [0.28; 6.47]
1.36 [0.28 ; 6.47 ] MDX010 Ipi plus gp100 vs gp100, 2010 1 0% 539 NA not evaluable Adrenal insufficiency TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 1.39 [0.06; 31.06]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
1.23 [0.11 ; 14.04 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Colitis TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 8.58 [0.50; 146.20]
MDX010 Ipi vs gp100, 2010 14.85 [0.83; 264.38]
11.24 [1.49 ; 84.76 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Diarrhoea TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 5.01 [0.65; 38.48]
MDX010 Ipi vs gp100, 2010 6.29 [0.75; 52.98]
5.59 [1.28 ; 24.37 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Endocrine disorders TRAE (grade 3-4) detailed results MDX010 Ipi plus gp100 vs gp100, 2010 2.80 [0.15; 53.28]
MDX010 Ipi vs gp100, 2010 10.44 [0.56; 193.00]
5.44 [0.68 ; 43.24 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Gastrointestinal disorders TRAE (grade 3-4) detailed results MDX010 Ipi plus gp100 vs gp100, 2010 8.05 [1.07; 60.32]
MDX010 Ipi vs gp100, 2010 10.83 [1.37; 85.84]
9.30 [2.19 ; 39.39 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Hepatitis TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.69 [0.02; 20.81]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.81 [0.06 ; 10.65 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Hepatobiliary disorders TRAE (grade 3-4) detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.46 [0.10; 2.07]
MDX010 Ipi vs gp100, 2010 0.16 [0.01; 3.32]
0.37 [0.10 ; 1.43 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Hypophysitis TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 1.39 [0.06; 31.06]
MDX010 Ipi vs gp100, 2010 4.08 [0.18; 91.29]
2.38 [0.26 ; 21.42 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Hypothyroidism TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.69 [0.02; 20.81]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.81 [0.06 ; 10.65 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Increase AST TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.17 [0.02; 1.91]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.28 [0.04 ; 2.17 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Increased ALT TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 1.39 [0.06; 31.06]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
1.23 [0.11 ; 14.04 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Pruritus TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.69 [0.02; 20.81]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.81 [0.06 ; 10.65 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Rash TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 3.51 [0.19; 64.62]
MDX010 Ipi vs gp100, 2010 2.02 [0.07; 60.83]
2.78 [0.30 ; 25.42 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Skin and subcutaneous tissue disorders TRAE (grade 3-4) detailed results MDX010 Ipi plus gp100 vs gp100, 2010 6.38 [0.37; 110.82]
MDX010 Ipi vs gp100, 2010 4.08 [0.18; 91.29]
5.20 [0.63 ; 42.56 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Vitiligo TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.35 [0.01; 17.55]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.59 [0.04 ; 9.49 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Abdominal pain AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.29 [0.09; 0.87]
MDX010 Ipi vs gp100, 2010 0.28 [0.06; 1.36]
0.28 [0.11 ; 0.70 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Anaemia AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.33 [0.14; 0.78]
MDX010 Ipi vs gp100, 2010 0.35 [0.11; 1.12]
0.33 [0.17 ; 0.67 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Constipation AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 1.04 [0.11; 10.11]
MDX010 Ipi vs gp100, 2010 3.07 [0.32; 29.91]
1.79 [0.36 ; 8.92 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Cough AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.69 [0.02; 20.81]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.81 [0.06 ; 10.65 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Decreased appetite AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.51 [0.14; 1.85]
MDX010 Ipi vs gp100, 2010 0.50 [0.09; 2.76]
0.51 [0.18 ; 1.42 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Diarrhoea AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 6.13 [0.81; 46.56]
MDX010 Ipi vs gp100, 2010 7.40 [0.90; 60.98]
6.71 [1.56 ; 28.94 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Dyspnoea AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.80 [0.30; 2.14]
MDX010 Ipi vs gp100, 2010 0.83 [0.25; 2.80]
0.81 [0.38 ; 1.74 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Fatigue AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 1.68 [0.56; 5.04]
MDX010 Ipi vs gp100, 2010 2.36 [0.71; 7.87]
1.96 [0.87 ; 4.42 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Headache AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.46 [0.10; 2.07]
MDX010 Ipi vs gp100, 2010 1.01 [0.20; 5.09]
0.66 [0.22 ; 1.99 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Nausea AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.69 [0.17; 2.80]
MDX010 Ipi vs gp100, 2010 1.01 [0.20; 5.09]
0.81 [0.28 ; 2.34 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Pyrexia AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.34 [0.05; 2.47]
MDX010 Ipi vs gp100, 2010 0.25 [0.01; 5.58]
0.31 [0.06 ; 1.66 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable Vomiting AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs gp100, 2010 0.81 [0.21; 3.17]
MDX010 Ipi vs gp100, 2010 1.01 [0.20; 5.09]
0.89 [0.31 ; 2.52 ] MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi vs gp100, 2010 2 0% 775 low not evaluable 0.2 20.0 1.0 relative treatment effect www.metaEvidence.org 2024-10-02 09:25 +02:00
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: 283,284,70,235,285,68,127,128,286,69,129
- treatments: 850,329,558,579,549,868