| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| melanoma | Interferon alpha | not classified | versus placebo or control No demonstrated result for efficacy rIFN alpha-2b inferior to observation in terms of OS in EORTC18871/DKG 80-1 stage III | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EORTC18871/DKG 80-1 stage III | rIFN alpha-2b vs observation | | OS 1.61 [1.01; 2.56] | |
| Trial | Treatments | Patients | Method |
|---|
| EORTC18871/DKG 80-1 stage III | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| melanoma | Interferon alpha | adjuvant | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EORTC18991 (Eggermont), 2008 | PEG IFN alpha-2b (I M) vs observation | PFS 0.87 [0.76; 1.00] | | OS 0.96 [0.83; 1.12] DMFS 0.93 [0.81; 1.07] |
| Trial | Treatments | Patients | Method |
|---|
| EORTC18991 (Eggermont), 2008 | pegylated interferon alfa-2b 6 mug/kg per week for 8 weeks (induction) then 3 mug/kg per week (maintenance) for an intended duration of 5 years (n=627) vs. (n=629) | patients with resected stage III melanoma | Sample size: 627/629 Primary endpoint: recurrence-free survival FU duration: 3.8 years |
|
| melanoma | ipilimumab | adjuvant | versus placebo or control ipilimumab superior to placebo in terms of recurrence free survival in EORTC 18071 (Eggermont), 2015 (adjuvant patients) ipilimumab inferior to placebo in terms of grade 3-4 in EORTC 18071 (Eggermont), 2015 (adjuvant patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EORTC 18071 (Eggermont), 2015 | ipilimumab vs placebo | recurrence free survival 0.76 [0.64; 0.90] Demonstrated OS 0.72 [0.58; 0.89] PFS 0.76 [0.64; 0.90] distant metastasis free survival 0.76 [0.63; 0.91] | grade 3-4 2.07 [1.74; 2.46] | |
| Trial | Treatments | Patients | Method |
|---|
| EORTC 18071 (Eggermont), 2015 | ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses, then every 3 months for up to 3 years or until disease recurrence or an unacceptable level of toxic effects occurred (n=475) vs. placebo (n=476) | high risk patients who had undergone complete resection of stage III melanoma | double-blind Parallel groups Sample size: 475/476 Primary endpoint: RFS FU duration: 5.3 years phase 3 |
|
| melanoma | nivolumab | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CheckMate 238 subgroup IIIB-C | nivolumab vs ipilimumab | PFS 0.65 [0.51; 0.82] recurrence free survival 0.65 [0.51; 0.82] distant metastasis free survival 0.73 [0.56; 0.96] | | |
| Trial | Treatments | Patients | Method |
|---|
| CheckMate 238 subgroup IIIB-C | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| melanoma | pembrolizumab | adjuvant | versus placebo or control pembrolizumab superior to placebo in terms of recurrence free survival in KEYNOTE-054, 2018 (adjuvant patients) pembrolizumab inferior to placebo in terms of Grade 3 or 4 drug-related adverse events in KEYNOTE-054, 2018 (adjuvant patients) pembrolizumab inferior to placebo in terms of Vitiligo any grade in KEYNOTE-054, 2018 (adjuvant patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| KEYNOTE-054, 2018 | pembrolizumab vs placebo | recurrence free survival 0.57 [0.43; 0.75] Demonstrated PFS LP-D1 positif 0.54 [0.42; 0.69] PFS PD-L1 negatif 0.47 [0.26; 0.85] PFS 0.57 [0.43; 0.75] | Grade 3 or 4 drug-related adverse events 4.35 [2.61; 7.26] Vitiligo any grade 2.96 [1.34; 6.52] | Vitiligo grade 3-4 NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| KEYNOTE-054, 2018 | Pembrolizumab (Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year)
(n=514) vs. placebo (n=505) | patients with complete Resection of High-Risk Stage III Melanoma | double-blind Parallel groups Sample size: 514/505 Primary endpoint: Recurrence-free survival , FU duration: 15 months (median) |
|
| melanoma | trametinib + dabrafenib | adjuvant | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| COMBI-AD, 2017 | trametinib and dabrafenib vs placebo | OS 0.57 [0.42; 0.78] PFS 0.47 [0.39; 0.57] distant metastasis free survival 0.51 [0.40; 0.65] | | |
| Trial | Treatments | Patients | Method |
|---|
| COMBI-AD, 2017 | dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months (n=-9) vs. placebo (n=-9) | Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma | double-blind Sample size: -9/-9 Primary endpoint: Relapse-free survival FU duration: |
|
| melanoma | vemurafenib | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| BRIM 8 (cohort IIIC) | vemurafenib vs placebo | | | PFS 0.80 [0.54; 1.18] RFS 0.80 [0.54; 1.18] DMFS 0.91 [0.57; 1.45] |
| Trial | Treatments | Patients | Method |
|---|
| BRIM 8 (cohort IIIC) | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| sarcoma | pazopanib | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PALETTE (van der Graaf), 2012 | pazopanib vs placebo | PFS 0.31 [0.24; 0.40] | | OS 0.86 [0.67; 1.11] |
| Trial | Treatments | Patients | Method |
|---|
| PALETTE (van der Graaf), 2012 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
