Table 1.
Patient | Gender/Age a | Melanoma Subtype/Site/Breslow in mm b | BRAF/PD-L1 c | ICI d | Pre-Treatment e | Tumor Burden in cm f | Involved Sites g | Response h | irAE/Grade i | S100/LDH j |
---|---|---|---|---|---|---|---|---|---|---|
1 | F/78 | uNM/HN/1.8 | WT/5% | 4NIVO | RT | 1.0 | PUL | CR | none | -/+ |
2 | M/76 | uNM/T/1.4 | WT/30% | 1IPI/NIVO, 6NIVO | none | 20.6 | CER, LN, MUS, PER, SC | PR | irFAT/G3 irTHY/G2 | -/- |
3 | F/70 | NM/LE/3.9 | WT/20% | 4PEMBRO | aIFN | 6.7 | LN, PUL | PD | irMUC/G2 | -/+ |
4 | M/67 | uALM/LE/3.1 | WT/5% | 4PEMBRO | none | 3.4 | HEP | PD | irHEP/G1 | -/+ |
5 | F/74 | mucM/AN/12.0 | WT/0% (cKIT WT) | 1IPI/NIVO, 1NIVO | naRT | 20.8 | AN, HEP, PUL | PD | irHEP/G2 | -/+ |
6 | F/91 | uNM/T/3.5 | V600E/30% | 4PEMBRO | none | 3.9 | CUT, HEP, PUL | PR | none | -/+ |
7 | M/78 | NM/T/9.6 | WT/10% | 2IPI/NIVO | none | 15 | HEP, LN, OSS | PR | irTHY/G2, irHYP/G2, irHEP/G1 | +/+ |
8 | M/75 | uNM/UE/3.4 | WT/0% | 4PEMBRO | none | 4.6 | CUT, LN, SC | PR | none | +/- |
9 | F/41 | NM/LE/3.1 | V600E/0% | 4IPI/NIVO, 1NIVO | aIFN, aNIVO, aTT | 1.9 | CER, LN | SD | none | +/- |
10 | F/57 | SSM/T/0.8 | V600E/5% | 2IPI/NIVO, 4NIVO | TT | 1.0 | CER, PUL | PR | irHEP/G2 | -/- |
11 | M/70 | MNOS/T/1.4 | WT/UKN | 3IPI/NIVO, 1NIVO | none | 13.6 | CER, INT, PUL, LN | PR | irFAT/G2, irCOL/G2, irTHY/G1 | +/+ |
12 | M/77 | uNM/T/9.0 | V600E/5% | 2NIVO | none | 18.7 | CUT, INT, LN, MUS, OSS, SPLE | n.a. | none | +/+ |
13 | M/76 | NM/HN/3.6 | WT/UKN | 1NIVO | none | 16.9 | ADR, BIL, OSS, PUL | PD | none | +/+ |
14 | M/61 | uSSM/OE/1.5 | WTUKN | 3PEMBRO | none | 7.6 | CUT, LN, PUL | n.a. | none | -/- |
15 | F/95 | uNM/HN/11.0 | WT/10% | 5NIVO | none | 7.5 | ADR, HEP, MUS, PUL | PR | none | -/- |
16 | F/52 | CUP/UKN/UKN | WT/2% | 2IPI/NIVO | RT | 2.6 | PAN, MUS | CR | irDER/G1, irTHY/G1, irNEP/G1 | -/- |
17 | M/48 | CUP/UKN/UKN | V600E/0% | 4IPI/NIVO | RT, TT | 5.4 | CER | PR | none | +/+ |
a gender female (F) or male (M). b melanoma subtype (ulcerated (u), nodular melanoma (NM), superficial spreading melanoma (SSM), acral lentiginous melanoma (ALM), mucosal melanoma (mucM), melanoma not otherwise specified (MNOS)), melanoma of unknown primary (CUP), site of primary (head and neck (HN), upper extremities (UE), torso (T), lower extremities (LE)), anal (AN), unknown site (UKN)/Breslow thickness in mm. c BRAF mutation (V600) or wild type (WT); PD-L1 positivity in percent of melanoma cells in immune histochemical staining vs. staining unknown (UKN). d number of treatment cycles during immune monitoring and therapy regimen of immune checkpoint inhibitors: nivolumab monotherapy (NIVO; 240 mg Q2W or 480 mg Q4W),ipilimumab/nivolumab combination therapy (IPI/NIVO; IPI 3 mg/kg bodyweight and NIVO 1 mg/kg bodyweight), pembrolizumab monotherapy (PEMBRO; 200 mg Q3W or 400 mg Q6W). e pre-treatment: adjuvant treatment (a), neoadjuvant (na,) targeted therapy with BRAF/MEK-inhibitors (TT), ICI (NIVO, PEMBRO), radiotherapy (RT), interferon-α (IFN). f tumor burden in cm (target + non-target lesions). g in metastasis involved sites: adrenal (ADR), anal (AN), gallbladder/bile (BIL), cerebral (CER), cutaneous (CUT), hepatic (HEP), intestinal (INT), lymph node (LN), muscular (MUS), skeletal (OSS), pancreatic (PAN), peritoneal (PER), pulmonary (PUL), subcutaneous (SC), splenic (SPLE). h complete response (CR, all target lesions (TL) and non-target lesions (NTL) regressed), partial response (PR, sum of diameters TL + NTL at least −30%), progressive disease (PD, at least +20% in sum of diameters of TL + NTL), stable disease (SD, sum of diameters TL + NTL between −29% and +19%); response not available (n.a.) due to early treatment change to TT or unknown cause of death before response evaluation. i immune-related adverse event (irAE) during immune monitoring and grade according to CTCAE v5.0 (G1-5): irHepatitis (irHEP), irFatigue (irFAT; irFAT grade 1 was not assessed as irAE), irGamma-glutamyltransferasis elevated (irGGT), irThyroiditis (irTHY), ir lichenoid mucositis (irMUC), irHypophysitis (irHYP), irNephritis (irNEP). j S100 and LDH above upper level of normal (+) vs. normal values (-) at start of ICI.