Table 1 Patients’ demographic and clinical characteristics before treatment
From: The role of diabetes in metastatic melanoma patients treated with nivolumab plus relatlimab
Type 2 diabetes at baseline n = 37, n (%) | No diabetes during observation n = 92, n (%) | Total population n = 129, n (%) | p-value | |
|---|---|---|---|---|
Baseline patient characteristics | ||||
Mean age, years (range) | 64 (17–85) | 60 (26–94) | 61 (17–94) | |
Gender | 0.9 | |||
Female | 7 (19) | 18 (20) | 25 (30) | |
Male | 30 (81) | 74 (80) | 104(70) | |
Race and ethnicity | 0.0001 | |||
Caucasian | 29 (78) | 91 (99) | 120 (93) | |
Asian | 2 (4) | 1 (1) | 3 (2) | |
NA | 6 (16) | 0 (0) | 6 (5) | |
BRAF status | 0.36 | |||
Wild-type | 21 (57) | 56 (61) | 77 (60) | |
Mutation | 12 (32) | 20 (22) | 32 (25) | |
NA | 4 (11) | 16 (17) | 20 (15) | |
NRAS status | 0.41 | |||
Wild-type | 15 (41) | 40 (43) | 55 (42) | |
Mutation | 5 (13) | 6 (7) | 11 (9) | |
NA | 17 (46) | 48 (52) | 63 (49) | |
CNS metastases at baseline | 0.19 | |||
Yes | 4 (11) | 16 (17) | 20 (15) | |
No | 29 (78) | 57 (62) | 86 (69) | |
NA | 4 (11) | 19 (21) | 23 (16) | |
M category | 0.15 | |||
M1a | 4 (11) | 4 (4) | 8 (6) | |
M1b | 7 (19) | 10 (11) | 17 (13) | |
M1c | 23 (62) | 60 (65) | 83 (66) | |
M1d | 3 (8) | 18 (20) | 21 (15) | |
BMI, mean (SD) | 29.7 (5.6) | 27.11 (5.5) | 0.01 | |
T2D at baseline | – | |||
Yes | 37 (100) | 0 (0) | 37 (29) | |
No | 0 (0) | 92 (100) | 88 (62) | |
Without diabetic episode during observation | – | – | 88 (68) | |
With ICI-DM development during treatment | – | – | 4 (3) | |
Antidiabetic treatments | – | |||
Taking metformin | 25 (68) | 0 (0) | 25 (19) | |
Taking insulin | 5 (14) | 0 (0) | 5 (4) | |
Other hypoglycemic* | 9 (24) | 0 (0) | 9 (7) | |
NA | 3 (5) | 0 (0) | 3 (2) | |
Diabetic with glucose > 126 mg/dl** | 19 (51) | 19 (15) | ||
Clinical parameters | ||||
ICI treatment | 0.01 | |||
First-line treatment | 15 (41) | 25 (27) | 40 (31) | |
Second-line treatment | 14 (38) | 19 (21) | 33 (25) | |
Third-line treatment | 3 (8) | 29 (31) | 32 (25) | |
> Third-line treatment | 5 (13) | 19 (21) | 24 (19) | |
Previous treatments | ||||
(Neo)adjuvant setting | 0,35 | |||
Chemotherapy | 2 (5) | 2 (2) | 4 (3) | |
Targeted therapy | 0 (0) | 3 (3) | 3 (2) | |
Immunotherapy | 4 (11) | 7 (8) | 11 (9) | |
Metastatic setting: | ||||
Chemotherapy | 1 (3) | 12 (13) | 13 (10) | 0.61 |
Targeted therapy | 3 (8) | 19 (21) | 23 (18) | |
Immunotherapy | 18 (49) | 52 (57) | 70 (76) | |
Systemic treatment post-nivolumab + relatlimab subministration | 11 (30) | 19 (21) | 30 (12) | 0.88 |
Immunotherapy | 10 (27) | 16 (17) | 26 (21) | |
Targeted therapy | 1 (3) | 2 (2) | 3 (2) | |
Chemotherapy | 0 (0) | 1 (1) | 1 (1) | |
ECOG PS | 0.12 | |||
0–1 | 35 (95) | 78 (85) | 113 (88) | |
≥ 2 | 2 (5) | 14 (15) | 16 (12) | |
Concomitant radiotherapy | 1 (3) | 9 (10) | 10 (8) | |