Adverse Events in Anti-PD-1-Treated Adjuvant and First-Line Advanced Melanoma Patients
Abstract
:Simple Summary
Abstract
1. Introduction
2. Methods
2.1. Study Design
2.2. Patients Characteristics
2.3. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Comorbidities
3.3. Characterization of Adverse Events
3.4. Univariate and Multivariate Analysis
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Advanced (N = 1465) | Adjuvant (N = 908) | p-Value | |
---|---|---|---|
Characteristics | |||
Age at diagnosis | <0.01 | ||
Median (interquartile range), years | 69 (59–77) | 63 (54–72) | |
Sex | 0.52 | ||
Male | 882 (60) | 523 (58) | |
Female | 583 (40) | 385 (42) | |
ECOG performance status | <0.01 | ||
0 | 818 (56) | 644 (71) | |
1 | 482 (33) | 203 (22) | |
>1 | 91 (6) | 14 (2) | |
Unknown | 74 (5) | 47 (5) | |
AJCC, 8th edition, stage | <0.01 | ||
IIIA | NA | 54 (6) | |
IIIB | NA | 319 (35) | |
IIIC | 158 (11) | 413 (46) | |
IIID | NA | 12 (1) | |
IVa | 236 (16) | 79 (9) | |
IVb | 385 (26 | 30 (3) | |
IVc | 483 (33) | 1 (1) | |
IVd | 202 (14) | NA | |
Unknown | 1 (1) | NA | |
LDH levels | |||
Normal (<250 U/L) | 1083 (74) | 850 (94) | <0.01 |
Increased (>250 U/L) | 366 (25) | 33 (4) | |
Missing | 16 (1) | 23 (3) | |
Total mean cycles | |||
10.9 | 9.20 | <0.01 |
Advanced (N = 1465) | Adjuvant (N = 908) | p-Value | ||
---|---|---|---|---|
Any comorbidity | no | 337 (23) | 281 (31) | <0.01 |
yes | 1128 (77) | 627 (69) | ||
Neurological | no | 1215 (83) | 780 (86) | 0.34 |
yes | 250 (17) | 128 (14) | ||
Cardiovascular | no | 1135 (77) | 779 (86) | <0.01 |
yes | 330 (23) | 129 (14) | ||
Diabetes | no | 1286 (88) | 811 (90) | 0.61 |
yes | 179 (12) | 94 (10) | ||
Pulmonary | no | 1300 (89) | 819 (90) | 0.38 |
yes | 165 (11) | 89 (10) | ||
Gastroenterological | no | 1313 (90) | 839 (92) | 0.19 |
yes | 152 (10) | 69 (8) | ||
Urological | no | 1303 (89) | 834 (92) | 0.13 |
yes | 162 (11) | 74 (8) | ||
Musculoskeletal | no | 197 (13) | 806 (89) | 0.13 |
yes | 1268 (87) | 102 (11) | ||
Infectious | no | 1426 (98) | 906 (98) | 0.74 |
yes | 29 (2) | 16 (2) | ||
Malignancy | no | 1164 (79) | 780 (86) | <0.01 |
yes | 301 (21) | 128 (14) | ||
Any autoimmune disease | no | 1284 (87) | 810 (89) | 0.25 |
yes | 181 (13) | 98 (11) | ||
IBD | no | 1441 (98) | 900 (99) | 0.12 |
yes | 24 (2) | 8 (1) | ||
Rheumatologic | no | 1371 (94) | 869 (96) | 0.03 |
yes | 94 (6) | 39 (4) | ||
Endocrine | no | 1381 (94) | 832 (92) | 0.01 |
yes | 84 (6) | 76 (8) |
Advanced (N = 1465) | Adjuvant (N = 908) | p-Value | ||
---|---|---|---|---|
Any type of adverse event | No | 1251 (85) | 789 (87) | 0.31 |
Yes | 214 (15) | 119 (13) | ||
Myelotoxicity | No | 1462 (1) | 907 (99) | 0.66 |
Yes | 3 (1) | 1 (1) | ||
Neuropathy | No | 1462 (99) | 905 (99) | 0.41 |
Yes | 3 (1) | 3 (1) | ||
Colitis | No | 1414 (96) | 875 (96) | 0.67 |
Yes | 53 (4) | 33 (4) | ||
Renal | No | 1455 (99) | 903 (99) | 0.62 |
Yes | 10 (1) | 5 (1) | ||
Pulmonary | No | 1451 (99) | 904 (99) | 0.25 |
Yes | 16 (1) | 4 (1) | ||
Endocrine | No | 1405 (96) | 870 (96) | 0.92 |
Yes | 60 (4) | 38 (4) | ||
Fatigue | No | 1456 (99) | 904 (99) | 0.14 |
Yes | 9 (1) | 2 (1) | ||
Cutaneous | No | 1448 (99) | 901 (99) | 0.27 |
Yes | 19 (1) | 7 (1) | ||
Hepatitis | No | 1432 (98) | 895 (98) | 0.10 |
Yes | 33 (2) | 13 (1) | ||
Other | No | 1377 (94) | 864 (95) | |
Yes | 88 (6) | 44 (5) |
Univariate (OR, 95% CI) | Multivariate (OR, 95% CI) | |
---|---|---|
Age | 1.00 (0.99–1.01) | |
Gender | ||
Male | Reference | |
Female | 0.93 (0.74–1.18) | |
ECOG | ||
0–1 | Reference | |
>1 | 2.11 (1.23–3.49) | 2.00 (1.20–3.32) |
Comorbidity | ||
Absent | Reference | |
Any | 1.24 (1.04–1.46) | 1.22 (1.02–1.44) |
Treatment Type | ||
Advanced | Reference | |
Adjuvant | 0.88 (0.69–1.12) | 0.95 (0.74–1.21) |
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Rauwerdink, D.J.W.; Not, O.v.; de Meza, M.; Doorn, R.v.; Hage, J.v.d.; Eertwegh, A.J.M.v.d.; Haanen, J.B.; Aarts, M.J.B.; Berkmortel, F.W.P.J.v.d.; Blank, C.U.; et al. Adverse Events in Anti-PD-1-Treated Adjuvant and First-Line Advanced Melanoma Patients. Cancers 2024, 16, 2656. https://doi.org/10.3390/cancers16152656
Rauwerdink DJW, Not Ov, de Meza M, Doorn Rv, Hage Jvd, Eertwegh AJMvd, Haanen JB, Aarts MJB, Berkmortel FWPJvd, Blank CU, et al. Adverse Events in Anti-PD-1-Treated Adjuvant and First-Line Advanced Melanoma Patients. Cancers. 2024; 16(15):2656. https://doi.org/10.3390/cancers16152656
Chicago/Turabian StyleRauwerdink, Daan Jan Willem, Olivier van Not, Melissa de Meza, Remco van Doorn, Jos van der Hage, A. J. M. van den Eertwegh, John B. Haanen, Maureen J. B. Aarts, Franchette W. P. J. van den Berkmortel, Christiaan U. Blank, and et al. 2024. "Adverse Events in Anti-PD-1-Treated Adjuvant and First-Line Advanced Melanoma Patients" Cancers 16, no. 15: 2656. https://doi.org/10.3390/cancers16152656