Cabozantinib Plus Nivolumab in Adult Patients with Advanced or Metastatic Renal Cell Carcinoma: A Retrospective, Non-Interventional Study in a Real-World Cohort/GUARDIANS Project
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patient Cohort and Treatment
2.2. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Efficacy
3.3. Safety/Adverse Events
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic, No. (%) | All Patients (N = 96) | Patients with ccRCC (N = 61) | Patients with Non-ccRCC (N = 35) |
---|---|---|---|
Median age at start of nivolumab/cabozantinib in years (range) | 66.0 (22–85) | 67.1 (35–85) | 65.4 (22–78) |
Age < 75 years | 80 (83.3) | 53 (86.9) | 27 (77.1) |
Age ≥ 75 years | 11 (11.5) | 5 (8.2) | 6 (17.1) |
Unknown | 5 (5.2) | 3 (4.9) | 2 (5.7) |
Gender | |||
Male | 64 (66.6) | 39 (63.9) | 25 (71.4) |
Female | 32 (33.3) | 22 (36.1) | 10 (28.6) |
Prior definitive treatment | |||
Yes | 58 (60.4) | 37 (60.6) | 21 (60) |
No | 38 (39.6) | 24 (39.4) | 14 (40) |
T-status | |||
T1 | 4 (4.2) | 0 (0) | 4 (11.4) |
T2 | 8 (8.3) | 6 (9.8) | 2 (5.7) |
T3 | 24 (25) | 18 (29.5) | 6 (17.1) |
T4 | 12 (12.5) | 7 (11.5) | 5 (8.2) |
Unknown | 48 (49.0) | 30 (49.2) | 18 (51.4) |
N-status | |||
N0 | 31 (32.2) | 21 (34.4) | 10 (28.6) |
N1 (regional) | 19 (19.8) | 13 (21.3) | 6 (17.1) |
N2 (non-regional) | 29 (30.2) | 19 (31.1) | 10 (28.6) |
Unknown | 17 (17.7) | 8 (13.1) | 9 (25.7) |
M-Status | |||
M0 | 12 (12.5) | 8 (13.1) | 4 (11.4) |
M1 | 84 (87.5) | 53 (86.9) | 31 (88.5) |
ECOG performance status score | |||
0 | 40 (41.7) | 24 (39.4) | 16 (45.7) |
1 | 26 (27.1) | 11 (18.0) | 15 (42.9) |
2 | 8 (8.3) | 8 (13.1) | 0 (0) |
3 | 6 (6.3) | 6 (9.8) | 0 (0) |
4 | 0 (0) | 0 (0) | 0 (0) |
Unknown | 16 (16.7) | 12 (19.7) | 4 (6.5) |
IMDC | |||
Favorable (0 points) | 22 (22.9) | 18 (29.5) | 4 (11.4) |
Intermediate (1–2 points) | 41 (42.7) | 23 (37.7) | 18 (51.4) |
Poor (≥3 points) | 16 (16.7) | 13 (21.3) | 3 (8.6) |
Unknown | 17 (17.7) | 7 (11.4) | 10 (28.6) |
Site of metastases | |||
Lymph nodes | 48 (50) | 32 (52.4) | 16 (45.7) |
Lung | 53 (55.2) | 40 (65.6) | 13 (37.1) |
Bone | 39 (40.6) | 25 (41.0) | 14 (40) |
Liver | 19 (19.8) | 8 (13.1) | 11(31.4) |
Adrenal | 14 (14.6) | 12 (19.7) | 2 (5.7) |
Brain | 13 (13.5) | 8 (13.1) | 5 (14.2) |
Other | 15 (15.6) | 12 (19.7) | 3 (8.6) |
No. (%) | All Patients (N = 96) |
---|---|
ORR | 44 (45.8) |
CR | 2 (2.0) |
PR | 42 (43.8) |
SD | 31 (32.3) |
PD | 8 (8.3) |
Not evaluable | 13 (13.5) |
DCR | 75 (78.1) |
No. (%) | All Patients (N = 96) |
---|---|
Treatment-related adverse events, any grade | 79 (82.3) |
Grade ≥ 3 TRAEs | 40 (41.7) |
Treatment-related adverse events resulting in any treatment discontinuation | 24 (25) |
Treatment-related adverse events leading to death | 1 (1.0) |
No. (%) | All Grades | Grades 3–5 |
---|---|---|
Increased liver enzymes | 33 (34.4) | 13 (13.5) |
Diarrhea | 30 (31.3) | 8 (8.3) |
Palmar–plantar erythrodysesthesia | 28 (29.2) | 9 (9.4) |
Fatigue | 18 (18.8) | 3 (3.1) |
Hypothyroidism | 12 (12.5) | 8 (8.3) |
Nausea | 11 (11.5) | 1 (1.0) |
Hypertension | 11 (11.5) | 8 (8.3) |
Mucosal inflammation | 10 (10.4) | 3 (3,1) |
Loss of weight | 8 (8.3) | 2 (2.1) |
Thrombopenia | 7 (7.3) | 1 (1.0) |
Leukopenia | 5 (5.2) | 1 (1.0) |
Anemia | 5 (5.2) | 1 (1.0) |
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Hilser, T.; Darr, C.; Niegisch, G.; Schnabel, M.J.; Foller, S.; Häuser, L.; Zschäbitz, S.; Lewerich, J.; Ivanyi, P.; Schlack, K.; et al. Cabozantinib Plus Nivolumab in Adult Patients with Advanced or Metastatic Renal Cell Carcinoma: A Retrospective, Non-Interventional Study in a Real-World Cohort/GUARDIANS Project. Cancers 2024, 16, 2998. https://doi.org/10.3390/cancers16172998
Hilser T, Darr C, Niegisch G, Schnabel MJ, Foller S, Häuser L, Zschäbitz S, Lewerich J, Ivanyi P, Schlack K, et al. Cabozantinib Plus Nivolumab in Adult Patients with Advanced or Metastatic Renal Cell Carcinoma: A Retrospective, Non-Interventional Study in a Real-World Cohort/GUARDIANS Project. Cancers. 2024; 16(17):2998. https://doi.org/10.3390/cancers16172998
Chicago/Turabian StyleHilser, Thomas, Christopher Darr, Günter Niegisch, Marco Julius Schnabel, Susan Foller, Lorine Häuser, Stefanie Zschäbitz, Jonas Lewerich, Philipp Ivanyi, Katrin Schlack, and et al. 2024. "Cabozantinib Plus Nivolumab in Adult Patients with Advanced or Metastatic Renal Cell Carcinoma: A Retrospective, Non-Interventional Study in a Real-World Cohort/GUARDIANS Project" Cancers 16, no. 17: 2998. https://doi.org/10.3390/cancers16172998