Comparison of Efficacy and Safety of Anti-Programmed Cell Death-1 Antibody Plus Lenvatinib and Chemotherapy as First-Line Therapy for Patients with Stage IV Gallbladder Cancer: A Real-World Study in a Chinese Population
Abstract
:1. Introduction
2. Patients and Methods
2.1. Ethics Statement
2.2. Study Design and Patients
2.3. Data Collection and Clinical Outcome Assessment
2.4. Treatment
2.5. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Efficacy
3.3. Safety
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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Characteristic | Gemcitabine + Cisplatin (N = 33) | Camrelizumab + Lenvatinib (N = 31) | p |
---|---|---|---|
Age, (median, IQR) | 62 (56–66) | 67 (61–70) | 0.06 |
Sex, n (%) | 0.79 | ||
Male | 16 (48.48) | 14 (45.16) | |
Female | 17 (51.52) | 17 (54.84) | |
Child–Pugh score, n (%) | 0.48 | ||
A | 28 (84.85) | 29 (93.55) | |
B | 5 (15.15) | 2 (6.45) | |
ECOG performance status, n (%) | 0.78 | ||
0, n (%) | 28 (84.85) | 28 (90.32) | |
1, n (%) | 5 (15.15) | 3 (9.68) | |
CA19-9, U/mL (median, IQR) | 45.00 (16.20–166.45) | 40.00 (11.90–220.30) | 0.67 |
<200, n (%) | 25 (75.76) | 22 (70.97) | |
≥200, n (%) | 8 (24.24) | 9 (29.03) | |
CEA, U/mL (median, IQR) | 2.70 (1.80–6.00) | 2.90 (2.00–6.10) | 0.93 |
Serum TBIL | 17.90 (13.10–21.75) | 16.90 (12.90–20.60) | 0.62 |
Serum DBIL | 4.70 (3.25–6.25) | 5.0 0(3.60–7.80) | 0.17 |
Biliary Drainage, n | 0 | 3 | |
Histology, n (%) | |||
Adenocarcinoma | 33 (100.00) | 31 (100.00) | |
Differentiated histology, n (%) | 0.25 | ||
Moderately differentiated | 18 (54.55) | 13 (41.94) | |
Poorly differentiated | 15 (45.45) | 16 (51.61) | |
Undifferentiated | 0 | 2 (6.45) | |
Previous therapy, n (%) | |||
None | 33 (100.00) | 31 (100.00) | |
Metastatic site, n (%) | |||
Intrahepatic | 33 (100.00) | 31 (100.00) | |
Lymph nodes | 33 (100.00) | 31 (100.00) | |
Peritoneum | 12 (36.36) | 6 (19.35) | |
Lung | 2 (6.06) | 3 (9.68) | |
TNM stage, n (%) | |||
IV | 33 (100.00) | 31 (100.00) | |
PD-L1 expression TPS (%) (median, IQR) | NA | 9.40 (5.00–30.20) | |
Frist antitumor therapy, n (%) | |||
Gemcitabine + Cisplatin | 33 (100.00) | 0 | |
Camrelizumab + Lenvatinib | 0 | 31 (100.00) | |
Subsequent antitumor therapy, n (%) | |||
Radical surgery resection | 0 | 1 (3.23) | |
Systemic chemotherapy | 4 (12.12) | 3 (9.68) | |
Radiotherapy | 2 (6.06) | 1 (3.22) | |
Immunotherapy and targeted therapy | 3 (9.09) | 0 | |
Type of anti-PD-1 antibody, n (%) | |||
Camrelizumab | 0 | 31 (100.00) |
Therapeutic Response Assessment | Gemcitabine + Cisplatin (N = 33) | Camrelizumab + Lenvatinib (N = 31) | p |
---|---|---|---|
Objective response rate, (ORR, n, %) | 13 (39.39) | 17 (54.84) | 0.22 |
Disease control rate, (DCR, n, %) | 24 (72.73) | 25 (80.65) | 0.46 |
Complete response (CR, n, %) | 0 | 0 | |
Partial response (PR, n, %) | 13 (39.39) | 17 (54.84) | |
Stable disease (SD, n, %) | 11 (33.33) | 8 (25.80) | |
Progressive disease (PD, n, %) | 9 (27.27) | 6 (19.35) |
Adverse Events (AEs) | Gemcitabine + Cisplatin (N = 33) | Camrelizumab + Lenvatinib (N = 31) | ||
---|---|---|---|---|
Grade 1–4, n (%) | Grade 3–4, n (%) | Grade 1–4, n (%) | Grade 3–4, n (%) | |
Hematologic toxic effects | ||||
Leukopenia | 15 (45.45) | 1 (3.03) | 0 | 0 |
Anemia | 6 (18.18) | 0 | 0 | 0 |
Thrombocytopenia | 6 (18.18) | 0 | 0 | 0 |
Nonhematologic toxic effects | ||||
Fatigue | 23 (69.70) | 0 | 12 (38.71) | 0 |
Hypertension | 3 (9.09) | 0 | 2 (6.45) | 1 (3.23) |
ALT or AST elevation | 6 (18.18) | 0 | 2 (6.45) | 0 |
Decreased appetite | 20 (60.61) | 0 | 6 (19.35) | 0 |
Abdominal pain | 0 | 0 | 3 (9.68) | 0 |
Vomiting | 10 (30.30) | 2 (6.06) | 2 (6.45) | 0 |
Diarrhea | 3 (9.09) | 1 (3.03) | 3 (9.68) | 1 (3.23) |
Decreased weight | 14 (42.42) | 0 | 2 (6.45) | 0 |
RCCEP | 0 | 0 | 1 (3.23) | 0 |
Gastrointestinal hemorrhage | 0 | 0 | 1 (3.23) | 1 (3.23) |
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Wu, T.; Pu, C.; Wang, Q.; Zhang, K. Comparison of Efficacy and Safety of Anti-Programmed Cell Death-1 Antibody Plus Lenvatinib and Chemotherapy as First-Line Therapy for Patients with Stage IV Gallbladder Cancer: A Real-World Study in a Chinese Population. Biomedicines 2023, 11, 2933. https://doi.org/10.3390/biomedicines11112933
Wu T, Pu C, Wang Q, Zhang K. Comparison of Efficacy and Safety of Anti-Programmed Cell Death-1 Antibody Plus Lenvatinib and Chemotherapy as First-Line Therapy for Patients with Stage IV Gallbladder Cancer: A Real-World Study in a Chinese Population. Biomedicines. 2023; 11(11):2933. https://doi.org/10.3390/biomedicines11112933
Chicago/Turabian StyleWu, Tiantian, Changsheng Pu, Qiang Wang, and Keming Zhang. 2023. "Comparison of Efficacy and Safety of Anti-Programmed Cell Death-1 Antibody Plus Lenvatinib and Chemotherapy as First-Line Therapy for Patients with Stage IV Gallbladder Cancer: A Real-World Study in a Chinese Population" Biomedicines 11, no. 11: 2933. https://doi.org/10.3390/biomedicines11112933