Efficacy and Safety of the Combination of Durvalumab Plus Gemcitabine and Cisplatin in Patients with Advanced Biliary Tract Cancer: A Real-World Retrospective Cohort Study
Abstract
1. Introduction
2. Materials and Methods
3. Results
3.1. The OS and PFS
3.2. The ORR and DCR
3.3. AEs
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
PD-L1 | programmed death ligand 1 |
GCD | durvalumab plus gemcitabine and cisplatin |
mGPS | modified Glasgow Prognostic Score |
NLR | neutrophil–lymphocyte ratio |
PLR | platelet–lymphocyte ratio |
ORR | overall response rate |
DCR | disease control rate |
PFS | progression-free survival |
OS | overall survival |
CTLA-4 | cytotoxic T-lymphocyte-associated protein 4 |
AEs | adverse events |
RECIST | Response Evaluation Criteria in Solid Tumors |
PNI | prognostic nutritional index |
BMI | body mass index |
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Characteristics | Number (%) or Median (IQR) | |
---|---|---|
Patients, n (%) | 52 (100) | |
Sex, n (%) | Male | 36 (69.2) |
Female | 16 (30.8) | |
Age, years (IQR) | 73.0 (67.8–77.3) | |
BMI, kg/m2 (IQR) | 21.9 (19.7–23.7) | |
Primary tumor type, n (%) | Intrahepatic cholangiocarcinoma | 7 (13.5) |
Extrahepatic cholangiocarcinoma (distal/perihilar) | 10 (19.2)/19 (36.5) | |
Gall bladder | 13 (25.0) | |
Ampullary carcinoma | 3 (5.8) | |
Cancer stage, n (%) | Local/locally advanced | 30 (57.7) |
Metastatic | 22 (42.3) | |
Performance status | 0/1/2 | 43 (82.7)/7 (13.5)/2 (3.8) |
Alb, g/dL (IQR) | 3.7 (3.4–4.0) | |
CRP (IQR) | 0.39 (0.17–2.08) | |
mGPS (%) | 0/1/2 | 23 (44.2)/18 (34.6)/11 (21.2) |
NLR (IQR) | 2.4 (1.7–3.9) | |
PLR (IQR) | 162.5 (118.3–242.8) | |
CRP–Alb ratio (IQR) | 0.12 (0.04–0.60) | |
PNI (IQR) | 44.5 (40.3–48.1) | |
CEA (IQR) | 4.8 (2.6–10.5) | |
CA19-9 (IQR) | 255.9 (40.8–1014.3) | |
Line of therapy at which GCD was administered (%) | 1st | 38 (73.1) |
2nd | 12 (23.1) | |
3rd | 2 (3.8) | |
First-line cancer therapy (%) | GCD | 38 (73.1) |
GC | 12 (23.1) | |
GCS | 1 (1.9) | |
GEM | 1 (1.9) |
All Patients (n = 52) | |
---|---|
Complete response, n (%) | 2 (3.8) |
Partial response, n (%) | 11 (21.2) |
Stable disease, n (%) | 28 (53.8) |
Progressive disease, n (%) | 10 (19.2) |
Not evaluable, n (%) | 1 (1.9) |
Overall response rate (%) | 13/52 (25.0%) |
Disease control rate (%) | 41/52 (78.8%) |
Toxicity | All | Grade 3/4 |
---|---|---|
Neutropenia | 22 (42.3) | 15 (28.8) |
Anemia | 13 (25.0) | 3 (5.8) |
Thrombocytopenia | 7 (13.5) | 0 (0) |
Appetite loss | 5 (9.6) | 0 (0) |
General fatigue | 4 (7.7) | 2 (3.8) |
Dysgeusia | 3 (5.8) | 0 (0) |
Nausea | 1 (1.9) | 0 (0) |
Cholangitis | 2 (3.8) | 1 (1.9) * |
Colitis | 1 (1.9) | 1 (1.9) * |
Constipation | 2 (3.8) | 0 (0) |
Abdominal infection | 1 (1.9) | 1 (1.9) |
Hypothyroidism | 2 (3.8) | 2 (3.8) * |
Eruption | 2 (3.8) | 0 (0) |
AST increased | 6 (11.5) | 1 (1.9) |
ALT increased | 5 (9.6) | 1 (1.9) |
Creatinine increased | 2 (3.8) | 0 (0) |
Hypersensitivity for cisplatin | 2 (3.8) | 1 (1.9) |
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Kurihara, E.; Kakizaki, S.; Ijima, M.; Hatanaka, T.; Kubo, N.; Suzuki, Y.; Yasuoka, H.; Hoshino, T.; Naganuma, A.; Tani, N.; et al. Efficacy and Safety of the Combination of Durvalumab Plus Gemcitabine and Cisplatin in Patients with Advanced Biliary Tract Cancer: A Real-World Retrospective Cohort Study. Biomedicines 2025, 13, 1915. https://doi.org/10.3390/biomedicines13081915
Kurihara E, Kakizaki S, Ijima M, Hatanaka T, Kubo N, Suzuki Y, Yasuoka H, Hoshino T, Naganuma A, Tani N, et al. Efficacy and Safety of the Combination of Durvalumab Plus Gemcitabine and Cisplatin in Patients with Advanced Biliary Tract Cancer: A Real-World Retrospective Cohort Study. Biomedicines. 2025; 13(8):1915. https://doi.org/10.3390/biomedicines13081915
Chicago/Turabian StyleKurihara, Eishin, Satoru Kakizaki, Masashi Ijima, Takeshi Hatanaka, Norio Kubo, Yuhei Suzuki, Hidetoshi Yasuoka, Takashi Hoshino, Atsushi Naganuma, Noriyuki Tani, and et al. 2025. "Efficacy and Safety of the Combination of Durvalumab Plus Gemcitabine and Cisplatin in Patients with Advanced Biliary Tract Cancer: A Real-World Retrospective Cohort Study" Biomedicines 13, no. 8: 1915. https://doi.org/10.3390/biomedicines13081915
APA StyleKurihara, E., Kakizaki, S., Ijima, M., Hatanaka, T., Kubo, N., Suzuki, Y., Yasuoka, H., Hoshino, T., Naganuma, A., Tani, N., Yamazaki, Y., & Uraoka, T. (2025). Efficacy and Safety of the Combination of Durvalumab Plus Gemcitabine and Cisplatin in Patients with Advanced Biliary Tract Cancer: A Real-World Retrospective Cohort Study. Biomedicines, 13(8), 1915. https://doi.org/10.3390/biomedicines13081915