Abstract
Background
Radiotherapy (RT) may function synergistically with immunotherapy and targeted agents (TA). This study aimed to assess the effectiveness and safety of RT combined with programmed death-1 (PD-1) inhibitors and lenvatinib in patients with relapsed or refractory advanced biliary tract carcinoma (BTC).
Methods
This retrospective study included patients with relapsed or refractory advanced BTC who received RT combined with PD-1 inhibitors and lenvatinib at the Peking Union Medical College Hospital (PUMCH). Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety were evaluated.
Results
Thirty-one patients who received RT combined with PD-1 inhibitors and lenvatinib as a second- or later-line therapy were analyzed. RT sites were mainly distributed in the liver lesions (64.5%) and lymph nodes (58.1%). The ORR and DCR were 32.3% (10/31; 95% CI: 14.8–49.7) and 87.1% (27/31; 95% CI: 74.6–99.6), respectively. The median PFS (mPFS) and median OS (mOS) were 7.9 (95% CI: 7.1–8.7) and 11.7 (95% CI: 8.3–15.0) months, respectively. Subgroup analyses of this cohort included 12 and 19 patients who received concurrent and salvage (> 6 weeks after commencing PD-1 inhibitor therapy) RT, respectively. The salvage RT group had higher mOS (11.7 vs. 10.5; p = 0.75) and mPFS (7.9 vs. 6.9; p = 0.85) than the concurrent RT group; however, statistical significance was not reached. All patients experienced any-grade adverse events (AEs), and excessive PD-1 inhibitors or RT toxicity were not observed.
Conclusions
RT, PD-1 inhibitors, and lenvatinib may be safely combined and have antitumor effectiveness in patients with advanced BTC.
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Data availability
All data generated or analyzed during this study are included in this published article and its supplementary information files.
Abbreviations
- AEs:
-
Adverse events
- BTCs:
-
Biliary tract cancers
- CR:
-
Complete response
- CTCAE:
-
Common Terminology Criteria Coastocellular Group
- DCR:
-
Disease control rate
- ECC:
-
Extrahepatic cholangiocarcinoma
- GBC:
-
Gallbladder cancer
- HR:
-
Hazard rate
- ICC:
-
Intrahepatic cholangiocarcinoma
- Lenvatinib:
-
Tyrosine kinase inhibitors
- ORR:
-
Objective response rate
- OS:
-
Overall survival
- PD:
-
Progressive disease
- PD-1:
-
Programmed cell death protein 1
- PD-L1:
-
Programmed cell death ligand 1
- PFS:
-
Progression-free survival
- PR:
-
Partial response
- RECIST:
-
Response evaluation criteria in solid tumors
- RT:
-
Radiotherapy
- SD:
-
Stable disease
- TA:
-
Targeted agents
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Funding
This work was supported by CAMS Innovation Fund for Medical Sciences (CIFMS) (2021–1-I2M-003 and 2021-I2M-1–061), CSCO-hengrui Cancer Research Fund (Y-HR2019-0239, Y-HR2020MS-0415, Y-HR2020QN-0414), CSCO-MSD Cancer Research Fund (Y-MSDZD2021-0213) and National Ten-thousand Talent Program.
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YCW and XBY collected the data and wrote the manuscript. XRH and HTZ designed and examined the study. NZ, JYL, and XY helped to collect the literature and participated in discussions. ZYX, JNX, and YYW performed the statistical analyses. All authors read and approved the final manuscript.
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All patients were fully informed about the objectives of this study and provided formal written consent a priori. The protocols of this study were compliant with the principles of the Declaration of Helsinki and were also approved by the institutional review board and ethics committee at Peking Union Medical College Hospital (PUMCH-JS-1391).
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Wang, Y., Yang, X., Wang, Y. et al. Effectiveness and safety of radiotherapy plus programmed death-1 inhibitors and lenvatinib in patients with advanced biliary tract carcinoma: a real-world study. Cancer Immunol Immunother 72, 2197–2204 (2023). https://doi.org/10.1007/s00262-023-03399-2
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DOI: https://doi.org/10.1007/s00262-023-03399-2