Abstract 197P
Background
The prognosis for unresectable biliary tract cancer (uBTC) following the standard treatment with gemcitabine-based chemotherapy remains limited. Recently, GemCis (gemcitabine, and cisplatin) combined with immune checkpoint inhibitors(KEYNOTE-966、TOPAZ-1) showed promising results for uBTC. In this study, we determined the preliminary clinical efficacy and safety of lenvatinib plus adebrelimab in combination with the GEMOX-HAIC (hepatic arterial infusion chemotherapy with gemcitabine, and oxaliplatin) in patients with previously untreated uBTC.
Methods
Patients with unresectable biliary tract cancer (uBTC) who initially received lenvatinib plus adebrelimab combined with GEMOX-HAIC at the First Affiliated Hospital of Sun Yat-sen University were reviewed. All patients had undergone at least two courses of HAIC treatment as part of their initial management. Efficacy was evaluated by tumor response rate and survival, and safety was assessed by the frequency of key adverse events (AEs).
Results
A total of 41 patients were included in this study. The objective response rate (ORR) and disease control rate (DCR) based on RECIST criteria were 46.3% and 78.0%, respectively. The median PFS was 6.1 months (95% CI, 5.1-7.2). Estimated 3-, 6-, 9-, and 12-month survival rates were 89.9%, 74.3%, 66.0%, and 52.8%, respectively. The median OS was 12.0 months (95% CI, 9.3-14.7). 89.7%(35/39) experienced adverse events (AEs), whereas 38.5% (15/39) experienced grade 3 or 4 AEs. The most common are nausea, feverand abdominal pain. Table: 197P
| Characteristics | Patients(n=41) |
| Gender | |
| Male | 27 (65.9%) |
| Female | 14 (34.1%) |
| Age, Mean (SD), year | 59.38 (1.8) |
| ≥65 | 14 (34.1%) |
| <65 | 27 (65.9%) |
| BTC staging | |
| iCCA | 29 (70.7%) |
| pCCA | 5 (12.2%) |
| dCCA | 3 (7.3%) |
| GBC | 2 (4.9%) |
| Child-Pugh | |
| A | 28 (68.3%) |
| B | 12 (29.3%) |
| C | 1 (2.4%) |
| Hepatitis virus infection | |
| HBV | 24 (58.5%) |
| HCV | 2 (4.9%) |
| None | 15 (36.6%) |
| Tumor size, cm | |
| Mean (SD) | 8.7 (4.1) |
| ≤5 | 8 (19.5%) |
| ＞5 | 33 (80.5%) |
| Tumor number | |
| Single | 15 (36.6%) |
| Multiple | 26 (63.4%) |
| Vascular Invasion | |
| Absence | 14 (34.1%) |
| Presence | 27 (65.9%) |
| LN metastasis | |
| Absence | 17 (41.5%) |
| Presence | 24 (58.5%) |
| Distant metastasis | |
| Absence | 34 (82.9%) |
| Presence | 7 (17.1%) |
| TNM stage | |
| I | 2 (4.9%) |
| II | 5 (12.2%) |
| IIIa | 6 (14.6%) |
| IIIb | 19 (46.3%) |
| IV | 9 (22.0%) |
| CA19-9, U/mL | |
| ≤40 | 17 (41.5%) |
| ＞40 | 24 (58.5%) |
Conclusions
Lenvatinib plus adebrelimab combined with GEMOX-HAIC showed promising antitumor activity and manageable AEs inpatients with treatment-naive uBTC. This regimen may be suitable as a novel first-line treatment option for this patient population.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.