Abstract 125P
Background
BTC is a diverse group of hepatic and perihepatic malignancies with a 5-year survival rate of <20%. This study described real-world treatment patterns and outcomes among patients with advanced and/or unresectable (aBTC) in France, Germany, Italy, Spain, and the United Kingdom (UK).
Methods
In this retrospective, web-based chart review survey, physicians reported anonymized patient-level data for adult patients diagnosed with aBTC between May 2018 and October 2021 who received first-line (1L) systemic therapy (index date). Patients were followed from index date until death or last available date at abstraction. Patient characteristics, treatment patterns, and clinical outcomes were summarized descriptively.
Results
A total of 196 physicians extracted data for 792 aBTC patients who initiated 1L systemic therapy. More patients had intrahepatic cholangiocarcinoma (CCA; 34.8%), than extrahepatic CCA (29.9%), gallbladder (23.5%), and ampullary cancer (10.2%) whereas 1.5% patients had missing information. During follow-up (median=12.4 months), less than half of patients were prescribed gemcitabine + cisplatin (GemCis; 47.9%) as 1L. Median 1L treatment duration was 5.3 months with disease progression (49.2%) being the most common reason for treatment discontinuation. Only 33.1% received 2L and 4.1% received 3L+ of treatment. Median real-world overall survival (rwOS) from index date was 13.4 months, with regional variation (Table).
Table: 125P
Key results by country*
France (N = 167) | Germany (N = 150) | Italy (N = 153) | Spain (N = 167) | UK (N = 155) | |
Male, % | 67.1 | 66.7 | 55.6 | 65.9 | 57.4 |
Age ≥60, % | 73.1 | 60.7 | 76.5 | 76.0 | 85.2 |
Site of primary BTC tumor, % | |||||
Intrahepatic CCA | 31.1 | 35.3 | 51.0 | 28.7 | 29.0 |
Extrahepatic CCA | 30.5 | 28.0 | 26.8 | 29.3 | 34.8 |
Gallbladder | 23.4 | 29.3 | 11.1 | 28.7 | 24.5 |
Ampulla of Vater | 13.8 | 6.0 | 9.8 | 13.2 | 7.7 |
Unknown | 1.2 | 1.3 | 1.3 | 0 | 3.9 |
ECOG at diagnosis, % | |||||
0 | 20.4 | 14.7 | 27.5 | 18.6 | 32.9 |
1 | 52.1 | 48.0 | 64.1 | 67.7 | 52.3 |
2+ | 22.2 | 22.0 | 8.5 | 11.4 | 11.6 |
Unknown | 5.4 | 15.3 | 0 | 2.4 | 3.2 |
GemCis 1L regimen, % | 28.7 | 30.0 | 69.9 | 44.3 | 67.7 |
Median rwOS (months) | 17.8 | 18.3 | 14.7 | 13.1 | 8.8 |
*All decimals have been rounded to the nearest tenth, thus the overall % may result in getting a value slightly higher than 100%.
Conclusions
This study demonstrated the unmet needs of patients with aBTC, with less than half of the patients receiving standard-of-care – GemCis (ESMO recommendation) and a median rwOS of just over one year suggesting the need for new treatments that extend survival. With the recent approval of immunotherapy for aBTC patients, exploration of the benefits in real-world is needed. Additional efforts in the earlier detection of BTC are essential to improve survival.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
J.A. Bridgewater: Financial Interests, Personal, Advisory Board: Taiho, BMS, Incyte, Basilea, Servier; Financial Interests, Institutional, Funding: Incyte. M. Paskow: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. A. Szende: Financial Interests, Personal, Full or part-time Employment: Labcorp Drug Development; Financial Interests, Personal, Stocks/Shares: Labcorp Drug Development. P. Messina: Financial Interests, Personal, Full or part-time Employment: Labcorp, IQVIA. J. Sah: Financial Interests, Personal, Stocks/Shares: AstraZeneca; Financial Interests, Personal, Full or part-time Employment: AstraZeneca. B. Baur: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca.
Resources from the same session
690P - Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: Updated clinical and biomarker results from a phase I/II study
Presenter: Manish R Patel
Session: Poster session 17
691P - Efficacy of ABBV-400 monotherapy in patients with MET gene amplified advanced solid tumors
Presenter: John Strickler
Session: Poster session 17
692P - First-in-human study of ELU001, a targeted nanoparticle drug conjugate, in subjects with folate receptor α (FRα) overexpressing solid tumors
Presenter: Wen wee Ma
Session: Poster session 17
693P - Preclinical activity of HLX43, a PD-L1-targeting ADC, in multiple PD-1/PD-L1 refractory/resistant models
Presenter: Yongqiang Shan
Session: Poster session 17
694P - Full efficacy analysis of phase I/II trial investigating bexmarilimab, a novel macrophage-guided immunotherapy in refractory solid tumors
Presenter: Petri Bono
Session: Poster session 17
695P - A phase I/Ib study evaluating the safety and tolerability of NIZ985 alone and in combination with spartalizumab (anti–PD-1) in patients (pts) with solid tumors or lymphoma
Presenter: Elena Garralda
Session: Poster session 17
696P - SIM1811-03 (SIM0235), an anti-tumor necrosis factor receptor-2 (TNFR2) monoclonal antibody, in patients with advanced solid tumor and/or cutaneous T cell lymphomas (CTCL): Preliminary results from an on-going first-in-human phase I trial in China
Presenter: Furong Liu
Session: Poster session 17
699P - Immunogenicity and reactogenicity of BNT162b2 COVID-19 mRNA vaccine in long-survivor (LS) patients with metastatic lung cancer (mLC) after primary immunization (PV) and booster (BD): COVALENCE study
Presenter: Emanuele Vita
Session: Poster session 17