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
669P - Patient-reported outcomes with selpercatinib in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial
Presenter: Hyunseok Kang
Session: Poster session 17
670P - Preliminary efficacy and safety of tinengotinib (TT-00420) monotherapy in Chinese patients (pts) with advanced solid tumors: Results from a phase Ib/II study
Presenter: Panpan Zhang
Session: Poster session 17
671P - Safety and efficacy of PM060184 plus gemcitabine in advanced solid tumors
Presenter: Sanjay Goel
Session: Poster session 17
672P - Phase I/II trial of RVU120 (SEL120), CDK8/CDK19 inhibitor in patients with relapsed/refractory metastatic or advanced solid tumors
Presenter: Rafal Dziadziuszko
Session: Poster session 17
673P - A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist brigimadlin (BI 907828) in patients (pts) with solid tumours
Presenter: Patrick Schoeffski
Session: Poster session 17
674P - Response of thrombopoietin receptor agonists in MDM2 inhibitor induced thrombocytopenia
Presenter: Raymond DeMatteo
Session: Poster session 17
675P - A phase I study of safety, pharmacokinetics, and pharmacodynamics of SCR-6920, a protein arginine methyltransferase 5 (PRMT5) inhibitor, in patients with advanced malignant tumors
Presenter: Jinming Yu
Session: Poster session 17
676P - Preclinical characterization of novel peptide binders for EphA2-targeted radiopharmaceutical therapy
Presenter: Renee Clift
Session: Poster session 17
677P - Preliminary findings from a phase I, open-label, dose-finding study of SNB-101 in patients with advanced solid tumors
Presenter: Yun Beom Sang
Session: Poster session 17
678P - ExoDS: A bioengineered exosome-based capsule for targeted delivery of chemotherapy drugs to cancer cells and cancer stem cells
Presenter: Abhishek Dutta
Session: Poster session 17