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Real-world treatments and outcomes for biliary tract cancer patients using administrative databases in Ontario, Canada
Background
There is a paucity of literature on treatment patterns and outcomes in biliary tract cancer (BTC) patients in Canada. The aim of this study was to better understand treatment patterns and survival outcomes of BTC patients in Ontario.
Methods
We conducted a retrospective population-level study in Ontario using ICES datasets on patients diagnosed with de novo or recurrent, advanced BTC (including: gallbladder cancer, intrahepatic and extrahepatic cholangiocarcinoma [IHC and EHC, respectively], Ampulla of Vater [AoV]) between January 1, 2010 and December 31, 2019. Follow-up data were available until December 31, 2020. Patients were categorized as de novo if they had stage IV disease at the time of first diagnosis, and as recurrent if they had a prior diagnosis of early stage (I-III) or unknown/missing (UNK/M) disease and received a BTC treatment (proxy for progression). Patients were excluded if they died before BTC diagnosis or had a prior cancer diagnosis. To determine the longitudinal trajectory of care for BTC patients, linkages were made between 8 national/provincial data sets.
Results
A total of 2,666 advanced BTC patients were identified, of which 471 (17.7%) were gallbladder, 785 (29.4%) were IHC, 864 (32.4%) were EHC, 304 (11.4%) were AoV and 242 (9.1%) had an unspecified BTC diagnosis. Out of 2,666, 828 (31.1%) were diagnosed with de novo and 1,838 (68.9%) were diagnosed with recurrent disease. The median age at diagnosis was 67 (interquartile range [IQR] 59-74) that significantly (p<0.001) varied between de novo and recurrent patients, and a majority (50.5%) of the patients were male. A total of 2,307 (86.5%) patients received first-line (1L) treatment. The most common 1L treatments were a platinum and gemcitabine combination – cisplatin and gemcitabine ( gem/cis ) (50.1%) and carboplatin and gemcitabine ( gem/carbo) (4.9%), followed by gemcitabine monotherapy ( gemmono ) (17.5%), and capecitabine- or fluorouracil-based treatments (fluoropyrimidine [ FP ]) (16.5%). For AoV patients, the most common 1L treatment was gemmono (47.6%). Of those treated with 1L treatments, 38.7% received subsequent treatment(s). The most common treatment in second line (2L) was FP (32.1%). Among the 2,307 treated patients, 1,132 (49.1%) of patients received a stenting procedure. The mean (standard error [SE]) and median (IQR) overall survival (OS) for all advanced BTC patients from diagnosis was 28.8 months (0.83) and 13.1 months (5.7-32.0), respectively. Mean and median OS from diagnosis was longer for patients who received a 1L treatment (32.3 months [0.93] and 16.4 months [IQR 7.8-37.0], respectively) versus untreated patients (6.2 months [0.71] and 2.8 months [1.7-5.6], respectively). Mean and median OS from initiation of treatment was 16.7 months [0.71] and 9.2 months (IQR 4.0-18.9), respectively for non-AoV patients who received gem/cis.
Conclusions
This is the first comprehensive, Canadian-specific, real-world evidence study of advanced BTC patients. This study showed that 1L treatment options vary between AoV and non-AoV BTC patients, and patients who receive 1L treatment have greater survival than those who do not. The short OS in advanced BTC patients highlight the need for novel and more effective first-line therapies.
Legal entity responsible for the study
The authors.
Funding
This study was funded by an unrestricted research grant from AstraZeneca Canada Inc.
Disclosures
I. Syed: Shareholder / Stockholder / Stock options: AstraZeneca; Full / Part-time employment: AstraZeneca. C. Shephard: Full / Part-time employment: AstraZeneca. All other authors have declared no conflicts of interest.
