Real-world (rw) outcomes of durvalumab plus gemcitabine and cisplatin (D + GemCis) or GemCis in patients (pts) with advanced biliary tract cancer in the US.
Abstract
497
Background:
D + GemCis is approved for the treatment of locally advanced or metastatic biliary tract cancer (aBTC) based on the results from the Phase 3 TOPAZ-1 trial (NCT03875235). This rw study describes characteristics and clinical outcomes of pts in the US with aBTC using claims-based data.
Methods:
This retrospective, observational study used Optum’s de-identified Market Clarity data (Optum Market Clarity) from adult pts diagnosed with
de novo
or recurrent aBTC receiving first-line D + GemCis on/after Mar 11, 2022 (date of NCCN guideline addition) or GemCis from Jan 1, 2019, to Nov 30, 2024. The primary objective was to describe baseline pt demographics and clinical characteristics. Exploratory objectives included assessing rw time to next treatment (rwTTNT) and overall survival (rwOS) estimated with Kaplan-Meier methods without direct comparisons.
Results:
A total of 581 pts met eligibility: 170 pts for D + GemCis and 411 pts for GemCis (n=340 pts prior to 2022). Demographics were similar in each cohort (Table). Most pts were diagnosed with
de novo
aBTC (~87% across groups) and intrahepatic cholangiocarcinoma (iCCA) (D + GemCis, 75.3%; GemCis, 68.9%). Median time from treatment initiation to the end of follow-up was 6.6 months for D + GemCis and 8.6 months for GemCis. For D + GemCis and GemCis, median (95% confidence interval [CI]) rwTTNT was 9.5 (7.1–18.8) and 7.5 (6.6–8.5) months, respectively; and median (95% CI) rwOS was 14.2 (10.7–15.6) and 11.9 (10.3–14.2),…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 340 participants or records.
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