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Every drug gallbladder cancer patients receive was tested in mixed bile duct trials where they were a subgroup. Requiring trials to pre-specify and publish gallbladder results, with a minimum number enrolled, would give the disease its own evidence at almost no cost.
ABC-02, BILCAP, ABC-06, TOPAZ-1 and KEYNOTE-966 enrolled gallbladder cancer alongside intrahepatic and extrahepatic cholangiocarcinoma and reported it, if at all, in forest plots. Yet the diseases differ: HER2 positivity runs at 9 to 20 percent in gallbladder and extrahepatic cancers against 5 percent intrahepatic; immune profiles differ by population; and the UK CAPBIL cohort saw no adjuvant benefit in a mostly gallbladder population. A reporting standard (pre-specified gallbladder stratum, minimum enrolment, mandatory subgroup publication) could be asked of sponsors by regulators and journals and would cost the trials almost nothing.
The adjuvant finding sits uneasily beside BILCAP, on which NHS adjuvant capecitabine rests; in a mostly gallbladder population the benefit is not visible. ACTICCA-1 and ARTEMIDE-Biliary01 are the trials that can settle it.
Evidence that the immune environment of gallbladder cancer differs by population even when the mutations do not; a reason to report gallbladder cancer and its regions separately in immunotherapy trials rather than as one biliary subgroup.
The prevalence estimate that made HER2 the first gallbladder-relevant target; it argues for testing every advanced gallbladder cancer, since one in five may qualify for zanidatamab or trastuzumab deruxtecan.
Shares Surgical outcomes in gallbladder cancer: evidence from the UK nationwide CAPBIL study, BILCAP, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
Shares ACTICCA-1, BILCAP, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Biliary tract cancer (all types) and the tag gallbladder-evidence.
Shares ABC-06, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Biliary tract cancer (all types), Gallbladder cancer and the tag gallbladder-evidence.
Shares Population-Specific Immunogenomic Alterations in Gallbladder Cancer and Prognostic Significance, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Rare and paediatric cancers without markets, Gallbladder cancer and the tag gallbladder-evidence.
Shares TOPAZ-1, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Biliary tract cancer (all types), Gallbladder cancer and the tag gallbladder-evidence.
Shares TOPAZ-1, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Trial design, endpoints and cost, Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Rare and paediatric cancers without markets, Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Trial design, endpoints and cost, Gallbladder cancer and the tag gallbladder-evidence.