Onco Wiki / Regimen

Durvalumab + gemcitabine + cisplatin (TOPAZ-1) — 1L advanced biliary tract cancer

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.

Source YAML: complete record

ComponentsDRUG-DURVALUMAB DRUG-GEMCITABINE DRUG-CISPLATIN
IDREG-DURVA-GEM-CIS-CHOLANGIO
TypeRegimen
Statusreviewed 2026-05-08 | pending_clinical_signoff
DiseasesNone declared
SourcesSRC-ESMO-BTC-2023 SRC-NCCN-HEPATOBILIARY SRC-TOPAZ-1-OH-2022

Notes

TOPAZ-1 (Oh DY et al., NEJM Evid 2022;1(8):EVIDoa2200015; NCT03875235): durvalumab 1500 mg q3w + gemcitabine 1000 mg/m² + cisplatin 25 mg/m² (D1, D8 q3w x up to 8 cycles), then durvalumab 1500 mg q4w maintenance, vs placebo + gem-cis in 1L advanced BTC (n=685). Primary endpoint OS: mOS 12.8 vs 11.5 mo (HR 0.80, 95% CI 0.66-0.97, p=0.021); mPFS 7.2 vs 5.7 mo (HR 0.75); ORR 26.7% vs 18.7%. Benefit consistent across PD-L1 CPS subgroups and BTC anatomic subsites (intra-/extrahepatic cholangiocarcinoma, gallbladder cancer). FDA-approved Sep 2022 for 1L advanced BTC. NCCN category 1 preferred regimen. Cisplatin (D1/D8 schedule, not standard D1-only) is per protocol — total cycles capped at 8 for chemo backbone; durvalumab maintenance continues until progression / toxicity. STUB pending Clinical Co-Lead sign-off per CHARTER §6.1 dev-mode exemption.

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