Practicalities accessing precision medicine in biliary tract cancer
Mené en Corée sur 34 patients atteints d'un cancer des voies biliaires HER2+ (durée médiane de suivi : 13 mois), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité d'un traitement de deuxième ou troisième ligne combinant trastuzumab et chimiothérapie de type FOLFOX, après l'échec d'une chimiothérapie à base de gemcitabine et de cisplatine
In The Lancet Gastroenterology & Hepatology, Choong-kun Lee and colleagues report the results of a single-arm, phase 2 trial assessing folinic acid, fluorouracil,and oxaliplatin (FOLFOX) and trastuzumab in patients with HER2-positive advanced biliarytract cancers pre-treated with gemcitabine and cisplatin (mostly as second-line treatment).As expected, the majority of patients had a gallbladder cancer (53%) or extrahepaticcholangiocarcinoma (29%). The trial met its primary endpoint, achieving an objectiveresponse rate of 29·4% (95% CI 16·7–46·3) that surpassed the planned 25%, and excludedthe null hypothesis of 10%. The median progression-free survival was 5·1 months (95%CI 3·6–6·7), the median duration of response was 4·9 months (95% CI 2·1–10·4) andthe median overall survival was 10·7 months (95% CI 7·9–not reached). Notably, responseswere seen only in extrahepatic cholangiocarcinomas (three [30%] of ten) or gallbladdercancer (seven [39%] of 18), whereas no responses were seen in the six patients withintrahepatic cholangiocarcinoma; a similar finding was seen in the MyPathway trialof a trastuzumab and pertuzumab combination, where no responses were shown in theseven patients with intrahepatic cholangiocarcinoma.
The Lancet Gastroenterology & Hepatology , commentaire, 2021