Adding second-line treatment with folinic acid, fluorouracil, and oxaliplatin (FOLFOX) to active symptom control (ASC) significantly improved overall survival (OS) in patients with advanced biliary tract cancer, according to results published in The Lancet Oncology.

In the phase 3 ABC-06 trial ( Identifier: NCT01926236), researchers compared the clinical benefit of ASC alone with ASC plus FOLFOX in patients with locally advanced or metastatic biliary tract cancer whose disease progressed after first-line cisplatin and gemcitabine.

The study enrolled 162 patients from 20 sites in the United Kingdom. Patients were randomly assigned 1:1 to receive ASC plus FOLFOX or ASC alone. ASC was defined as “early identification and treatment of biliary-related complications and cancer-related symptom management.”

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The median follow-up was 21.7 months. Patients treated with ASC plus FOLFOX had a significantly longer median OS of 6.2 months, compared with 5.3 months for the ASC-alone group (adjusted hazard ratio, 0.69; 95% CI, 0.50-0.97; P =.031). 

The 6-month OS rate was 35.5% in the ASC-alone arm and 50.6% in the FOLFOX arm. The 12-month OS rate was 11.4% and 25.9%, respectively.

Grade 3-5 adverse events (AEs) occurred in 52% of patients treated with ASC alone and 69% of patients in the FOLFOX arm. Neutropenia, fatigue, and infection were the most common grade 3-5 AEs related to FOLFOX.

There were 3 chemotherapy-related deaths, 1 each due to infection, acute kidney injury, and febrile neutropenia. There were no known treatment-related deaths in the ASC-alone arm.

“To our knowledge, this trial is the first prospective, randomized study providing reliable, high-quality evidence to allow an informed discussion with patients of the potential benefits and risks from second-line FOLFOX chemotherapy in advanced biliary tract cancer,” the study authors wrote. “Based on these findings, FOLFOX should become standard-of-care chemotherapy in second-line treatment for advanced biliary tract cancer and the reference regimen for further clinical trials.”

Disclosures: This research was supported by Cancer Research UK and others. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Lamarca A, Palmer DH, Wasan HS, et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): A phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021;22(5)690-701. doi:10.1016/S1470-2045(21)00027-9