Second-line FOLFOX chemotherapy for advanced biliary tract cancer - Authors' reply.

Abstract

We thank our colleagues for their observations about our ABC-06 trial comparing FOLFOX chemotherapy (folinic acid, fluorouracil, and oxaliplatin) and active symptom control (ASC) with ASC alone in patients with advanced biliary tract cancer. 1 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: 690-701 Summary Full Text Full Text PDF PubMed Scopus (85) Google Scholar The ABC-06 trial stratified patients according to serum albumin, disease stage, and platinum sensitivity to first-line therapy. Tiffany Foo and colleagues, Giovanni Brandi and colleagues, and Raja Pramanik and colleagues suggested other stratification factors such as progression-free survival after first-line chemotherapy of at least 6 months, previous resection, pretreatment serum CA19.9, peritoneal carcinomatosis, primary tumour site, and molecular profiling results. Second-line FOLFOX chemotherapy for advanced biliary tract cancerI read with great interest the results of the ABC-06 trial published by Angela Lamarca and colleagues.1 This randomised study compared active symptom control (ASC) and FOLFOX chemotherapy (folinic acid, fluorouracil, and oxaliplatin) against ASC alone in patients with locally advanced or metastatic biliary tract cancer with disease progression after first-line cisplatin and gemcitabine chemotherapy. The authors concluded that FOLFOX should become standard-of-care chemotherapy in second-line treatment for advanced biliary tract cancer. Full-Text PDF Second-line FOLFOX chemotherapy for advanced biliary tract cancerIn the ABC-06 trial, Angela Lamarca and colleagues showed that in patients with advanced biliary tract cancer, systemic chemotherapy with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) plus active symptom control (ASC) improved median overall survival after progression on cisplatin-gemcitabine compared with ASC alone.1 Given the lack of randomised data to guide treatment decisions in the second-line setting, the ABC-06 trial represents a relevant contribution to the field, with potentially practice-changing implications. Full-Text PDF Second-line FOLFOX chemotherapy for advanced biliary tract cancerThe ABC-06 trial is an important, prospective, randomised phase 3 clinical trial that examined the role of second-line chemotherapy in advanced biliary tract cancers.1 Angela Lamarca and colleagues randomly assigned 162 patients to active symptom control (ASC) and FOLFOX chemotherapy (folinic acid, fluorouracil, and oxaliplatin) or ASC alone. Although the study met its endpoint, the improvement in overall survival was modest. Full-Text PDF Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trialThe addition of FOLFOX to ASC improved median overall survival in patients with advanced biliary tract cancer after progression on cisplatin and gemcitabine, with a clinically meaningful increase in 6-month and 12-month overall survival rates. To our knowledge, this trial is the first prospective, randomised 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. Full-Text PDF Open AccessSecond-line FOLFOX chemotherapy for advanced biliary tract cancerWe read with great interest the ABC-06 study by Angela Lamarca and colleagues1 and congratulate the authors for clinical research in this area of unmet need. In this phase 3, open-label, randomised, controlled trial, patients with advanced biliary tract cancers progressing on cisplatin– gemcitabine were randomly assigned to active symptom control (ASC) and FOLFOX chemotherapy (folinic acid, fluorouracil, and oxaliplatin) or ASC alone. The authors report a significant improvement in overall survival (the primary endpoint) with FOLFOX. Full-Text PDF