I was presenting the ABC-06 clinical trial. This study is a phase III randomised study for patients with biliary tract cancer who had already progressed with cisplatin and gemcitabine chemotherapy. It was assessing whether there was any benefit from second line chemotherapy after progression to first line treatment. This is a phase III study and it was randomising patients to active symptom control or chemotherapy in the form of modified FOLFOX. Those patients in the active symptom control were being reviewed in clinic every four weeks with a special focus on symptom control and on early detection and treatment of biliary related complications. The patients in the chemotherapy arm were also receiving two-weekly chemotherapy with modified FOLFOX. The study was powered for identifying differences in overall survival which was the primary endpoint and a total of 162 patients were randomised, 81 in each arm.
The study did show a benefit in overall survival. We were able to show that those patients who were receiving palliative treatment had a smaller risk of death with a hazard ratio of 0.68 which was statistically significant.
The ABC-06 clinical trial is showing that there is a benefit from second line chemotherapy after progression to cisplatin gemcitabine. So we believe that this should be the new standard of care and that patients with advanced biliary tract cancer who have already progressed on first line cisplatin gemcitabine, if they have a good performance status, a good performance status 0-1, they could be offered modified FOLFOX as a second line option.
Were there any adverse events during the course?
The toxicity was as expected for this type of chemotherapy. It’s true that we saw more fatigue and more lethargy and more infection in those patients receiving chemotherapy with modified FOLFOX but this is as expected for this treatment. So there was nothing surprising or nothing that we didn’t know about this treatment before. The treatment was tolerable.
How do these results compare to use, maybe, in the first line setting?
That’s a difficult question because we are dealing with a completely different scenario. In the first line setting we had the ABC-02 clinical trial and that trial was comparing cisplatin gemcitabine versus gemcitabine and there was a benefit in overall survival. That’s why cisplatin gemcitabine became the standard of care in the first line setting. With the second line clinical trial what we are exploring is whether a second line is providing patients with any benefit. We have shown that, yes, there is some benefit but, of course, this is a selected population of patients because not everyone is unfortunately fit for this treatment.