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ABC-06 was the first randomised trial to show that a second round of chemotherapy, FOLFOX, helps people with bile duct and gallbladder cancer live somewhat longer once gemcitabine and cisplatin have stopped working.
The UK ABC-06 trial randomised 162 patients with locally advanced or metastatic biliary tract cancer (cholangiocarcinoma, gallbladder or ampullary cancer) whose disease had progressed on first-line gemcitabine and cisplatin to active symptom control alone or with modified FOLFOX (oxaliplatin, folinic acid and fluorouracil). The primary endpoint was overall survival.
FOLFOX produced a modest but significant improvement in overall survival with acceptable toxicity, and gave biliary cancer its first evidence-based second-line chemotherapy. Targeted drugs for FGFR2 and IDH1 alterations and the NIFTY trial of liposomal irinotecan have since added other options.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
162 enrolled.
Adjusted hazard ratio; median follow-up 21.7 months
SourceThree chemotherapy-related deaths
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Active symptom control + FOLFOX | 81 | 6.2 months | 0.69 (0.5 to 0.97) | 0.031 | link |
| Active symptom control alone | 81 | 5.3 months | ||||
| Overall survival at 12 months | Active symptom control + FOLFOX | 81 | 25.9% | - | - | link |
| Active symptom control alone | 81 | 11.4% | ||||
| Overall survival at 6 months | Active symptom control + FOLFOX | 81 | 50.6% | - | - | link |
| Active symptom control alone | 81 | 35.5% | ||||
| Grade 3-5 adverse events | Active symptom control + FOLFOX | 81 | 69% | - | - | link |
| Active symptom control alone | 81 | 52% |
Shares Leucovorin (folinic acid), Oxaliplatin, Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag subtype-trials.
Shares Leucovorin (folinic acid), Oxaliplatin, Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag subtype-trials.
Shares Intrahepatic cholangiocarcinoma, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma) and the tag subtype-trials.
Shares Oxaliplatin, Fluorouracil (5-FU) and the tag subtype-trials.
Shares Platinum agents, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag subtype-trials.
Shares Platinum agents, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Platinum agents, Cytotoxic chemotherapy and the tag subtype-trials.