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ABC-06

Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial

Phase 3N = 162NCT01926236

Population
Adults with histologically or cytologically verified locally advanced or metastatic biliary tract cancer (cholangiocarcinoma, gallbladder or ampullary carcinoma) with radiological progression on first-line cisplatin and gemcitabine and ECOG performance status 0 or 1
Design
Open-label randomised (1:1) phase 3 trial at 20 sites in the UK: active symptom control plus FOLFOX, or active symptom control alone. FOLFOX was given intravenously every 2 weeks for a maximum of 12 cycles. Randomisation used a minimisation algorithm with platinum sensitivity, serum albumin concentration and stage as stratification factors. The primary end point was overall survival in the intention-to-treat population. 162 patients were randomly assigned; median follow-up was 21.7 months.
Primary endpoint
OS
Arms
  • Active symptom control plus FOLFOX (experimental, n = 81): Active symptom control plus FOLFOX every 2 weeks for a maximum of 12 cycles (oxaliplatin 85 mg/m2, L-folinic acid 175 mg [or folinic acid 350 mg], fluorouracil 400 mg/m2 bolus and 2400 mg/m2 as a 46-hour continuous infusion)
  • Active symptom control alone (control, n = 81): Active symptom control alone
People
Lamarca A
OSHR 0.69 (95% CI 0.50–0.97)Δ median OS+0.9 monthsΔ 6-month OS+15.1 points
Show the numbers
Results reported for ABC-06
EndpointAnalysisActive symptom control plus FOLFOXActive symptom control aloneEffect
OSfinalmedian follow-up 21.7 monthsLamarca 2021median 6.2 months (5.4–7.6); 50.6% at 6 mo (39.3–60.9%); 25.9% at 12 mo (17.0–35.8%)median 5.3 months (4.1–5.8); 35.5% at 6 mo (25.2–46.0%); 11.4% at 12 mo (5.6–19.5%)HR 0.69 (95% CI 0.50–0.97)P=0.031Adjusted hazard ratio. The open full text states the primary analysis was a multivariable Cox regression adjusted for the stratification factors (platinum sensitivity, serum albumin concentration and disease stage). A post hoc sensitivity analysis using the stratification categories entered at randomisation gave an adjusted hazard ratio of 0.68 (95% CI 0.49 to 0.95; p=0.022). Median follow-up 21.7 months (IQR 17.2 to 30.8).
Results reported for ABC-06
EndpointAnalysisActive symptom control plus FOLFOXActive symptom control aloneEffect
OSfinalmedian follow-up 21.7 monthsLamarca 2021median 6.2 months (5.4–7.6); 50.6% at 6 mo (39.3–60.9%); 25.9% at 12 mo (17.0–35.8%)median 5.3 months (4.1–5.8); 35.5% at 6 mo (25.2–46.0%); 11.4% at 12 mo (5.6–19.5%)HR 0.69 (95% CI 0.50–0.97)P=0.031Adjusted hazard ratio. The open full text states the primary analysis was a multivariable Cox regression adjusted for the stratification factors (platinum sensitivity, serum albumin concentration and disease stage). A post hoc sensitivity analysis using the stratification categories entered at randomisation gave an adjusted hazard ratio of 0.68 (95% CI 0.49 to 0.95; p=0.022). Median follow-up 21.7 months (IQR 17.2 to 30.8).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.690.5–0.97
Illustrative — modelled from reported values, not trial data. OS, final.
0%25%50%75%100%024681012Months (modelled)
  • Active symptom control plus FOLFOX (experimental)
  • Active symptom control alone (control)
Data table (modelled values)
MonthsActive symptom control plus FOLFOXActive symptom control alone
0100.0%100.0%
373.8%65.2%
650.6%35.5%
1033.2%17.9%
1325.9%11.4%
Primary publication: Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, 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. PubMedDOI

Appears in

Sources

  1. Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, 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.

    PubMedDOI