BCAT
Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer (BCAT)
Phase 3N = 225
- Population
- Patients with resected extrahepatic bile duct cancer (perihilar and distal cholangiocarcinoma; intrahepatic tumours and gallbladder cancer were not eligible); 225 analysed of 226 enrolled in 48 Japanese hospitals.
- Design
- Randomised phase III trial in patients with resected bile duct cancer, randomly assigned to gemcitabine or observation and balanced for lymph node status, residual tumour status and tumour location. Gemcitabine 1000 mg/m2 intravenously on days 1, 8 and 15 every 4 weeks for six cycles. Primary endpoint overall survival; secondary endpoints relapse-free survival, subgroup analysis and toxicity. Registered UMIN 000000820 (University hospital Medical Information Network, Japan); the abstract gives no ClinicalTrials.gov number. 226 patients were enrolled in 48 Japanese hospitals between 1 September 2007 and 31 January 2011, and 225 (117 gemcitabine, 108 observation) were analysed in the full analysis set; one randomised patient was excluded as ineligible. The abstract does not state masking.
- Primary endpoint
- OS
- Arms
- Observation (control, n = 108): Observation after resection
- Gemcitabine (experimental, n = 117): Gemcitabine 1000 mg/m2 intravenously on days 1, 8 and 15 every 4 weeks for six cycles
- People
- Ebata T, Bile Duct Cancer Adjuvant Trial (BCAT) Study Group
OSHR 1.01 (95% CI 0.70–1.45)Δ median OS−1.5 monthsRFSHR 0.93 (95% CI 0.66–1.32)Δ median RFS−3.9 months
Show the numbers
| Endpoint | Analysis | Gemcitabine | Observation | Effect |
|---|---|---|---|---|
| OSFull analysis set: 117 gemcitabine and 108 observation patients | primaryEbata 2018 | median 62.3 months | median 63.8 months | HR 1.01 (95% CI 0.70–1.45)P=0.964The abstract reports no significant difference in overall survival, or in survival within subsets defined by lymph node status and margin status. Most toxicities in the gemcitabine group were transient and grade 3/4 non-haematological toxicity was rare. |
| RFSFull analysis set: 117 gemcitabine and 108 observation patients | primaryEbata 2018 | median 36 months | median 39.9 months | HR 0.93 (95% CI 0.66–1.32)P=0.693Secondary endpoint. |
| Endpoint | Analysis | Gemcitabine | Observation | Effect |
|---|---|---|---|---|
| OSFull analysis set: 117 gemcitabine and 108 observation patients | primaryEbata 2018 | median 62.3 months | median 63.8 months | HR 1.01 (95% CI 0.70–1.45)P=0.964The abstract reports no significant difference in overall survival, or in survival within subsets defined by lymph node status and margin status. Most toxicities in the gemcitabine group were transient and grade 3/4 non-haematological toxicity was rare. |
| RFSFull analysis set: 117 gemcitabine and 108 observation patients | primaryEbata 2018 | median 36 months | median 39.9 months | HR 0.93 (95% CI 0.66–1.32)P=0.693Secondary endpoint. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 1.01 | 0.7–1.45 |
| RFS | 0.93 | 0.66–1.32 |
- Gemcitabine (experimental)
- Observation (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Gemcitabine | Observation |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 40 | 64.1% | 64.8% |
| 80 | 41.1% | 41.9% |
| 120 | 26.3% | 27.2% |
| 160 | 16.9% | 17.6% |
- Gemcitabine (experimental)
- Observation (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Gemcitabine | Observation |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 25 | 61.8% | 64.8% |
| 50 | 38.2% | 42.0% |
| 75 | 23.6% | 27.2% |
| 100 | 14.6% | 17.6% |