| General information |
| Database: | DB00881 |
| Objective: | Gemcitabine plus a platinumbased agent (eg, cisplatin or oxaliplatin) is the standard of care for advanced biliary cancers. they investigated the addition of cetuximab to chemotherapy in patients with advanced biliary cancers |
| Authors: | Malka D, et al |
| Title: | Gemcitabine and oxaliplatin with or without cetuximab in advanced biliarytract cancer (BINGO): a randomised, openlabel, noncomparativephase 2 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2014 |
| PMID: | 24852116 |
| Trial Design |
| Clinical Trial Id: | NCT00552149 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | biliary tract and gallbladder cancer |
| Cancer Subtype: | advanced biliarytract cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Gemcitabine + oxaliplatin with cetuximab |
| Study Type: | noncomparative, openlabel, randomisedphase II trial |
| Key Patients Feature: | patients with locally advanced (nonresectable) or metastatic cholangiocarcinoma, gallbladder carcinoma, or ampullary carcinoma and a WHO performance status of 0 or 1 from 18 hospitals across France and Germany |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Gemcitabine and oxaliplatin with cetuximab versus Gemcitabine and oxaliplatin |
| Treatment Info: | Eligible patients were randomly assigned (1:1) centrally with a minimisation procedure to firstline treatment with gemcitabine (1000 mg/m(2)) and oxaliplatin (100 mg/m(2)) with or without cetuximab (500 mg/m(2)), repeated every 2 weeks until disease progression or unacceptable toxicity. |
| Primary End Point: | the proportion of patients who were progression free at 4 months, analysed by intention to treat |
| Secondary End Point: | NA |
| Patients Number: | 76 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 24% in the chemotherapy plus cetuximab group, 23% in the chemotherapy alone group |
| Disease Control Rate: | 82% in the chemotherapy plus cetuximab group, 65% in the chemotherapy alone group |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.1 months (95% CI 5.1-7.6) in the chemotherapy plus cetuximab group and 5.5 months (3.7-6.6) in the chemotherapy alone group |
| Median OS A vs. C: | 11.0 months (9.113.7) in the chemotherapy plus cetuximab group and 12.4 months (8.616.0) in the chemotherapy alone group. |
| Adverse Event(agent arm): | The most common grade 3-4 adverse events were peripheral neuropathy (in 18 [24%] of 76 patients who received chemotherapy plus cetuximab vs ten [15%] of 68 who received chemotherapy alone), neutropenia (17 [22%] vs 11 [16%]), and increased aminotransferase concentrations (17 [22%] vs ten [15%]). 70 serious adverse events were reported in 39 (51%) of 76 patients who received chemotherapy plus cetuximab (34 events in 19 [25%] patients were treatmentrelated), whereas 41 serious adverse events were reported in 25 (35%) of 71 patients who received chemotherapy alone (20 events in 12 [17%] patients were treatmentrelated). One patient died of atypical pneumonia related to treatment in the chemotherapy alone group |
| Conclusions: | The addition of cetuximab to gemcitabine and oxaliplatin did not seem to enhance the activity of chemotherapy in patients with advanced biliary cancer, although it was well tolerated. Gemcitabine and platinumbased combination should remain the standard treatment option. |