| General information |
| Database: | DB00898 |
| Objective: | Current data suggest that platinumbased combination therapy is the standard firstline treatment for biliary tract cancer. EGFR inhibition has proven beneficial across a number of gastrointestinal malignancies; and has shown specific advantages among KRAS wildtype genetic subtypes of colon cancer. they report the combination of panitumumab with gemcitabine (GEM) and oxaliplatin (OX) as firstline therapy for KRAS wildtype biliary tract cancer. |
| Authors: | Hezel AF, et al |
| Title: | Phase II study of gemcitabine, oxaliplatin in combination with panitumumab in KRAS wildtype unresectable or metastatic biliary tract and gallbladder cancer. |
| Journal: | Br J Cancer |
| Year: | 2014 |
| PMID: | 24960403 |
| Trial Design |
| Clinical Trial Id: | NCT01308840 |
| Agent: | panitumumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | biliary tract and gallbladder cancer |
| Cancer Subtype: | KRAS wildtype unresectable or metastatic biliary tract and gallbladder cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gemcitabine, oxaliplatin + panitumumab |
| Study Type: | Phase II study |
| Key Patients Feature: | Patients with histologically confirmed, previously untreated, unresectable or metastatic KRAS wildtype biliary tract or gallbladder adenocarcinoma with ECOG performance status 02 |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with panitumumab 6 mg kg(1), GEM 1000 mg m(2) (10 mg m(2) min(1)) and OX 85 mg m(2) on days 1 and 15 of each 28day cycle. |
| Primary End Point: | the objective response rate by RECIST criteria v.1.1. |
| Secondary End Point: | toxicity, progression free survival (PFS), and overall survival. |
| Patients Number: | 31 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 45% |
| Disease Control Rate: | 90% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 10.6 months (95% CI 524 months) |
| Median OS A vs. C: | 20.3 months (95% CI 925 months) |
| Adverse Event(agent arm): | Grade 3 fatigue, anaemia, neuropathy, and electrolyte changes were fairly common; there were no grade 3 or 4 cases of motor toxicity. patients were not prophylactically treated for EGFRrelated rash. |
| Conclusions: | The combination of gemcitabine, oxaliplatin and panitumumab in KRAS wild type metastatic biliary tract cancer showed encouraging efficacy, additional efforts of genetic stratification and targeted therapy is warranted in biliary tract cancer. |