Back to Search
Start Over
Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in wild-type KRAS advanced biliary tract cancer: A randomized phase 2 trial (Vecti-BIL study).
- Source :
-
Cancer (0008543X) . Feb2016, Vol. 122 Issue 4, p574-581. 9p. - Publication Year :
- 2016
-
Abstract
- <bold>Background: </bold>Biliary tract cancer (BTC) is a rare and lethal disease with few therapeutic options. Preclinical data suggest that the epidermal growth factor receptor (EGFR) pathway could be involved in its progression.<bold>Methods: </bold>This open-label, randomized phase 2 trial recruited chemotherapy-naive patients with advanced BTC displaying a wild-type (WT) KRAS status. Patients were randomized to gemcitabine (1000 mg/m(2) ) and oxaliplatin (100 mg/m(2) ) with (arm A) or without (arm B) panitumumab (6 mg/kg) for up to 12 cycles. The primary endpoint was progression-free survival (PFS) analyzed in an intention-to-treat fashion.<bold>Results: </bold>Eighty-nine patients (45 in arm A and 44 in arm B) were enrolled between June 2010 and September 2013. After a median follow-up of 10.1 months, the median PFS was 5.3 months (95% confidence interval, 3.3-7.2 months) in arm A and 4.4 months (95% confidence interval, 2.6-6.2 months) in arm B (P = .27). No survival differences were observed: the median overall survival was 9.9 months in arm A and 10.2 months in arm B (P = .42). In a subgroup analysis, no differences in PFS according to the site of the primary tumor were observed; patients with intrahepatic cholangiocarcinoma treated with panitumumab may have had a survival benefit in comparison with the control group (15.1 vs 11.8 months, P = .13). As for safety, skin toxicity was the main adverse event in arm A (80% of the patients). A higher incidence of diarrhea (55.5% vs 31.8%), mucositis (22.2% vs 13.6%), and constipation (24.4% vs 15.9%) was seen in arm A.<bold>Conclusions: </bold>These results confirm the marginal role of anti-EGFR therapy even for WT KRAS-selected BTC. [ABSTRACT FROM AUTHOR]
- Subjects :
- *OXALIPLATIN
*ANTINEOPLASTIC agents
*EPIDERMAL growth factor receptors
*CANCER treatment
*ADENOCARCINOMA
*BILE ducts
*CLINICAL trials
*COMPARATIVE studies
*EPIDERMAL growth factor
*GALLBLADDER tumors
*RESEARCH methodology
*MEDICAL cooperation
*MONOCLONAL antibodies
*ORGANOPLATINUM compounds
*PROGNOSIS
*PROTEINS
*RESEARCH
*CHOLANGIOCARCINOMA
*EVALUATION research
*RANDOMIZED controlled trials
*TREATMENT effectiveness
*DEOXYCYTIDINE
*CHEMICAL inhibitors
BILIARY tract cancer
BILE duct tumors
Subjects
Details
- Language :
- English
- ISSN :
- 0008543X
- Volume :
- 122
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- Cancer (0008543X)
- Publication Type :
- Academic Journal
- Accession number :
- 112733337
- Full Text :
- https://doi.org/10.1002/cncr.29778