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Cancer. 2016 Feb 15;122(4):574-81. doi: 10.1002/cncr.29778. Epub 2015 Nov 5.

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).

Author information

1
Department of Oncology, University of Turin Medical School/Piedmont Foundation for Oncology, Candiolo Cancer Institute - FPO, IRCCS, Candiolo, Italy.
2
Department of Medical Oncology, San Raffaele Scientific Institute, IRCCS, Milan, Italy.
3
Department of Oncology, Medical Oncology 1 Division, Città Della Salute e Della Scienza Hospital and University, Turin, Italy.
4
Department of Colorectal Oncology, National Cancer Institute G. Pascale Foundation, Naples, Italy.
5
Niguarda Cancer Center, Niguarda Ca' Granda Hospita, Milan, Italy.
6
Department of Oncology, University and General Hospital, Udine, Italy.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

These results confirm the marginal role of anti-EGFR therapy even for WT KRAS-selected BTC.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01389414.

KEYWORDS:

KRAS; biliary cancer; chemotherapy; cholangiocarcinoma; gemcitabine and oxaliplatin (GEMOX); panitumumab

PMID:
26540314
DOI:
10.1002/cncr.29778
[Indexed for MEDLINE]
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