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)

Roberto Filippi, Carmen Belli, Rossella Spadi, Guglielmo Nasti, Massimo Montano, Alessio Amatu, Giuseppe Aprile, Gianpiero Fasola, S. Siena, Libero Ciuffreda

Research output: Contribution to journalArticle

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/m2) and oxaliplatin (100 mg/m2) 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.

Original languageEnglish
Pages (from-to)574-581
Number of pages8
JournalCancer
Volume122
Issue number4
DOIs
Publication statusPublished - Feb 15 2016

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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