Molecular Subgroup Analysis of Clinical Outcomes in a Phase 3 Study of Gemcitabine and Oxaliplatin with or without Erlotinib in Advanced Biliary Tract Cancer

Translational Oncology
Seung Tae KimJoon Oh Park

Abstract

We previously reported that the addition of erlotinib to gemcitabine and oxaliplatin (GEMOX) resulted in greater antitumor activity and might be a treatment option for patients with biliary tract cancers (BTCs). Molecular subgroup analysis of treatment outcomes in patients who had specimens available for analysis was undertaken. Epidermal growth factor receptor (EGFR), KRAS, and PIK3CA mutations were evaluated using peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp reactions. Survival and response rates (RRs) were analyzed according to the mutational status. Sixty-four patients (48.1%) were available for mutational analysis in the chemotherapy alone group and 61 (45.1%) in the chemotherapy plus erlotinib group. 1.6% (2/116) harbored an EGFR mutation (2 patients; exon 20), 9.6% (12/121) harbored a KRAS mutation (12 patients; exon 2), and 9.6% (12/118) harbored a PIK3CA mutation (10 patients, exon 9 and 2 patients, exon 20). The addition of erlotinib to GEMOX in patients with KRAS wild-type disease (n = 109) resulted in significant improvements in overall response compared with GEMOX alone (30.2% vs 12.5%, P = .024). In 95 patients with both wild-type KRAS and PIK3CA, there was evidence of a benefit associa...Continue Reading

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Citations

Jan 20, 2016·Expert Opinion on Investigational Drugs·Lars Henrik Jensen
Jul 4, 2017·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Anna PellatLaura Fouassier
Oct 27, 2015·Oncotarget·Seung Tae KimJoon Oh Park
Jun 2, 2017·Therapeutic Advances in Gastroenterology·Hwajeong Lee, Jeffrey S Ross

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Methods Mentioned

BETA
PCR

Clinical Trials Mentioned

NCT01149122

Software Mentioned

GEMOX
GEMOXT

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