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Abstract
BackgroundThe aim of this study was to determine whether early tumor shrinkage (ETS) at 6 weeks after treatment correlates with progression-free survival (PFS) and overall survival (OS) in advanced biliary tract cancer (BTC) patients receiving gemcitabine plus oxaliplatin (GEMOX), with or without erlotinib.MethodsThis was a multicenter, open label, randomized, phase III trial of 103 BTC patients (ClinicalTrials.gov Identifier; NCT01149122, and Rigistration date; January, 7, 2010), comparing GEMOX with GEMOX plus erlotinib. Tumor shrinkage was expressed as a relative decrease compared to baseline and was dichotomized according to a previously reported cutoff value of 10 %.ResultsFifty-four patients (52.4 %) received GEMOX and 49 patients (47.6 %) received GEMOX plus erlotinib. The latter achieved a better overall response rate (RR) (40.8 % vs. 18.6 %, p = 0.02) and showed ETS more frequently (63.2 % vs. 40.7 %, p = 0.03). ETS was significantly correlated with the overall RR (correlation coefficient, 0.53; p < 0.01). The median PFS and OS did not differ according to erlotinib administration. However, the median PFS (7.3 vs. 2.1 months, p < 0.01) and OS (10.7 vs. 5.8 months, p < 0.01) were significantly longer amongst patients with ETS at 6 weeks after treatment, irrespective of erlotinib administration. In patients with wild-type KRAS who were treated with GEMOX plus erlotinib, ETS was a significant prognostic factor for PFS (p < 0.01).ConclusionsETS might predict PFS and OS in BTC patients treated with GEMOX with or without erlotinib. Additionally, ETS may be an indication for adding erlotinib to chemotherapy for BTC patients wild-type KRAS. These findings need to be prospectively validated.
Highlights
The aim of this study was to determine whether early tumor shrinkage (ETS) at 6 weeks after treatment correlates with progression-free survival (PFS) and overall survival (OS) in advanced biliary tract cancer (BTC) patients receiving gemcitabine plus oxaliplatin (GEMOX), with or without erlotinib
Kim et al BMC Cancer (2015) 15:530 was 4.2 months in the GEMOX group and 5.8 months in the GEMOX plus erlotinib group [6]. These findings suggested that the addition of erlotinib to GEMOX might be considered as one of treatment options for BTC patients, the difference in PFS between the groups was not significant
We evaluated the roles of epidermal growth factor receptor (EGFR), KRAS, and PIK3CA as biomarkers in patients with advanced BTC who received GEMOX with or without erlotinib, and found that KRAS status might be a predictive marker of response to erlotinib, but not of survival
Summary
The aim of this study was to determine whether early tumor shrinkage (ETS) at 6 weeks after treatment correlates with progression-free survival (PFS) and overall survival (OS) in advanced biliary tract cancer (BTC) patients receiving gemcitabine plus oxaliplatin (GEMOX), with or without erlotinib. Identifying patients who will derive the most benefit from treatment with a targeted agent is an important goal [7] It is clear from the history of using anti-EGFR monoclonal antibodies (mAbs), including cetuximab, to treat cancer that not all patients benefit from these agents [8,9,10]. Colorectal cancer (CRC) patients with mutant KRAS tumors will not respond to or derive long-term benefit from treatment with anti-EGFR mAbs. no clinical characteristics or molecular biomarkers are currently available to identify subgroups of BTC patients who might survive longer if treated with a targeted agent. We evaluated the roles of EGFR, KRAS, and PIK3CA as biomarkers in patients with advanced BTC who received GEMOX with or without erlotinib, and found that KRAS status might be a predictive marker of response to erlotinib, but not of survival.
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