719P - Tumour shrinkage at 6 weeks predicts favorable clinical outcomes in a phase III study of gemcitabine and oxaliplatin with or without erlotinib for...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Hepatobiliary Cancers
Biological Therapy
Presenter Joon Oh Park
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors J.O. Park1, S. Kim1, H. Kim2, S.J. Lee3, J. Lee3, S.H. Park4, Y.S. Park3, H.Y. Lim5, W. Kang6
  • 1Department Of Internal Medicine, Hematology, Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 2Internal Medicine, Samsung Medical Center, 135-710 - Seoul/KR
  • 3Medicine, Samsung Medical Center, 135-710 - Seoul/KR
  • 4Internal Medicine, Sam Sung Medical Center, Seoul/KR
  • 5Department Of Medicine, Samsung Medical Center, Seoul/KR
  • 6Medical Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, seoul/KR



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.


This was a multicenter, open label, randomized, phase III trial of 103 BTC patients, 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%.


Fifty-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).


ETS 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.


All authors have declared no conflicts of interest.