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Efficacy and Possible Biomarker of Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
Annals of Oncology 25 (Supplement 5): v44–v74, 2014 doi:10.1093/annonc/mdu435.87
Oral Session (Oral presentations categorized by each organ) O2
13
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Hideaki Takahashi1, Akiko Kuwahara1, Hiroyuki Okuyama1, Izumi Ohno1, Satoshi Shimizu1, Shuichi Mitsunaga1, Akira Shinohara2, Misaki Kobayashi2, Takuji Okusaka3, Masafumi Ikeda1 1 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East 2 Division of Pharmacy, National Cancer Center Hospital East 3 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital
abstracts
Backgrounds: Gemcitabine and erlotinib, which inhibits epidermal growth factor receptor (EGFR), (G + E) is one of the standard treatments in patients with advanced pancreatic cancer (APC). But, the superiority of G + E compared to gemcitabine (G) has not been clarified in Japan, and predictive factors for the benefit of G + E have not
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_5/v65/2240328 by guest on 25 October 2019
EFFICACY AND POSSIBLE BIOMARKER OF GEMCITABINE AND ERLOTINIB FOR ADVANCED PANCREATIC CANCER
been established yet. Serum carcinoembryonic antigen (CEA) has been reported to be associated with the expression of EGFR in colorectal cancer and to be related to the response of EGFR inhibitor in lung cancer, and it needs to be evaluated as a biomarker of G + E in APC. Methods: Patients enrolled in this retrospective study were pathologically diagnosed as APC and had received following regimen as a first line chemotherapy in our hospital; G in January 2009 to July 2011 or G + E in August 2011 to March 2013. Results: A total of 304 patients were enrolled, of which 102 received G + E and 202 received G. Baseline characteristics was well balanced between both arm except for Alb (G + E: 4.0 vs. G: 3.8 g/dl) and metastatic disease (80 vs. 65%). G + E showed slightly better tendency in response rate (7.9 vs. 6.4%), disease control rate (DCR) (76 vs. 65 %) and progression free survival (PFS) (median: 4.7 vs. 3.8 months (m)) compared with G. There was no statistically significant difference in OS between G + E and G (10.8 vs 9.9 m, HR 0.80 [95% CI 0.59-1.06]), but this hazard ratio value was similar to the results of previous phase III trial of G + E vs. G for APC (PA.3 study). In the subgroup analyses stratified by pretreatment variables, we found that G + E showed significantly better DCR, PFS and OS (7.9 vs 5.7 m, HR 0.49 [95% CI 0.33-0.75]) compared with G in patients with high pretreatment serum CEA level (>5.0ng/ml), but not in patients with low CEA level. Conclusion: In Japanese patients with APC, G + E showed similar efficacy with previous report. Serum CEA level might be a predictive factor for the benefit of G + E, and further evaluation would be warranted.
Oral Session (Oral presentations categorized by each organ) O2
13
4
Hideaki Takahashi1, Akiko Kuwahara1, Hiroyuki Okuyama1, Izumi Ohno1, Satoshi Shimizu1, Shuichi Mitsunaga1, Akira Shinohara2, Misaki Kobayashi2, Takuji Okusaka3, Masafumi Ikeda1 1 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East 2 Division of Pharmacy, National Cancer Center Hospital East 3 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital
abstracts
Backgrounds: Gemcitabine and erlotinib, which inhibits epidermal growth factor receptor (EGFR), (G + E) is one of the standard treatments in patients with advanced pancreatic cancer (APC). But, the superiority of G + E compared to gemcitabine (G) has not been clarified in Japan, and predictive factors for the benefit of G + E have not
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_5/v65/2240328 by guest on 25 October 2019
EFFICACY AND POSSIBLE BIOMARKER OF GEMCITABINE AND ERLOTINIB FOR ADVANCED PANCREATIC CANCER
been established yet. Serum carcinoembryonic antigen (CEA) has been reported to be associated with the expression of EGFR in colorectal cancer and to be related to the response of EGFR inhibitor in lung cancer, and it needs to be evaluated as a biomarker of G + E in APC. Methods: Patients enrolled in this retrospective study were pathologically diagnosed as APC and had received following regimen as a first line chemotherapy in our hospital; G in January 2009 to July 2011 or G + E in August 2011 to March 2013. Results: A total of 304 patients were enrolled, of which 102 received G + E and 202 received G. Baseline characteristics was well balanced between both arm except for Alb (G + E: 4.0 vs. G: 3.8 g/dl) and metastatic disease (80 vs. 65%). G + E showed slightly better tendency in response rate (7.9 vs. 6.4%), disease control rate (DCR) (76 vs. 65 %) and progression free survival (PFS) (median: 4.7 vs. 3.8 months (m)) compared with G. There was no statistically significant difference in OS between G + E and G (10.8 vs 9.9 m, HR 0.80 [95% CI 0.59-1.06]), but this hazard ratio value was similar to the results of previous phase III trial of G + E vs. G for APC (PA.3 study). In the subgroup analyses stratified by pretreatment variables, we found that G + E showed significantly better DCR, PFS and OS (7.9 vs 5.7 m, HR 0.49 [95% CI 0.33-0.75]) compared with G in patients with high pretreatment serum CEA level (>5.0ng/ml), but not in patients with low CEA level. Conclusion: In Japanese patients with APC, G + E showed similar efficacy with previous report. Serum CEA level might be a predictive factor for the benefit of G + E, and further evaluation would be warranted.