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HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib

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HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib. / Press, Michael F; Ellis, Catherine E; Gagnon, Robert C; Grob, Tobias J; Buyse, Marc; Villalobos, Ivonne; Liang, Zhiyong; Wu, Shafei; Bang, Yung-Jue; Qin, Shu-Kui; Chung, Hyun Cheol; Xu, Jianming; Park, Joon Oh; Jeziorski, Krzysztof; Afenjar, Karen; Ma, Yanling; Estrada, Monica C; Robinson, Douglas M; Scherer, Stefan J; Sauter, Guido; Hecht, J Randolph; Slamon, Dennis J.

In: MOL CANCER THER, Vol. 16, No. 1, 01.2017, p. 228-238.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Press, MF, Ellis, CE, Gagnon, RC, Grob, TJ, Buyse, M, Villalobos, I, Liang, Z, Wu, S, Bang, Y-J, Qin, S-K, Chung, HC, Xu, J, Park, JO, Jeziorski, K, Afenjar, K, Ma, Y, Estrada, MC, Robinson, DM, Scherer, SJ, Sauter, G, Hecht, JR & Slamon, DJ 2017, 'HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib', MOL CANCER THER, vol. 16, no. 1, pp. 228-238. https://doi.org/10.1158/1535-7163.MCT-15-0887

APA

Press, M. F., Ellis, C. E., Gagnon, R. C., Grob, T. J., Buyse, M., Villalobos, I., Liang, Z., Wu, S., Bang, Y-J., Qin, S-K., Chung, H. C., Xu, J., Park, J. O., Jeziorski, K., Afenjar, K., Ma, Y., Estrada, M. C., Robinson, D. M., Scherer, S. J., ... Slamon, D. J. (2017). HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib. MOL CANCER THER, 16(1), 228-238. https://doi.org/10.1158/1535-7163.MCT-15-0887

Vancouver

Press MF, Ellis CE, Gagnon RC, Grob TJ, Buyse M, Villalobos I et al. HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib. MOL CANCER THER. 2017 Jan;16(1):228-238. https://doi.org/10.1158/1535-7163.MCT-15-0887

Bibtex

@article{5ebadf81266c45dd9614b5f6a54f21d3,
title = "HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib",
abstract = "HER2/ERBB2 status is used to select patients for HER2-targeted therapy. HER2/ERBB2 amplification/overexpression of upper gastrointestinal (UGI) adenocarcinomas was determined locally or in two central laboratories to select patients for the TRIO-013/LOGiC trial of chemotherapy with or without lapatinib. Patients selected locally had central laboratory confirmation of HER2 amplification for inclusion in the primary efficacy population. HER2 was assessed with PathVysion or IQ PharmDx FISH and HercepTest immunohistochemistry assays. Associations with outcomes were retrospectively evaluated. Overall, HER2 status was determined in UGI cancers from 4,674 patients in a central laboratory for eligibility (1,995 cases) and for confirmation of local HER2 results (333 cases). Of 1,995 adenocarcinomas screened centrally, 322 (16.1%) had HER2-amplified disease with 29 (1.5%) showing HER2 genomic heterogeneity. Men and older patients had higher rates of amplification. Of 545 patients accrued to the trial (gastric, 87.3%; GEJ, 8.3% and esophageal cancer, 4.4%), 487 patients (89%) were centrally confirmed as having HER2-amplified disease. Concordance between central and local HER2 testing was 83%. Concordance between PathVysion and IQ PharmDx FISH assays was 99% and FISH in the two central laboratories was 95%. Lapatinib-treated Asian participants and those less than 60 years had significant improvement in progression-free survival (PFS), particularly among those whose cancers had 5.01-10.0 and >10.0-fold amplification of HER2 In conclusion, HER2 is commonly amplified in UGI adenocarcinomas with amplification highly correlated to overexpression, and HER2 amplification levels correlated with PFS. While HER2 genomic heterogeneity occurs, its prevalence is low. Mol Cancer Ther; 16(1); 228-38. {\textcopyright}2016 AACR.",
author = "Press, {Michael F} and Ellis, {Catherine E} and Gagnon, {Robert C} and Grob, {Tobias J} and Marc Buyse and Ivonne Villalobos and Zhiyong Liang and Shafei Wu and Yung-Jue Bang and Shu-Kui Qin and Chung, {Hyun Cheol} and Jianming Xu and Park, {Joon Oh} and Krzysztof Jeziorski and Karen Afenjar and Yanling Ma and Estrada, {Monica C} and Robinson, {Douglas M} and Scherer, {Stefan J} and Guido Sauter and Hecht, {J Randolph} and Slamon, {Dennis J}",
note = "{\textcopyright}2016 American Association for Cancer Research.",
year = "2017",
month = jan,
doi = "10.1158/1535-7163.MCT-15-0887",
language = "English",
volume = "16",
pages = "228--238",
journal = "MOL CANCER THER",
issn = "1535-7163",
publisher = "American Association for Cancer Research Inc.",
number = "1",

}

RIS

TY - JOUR

T1 - HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib

AU - Press, Michael F

AU - Ellis, Catherine E

AU - Gagnon, Robert C

AU - Grob, Tobias J

AU - Buyse, Marc

AU - Villalobos, Ivonne

AU - Liang, Zhiyong

AU - Wu, Shafei

AU - Bang, Yung-Jue

AU - Qin, Shu-Kui

AU - Chung, Hyun Cheol

AU - Xu, Jianming

AU - Park, Joon Oh

AU - Jeziorski, Krzysztof

AU - Afenjar, Karen

AU - Ma, Yanling

AU - Estrada, Monica C

AU - Robinson, Douglas M

AU - Scherer, Stefan J

AU - Sauter, Guido

AU - Hecht, J Randolph

AU - Slamon, Dennis J

N1 - ©2016 American Association for Cancer Research.

PY - 2017/1

Y1 - 2017/1

N2 - HER2/ERBB2 status is used to select patients for HER2-targeted therapy. HER2/ERBB2 amplification/overexpression of upper gastrointestinal (UGI) adenocarcinomas was determined locally or in two central laboratories to select patients for the TRIO-013/LOGiC trial of chemotherapy with or without lapatinib. Patients selected locally had central laboratory confirmation of HER2 amplification for inclusion in the primary efficacy population. HER2 was assessed with PathVysion or IQ PharmDx FISH and HercepTest immunohistochemistry assays. Associations with outcomes were retrospectively evaluated. Overall, HER2 status was determined in UGI cancers from 4,674 patients in a central laboratory for eligibility (1,995 cases) and for confirmation of local HER2 results (333 cases). Of 1,995 adenocarcinomas screened centrally, 322 (16.1%) had HER2-amplified disease with 29 (1.5%) showing HER2 genomic heterogeneity. Men and older patients had higher rates of amplification. Of 545 patients accrued to the trial (gastric, 87.3%; GEJ, 8.3% and esophageal cancer, 4.4%), 487 patients (89%) were centrally confirmed as having HER2-amplified disease. Concordance between central and local HER2 testing was 83%. Concordance between PathVysion and IQ PharmDx FISH assays was 99% and FISH in the two central laboratories was 95%. Lapatinib-treated Asian participants and those less than 60 years had significant improvement in progression-free survival (PFS), particularly among those whose cancers had 5.01-10.0 and >10.0-fold amplification of HER2 In conclusion, HER2 is commonly amplified in UGI adenocarcinomas with amplification highly correlated to overexpression, and HER2 amplification levels correlated with PFS. While HER2 genomic heterogeneity occurs, its prevalence is low. Mol Cancer Ther; 16(1); 228-38. ©2016 AACR.

AB - HER2/ERBB2 status is used to select patients for HER2-targeted therapy. HER2/ERBB2 amplification/overexpression of upper gastrointestinal (UGI) adenocarcinomas was determined locally or in two central laboratories to select patients for the TRIO-013/LOGiC trial of chemotherapy with or without lapatinib. Patients selected locally had central laboratory confirmation of HER2 amplification for inclusion in the primary efficacy population. HER2 was assessed with PathVysion or IQ PharmDx FISH and HercepTest immunohistochemistry assays. Associations with outcomes were retrospectively evaluated. Overall, HER2 status was determined in UGI cancers from 4,674 patients in a central laboratory for eligibility (1,995 cases) and for confirmation of local HER2 results (333 cases). Of 1,995 adenocarcinomas screened centrally, 322 (16.1%) had HER2-amplified disease with 29 (1.5%) showing HER2 genomic heterogeneity. Men and older patients had higher rates of amplification. Of 545 patients accrued to the trial (gastric, 87.3%; GEJ, 8.3% and esophageal cancer, 4.4%), 487 patients (89%) were centrally confirmed as having HER2-amplified disease. Concordance between central and local HER2 testing was 83%. Concordance between PathVysion and IQ PharmDx FISH assays was 99% and FISH in the two central laboratories was 95%. Lapatinib-treated Asian participants and those less than 60 years had significant improvement in progression-free survival (PFS), particularly among those whose cancers had 5.01-10.0 and >10.0-fold amplification of HER2 In conclusion, HER2 is commonly amplified in UGI adenocarcinomas with amplification highly correlated to overexpression, and HER2 amplification levels correlated with PFS. While HER2 genomic heterogeneity occurs, its prevalence is low. Mol Cancer Ther; 16(1); 228-38. ©2016 AACR.

U2 - 10.1158/1535-7163.MCT-15-0887

DO - 10.1158/1535-7163.MCT-15-0887

M3 - SCORING: Journal article

C2 - 27811012

VL - 16

SP - 228

EP - 238

JO - MOL CANCER THER

JF - MOL CANCER THER

SN - 1535-7163

IS - 1

ER -