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Personalized Medicine and Imaging

Detection and Dynamic Changes of EGFR Mutations from Circulating Tumor DNA as a Predictor of Survival Outcomes in NSCLC Patients Treated with First-line Intercalated Erlotinib and Chemotherapy

Tony Mok, Yi-Long Wu, Jin Soo Lee, Chong-Jen Yu, Virote Sriuranpong, Jennifer Sandoval-Tan, Guia Ladrera, Sumitra Thongprasert, Vichien Srimuninnimit, Meilin Liao, Yunzhong Zhu, Caicun Zhou, Fatima Fuerte, Benjamin Margono, Wei Wen, Julie Tsai, Matt Truman, Barbara Klughammer, David S. Shames and Lin Wu
Tony Mok
1State Key Laboratory of South China, Hong Kong Cancer Institute, The Chinese University of Hong Kong, Hong Kong.
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Yi-Long Wu
2Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.
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  • For correspondence: syylwu@live.cn
Jin Soo Lee
3National Cancer Center, Goyang, Korea.
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Chong-Jen Yu
4National Taiwan University Hospital, Taipei, Taiwan.
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Virote Sriuranpong
5The King Chulalongkorn Memorial Hospital and Chulalongkorn University, Bangkok, Thailand.
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Jennifer Sandoval-Tan
6Philippine General Hospital, Manila, Philippines.
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Guia Ladrera
7Lung Centre of the Philippines, Quezon City, Philippines.
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Sumitra Thongprasert
8Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
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Vichien Srimuninnimit
9Siriraj Hospital, Bangkok, Thailand.
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Meilin Liao
10Shanghai Lung Tumour Clinical Medical Center, Shanghai Chest Hospital, Shanghai, China.
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Yunzhong Zhu
11Beijing Chest Hospital, Beijing, China.
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Caicun Zhou
12Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
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Fatima Fuerte
13Rizal Medical Center, Pasig City, Philippines.
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Benjamin Margono
14Dokter Soetomo Hospital, Surabaya, Indonesia.
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Wei Wen
15Roche Molecular Systems, Inc., Pleasanton, California.
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Julie Tsai
15Roche Molecular Systems, Inc., Pleasanton, California.
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Matt Truman
16Roche Products Ltd, Dee Why, Australia.
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Barbara Klughammer
17F. Hoffmann-La Roche Ltd, Basel, Switzerland.
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David S. Shames
18Oncology Biomarker Development, Genentech Inc., San Francisco, California.
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Lin Wu
15Roche Molecular Systems, Inc., Pleasanton, California.
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DOI: 10.1158/1078-0432.CCR-14-2594 Published July 2015
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Abstract

Purpose: Blood-based circulating-free (cf) tumor DNA may be an alternative to tissue-based EGFR mutation testing in NSCLC. This exploratory analysis compares matched tumor and blood samples from the FASTACT-2 study.

Experimental Design: Patients were randomized to receive six cycles of gemcitabine/platinum plus sequential erlotinib or placebo. EGFR mutation testing was performed using the cobas tissue test and the cobas blood test (in development). Blood samples at baseline, cycle 3, and progression were assessed for blood test detection rate, sensitivity, and specificity; concordance with matched tumor analysis (n = 238), and correlation with progression-free survival (PFS) and overall survival (OS).

Results: Concordance between tissue and blood tests was 88%, with blood test sensitivity of 75% and a specificity of 96%. Median PFS was 13.1 versus 6.0 months for erlotinib and placebo, respectively, for those with baseline EGFR mut+ cfDNA [HR, 0.22; 95% confidence intervals (CI), 0.14–0.33, P < 0.0001] and 6.2 versus 6.1 months, respectively, for the EGFR mut− cfDNA subgroup (HR, 0.83; 95% CI, 0.65–1.04, P = 0.1076). For patients with EGFR mut+ cfDNA at baseline, median PFS was 7.2 versus 12.0 months for cycle 3 EGFR mut+ cfDNA versus cycle 3 EGFR mut− patients, respectively (HR, 0.32; 95% CI, 0.21–0.48, P < 0.0001); median OS by cycle 3 status was 18.2 and 31.9 months, respectively (HR, 0.51; 95% CI, 0.31–0.84, P = 0.0066).

Conclusions: Blood-based EGFR mutation analysis is relatively sensitive and highly specific. Dynamic changes in cfDNA EGFR mutation status relative to baseline may predict clinical outcomes. Clin Cancer Res; 21(14); 3196–203. ©2015 AACR.

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Received October 8, 2014.
  • Revision received February 25, 2015.
  • Accepted February 28, 2015.
  • ©2015 American Association for Cancer Research.
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Clinical Cancer Research: 21 (14)
July 2015
Volume 21, Issue 14
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Detection and Dynamic Changes of EGFR Mutations from Circulating Tumor DNA as a Predictor of Survival Outcomes in NSCLC Patients Treated with First-line Intercalated Erlotinib and Chemotherapy
Tony Mok, Yi-Long Wu, Jin Soo Lee, Chong-Jen Yu, Virote Sriuranpong, Jennifer Sandoval-Tan, Guia Ladrera, Sumitra Thongprasert, Vichien Srimuninnimit, Meilin Liao, Yunzhong Zhu, Caicun Zhou, Fatima Fuerte, Benjamin Margono, Wei Wen, Julie Tsai, Matt Truman, Barbara Klughammer, David S. Shames and Lin Wu
Clin Cancer Res July 15 2015 (21) (14) 3196-3203; DOI: 10.1158/1078-0432.CCR-14-2594

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Detection and Dynamic Changes of EGFR Mutations from Circulating Tumor DNA as a Predictor of Survival Outcomes in NSCLC Patients Treated with First-line Intercalated Erlotinib and Chemotherapy
Tony Mok, Yi-Long Wu, Jin Soo Lee, Chong-Jen Yu, Virote Sriuranpong, Jennifer Sandoval-Tan, Guia Ladrera, Sumitra Thongprasert, Vichien Srimuninnimit, Meilin Liao, Yunzhong Zhu, Caicun Zhou, Fatima Fuerte, Benjamin Margono, Wei Wen, Julie Tsai, Matt Truman, Barbara Klughammer, David S. Shames and Lin Wu
Clin Cancer Res July 15 2015 (21) (14) 3196-3203; DOI: 10.1158/1078-0432.CCR-14-2594
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