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Poster Display

2800 - Efficacy and safety of first-line gefitinib treatment in metastatic lung adenocarcinoma patients with sensitizing EGFR mutation determined by ddPCR in plasma cell-free DNA (BENEFIT trial)

Date

08 Oct 2016

Session

Poster Display

Presenters

jie Wang

Citation

Annals of Oncology (2016) 27 (6): 416-454. 10.1093/annonc/mdw383

Authors

J. Wang1, Y. Cheng2, Y. Wu3, T. An4, H. Gao5, K. Wang6, Q. Zhou3, Y. Hu7, Y. Song8, C. Ding9, X. Ye10, F. Peng11, L. Liang12, Y. Hu13, C. Huang14, C. Zhou15, Y. Shi16, L. Zhang17, Y. Gu10

Author affiliations

  • 1 Internal Medicine, Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS), 100021 - Beijing/CN
  • 2 Medical Oncology, Jilin Province Cancer Hospital, 130012 - Changchun/CN
  • 3 Guangdong Lung Cancer Institute, Guangdong General Hospital, 510080 - Guangzhou/CN
  • 4 Thoracic Medicine Oncology, Peking University Cancer Hospital-Beijing Cancer Hospital, 100142 - Beijing/CN
  • 5 Medical Oncology, 307th Hospital of PLA (AMMS China), 100152 - Beijing/CN
  • 6 Genetics, Zhejiang Cancer Hospital, 310009 - Hangzhou/CN
  • 7 Medical Oncology, Hubei Province Tumor Hospital, 100356 - Wuhan/CN
  • 8 Oncology, Nanjing Military General Hospital, Nanjing/CN
  • 9 Oncology, Hebei Provincial Tumor Hospital, Shijiazhuang/CN
  • 10 Asia & Emerging Markets Imed, AstraZeneca, Shanghai/CN
  • 11 Medical Oncology, West China Hospital, Huaxi, Sichuan University, Chengdu/CN
  • 12 Medical Oncology, 3rd Hospital Beijing University, Beijing/CN
  • 13 Medical Oncology, Chinese People’s Liberation Army General Hospital, Beijing/CN
  • 14 Medical Oncology, Fujian Provincial Cancer Hospital, Fuzhou/CN
  • 15 Lung Cancer Oncology & Immunology, Tongji Hospital of Tongji University, 200433 - Shanghai/CN
  • 16 Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS), 100021 - Beijing/CN
  • 17 State Key Laboratory Of Oncology In South China, Sun Yat-sen University Cancer Center, Guangzhou/CN
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Resources

Abstract 2800

Background

This study is to evaluate efficacy and safety of first-line gefitinib treatment in metastatic lung adenocarcinoma patients with sensitizing EGFR mutation determined by digital PCR (ddPCR) in plasma cell-free DNA (cf-DNA)

Trial design

Adenocarcinoma NSCLC patients (stage IV, PS 0-2, available tumor tissue) with EGFR mutation detected by ddPCR in plasma will accept gefitinib treatment until PD. Primary endpoint is ORR. Secondary endpoints are PFS, DCR, QOL, and the concordance, sensitivity, specificity of EGFR mutation between ddPCR in plasma DNA and ARMS in tissue. EGFR mutation status in cf-DNA will be dynamically monitored every 8 weeks. A sample size of 159 will provide a precision of 7% (95% CI: 65%, 79%) assuming 72% ORR, 177 patients should be enrolled with 10% drop-off rate. By Dec 25th, 2015, 426 patients were screened using ddPCR in plasma, 188 patients were enrolled, and last patient last visit will be at October 2016. (NCT02282267).

Clinical trial identification

NCT02282267

Legal entity responsible for the study

N/A

Funding

AstraZeneca R&D

Disclosure

All authors have declared no conflicts of interest.

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