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First-line icotinib versus cisplatine/pemetrexed plus pemetrexed maintenance therapy in lung adenocarcinoma patients with EGFR mutation (CONVINCE)

Date

08 Oct 2016

Session

Poster Display

Presenters

Yuan-Kai Shi

Citation

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

Authors

Y. Shi1, L. Wang1, B. Han2, W. Li3, P. Yu4, Y. Liu5, C. Ding6, X. Song7, Z. Ma8, X. Ren9, J. Feng10, H. Zhang11, G. Chen12, N. Wu13, X. Han1, C. Yao14, Y. Song15, S. Zhang16, L. Ding17, F. Tan18

Author affiliations

  • 1 Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100021 - Beijing/CN
  • 2 Oncology, Shanghai Chest Hospital, Shanghai/CN
  • 3 Oncology, First Hospital Affiliated to Jilin University, Changchun/CN
  • 4 Lung Cancer Medical Oncology, Sichuan Cancer Hospital, Chengdu/CN
  • 5 Medical Oncology, the First Hospital of China Medical University, Shenyang/CN
  • 6 Oncology, Hebei Provincial Tumor Hospital, Shijiazhuang/CN
  • 7 Respiratory, Shanxi Tumor Hospital, 030013 - Taiyuan/CN
  • 8 Oncology, Henan Cancer Hospital, 450003 - Zhengzhou/CN
  • 9 Meidical Oncology, Xijing Hospital, 4th Military Medical University, Xi'an/CN
  • 10 Oncology, Jiangsu Cancer Institute and Hospital, Nanjing/CN
  • 11 Oncology, Tangdu Hospital, Fourth Military Medical University, Xi'an/CN
  • 12 Medical Oncology, The Affiliated Tumor Hospital of Harbin Medical University, Harbin/CN
  • 13 Imaging Diagnosis, National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100021 - Beijing/CN
  • 14 Clinical Research, Peking University Clinical Research Institute, Beijing/CN
  • 15 Oncology, Nanjing Military General Hospital, Nanjing/CN
  • 16 Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing/CN
  • 17 Headquarter, Betta Pharmaceuticals Co.,Ltd., Hangzhou/CN
  • 18 R & D Center, Betta Pharmaceuticals Co.,Ltd., Hangzhou/CN
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Resources

Background

We assessed icotinib as first-line therapy compared with pemetrexed/cisplatine plus pemetrexed maintenance in advanced lung adenocarcinoma patients with sensitizing EGFR mutation.

Methods

This phase 3, open-label, randomized study (CONVINCE) was conducted at 18 sites in China. Eligible patients (pathologically confirmed lung adenocarcinoma, 19/21 EGFR mutation, treatment naive) were 1:1 randomized to receive icotinib (125 mg, three times daily) or pemetrexed (500 mg/m2, day 1) plus cisplatine (75 mg/m2, day 1) every 21 days, non-progressive patients after 4-cycle chemotherapy continue to receive pemetrexed (500 mg/m2, day 1, every 21 days) as maintenance until disease progression or intolerable toxicity. Randomization was stratified by performance status, smoking status, disease stage, and mutation type. The primary endpoint was progression free survival (PFS).

Results

669 patients were screened (January, 2013 to August, 2014), in which 296 were enrolled and randomized (148 for each group), and 285 patients were treated (icotinib: 148, chemotherapy: 137). Patients' characteristics were well balanced between groups. Icotinib significantly improved PFS (9.9 months [95%CI 8.5-11.2] vs 7.3 months [6.0-8.0]; HR 0.65, 95%CI 0.48-0.88, p = 0.004) compared with the chemotherapy group. Subgroup analyses showed the PFS benefit for icotinib persisted among most clinically relevant subgroups (gender, performance status, smoking status, and disease stage), especially in patients harboring EGFR 19del mutation (11.2 months [95%CI 9.2-13.5] vs 7.3 months [5.7-8.4]; p 

Conclusions

First-line icotinib offers superior efficacy compared with cisplatine/pemetrexed plus pemetrexed maintenance therapy in advanced lung adenocarcinoma patients with sensitizing EGFR mutation.

Clinical trial identification

ClinicalTrials.Gov NCT01719536.

Legal entity responsible for the study

Betta Pharmaceuticals Co.,Ltd.

Funding

Betta Pharmaceuticals Co.,Ltd.

Disclosure

L. Ding: Salaried, F. Tan: Salaried employee and stock owner of Betta Pharmaceuticals Co.,Ltd. All other authors have declared no conflicts of interest.

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