Efficacy according to blind independent central review: Post-hoc analyses from the phase III, randomized, multicenter, IPASS study of first-line gefitinib versus carboplatin/paclitaxel in Asian patients with EGFR mutation-positive advanced NSCLC.

Journal: Lung cancer (Amsterdam, Netherlands)
PMID: 28212993

Abstract

OBJECTIVE: The Phase III, randomized, open-label IPASS study (NCT00322452) of first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) gefitinib versus carboplatin/paclitaxel for Asian patients with advanced non-small-cell lung cancer (NSCLC) showed that investigator-assessed progression-free survival (PFS) and objective response rate (ORR) were significantly prolonged in patients with EGFR mutation-positive NSCLC who received gefitinib versus patients with EGFR mutation-negative NSCLC. We report post-hoc analyses of IPASS data by blind independent central review (BICR), performed at the request of the US FDA, in a subset of patients with EGFR mutation-positive NSCLC.

Authors

  • Yi-Long Wu
    Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080, China. Electronic address: syylwu@live.cn.
  • Nagahiro Saijo
    Medical Oncology Division, Kinki University School of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama City, Osaka 589 8511, Japan. Electronic address: saijo@jsmo.or.jp.
  • Sumitra Thongprasert
    Medical Oncology Unit, Department of Medicine, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, 110 Intavaroros Road, Muang, Chiang Mai 50200, Thailand. Electronic address: sumitra95@gmail.com.
  • J C-H Yang
    Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, No. 7, Chung-Shan South Road, Taipei 100, Taiwan. Electronic address: chihyang@ntu.edu.tw.
  • Baohui Han
    Department of Respiratory Disease, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai 200030, China. Electronic address: xkyyhan@gmail.com.
  • Benjamin Margono
    Jl. Mayjend Prof. Dr. Moestopo No. 6-8 Surabaya, Jawa Timur 60285, Indonesia. Electronic address: bmargono@yahoo.com.
  • Busayamas Chewaskulyong
    Medical Oncology Unit, Department of Medicine, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, 110 Intavaroros Road, Muang, Chiang Mai 50200, Thailand. Electronic address: bchewask@gmail.com.
  • Patrapim Sunpaweravong
    Songklanagarind Hospital, Prince of Songkla University, 15 Karnjanavanich Road, Hat Yai, Songkhla 90110, Thailand. Electronic address: sunpawep@myumanitoba.ca.
  • Yuichiro Ohe
    Division of Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chou-ku, Tokyo 104-0045, Japan. Electronic address: yohe@ncc.go.jp.
  • Yukito Ichinose
    National Hospital Organization Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan. Electronic address: ichinose.yukito@gmail.com.
  • Jin-Ji Yang
    Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080, China. Electronic address: yangjinji2003@163.com.
  • Tony S K Mok
    Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, 30-32 Ngan Shing Street, Sha Tin, New Territories, Hong Kong, China. Electronic address: tony@clo.cuhk.edu.hk.
  • Helen Young
    (Formerly of) AstraZeneca, 310 Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0FZ, United Kingdom. Electronic address: hhyoung@btinternet.com.
  • Vincent Haddad
    AstraZeneca, Da Vinci Building, Melbourn Science Park, Cambridge Road, Melbourn, Royston, Hertfordshire, SG8 6HB, United Kingdom. Electronic address: vincent.haddad@astrazeneca.com.
  • Yuri Rukazenkov
    AstraZeneca, Mereside, Alderley Park, Macclesfield, SK10 4TG, United Kingdom. Electronic address: yuri.rukazenkov@astrazeneca.com.
  • Masahiro Fukuoka
    Medical Oncology Division, Kinki University School of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama City, Osaka 589 8511, Japan. Electronic address: fukuoka@izumi-hp.com.

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