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Lung Cancer 104 (2017) 119–125

Contents lists available at ScienceDirect

Lung Cancer

journal homepage: www.elsevier.com/locate/lungcan

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

e
d
b
c
Yi-Long Wu a,∗ , Nagahiro Saijo , Sumitra Thongprasert , J. C.-H. Yang , Baohui Han ,
f
g
c
Benjamin Margono , Busayamas Chewaskulyong , Patrapim Sunpaweravong ,
a
Yuichiro Ohe , Yukito Ichinose , Jin-Ji Yang , Tony S.K. Mok , Helen Young ,
j
i
h
k
l
m
Vincent Haddad , Yuri Rukazenkov , Masahiro Fukuoka b
a Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080,
China
b Medical Oncology Division, Kinki University School of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama City, Osaka 589 8511, Japan
c 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
d Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, No. 7, Chung-Shan South Road, Taipei 100,
Taiwan
e Department of Respiratory Disease, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai 200030, China
f Jl. Mayjend Prof. Dr. Moestopo No. 6-8 Surabaya, Jawa Timur 60285, Indonesia
g Songklanagarind Hospital, Prince of Songkla University, 15 Karnjanavanich Road, Hat Yai, Songkhla 90110, Thailand
h Division of Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chou-ku, Tokyo 104-0045, Japan
i National Hospital Organization Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan
j 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
k (Formerly of) AstraZeneca, 310 Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0FZ, United Kingdom
l AstraZeneca, Da Vinci Building, Melbourn Science Park, Cambridge Road, Melbourn, Royston, Hertfordshire, SG8 6HB, United Kingdom
m AstraZeneca, Mereside, Alderley Park, Macclesfield, SK10 4TG, United Kingdom
a r t i c l e i n f o a b s t r a c t
Article history: Objective: The Phase III, randomized, open-label IPASS study (NCT00322452) of first-line epidermal
Received 31 October 2016 growth factor receptor tyrosine kinase inhibitor (EGFR TKI) gefitinib versus carboplatin/paclitaxel for
Accepted 29 November 2016 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
Keywords: with EGFR mutation-positive NSCLC who received gefitinib versus patients with EGFR mutation-negative
Epidermal growth factor receptor tyrosine NSCLC. We report post-hoc analyses of IPASS data by blind independent central review (BICR), performed
kinase inhibitor at the request of the US FDA, in a subset of patients with EGFR mutation-positive NSCLC.
Epidermal growth factor receptor-mutation
positive Patients and methods: Eligible patients (aged ≥18 years; histologically/cytologically confirmed Stage IIB/IV
IPASS study adenocarcinoma NSCLC; non- or former light-smokers; treatment-naïve) were randomly assigned 1:1
Non-small-cell lung cancer to gefitinib (250 mg/day) or carboplatin. (dose calculated to produce an area under the curve of 5 or
6 mg/mL/minute)/paclitaxel (200 mg/m ). Primary endpoint: PFS. BICR analyses included PFS, ORR, and
2
duration of response (DoR)
Abbreviations: ADC, adenocarcinoma; ALK, anaplastic lymphoma kinase; ASR, age-standardized rate; BICR, blind independent central review; CI, confidence interval;
CNS, central nervous system; CONSORT, Consolidated Standards of Reporting Trials; CT, computed tomography; DoR, duration of response; EGFR, epidermal growth factor
receptor; FDA, Food and Drug Administration; HR, hazard ratio; IPASS, Iressa Pan-ASia Study; ITT, intent-to-treat; NA, not available; NPV, negative predictive value; NSCLC,
non-small-cell lung cancer; OR, odds ratio; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PPV, positive predictive value; PS, performance
status; RECIST, Response Evaluation Criteria in Solid Tumors; TKI, tyrosine kinase inhibitor; US, United States; WHO, World Health Organization.
∗ Corresponding author.
E-mail addresses: syylwu@live.cn (Y.-L. Wu), saijo@jsmo.or.jp (N. Saijo), sumitra95@gmail.com (S. Thongprasert), chihyang@ntu.edu.tw (J.C.-H. Yang),
xkyyhan@gmail.com (B. Han), bmargono@yahoo.com (B. Margono), bchewask@gmail.com (B. Chewaskulyong), sunpawep@myumanitoba.ca (P. Sunpaweravong),
yohe@ncc.go.jp (Y. Ohe), ichinose.yukito@gmail.com (Y. Ichinose), yangjinji2003@163.com (J.-J. Yang), tony@clo.cuhk.edu.hk (T.S.K. Mok), hhyoung@btinternet.com
(H. Young), vincent.haddad@astrazeneca.com (V. Haddad), yuri.rukazenkov@astrazeneca.com (Y. Rukazenkov), fukuoka@izumi-hp.com (M. Fukuoka).

http://dx.doi.org/10.1016/j.lungcan.2016.11.022
0169-5002/© 2016 The Authors. Published by Elsevier Ireland Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-
nc-nd/4.0/).
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