Cited by 413Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentHER2/EGFR in Cancer Research

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Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial

Soria, Jean-Charles, Wu, Yi-Long, Nakagawa, Kazuhiko, Kim, Sang-We, Yang, Jin-Ji, Ahn, Myung-Ju, Wang, Jie, Yang, James Chih-Hsin, Lu, You, Atagi, Shinji, Ponce, Santiago, Lee, Dae Ho, Liu, Yunpeng, Yoh, Kiyotaka, Zhou, Jian-Ying, Shi, Xiaojin, Webster, Alan, Jiang, Haiyi, Mok, Tony S K·2015·The Lancet Oncology

DOI 10.1016/s1470-2045(15)00121-7

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Abstract

Background Optimum management strategies for patients with advanced non-small-cell lung cancer (NSCLC) with acquired resistance to EGFR tyrosine-kinase inhibitors are undefined. We aimed to assess the efficacy and safety of continuing gefitinib combined with chemotherapy versus chemotherapy alone in patients with EGFR-mutation-positive advanced NSCLC with acquired resistance to first-line gefitinib.Methods The randomised, phase 3, multicentre IMPRESS study was done in 71 centres in 11 countries in Europe and the Asia-Pacific region. Eligible patients were aged at least 18 years with histologically confirmed, chemotherapy-naive, stage IIIB-IV EGFR-mutation-positive advanced NSCLC with previous disease control with first-line gefitinib and recent disease progression (Response Evaluation Criteria in Solid Tumors version 1.1). Participants were randomly assigned (1:1) by central block randomisation to oral gefitinib 250 mg or placebo once daily in tablet form; randomisation did not include stratification factors. All patients also received the platinum-based doublet chemotherapy cisplatin 75 mg/m(2) plus pemetrexed 500 mg/m(2) on the first day of each cycle. After completion of a maximum of six chemotherapy cycles, patients continued their randomly assigned treatment until disease progression or another discontinuation criterion was met. All study investigators and participants were masked to treatment allocation. The primary endpoint was progression-free survival in the intention-to-treat population. Safety was assessed in patients who received at least one dose of study treatment. The study has completed enrolment, but patients are still in follow-up for overall survival. This trial is registered with ClinicalTrials.gov, number NCT01544179.Findings Between March 29, 2012, and Dec 20, 2013, 265 patients were randomly assigned: 133 to the gefitinib group and 132 to the placebo group. At the time of data cutoff (May 5, 2014), 98 (74%) patients had disease progression in the gefitinib group compared with 107 (81%) in the placebo group (hazard ratio 0·86, 95% CI 0·65-1·13; p=0·27; median progression-free survival 5·4 months in both groups [95% CI 4·5-5·7 in the gefitinib group and 4·6-5·5 in the placebo group]). The most common adverse events of any grade were nausea (85 [64%] of 132 patients in the gefitinib group and 81 [61%] of 132 patients in the placebo group) and decreased appetite (65 [49%] and 45 [34%]). The most common adverse events of grade 3 or worse were anaemia (11 [8%] of 132 patients in the gefitinib group and five [4%] of 132 patients in the placebo group) and neutropenia (nine [7%] and seven [5%]). 37 (28%) of 132 patients in the gefitinib group and 28 (21%) of 132 patients in the placebo group reported serious adverse events.Interpretation Continuation of gefitinib after radiological disease progression on first-line gefitinib did not prolong progression-free survival in patients who received platinum-based doublet chemotherapy as subsequent line of treatment. Platinum-based doublet chemotherapy remains the standard of care in this setting.Funding AstraZeneca.

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Background
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Authors: Soria, J.-C., Wu, Y.-L., Nakagawa, K., Kim, S.-W., Yang, J.-J., Ahn, M.-J., Wang, J., Yang, J. C.-H., Lu, Y., Atagi, S., Ponce, S., Lee, D. H., Liu, Y., Yoh, K., Zhou, J.-Y., Shi, X., Webster, A., Jiang, H., & Mok, T. S. K.
Affiliations: Institut Gustave Roussy (FR)
Guangdong General Hospital (CN)
Kindai University (JP)
Asan Medical Center (KR)
National Taiwan University (TW)
Samsung Medical Center (KR)
Peking University Cancer Hospital (CN)
NHO Kinki Chuo Chest Medical Center (JP)
Hospital Universitario 12 De Octubre (ES)
First Hospital of China Medical University (CN)
National Cancer Center Hospital East (JP)
AstraZeneca (United Kingdom) (GB)
Chinese University of Hong Kong (HK)
Corresponding author: Mok, Tony S K
ORCID: Soria, Jean-Charles
Wu, Yi-Long
Nakagawa, Kazuhiko
Yang, Jin-Ji
Ahn, Myung-Ju
Wang, Jie
Yang, James Chih-Hsin
Atagi, Shinji
Ponce, Santiago
Liu, Yunpeng
Yoh, Kiyotaka
Shi, Xiaojin
Jiang, Haiyi
Mok, Tony S K
Venue: The Lancet Oncology
Publisher: Elsevier BV
Published: 2015-08
Volume: 16
Issue: 8
Pages: 990-998
ISSN: 1470-2045 (ISSN-L)
DOI: 10.1016/s1470-2045(15)00121-7
OpenAlex: W2152481222
Semantic Scholar: 8a3893572a340f3e2e3dc31440e3947d55eb0893
Cited by: 413
References: 30
Citations by year: 2026: 13 · 2025: 22 · 2024: 21 · 2023: 28 · 2022: 28 · 2021: 34 · 2020: 36 · 2019: 35 · 2018: 53 · 2017: 66 · 2016: 61 · 2015: 15
FWCI: 51.33
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Oncology (publishedVersion)
PubMed (publishedVersion)
Funders: AstraZeneca
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Keywords: gefitinib, EGFR mutation, non-small cell lung cancer, acquired resistance, EGFR tyrosine kinase inhibitors, cisplatin, pemetrexed, platinum-based chemotherapy, progression-free survival, second-line therapy, treatment safety, overall survival, quality of life, patient-reported outcomes, adverse events
MeSH terms: Pemetrexed, Gefitinib, Administration, Oral, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Asia, Carcinoma, Non-Small-Cell Lung, Cisplatin, Drug Administration Schedule, Europe, Female, Glutamates, Guanine, Humans, Infusions, Intravenous, Lung Neoplasms, Male, Middle Aged, Mutation, Phenotype, Prospective Studies, Quinazolines, Time Factors, Biomarkers, Tumor, Proportional Hazards Models, Treatment Outcome, Disease Progression, Disease-Free Survival, Genetic Predisposition to Disease, Protein Kinase Inhibitors, Kaplan-Meier Estimate, ErbB Receptors

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Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial

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