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Cited by 179Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

The DOI matches its Crossref record; 17 of the 17 references it cites were found in a registry or an index.

Randomized Phase III Trial of Gefitinib versus Docetaxel in Non–Small Cell Lung Cancer Patients Who Have Previously Received Platinum-Based Chemotherapy

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Lee, Dae Ho, Park, Keunchil, Kim, Joo Hang, Lee, Jong-Seok, Shin, Sang Won, Kang, Jin-Hyoung, Ahn, Myung-Ju, Ahn, Jin Seok, Suh, Cheolwon, Kim, Sang-We·2010·Clinical Cancer Research
DOI 10.1158/1078-0432.ccr-09-1903
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Abstract

Purpose: The ISTANA (IRESSA as Second-line Therapy in Advanced NSCLC—KoreA) study compared gefitinib with docetaxel in patients with advanced or metastatic non–small cell lung carcinoma (NSCLC) pretreated with platinum-based chemotherapy. Experimental Design: We conducted a multicenter, randomized, open-label phase III trial of gefitinib (250 mg/d) versus docetaxel (75 mg/m2 day 1 every 3 weeks) in patients with advanced or metastatic NSCLC treated with one previous platinum-based chemotherapy. The primary endpoint was progression-free survival. Results: A total of 161 patients (male, 62%; never smoker, 41%; adenocarcinoma, 68%) were enrolled. Progression-free survival was longer for gefitinib compared with docetaxel (hazard ratio, 0.729; 90% confidence interval, 0.533-0.998; one-sided P = 0.0441). Gefitinib significantly improved objective response rate (28.1% versus 7.6%; two-sided P = 0.0007). In the final analysis of overall survival, the hazard ratio was 0.870 (95% confidence interval, 0.613-1.236; two-sided P = 0.4370). No significant differences were seen in the quality of life or symptom improvement rates between the two treatment groups. Gefitinib was well tolerated, was consistent with previous data and disease, and had fewer serious adverse events and fewer Common Terminology Criteria for Adverse Events grade 3 or 4 adverse events than docetaxel. The incidence of interstitial lung disease–type events was 3.7% (n = 3) with gefitinib and 3.9% (n = 3) with docetaxel. Conclusions: The primary endpoint of progression-free survival was longer with gefitinib than docetaxel, and the secondary endpoints showed superior objective response rate, good tolerability, and similar quality of life improvement rates for gefitinib than docetaxel. Therefore, gefitinib is an important valid treatment option for second-line therapy for Korean NSCLC patients. Clin Cancer Res; 16(4); 1307–14

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Crossref · 10.1158/1078-0432.ccr-09-1903

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Metadata

Authors
Lee, D. H., Park, K., Kim, J. H., Lee, J.-S., Shin, S. W., Kang, J.-H., Ahn, M.-J., Ahn, J. S., Suh, C., & Kim, S.-W.
Affiliations
  • Authors' Affiliations: 1Asan Medical Center, University of Ulsan College of Medicine; 2Samsung Medical Center, Sungkyunkwan University; 3Yonsei University Medical Center; 4Korea University Anam Hospital; 5Catholic University Kangnam St. Mary's Hospital, Seoul, Korea; and 6Seoul National University Bundang Hospital, Sungnam, Korea
  • Yonsei University (KR)
Corresponding author
Kim, Sang-We
ORCID
Venue
Clinical Cancer Research
Publisher
American Association for Cancer Research (AACR)
Published
2010-02-15
Volume
16
Issue
4
Pages
1307-1314
ISSN
  • 1078-0432 (ISSN-L)
  • 1557-3265
DOI
10.1158/1078-0432.ccr-09-1903
OpenAlex
W2118548009
Cited by
179
References
16
Citations by year
2026: 1 · 2025: 2 · 2024: 4 · 2023: 2 · 2022: 3 · 2021: 3 · 2020: 4 · 2019: 3 · 2018: 7 · 2017: 9 · 2016: 14 · 2015: 20 · 2014: 19 · 2013: 27 · 2012: 24
FWCI
23.47
Type
journal article
Language
en
Open access
Locations
  • Clinical Cancer Research (publishedVersion)
  • PubMed (publishedVersion)
  • YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
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 › Lung Cancer Research Studies
Keywords
gefitinib, docetaxel, non-small cell lung cancer, second-line therapy, platinum-based chemotherapy, progression-free survival, objective response rate, interstitial lung disease, adverse events, quality of life, EGFR tyrosine kinase inhibitors
MeSH terms
Docetaxel, Gefitinib, Adult, Aged, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Quinazolines, Time Factors, Platinum Compounds, Disease-Free Survival, Retreatment, Taxoids

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