Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non-small-cell lung cancer: SWOG S0023
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PURPOSE: Early clinical studies with gefitinib showed promising efficacy and mild toxicity in patients with advanced non-small-cell lung cancer (NSCLC). Thus, gefitinib was an ideal agent to evaluate in a maintenance setting in stage III disease. PATIENTS AND METHODS: Untreated patients with stage III NSCLC, a performance score of 0 to 1, and adequate organ function were eligible. All patients received cisplatin 50 mg/m(2) on days 1 and 8 plus etoposide 50 mg/m(2) on days 1 to 5, every 28 days for two cycles with concurrent thoracic radiation (1.8- to 2-Gy fractions per day; total dose, 61 Gy) followed by three cycles of docetaxel 75 mg/m(2). Patients whose disease did not progress were randomly assigned to gefitinib 250 mg/d or placebo until disease progression, intolerable toxicity, or the end of 5 years. The planned sample size was 672 patients to confer power of 0.89 to detect a 33% increase over the expected median survival time of 21 months (one-sided P = .025, log-rank test). Random assignment was stratified by stage, histology, and measurable versus nonmeasurable disease. RESULTS: Enrollment began in July 2001. An unplanned interim analysis conducted in April 2005 rejected the alternative hypothesis of improved survival at the P = .0015 level for 243 randomly assigned patients. The study closed, and preliminary results were reported. Now, with a median follow-up time of 27 months, median survival time was 23 months for gefitinib (n = 118) and 35 months for placebo (n = 125; two-sided P = .013). The toxic death rate was 2% with gefitinib compared with 0% for placebo. CONCLUSION: In this unselected population, gefitinib did not improve survival. Decreased survival was a result of tumor progression and not gefitinib toxicity.
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In stage III disease, combining an EGFR TKI with curative-intent chemotherapy and radiation in unselected patients has been shown to be harmful.
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- Authors
- Kelly, K., Chansky, K., Gaspar, L. E., Albain, K. S., Jett, J., Ung, Y. C., Lau, D. H. M., Crowley, J. J., & Gandara, D. R.
- Affiliations
- Sunnybrook Health Science Centre (CA)
- Venue
- Journal of Clinical Oncology
- Published
- 2008-05-20
- Volume
- 26
- Issue
- 15
- Pages
- 2450-2456
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2153865661
- Cited by
- 573
- References
- 31
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 11 · 2023: 18 · 2022: 11 · 2021: 31 · 2020: 24 · 2019: 22 · 2018: 39 · 2017: 24 · 2016: 41 · 2015: 40 · 2014: 44 · 2013: 57 · 2012: 41
- FWCI
- 48.16
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- AstraZeneca
- Sanofi
- National Institutes of Health (2u10ca038926-25, 5r01ca037663-18)
- National Cancer Institute (CA35192, U10CA004919, CA 35176, CA-11083, CA52654, CA-45377, U10CA035261, CA35281, CA 74811, CA-35261, CA-46282, CA 20319, CA-32102, U10CA074647, CA 45450, CA35119, CA 42777, U10CA045377, CA04919, U10CA058882, U10CA074811, U10CA014028, U10CA045560, U10CA063848, U10CA035178, CA 74647, U10CA045808, CA35128, CA46368, CA46441, CA 63845, U10CA046368, CA45808, CA 45461, CA67575, U10CA035090, CA 14028, U10CA020319, U10CA086780, U10CA011083, CA-58882, CA35178, CA-45807, U10CA013612, CA 37663, U10CA035119, U10CA063850, CA35431, U10CA032102, U10CA046282, U10CA045461, U10CA052654, U10CA045450, U10CA042777, U10CA035281, CA 13612, U10CA063845, U10CA045807, U10CA063844, U10CA035431, CA-35262, U10CA035192, CA 38926, U10CA035262, CA63844, CA86780, U10CA035176, U10CA035128, CA-63850, CA-63848, CA45560, U10CA067575, CA-35090, U10CA046441)
- 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, maintenance therapy, non-small cell lung cancer, stage III NSCLC, inoperable lung cancer, concurrent chemoradiotherapy, cisplatin, etoposide, thoracic radiotherapy, EGFR tyrosine kinase inhibitors, survival, toxic death
- MeSH terms
- Docetaxel, Gefitinib, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Cisplatin, Combined Modality Therapy, Etoposide, Female, Follow-Up Studies, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Prognosis, Quinazolines, Remission Induction, Survival Rate, Maximum Tolerated Dose, Taxoids
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