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Clinical Medicine Insights: Oncology

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Phase II Clinical Trial of Gefitinib for the Treatment of Chemonaïve Patients with Advanced Non-small Cell Lung Cancer with Poor Performance Status

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Publication Date: 25 Nov 2014

Type: Original Research

Journal: Clinical Medicine Insights: Oncology

Citation: Clinical Medicine Insights: Oncology 2014:8 121-128

doi: 10.4137/CMO.S15172


Background: Patients with advanced non-small cell lung cancer (NSCLC) have no curative treatment options; therefore, improving their quality of life (QOL) is an important goal. Gefitinib, an epidermal growth factor receptor (EGFR) inhibitor, is a safe oral agent that may be of benefit to a specific population of NSCLC.

Patients and methods: A Phase II clinical trial included chemonaïve patients with advanced NSCLC and poor performance status (PS). Response rate, progression-free survival, overall survival, QOL using the Functional Assessment of Cancer Therapy – Lung (FACT-L) questionnaire, and Trial Outcome Index (TOI) were evaluated.

Results: Twelve out of 19 enrolled patients were evaluable. The median age for the evaluable patients was 68.8 years (59.7–74.6). Out of all the patients, 7 (58.3%) had adenocarcinoma and 5 (41.7%) had squamous cell carcinoma. The median duration of treatment was 62.5 days (26.5–115.0) in the evaluable patients. Grade 3/4 toxicities included fatigue, rash, diarrhea, and nausea. One patient had partial response, eight patients had stable disease (SD), and three patients progressed. The median overall survival for the evaluable population was 4.9 months (2.3–16). The median progression-free survival was 3.7 months (1.9–6.6). TOI was marginally associated with the overall survival, with a hazard ratio of 0.92 (95% confidence interval: 0.84, 1.0) (P = 0.061). FACT-L score and the TOI were highly correlated (r = 0.96, P < 0.0001). TOI scores were higher in African Americans compared to Caucasians and increased with age.

Conclusion: Our results suggest that gefitinib use in patients with NSCLC and poor PS may improve the QOL of older patients and African American patients.




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This is my second publication with Libertas. I greatly appreciate the attention to details throughout the process, especially the graphical enhancement of my figures. The author interface was very easy to use and the turnaround time on your end was swift and accurate.  I compliment you and your team on your administrative efficiency and high quality of work.
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