Phase II clinical trial of gefitinib for the treatment of chemonaïve patients with advanced non-small cell lung cancer with poor performance status

Nagla Abdel Karim, Salma Musaad, Ahmad Zarzour, Sadanand Patil, Abdul Rahman Jazieh

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)121-128
Number of pages8
JournalClinical Medicine Insights: Oncology
Volume8
DOIs
StatePublished - Nov 25 2014
Externally publishedYes

Fingerprint

Phase II Clinical Trials
Non-Small Cell Lung Carcinoma
Therapeutics
Quality of Life
African Americans
gefitinib
Disease-Free Survival
Survival
Lung Neoplasms
Exanthema
Epidermal Growth Factor Receptor
Nausea
Population
Fatigue
Squamous Cell Carcinoma
Diarrhea
Adenocarcinoma

Keywords

  • Advanced non-small cell lung cancer
  • Gefitinib
  • Poor performance status
  • Quality of life

ASJC Scopus subject areas

  • Oncology

Cite this

Phase II clinical trial of gefitinib for the treatment of chemonaïve patients with advanced non-small cell lung cancer with poor performance status. / Karim, Nagla Abdel; Musaad, Salma; Zarzour, Ahmad; Patil, Sadanand; Jazieh, Abdul Rahman.

In: Clinical Medicine Insights: Oncology, Vol. 8, 25.11.2014, p. 121-128.

Research output: Contribution to journalArticle

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abstract = "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 chemona{\"i}ve 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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AU - Jazieh, Abdul Rahman

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KW - Poor performance status

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