Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors

摘要: PURPOSE: The feasibility and utility of assessing quality life (QoL) disease-related symptoms in patients with advanced cancer have been evaluated two Phase I clinical trials p.o. administered ZD1839 ('Iressa'), an epidermal growth factor receptor tyrosine kinase inhibitor, cancer. EXPERIMENTAL DESIGN: Functional Assessment Cancer Therapy (FACT) questionnaires, including disease-specific subscales for lung, head neck, colorectal, prostate, ovarian cancer, were completed by open-label, I, escalating multiple-dose safety tolerability trials. RESULTS: In 157 patients, 92% whom had received prior therapy, compliance returning FACT questionnaires was 87% (European/Australian trial) 57% (United States trial). This did not appear to be influenced dose level or tumor type. For median QoL [FACT Trial Outcome Index (TOI)] scores deteriorated over time. contrast, non-small cell lung (NSCLC) neck TOI deteriorate significantly, the United trial, improved significantly NSCLC, symptom-related measured Lung Subscale FACT-L appeared sensitive change. CONCLUSIONS: (FACT-L) used successfully ZD1839. They a tool monitor changes five types these showed that has potential improve patients' QoL.