Clinically Meaningful Improvement in Symptoms and Quality of Life for Patients With Non-Small-Cell Lung Cancer Receiving Gefitinib in a Randomized Controlled Trial

Abstract

PURPOSE Evaluation of disease-related symptom improvement rate by the Lung Cancer Subscale (LCS) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire was a coprimary end point of the pivotal phase II trial of gefitinib (Iressa; AstraZeneca, Wilmington, DE) conducted in the United States. This report includes the results of analyses exploring the relationship between weekly LCS scores and radiographic response and survival, as well as detailed protocol-specified analysis of symptom and quality-of-life data. PATIENTS AND METHODS In this trial, 216 symptomatic patients with advanced non-small-cell lung cancer (NSCLC) who had at least two prior chemotherapy regimens received gefitinib 250 or 500 mg/d. Disease-related symptoms were assessed weekly and quality of life was assessed monthly by LCS and FACT-L, respectively. Results Symptom improvement was rapid and correlated with tumor response and survival. At the recommended gefitinib dose of 250 mg/d, median overall survival times were 13.6 and 4.6 months for patients with and without symptom improvement, respectively, and 9.7 months for patients with symptom improvement without tumor response. Among patients with stable disease or disease progression, those with symptom improvement had significantly better overall survival than those without improvement. At 250 mg/d, 30% of patients showed a quality-of-life improvement that was correlated with tumor response. CONCLUSION This triadic analysis of response, survival, and symptom data supports the hypothesis that tumor response and symptom response are related and that each predicts survival. Among these NSCLC patients treated with gefitinib, symptom improvement was complementary to and, for most patients, preceded evidence of radiographic regression.

Clinical benefit of readministration of gefitinib for initial gefitinib-responders with non-small cell lung cancer

“…In the present study, the OS was 29.2 months, which was much longer than that in three previous retrospective reports [19,30,31] focusing on patients who had responded to gefitinib (16 to 20.3 months). Differences in gender, never-smoked status, presence of adenocarcinoma, and ethnicity may be responsible in part for the altered outcome between the responders in the present study and those in the three previous studies.…”

Management of non-small cell lung cancer with EGFR mutation: the role of radiotherapy in the era of tyrosine kinase inhibitor therapy—opportunities and challenges

“…As to their report, the response rates were 64.7% and 81.3% and the timeto-partial response were 40 and 20 days respectively, with evaluation limited to patients with a response. Other studies have also reported that the median time to symptomatic relief was observed within 2-3 weeks for patients treated with EGFR TKIs (18,19). These results suggest that TKI can be considered as the first choice if the primary goal was to achieve prompt symptomatic relief.…”

Quality of Life with Gefitinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer: Quality of Life Analysis of North East Japan Study Group 002 Trial

“…When patients were treated with gefitinib monotherapy in other trials, QoL and symptom improvement were rapid and were correlated with tumor response and survival [26,27]. In the BR.21 study using unselected patients, another EGFR TKI, erlotinib, also improved tumor-related symptoms and important aspects of QoL such as physical functioning [28].…”