annie1129 Posted June 8, 2004 Share Posted June 8, 2004 Could anyone tell me the meaning of "95% CI, 28.8-31.1"??? Data presented at the American Society of Clinical Oncology (ASCO) 40th Annual Meeting NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Final data from more than 21,000 non-small-cell lung cancer (NSCLC) patients who received the oral cancer drug IRESSA® (gefitinib) through AstraZeneca's pre-approval expanded access program (EAP) in the United States were presented today at the American Society of Clinical Oncology (ASCO) meeting. The one-year survival rate in patients treated with IRESSA on a compassionate basis was reported as 29.9%. This data set represents the largest reporting to date of clinical use of an agent in the epidermal growth factor receptor (EGFR) class. The IRESSA EAP was initiated to allow access to the drug while it was pending U.S. Food and Drug Administration (FDA) approval. The program ran from August 2000 to July 2003 in the United States and enrolled 23,383 advanced (stage III/IV) non-small-cell lung cancer patients who had exhausted all approved treatment options or were unable to tolerate chemotherapy. "Because the EAP enabled the use of IRESSA outside of a formal clinical trial setting, it provides a unique look at patient impact in a true clinical setting," said Judith Ochs M.D., Senior Medical Director, AstraZeneca LP, lead author of the study. The data presented followed 21,064 patients who received greater than or equal to 1 dose of IRESSA. Patient demographics included 9,979 women and 11,040 men. Median age was 67 years and 72.7% of patients had stage IV disease. Median survival was 5.3 months (95% CI, 5.1 - 5.5 mo) and 1-year survival was 29.9% (95% CI, 28.8 - 31.1). Duration of therapy and survival were measured from the start of initial therapy to the last resupply date for ongoing patients or the date of last dose for withdrawn patients. For surviving patients who withdrew, periodic follow-up data were not collected, and patients were censored for survival at withdrawal until death was reported. In the EAP 2.3% of patients reported a serious treatment-related adverse (AE) event; 1.1% discontinued therapy due to a serious drug-related AE, and 0.3% had an investigator-assessed, drug-related death. Quote Link to comment Share on other sites More sharing options...
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