EGFR tyrosine kinase inhibitors in non-small cell lung cancer: report of a 3-year compassionate use experience with gefitinib in stage IIIB/IV outpatients.
BACKGROUND
Since March 2002, 240 patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) have been treated inside a compassionate use program with oral gefitinib (250 mg o.d.).


METHODS
Within a 36-month observation period, 32 patients who showed either partial remission or confirmed disease stabilization for at least 3 months, were retrospectively analyzed.


RESULTS
Our reported 4% overall response rate matches with literature data for an unselected patient population. The median progression-free survival (PFS) was 9 months, the median overall survival (OS) since detection of advanced disease was 21 months. Interestingly, no relevant differences in PFS were observed for chemo-naive and second/third-line patients, whereas a reduced benefit in terms of response rate, PFS and OS was found for forth-line patients. 12 patients survived for at least 2 years since manifestation of their advanced disease. A slight benefit regarding cough and performance status conservation was observed. Mild to modest skin reactions and diarrhea were the adverse events reported most often. Grade 3 toxicities were rarely observed.


CONCLUSIONS
The retrospective evaluation of therapy results from compassionate use patients helps clinicians to better evaluate new drugs in practice. EGFR tyrosine kinase (TK) inhibitors require ongoing intensive evaluation to optimize their clinical use in NSCLC.
Reck
Martin
M
Krankenhaus Grosshansdorf, Zentrum für Thoraxchirurgie, Grosshansdorf, Germany. Dr.Martin.Reck@web.de
Gatzemeier
Ulrich
U
D000328:Adult; D000368:Aged; D000553:Ambulatory Care / Q000706:statistics & numerical data*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000453:epidemiology*; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D005260:Female; D000077156:Gefitinib; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000706:statistics & numerical data; D011799:Quinazolines / Q000627:therapeutic use*; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D016019:Survival Analysis; D015996:Survival Rate; D013727:Terminal Care / Q000706:statistics & numerical data*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib