BACKGROUNDTo summarize the preliminary experience on Iressa for refractory non-small cell lung cancer (NSCLC).

METHODSFifty-five patients with NSCLC, who failed after surgery, radiotherapy, chemotherapy or combination of the above modalities, were registered in this clinical trail. Prior to Iressa, 50 patients were in stage IV, and 5 in stage III. Iressa was administered orally at 250 mg, once a day until cancer progressed or severe toxicity occured, which made patients intolerable. The median time for administration of Iressa was 4 months.

RESULTSThe toxicity of Iressa was tolerable with 47% of skin toxicity (rash) and 2%-7% of diarrhea, nausea, orally mucosal ulceration and alopecia. Overall response rate was 20%. Different sites of distant metastases responded to Iressa in different ways with higher response rate for pulmonary disseminations. One quarter of patients felt improvement of their symptoms over 2 weeks. Median survival time for entire group was 5 months (1-17 months). Median time to progression (TTP) was 3.6 months. Survival at 6 months was 67%. Prognostic predictor, which could imply the outcome, was skin toxicity with higher response rate and longer survival time ( P < 0.05), and no relationship with sex, histological types of NSCLC and distant metastasis had been found.

CONCLUSIONSIressa could be tolerated by refractory NSCLC patients with acceptable side-effects, and have palliative effects.