Iressa - Side Effects & Drug Interactions

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Response rates appeared to be highly variable in subgroups of the treated population:

5.1% (4/ 79) in males, 17.5% (11/ 63) in females, 4.6% (5/ 108) in previous or current smokers, 29.4% (10/ 34) in nonsmokers, 12.4% (12/ 97) with adenocar-cinoma histology, and 6.7% (3/ 45) with other NSCLC histologies. Similar differences in response were seen in a multinational study in patients who had received 1 or 2 prior chemotherapy regimens, at least 1 of which was platinum-based. In responders, the median time from diagnosis to study randomization was 16.7 months (range 8 to 34 months). Table 2 - Efficacy Results Evaluable Patients 250 mg 500 mg Combined (N= 66) (N= 76) (N= 142) Objective Tumor Response Rate (%) 13.6 7.9 10.6 95% CI (%) 6.4 - 24.3 3.0 - 16.4 6. 0 - 16.8 Median Duration of Objective Response (months) 8.9 4.5 7.0 Range (months) 4.6 - 18.6+ 4.4 - 7.6 4.4 - 18.6+ + = data are ongoing Non- Small Cell Lung Cancer (NSCLC); Studies of First-line Treatment in Combination with Chemotherapy Two large trials were conducted in chemotherapy-naïve patients with stage III and IV non- small cell lung cancer. Two thousand one hundred thirty patients were randomized to receive IRESSA 250 mg daily, IRESSA 500 mg daily, or placebo in combination with platinum-based chemotherapy regimens.

The chemotherapies given in these first-line trials were gemcitabine and cis- platinum (N= 1093) or carboplatin and paclitaxel (N= 1037). The addition of IRESSA did not demonstrate any increase, or trend toward such an increase, in tumor response rates, time to progression, or overall survival.