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Effectiveness of IRESSA as third line therapy was determined in the 142 evaluable patients with documented disease progression on platinum and docetaxel therapies or who had had unacceptable toxicity on these agents. Table 1: Demographic and Disease Characteristics IRESSA Dose 250 mg/ day 500 mg/ day Characteristic N= 66 (%) N= 76 (%) Age Group 18-64 years 43 (65) 43 (57) 64-74 years 19 (29) 30 (39) 75 years and above 4 (6) 3 (4) Sex Male 38 (58) 41 (54) Female 28 (42) 35 (46) Race White 61 (92) 68 (89) Black 1 (2) 2 (3) Asian/ Oriental 1 (2) 2 (3) Hispanic 0 (0) 3 (4) Other 3 (5) 1 (1) Smoking History Yes (Previous or current smoker) 45 (68) 62 (82) No (Never smoked) 21 (32) 14 (18) Baseline WHO Performance Status 0 14 (21) 9 (12) 1 36 (55) 53 (70) 2 15 (23) 14 (18) Not Recorded 1 (2) 0 (0) Tumor Histology Squamous 9 (14) 11 (14) Adenocarcinoma 47 (71) 50 (66) Undifferentiated 6 (9) 4 (5) Large Cell 1 (2) 2 (3) Squamous and Adenocarcinoma 3 (5) 7 (9) Not Recorded 0 (0) 2 (3) Current Disease Status Locally Advanced 11 (17) 5 (7) Metastatic 55 (83) 71 (93) Table 2 shows tumor response rates and response duration. The overall response rate for the 250 and 500 mg doses combined was 10.6% (95% CI: 6%, 16.8%). 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. Text Continues Below
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. Page: << Prev | 1 | 2 | 3 | 4
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