|
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%). Text Continues Below
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 Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
