In the Shepherd studyr all patients were included in the survival analysis. At the time of analysis 587 deaths had occurred (378 in the erlotinib groups and 209 in the placebo group). The likelihood of a response was to erlotinib was not significantly altered by performance status, prior treatments, prior response, or age, but it was higher among women (p=0.006), and non smokers (p <0.001)
The Response Rate was x 8.9% in the erlotinib group and less than 1% in the placebo group( p=<0.001) The OS was 6.7 months and 4.7 months respectively (HR= 0.70; p=<0.001).
Factors predictive of response to erlotinib were gender, histology and smoking history, factors predictive for survival benefit were smoking survival, response to prior therapy, performance status, histology and exposure to prior platinum. Patients who developed a rash had a better response rate.
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In the OPTIMAL studyr median progression-free survival (PFS) was significantly longer in the erlotinib group 13.1 (95% CI 10.58-16.53) vs 4.6 (95%CI 4.21-5.42) months; HR 0.16, 95% CI 0.10-0.26; p<0.0001.
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PFS in the EURTACr study at final analysis was 9.7 months (95% CI 8.4-12.3 ) in the erlotinib group and 5.2 months (95% CI 4.5-5.8) in the chemotherapy group (HR 0.37, 95% CI 0.25-0.54; p<0.0001).
1 year PFS was 40% (95% CI 28-52) in the erlotinib group and 10% (4-20) in the chemotherapy group.
2 year PFS was 11% (5-26) in the erlotinib group and 0% (not assessable) in the chemotherapy group.
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The secondary endpoint of overall survival did not differ significantly between the groups 19.3 months (95% CI 14.7-26.8) in the erlotinib group and 19.5 months (16.1- not assessable) in the chemotherapy group (HR 1.04, 95% CI 0.65-1.68; p=0.87).
Response rate was 3% complete response and 61% partial response in the erlotinib group vs no complete response and 18% partial response in the chemotherapy group.