Preliminary results from a phase II study of the epidermal growth factor receptor tyrosine kinase inhibitor XXXX in @entity1 > 70 years of age with previously untreated advanced non-small cell lung carcinoma.

@entity1 @entity137 @entity55 @entity5 @entity294 @entity3866
UNASSIGNED: 7080 Background: Chemotherapy for @entity1 >=  70 years of age with advanced NSCLC can be associated with greater @entity137 than in younger @entity1 . The identification of an efficacious therapy with minimal systemic @entity137 would be particularly beneficial to elderly subjects. @entity3866 ( @entity3866   ) has shown promising activity, and a tolerable side effect profile, in the treatment of @entity1 who have failed prior chemotherapy. We thus chose to conduct a single center phase II trial of @entity3866 in @entity1 >=  70 with previously untreated advanced NSCLC. METHODS: @entity1 : chemotherapy na  ve, IIIB (w/malignant effusion)/IV, PS 0-2; treated with @entity3866 , 150 mg p.o. q.d., until evidence of disease progression or @entity137 . Primary endpoint: median survival; secondary endpoints: response rate, quality of life (using LCSS), changes in FDG-PET, and analysis of EGFR signaling pathway from pre-treatment @entity5 specimens. RESULTS: From 3/03 to 12/03, 36 pts were treated; 30 evaluable for @entity137 and response; 1 for @entity137 only; 5 too early. M/F: 19/17; median age 76 (70-86); PS 0/1/2:6/28/2; Path: adeno, 56%; squamous 14%; adeno w/BAC features, 11%; BAC, 11%; NSCLC unclassified 11%, large cell, 2%. Smoking: current/former/never: 2/30/4. @entity137 : rash 77%(grade 1/2: 92%, grade 3: 8%, grade 4:0%), @entity294 61% (grade 1/2: 100%, grade3/4:0%). Other >=  grade 3 @entity137 : @entity55 2/31 (6.5%) and lacrimation 1/31 (3.2%). One @entity1 died from @entity137 ( @entity55 ); 3/31 (9.6%) were dose reduced; 2/31 (6.5%) discontinued. RESPONSE: CR:0; PR: 4 (13.3%; 95% CI 5 - 29%); SD: 14 (46.6%; 95% CI 31-64%); PD:12 (40%). Median duration of response and stable disease: 6.8 (range 3.5-7.5+) and 3.5 months (range 1.5-8.0+), respectively. Survival and FDG-PET imaging are too early to evaluate. CONCLUSIONS: @entity3866 appears to be well tolerated and demonstrates encouraging activity in @entity1 >=  70 years of age with previously untreated advanced NSCLC. Accrual is continuing to 60 @entity1 and updated response, survival and FDG-PET data will be presented. [Table: see text].
