P3-094: An expanded access clinical program of erlotinib (Tarceva™) in patients with advanced stage IIIB/ IV non-small cell lung cancer

Erlotinib (Tarcevar®) is the first EGFR tyrosine kinase inhibitor which demonstrated the survival benefit to non-small cell lung cancer (NSCLC) patients. An expanded access program was designed to provide Erlotinib to NSCLC patients and evaluate the efficacy and safety of Erlotinib in Taiwanese population. Patients with proven stage IIIB/IV NSCLC and received at least one course of standard systemic chemotherapy or radiation therapy were enrolled in this study. No more than 2 prior chemotherapy regimens are permissible. All patients were given oral erlotinib, 150 mg/d till disease progression, according to the criteria of RECIST. Patients were monitored monthly and tumor assessments were evaluated every 2 months by x-ray, CT, or MRI. From Apr. 2005 to Feb. 2006, 297 patients were registered from 15 medical centers in Taiwan. The interim study evaluated the 297 patients (53% male; median age 62 [27-84]). 80% patients were with ECOG PS 0-1. Most patients had adenocarcinoma (67%) and squamous cell carcinoma (20%). 62 % of patients receiving erlotinib as 2nd-line treatment. 44% of patients were current-smoker. The profile of 297 patients was similar to the above baseline characteristics. The best response rate was 25% PR and 42% SD according to RECIST (disease control rate= 73%). The time to progression (TTP) analysis for all patients was based on 297 patients with 89 censored observations (30%). Due to the high number of censored observations it is too early to assess the median TTP for the overall population. Overall survival was also assessed for patients on 2nd and 3rd line treatment. Due to the high number of censored observations it is too early to assess the median survival by treatment line. As expected, rash was a common adverse event (any grade [gr]: 83%; gr 3-4: 15%). Skin toxicity (gr 3-4 vs. gr 0-2) was sig-nificantly correlated with best response (Chi-sq p value 0.0095). Erlotinib-related AEs were seen in 29% patients. Erlotinib-related AEs leading to treatment discontinuation were seen in 8 patients due to GI disorder, GOT/GPT elevation, skin toxicity, dyspnea or pneumonitis. There were 24% of patients had dose reductions, mainly due to rash (66%) and diarrhea (2%). Erlotinib-related SAEs were seen in 4% of patients, mainly GI disorders (2%). This is the largest multicenter prospective clinical study of NSCLC in Taiwan. This interim result demonstrated the superb response rates, time-to-progression and overall survival of erlotinib in a large population of East Asian advanced chemotherapy-treated NSCLC patients.