Previous studies have shown Tarceva (erlotinib) renders a significant survival benefit to patients with non-small cell lung cancer (NSCLC). Today, data presented at American Society of Clinical Oncology (ASCO), Gastrointestinal Cancers Symposium, showed that adding Tarceva to chemotherapy also improves survival in patients with locally advanced or metastatic pancreatic cancer.
The Phase III international study was multi-centre, randomised, double-blind and placebo-controlled. The study evaluated Tarceva at 100mg/day or 150mg/day in patients with locally advanced or metastatic pancreatic cancer. 569 patients were randomised to receive either gemcitabine with concurrent Tarceva or gemcitabine plus placebo. 521 patients were randomized to receive 100 mg/day of Tarceva plus 1,000 mg/m2 IV once weekly gemcitabine or 1,000 mg/m2 IV once weekly gemcitabine plus placebo, and 48 patients received 150 mg/day of Tarceva plus 1,000 mg/m2 IV once weekly gemcitabine or 1,000 mg/m2 IV once weekly gemcitabine plus placebo. Approximately three-quarters of patients in the study had metastatic disease and one quarter had locally advanced disease. The study had sites in the United States, Asia, Canada, Europe, Australia and South America. Researchers found there was a statistically significant increase (23.5%) in overall survival in patients with locally advanced or metastatic pancreatic cancer who received Tarceva plus gemcitabine, compared to patients receiving gemcitabine alone. A higher percentage of patients were alive at 12 months in the group treated with Tarceva plus gemcitabine with a 24% survival rate compared to those treated with chemotherapy alone who showed a 17% survival rate. Median survival in the Tarceva plus gemcitabine arm was 6.4 months compared to 5.9 months in the gemcitabine plus placebo arm. An exploratory analysis of survival by pre-treatment characteristics also showed that patients with metastatic disease and patients with poor performance status derived a survival benefit. Although there was no significant difference in tumour response, progression-free survival was also significantly improved for patients treated with Tarceva.Early-stage trials of Tarceva are currently being conducted in other solid tumours, such as ovarian, colorectal, head and neck, renal cell carcinoma, glioma and gastrointestinal cancers.