Erlotinib/Gemcitabine Ups Survival in Advanced Pancreatic Cancer

HOLLYWOOD, Florida-A randomized phase III clinical study of erlotinib (Tarceva) in combination with gemcitabine(Drug information on gemcitabine) (Gemzar) met its primary endpoint of improving survival in patients with locally advanced or metastatic pancreatic cancer, compared with patients receiving gemcitabine plus placebo. These results from a phase III trial were reported at the 2005 Gastrointestinal Cancers Symposium (abstract 77). The international study randomized 569 patients to receive either gemcitabine plus concurrent erlotinib at 100 mg/d or 150 mg/d, or gemcitabine plus placebo. The results showed a 19% decrease in the risk of dying from pancreatic cancer for the combination chemotherapy, compared with gemcitabine/placebo (hazard ratio 0.81, P = .025). Median overall survival and 1-year survival in the erlotinib/ gemcitabine group were 6.37 months and 24%, respectively, compared with 5.91 months and 17% in the gemcitabine/ placebo arm (see Figure 1). Improvement in progression-free survival was also significant, even though there was no significant difference in tumor response between the two groups. A preliminary safety analysis did not show any unexpected adverse events beyond those seen previously with erlotinib. As expected, rash and diarrhea were the principal erlotinibrelated side effects. The study was sponsored by OSI Pharmaceuticals and coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University. Malcolm J. Moore, MD, of the Princess Margaret Hospital, Toronto, reported the results.