Tarceva联合吉西他滨治疗胰腺癌

Data from Phase III Study Show Tarceva Plus Gemcitabine Significantly Improves Survival Compared to Gemcitabine Alone in Advanced Pancreatic Cancer Patients
Thursday January 27, 11:05 am ET
Tarceva is the Only Epidermal Growth Factor Receptor (EGFR) Therapy to Show an Improvement in Survival in Pancreatic Cancer

HOLLYWOOD, Fla.--(BUSINE WIRE)--Jan. 27, 2005-- OSI Pharmaceuticals, Inc. , Genentech, Inc. , and Roche (SWX Zurich) aounced today that a randomized Phase III clinical study of Tarceva(TM) (erlotinib) plus gemcitabine chemotherapy in patients with locally advanced or metastatic pancreatic cancer met its primary endpoint by demotrating a statistically significant 23.5 percent improvement in overall survival when compared to patients receiving gemcitabine plus placebo. The data were presented at the Second Aual Gastrointestinal Cancers Symposium in Hollywood, Fla. Tarceva is the first drug shown in a Phase III trial to prolong survival when added to the standard of care (gemcitabine) in the treatment of patients with previously untreated advanced pancreatic cancer.

Results from the Pancreatic Cancer Study

The study data demotrated an improvement in overall survival for patients receiving Tarceva plus gemcitabine compared to patients receiving gemcitabine plus placebo (hazard ratio = 0.81, p-value = 0.025; a hazard ratio of le than one indicates a decreased risk of death and a p-value of le than 0.05 indicates statistical significance). Twenty-four percent of patients receiving Tarceva plus gemcitabine were alive after one year compared to 17 percent of patients receiving gemcitabine plus placebo. 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. Progreion-free survival in the Tarceva plus gemcitabine arm also was significantly improved (hazard ratio = 0.76, p-value = 0.003), although there was virtually no difference in tumor reoe (9 percent in patients receiving Tarceva plus gemcitabine versus 8 percent in the gemcitabine plus placebo arm).

The international study was a multi-center, randomized, double-blind, placebo-controlled Phase III trial evaluating Tarceva at 100 mg/day or 150 mg/day in patients with locally advanced or metastatic pancreatic cancer. The study randomized patients to receive either gemcitabine plus concurrent Tarceva or gemcitabine plus placebo. Gemcitabine was dosed at 1,000 mg/m2 IV once weekly. A total of 569 patients were randomized in the study, 521 patients were randomized to receive 100 mg/day of Tarceva plus gemcitabine or gemcitabine plus placebo, and 48 patients received 150 mg/day of Tarceva plus gemcitabine or gemcitabine plus placebo. Aroximately 75 percent of the patients in the study had metastatic disease and 25 percent had locally advanced disease. The study had sites in the United States, Asia, Canada, Europe, Australia and South America. The study was conducted by the National Cancer Ititute of Canada Clinical Trials Group based at Queen‘s University, Ontario in collaboration with OSI Pharmaceuticals.
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A preliminary analysis of the safety data did not reveal any unexpected safety signals beyond that seen in previous studies of Tarceva in both monotherapy and combination settings. As expected, rash and diarrhea were the principal Tarceva related side effects seen in the study. Rash was reported by 72 percent of patients who received Tarceva plus gemcitabine and by 28 percent of patients who received gemcitabine plus placebo. Diarrhea was reported by 51 percent of patients who received Tarceva plus gemcitabine and by 36 percent of patients who received gemcitabine plus placebo.

"The results of this trial underscore the importance and potential utility of Tarceva in combination with gemcitabine in the treatment of patients with pancreatic cancer," stated Malcolm Moore, M.D., Study Chair and Medical Oncologist at Prince Margaret Hoital in Toronto, Canada and Chair of the Gastrointestinal Disease Site, NCIC Clinical Trials Group. "These Tarceva results represent an important medical advance in the treatment of patients with pancreatic cancer and we hope will open the door to a completely new aroach to treating the disease."

"The positive outcome of this trial is great news for pancreatic patients and their families. OSI is working closely with the FDA to complete a Sulemental New Drug Alication (DA) which we hope to file in the first half of 2005," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "Tarceva has now shown a survival benefit in two cancers that are widely recognized among the most difficult to treat, pancreatic cancer and lung cancer."