Measuring the Effects of Cancer Drug Tarceva
“FDA Weighs Days of Survival” (Nov. 2) did not give readers a complete picture of the potential benefit of Tarceva for pancreatic cancer because it centered on a single statistic: median survival, a secondary goal of the clinical study that supported Tarceva’s FDA approval.
While median survival is a frequently quoted statistic to measure benefit in studies, it does not provide the reader with the full scope of the treatment effect since it represents the benefit at but a single instant in time, rather than throughout the overall duration of therapy as the study was designed.
For the record:
12:00 a.m. Dec. 9, 2005 For The Record
Los Angeles Times Friday December 09, 2005 Home Edition Main News Part A Page 2 National Desk 2 inches; 75 words Type of Material: Correction
Genentech letter -- A letter in the Sunday Business section from Dr. Hal Barron, chief medical officer and senior vice president of development for Genentech Inc., about a study of the effectiveness of the drug Tarceva against pancreatic cancer, was edited to indicate that the trial’s primary goal was to improve the overall rate of survival after one year. Genentech, however, said that the goal of improving survival was not limited to a one-year period.
For The Record
Los Angeles Times Sunday December 11, 2005 Home Edition Business Part C Page 2 Business Desk 2 inches; 73 words Type of Material: Correction
Genentech -- A letter that ran Dec. 4 from Dr. Hal Barron, chief medical officer and senior vice president of development for Genentech Inc., about a study of the effectiveness of the drug Tarceva against pancreatic cancer, was edited to indicate that the trial’s primary goal was to improve the overall rate of survival after one year. Genentech, however, said that the goal of improving survival was not limited to a one-year period.
In the Tarceva Phase 3 study, the primary goal was to improve the overall rate of survival after one year, as measured across all 569 patients in the trial.
In our study, only 19% of the patients who received chemotherapy survived for one year, compared with 24% of patients who also received Tarceva.
One must view this improvement in the context of a disease in which only about 4% of patients are expected to live five years after their diagnosis.
Dr. Hal Barron
Chief Medical Officer
Senior Vice President,
Development
Genentech
South San Francisco
