Herceptin Study out of California

snowyday

Can anyone help me fiquire out these numbers in this study. It does look like good news.

Trastuzumab Beneficial After Progression in HER2-Positive Metastatic Breast Cancer Elsevier Global Medical News. 2009 Jan 8, K WachterSAN ANTONIO (EGMN) - Trastuzumab appears to improve survival after disease progression in patients with HER2-positive metastatic breast cancer, according to an analysis of data from more than 1,000 patients enrolled in the registHER observational study.The unadjusted hazard ratio comparing survival beyond progression in patients receiving trastuzumab (Herceptin) at any time after first progression with those who did not receive the drug after progression was 0.25 (95% confidence interval, 0.19-0.33). This finding suggests improved survival beyond progression in patients on trastuzumab, Dr. Hope S. Rugo and her coinvestigators reported in a poster at the San Antonio Breast Cancer Symposium.The adjusted hazard ratio, based on a multivariate analysis that included significant predictors of survival, was 0.23 (95% CI, 0.17-0.31)."These registHER data suggest that patients who continued use of trastuzumab following progression on a trastuzumab-containing first-line regimen had reduced risk of death and a longer survival [than did] patients who did not," wrote Dr. Rugo, director of the breast oncology clinical trials program at the University of California, San Francisco, and her colleagues.The study was supported in part by Genentech Inc., which makes Herceptin. Dr. Rugo reported that she has received grant support from Genentech. Several of her coinvestigators are employed by the company.The study includes men and women with newly diagnosed (in the last 6 months) HER2-positive metastatic breast cancer who were recruited between December 2003 and February 2006. Treatments for metastatic breast cancer were administered according to the standard of care by the treating physician. First-line regimens consisted of therapies received before the first disease progression; second-line therapies were those received between first and second progressions. Tumor progression was determined according to physician-reported assessments of radiologic and clinical data.A total of 1,023 patients had enrolled in the study by January 2008. At that time, almost half (48%) of the patients remained in the study; 44% had died and the remainder were lost to follow-up. Median follow-up from metastatic diagnosis was 25 months. Almost all (96%) of the patients had known hormone-receptor (HR) status at the time metastatic disease was diagnosed. Slightly more than half (55%) were HR positive.In all, 1,011 patients received systemic treatment for metastatic disease. Most (87%) of these patients received trastuzumab as part of a first-line regimen. For 86% (754 out of 879 of such patients), first-line trastuzumab was received in combination with chemotherapy, with or without endocrine therapy.A total of 685 patients who were receiving trastuzumab as part of first-line therapy experienced disease progression. Most (79%) of these were treated with trastuzumab as part of second-line therapy. A total of 420 patients who were treated with trastuzumab as part of first- or second-line therapy experienced a second progression of disease. Of these, 83% received additional trastuzumab in a third or later line of therapy.Median overall survival from metastatic disease diagnosis was 35 months for all patients. For patients who received trastuzumab as part of first-line therapy, median overall survival was 35.9 months, compared with 31.4 months for those who did not receive it as first-line therapy.Median progression-free survival from metastatic disease diagnosis was 10.2 months for the whole cohort. Progression-free survival was 11 months for those who received first-line trastuzumab, compared with 5.4 months for those who did not get the drug as first-line therapy.For 653 patients who received at least 21 days of trastuzumab before first progression, the researchers evaluated clinical and first-line treatment factors that may have played a role in whether a patient received trastuzumab in a subsequent treatment regimen. Patients who received trastuzumab beyond first progression were generally younger than age 50 years, nonwhite, and HR positive, and they had fewer cardiac morbidities (see graphic).Lapatinib (Tykerb) was approved in March 2007, which allowed some data on lapatinib use from this data set. Of 527 patients who were treated with trastuzumab following progression after first-line therapy, 23% also received lapatinib following first progression. Most (106) of these patients received lapatinib as third-line therapy. Of 115 patients who were not treated with trastuzumab following progression after first-line therapy, 15% received lapatinib after first progression.Trastuzumab is approved for the adjuvant treatment of HER2-overexpressing, node-positive, or node-negative breast cancer. It is also approved for use in combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer. As a single agent, the drug is approved for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

click for full imageFactors Linked With Trastuzumab Therapy After First Progression