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| |  Letrozole/Trastuzumab Superior to Letrozole Alone for Patients With Both HR+, HER2+ Metastatic Breast Cancer: Presented at SABCS By Jennifer Reising SAN ANTONIO, Tex -- December 15, 2009 -- The combination of letrozole and trastuzumab is safe and superior, compared with letrozole monotherapy as first-line treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive and hormone receptive (HR)-positive metastatic breast cancer. “[Our] trial confirms recent studies that have shown a greater benefit of adding [trastuzumab] to aromatase inhibitors instead of using an aromatase inhibitor by itself,” said Jens Huober, MD, Kantonsspital St. Gallen, St. Gallen, Switzerland, and the University of Zurich, Zurich, Switzerland, on December 12 at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). The international, multicentre study enrolled 92 women with both HER2-positive and HR-positive metastatic breast cancer from 2003 to 2007. Patients were randomised to either letrozole monotherapy (arm A; n = 31) or letrozole plus trastuzumab (arm B; n = 26) as first-line treatment. In addition, 35 patients with both HER2-negative and HR-positive tumours were assigned to receive letrozole alone as first-line treatment (arm C). The primary endpoint of the study was time to progression (TTP) and secondary endpoints were overall response rate (ORR) and clinical benefit rate (CBR). Median TTP in arm A was 3.3 months, compared with 14.1 in combination arm B (P = .23) and 15.2 months for arm C (P = .03). The CBR was 39% for arm A, compared with 65% for arm B (P = .0636) and 77% in arm C (P = .0024 for arm A vs C). The ORR was 13% for arm A, 27% for the combination group, and 11% for arm C. Left ventricular ejection fraction was used as a cardiac safety parameter and showed no change from baseline to the minimum value during the treatment for arms A and C, and a slight decrease by 5% in arm B. Other cardiac adverse events were comparable in all arms (10%, 8%, and 9%, respectively). GI disorders or musculoskeletal and connective tissue disorders were slightly more frequent for patients in arm B. The study shows that aromatase-inhibitor therapy alone has a relatively short TTP of 3.3 months, while the combination of letrozole and trastuzumab has a TTP that is 10.8 months longer (14.1 months) in patients with HER2-positive and HR-positive metastatic breast cancer. [Presentation title: Letrozole in Combination With Trastuzumab Is Superior to Letrozole Monotherapy as First-Line Treatment in Patients With Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer (MBC) – Results of the eLEcTRA Trial. Abstract 4094]
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