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| |  BREAST CANCER: Navelbine Plus Herceptin Promising For Metastatic Breast Cancer SAN ANTONIO, TX -- December 10, 1999 -- Preliminary data from a Phase II, single institution trial presented at the 22nd Annual San Antonio Breast Cancer Symposium discussed the potential role of Navelbine(R) (vinorelbine tartrate) Injection and Herceptin(R) (trastuzumab) therapy in the treatment of women with HER2 positive metastatic breast cancer.
The study, sponsored by Genentech, Inc., the maker of Herceptin, was conducted at Dana-Farber Cancer Institute in Boston to assess the safety and efficacy of this combination. The study population included patients who presented with measurable disease and Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to two. At the time of this presentation, 34 of 40 patients were evaluable. Fifty-six percent of these patients had received prior chemotherapy in the adjuvant setting, 62 percent in the metastatic setting and 12 percent had received no prior chemotherapy. The chemotherapy regimens included anthracyclines, 62 percent; taxanes, and both anthracyclines and taxanes, 43 percent. In addition, 12 percent of patients had received a prior bone marrow transplant. No patients received prior Herceptin. To date, treatment has been well tolerated with neutropenia as the only grade 3 or 4 toxicity reported (30 percent), and this has been managed without growth factor support. Only one patient experienced febrile neutropenia. Three patients experienced decreases in Ejection Fraction (EF) greater than 15 percent and/or to less than 50 percent. The overall response rate was 71 percent (24/34) of patients; all partial responses (PR). Activity was reported regardless of prior chemotherapy for metastatic disease (first-line PR = 77 percent, second-line PR = 60 percent, and third-line PR = 83 percent). These preliminary data suggest promising activity with favorable tolerability between Navelbine and Herceptin in HER2 positive metastatic breast cancer and warrant confirmation with further studies. Navelbine, which is available in the United States from Glaxo Wellcome Inc., is not indicated for the treatment of advanced breast cancer. Navelbine Injection is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC). In clinical trials to date, granulocytopenia is the major dose-limiting toxicity with Navelbine, although it has been generally reversible and not cumulative over time. Administration of Navelbine is contraindicated in patients with pretreatment granulocyte counts of less than 1000 cells/mm(3). Patients treated with Navelbine should be frequently monitored for myelosuppression during and after therapy. In North American clinical trials with single-agent Navelbine, nonhemataologic toxicities were usually mild or moderate and included injection-site reactions (38 percent), nausea (34 percent), vomiting (15 percent), constipation (29 percent), fatigue (27 percent), peripheral neuropathy (20 percent), diarrhea (13 percent), and alopecia (12 percent).
Related Link: Navelbine (vinorelbine tartrate), Genentech, Inc. and Glaxo Wellcome Inc.
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