WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, AND PULMONARY TOXICITY
Cardiomyopathy
Herceptin can result in sub‑clinical and clinical cardiac failure manifesting as CHF and decreased LVEF. The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracycline containing chemotherapy regimens.
Evaluate left ventricular function in all patients prior to and during treatment with Herceptin. Discontinue Herceptin treatment in patients receiving adjuvant therapy and strongly consider discontinuation of Herceptin treatment in patients with metastatic breast cancer for clinically significant decrease in left ventricular function. [ see Warnings and Precautions (5.1) and Dosage and Administration (2.2) ]
Infusion Reactions; Pulmonary Toxicity
Herceptin administration can result in serious infusion reactions and pulmonary toxicity. Fatal infusion reactions have been reported. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [ see Warnings and Precautions (5.2, 5.4) ]
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NEWS HIGHLIGHTSMedia Articles Related to Herceptin (Trastuzumab)
Routine Testing Would Improve Herceptin Use in Breast Cancer
Source: MedicineNet trastuzumab Specialty [2009.09.14]
Title: Routine Testing Would Improve Herceptin Use in Breast Cancer
Category: Health News
Created: 9/14/2009 8:10:00 AM
Last Editorial Review: 9/14/2009
Columnists, Cancer Groups Weigh In On Breast Cancer Screening Recommendations
Source: Health News from Medical News Today [2009.11.23]
Several newspapers recently published opinion pieces regarding recent recommendations by the U.S. Preventive Services Task Force that recommend mammograms every two years for most women starting at age 50, rather than at age 40 as previously recommended. The recommendations also say that doctors should not instruct women on breast self-examinations. Summaries of the opinion pieces appear below.
FISH Technology Preferred For Choosing HER-2-Positive Breast Cancer Treatments
Source: Breast Cancer News From Medical News Today [2009.11.22]
The debate on how to select patients who will respond best to costly drug treatments for aggressive breast cancer now favors fluorescence in situ hybridization (FISH) to measure the HER-2 receptor found in human breast tumors, according to a leading pathologist presenting at the Association for Molecular Pathology annual meeting. Michael Press, M.D., Ph.D., pathologist and Harold E.
Secretary Sebelius Statement On New Breast Cancer Recommendations
Source: Breast Cancer News From Medical News Today [2009.11.19]
HHS Secretary Kathleen Sebelius issued the following statement today on new breast cancer screening recommendations from the U.S. Preventive Services Task Force: "There is no question that the U.S. Preventive Services Task Force Recommendations have caused a great deal of confusion and worry among women and their families across this country. I want to address that confusion head on. The U.S.
Some Physicians Say New Breast Cancer Screening Guidelines Unlikely To Alter Their Practices
Source: Breast Cancer News From Medical News Today [2009.11.19]
One day after the release of new breast cancer screening guidelines, many physicians and some medical groups are saying that they do not plan to adopt the new recommendations -- which represent a drastic change -- the New York Times reports (Belluck, New York Times, 11/18). The guidelines, released by the U.S.
Published Studies Related to Herceptin (Trastuzumab)
Disease-free survival according to degree of HER2 amplification for patients treated with adjuvant chemotherapy with or without 1 year of trastuzumab: the HERA Trial. [2009.06.20]
PURPOSE: To determine whether (1) immunohistochemical (IHC) HER2 status (ie, 2+ or 3+), (2) degree of fluorescence in situ hybridization (FISH) amplification according to (2a) HER2/CEP17 ratio or (2b) HER2 gene copy number, or (3) polysomy significantly influenced clinical outcome for patients with human epidermal growth factor receptor 2 (HER2) -positive breast cancer enrolled in the Herceptin Adjuvant trial of trastuzumab versus no trastuzumab administered after completion of chemotherapy... CONCLUSION: There was no evidence for reduced benefit of trastuzumab in HER2 IHC2+FISH+ cases. The degree of HER2 amplification does not influence prognosis or benefit from adjuvant trastuzumab in patients treated with prior adjuvant chemotherapy.
Radiotherapy and adjuvant trastuzumab in operable breast cancer: tolerability and adverse event data from the NCCTG Phase III Trial N9831. [2009.06.01]
PURPOSE: To assess whether trastuzumab (H) with radiotherapy (RT) increases adverse events (AEs) after breast-conserving surgery or mastectomy... CONCLUSION: Concurrent adjuvant RT and H for early-stage BC was not associated with increased acute AEs. Further follow-up is required to assess late AEs.
Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a german breast group 26/breast international group 03-05 study. [2009.04.20]
PURPOSE: Trastuzumab shows clinical activity in human epidermal growth factor receptor 2 (HER-2)-positive early and advanced breast cancer. In the German Breast Group 26/Breast International Group 03-05 trial, we investigated if trastuzumab treatment should be continued beyond progression... CONCLUSION: Continuation of trastuzumab plus capecitabine showed a significant improvement in overall response and time to progression compared with capecitabine alone in women with HER-2-positive breast cancer who experienced progression during trastuzumab treatment.
A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. [2008.12]
PURPOSE: Lapatinib is a small molecule, dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor type 2 (HER2). Initial results of a phase III trial demonstrated that lapatinib plus capecitabine is superior to capecitabine alone in women with HER2-positive advanced breast cancer that progressed following prior therapy including trastuzumab. Updated efficacy and initial biomarker results from this trial are reported... CONCLUSION: The addition of lapatinib to capecitabine provides superior efficacy for women with HER2-positive, advanced breast cancer progressing after treatment with anthracycline-, taxane-, and trastuzumab-based therapy. Biomarker studies could not identify a subgroup of patients who failed to benefit from the addition of lapatinib to capecitabine.
The model-based cost-effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data. [2008.06]
Background Several randomized controlled trials have confirmed the usefulness of trastuzumab as an adjuvant therapy for HER2-overexpressed breast cancer patients; however, the costs for 1-year treatment are high. Therefore, we performed an economic analysis regarding the efficient distribution of medical resources...
Clinical Trials Related to Herceptin (Trastuzumab)
Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer [Active, not recruiting]
Purpose: The purpose of this study is to evaluate the efficacy and safety of treatment with
trastuzumab (Herceptin) along with the three other chemotherapy drugs, paclitaxel,
carboplatin and gemcitabine, in patients who have advanced urothelial cancer. This clinical
trial will also collect information (alternative therapy, response rates, overall survival)
from enrolled patients with HER2 negative tumors who are ineligible to receive study
treatment.
Faslodex and Herceptin, Alone and Combined [Recruiting]
The purpose of this study is to evaluate the the relative anti-tumor efficacy of combined Faslodex and Herceptin therapy as compared with that of Faslodex or Herceptin given alone for first-line treatment in patients with metastatic breast cancer.
Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer [Completed]
The purpose of this study is to compare two different combinations of chemotherapy with
trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the
patients will receive trastuzumab in combination with a taxane form of chemotherapy (either
paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with
vinorelbine.
Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients [Completed]
Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood
[disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively] of otherwise
metastases-free patients with early breast cancer. Several studies have shown that the
presence of these cells is an independent factor associated with an increased incidence of
early disease relapse and disease-related death. In almost 50% of the patients, adjuvant
chemotherapy cannot eliminate these occult tumor cells and this is also associated with a
higher probability of early relapse and death. In 60-70% of the patients, DTCs and/or CTCs
express the HER2/c-neu molecule and one or two administrations of their monoclonal antibody
trastuzumab (HERCEPTIN) could eliminate these cells for a period ranging from 3-12 months.
Preoperative Herceptin and Navelbine for Breast Cancer [Active, not recruiting]
The purpose of this study is to find out what effects the preoperative combination therapy of
herceptin and navelbine have on HER-2 positive breast cancer.
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