scholarly journals Tucatinib (Tukysa)

2021 ◽  
Vol 1 (11) ◽  
Author(s):  
Reimbursement Team
Keyword(s):  
Breast Cancer ◽  
Growth Factor Receptor ◽  
Trastuzumab Emtansine ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Previously Treated ◽  
Epidermal Growth ◽  
The Cost ◽  
Public Drug ◽  
Positive Breast Cancer

CADTH recommends that Tukysa should be reimbursed by public drug plans for the treatment of patients with advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or is metastatic, including patients with brain metastases, if certain conditions are met. Tukysa should only be reimbursed if prescribed in combination with trastuzumab-capecitabine and the cost of Tukysa is reduced. Tukysa should only be covered to treat patients who have been previously treated for HER2-positive breast cancer with trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1).

scholarly journals Anthracycline-containing versus carboplatin-containing neoadjuvant chemotherapy in combination with trastuzumab for HER2-positive breast cancer: the neoCARH phase II randomized clinical trial

2021 ◽  
Vol 13 ◽  
pp. 175883592110090
Author(s):  
Hong-Fei Gao ◽  
Zhiyong Wu ◽  
Ying Lin ◽  
Xiang-Yang Song ◽  
Yin Cao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Primary Endpoint ◽  
Growth Factor Receptor ◽  
Group Versus ◽  
Complete Response ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Epidermal Growth ◽  
Positive Breast Cancer

Background: Although dual blockade HER2-based neoadjuvant chemotherapy is associated with excellent outcomes for human epidermal growth factor receptor 2 (HER2)-positive breast cancer, pertuzumab is not available to all patients due to cost. The optimal neoadjuvant chemotherapy for HER2-positive breast cancer in the presence of a single HER2 blockade is unknown. This study aimed to compare the efficacy and safety of epirubicin/cyclophosphamide followed by docetaxel/trastuzumab (EC-TH) with docetaxel/carboplatin/trastuzumab (TCH) neoadjuvant setting for HER2-positive breast cancer under the single HER2 blockade. Methods: Patients with stage II-IIIC HER2-positive breast cancer were randomly assigned to either eight cycles of EC-TH every 3 weeks during all chemotherapy cycles, or six cycles of TCH every 3 weeks. The primary endpoint was pathological complete response (pCR) (defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0). Results: From May 2017 to November 2019, 140 patients were randomly assigned, and 135 patients were ultimately found evaluable for the primary endpoint. The pCR was recorded in 25 of 67 patients [37.3%; 95% confidence interval (CI), 25.8–50.0] in the EC-TH group and in 38 of 68 patients (55.9%, 95% CI, 43.3–67.9) in the TCH group ( p = 0.032). The most common adverse events (AEs) were neutropenia in 24 of 67 (35.8%) patients in the EC-TH group versus 27 of 68 (39.7%) in the TCH group ( p = 0.642), anemia in 33 of 67 (49.3%) patients in the EC-TH group versus 34 of 68 (50.0%) in the TCH group ( p = 0.931), and thrombocytopenia in five of 67 (7.5%) patients in the EC-TH group versus 17 of 68 (25.0%) in the TCH group ( p = 0.006). Conclusion: For patients receiving the single HER2 blockade trastuzumab for HER2-positive breast cancer, TCH regimen might be a preferred neoadjuvant therapy. Trial registration: This trial was registered with ClinicalTrials.gov identifier: NCT03140553) on 2 May 2017.

scholarly journals Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases

2016 ◽  
Vol 34 (9) ◽  
pp. 945-952 ◽  
Author(s):  
Rachel A. Freedman ◽  
Rebecca S. Gelman ◽  
Jeffrey S. Wefel ◽  
Michelle E. Melisko ◽  
Kenneth R. Hess ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Brain Metastases ◽  
Objective Response ◽  
Growth Factor Receptor ◽  
Whole Brain Radiotherapy ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Brain Radiotherapy ◽  
Epidermal Growth ◽  
Positive Breast Cancer

Purpose Evidence-based treatments for metastatic, human epidermal growth factor receptor 2 (HER2)–positive breast cancer in the CNS are limited. Neratinib is an irreversible inhibitor of erbB1, HER2, and erbB4, with promising activity in HER2-positive breast cancer; however, its activity in the CNS is unknown. We evaluated the efficacy of treatment with neratinib in patients with HER2-positive breast cancer brain metastases in a multicenter, phase II open-label trial. Patients and Methods Eligible patients were those with HER2-positive brain metastases (≥ 1 cm in longest dimension) who experienced progression in the CNS after one or more line of CNS-directed therapy, such as whole-brain radiotherapy, stereotactic radiosurgery, and/or surgical resection. Patients received neratinib 240 mg orally once per day, and tumors were assessed every two cycles. The primary endpoint was composite CNS objective response rate (ORR), requiring all of the following: ≥50% reduction in volumetric sum of target CNS lesions and no progression of non-target lesions, new lesions, escalating corticosteroids, progressive neurologic signs/symptoms, or non-CNS progression—the threshold for success was five of 40 responders. Results Forty patients were enrolled between February 2012 and June 2013; 78% of patients had previous whole-brain radiotherapy. Three women achieved a partial response (CNS objective response rate, 8%; 95% CI, 2% to 22%). The median number of cycles received was two (range, one to seven cycles), with a median progression-free survival of 1.9 months. Five women received six or more cycles. The most common grade ≥ 3 event was diarrhea (occurring in 21% of patients taking prespecified loperamide prophylaxis and 28% of those without prophylaxis). Patients in the study experienced a decreased quality of life over time. Conclusion Although neratinib had low activity and did not meet our threshold for success, 12.5% of patients received six or more cycles. Studies combining neratinib with chemotherapy in patients with CNS disease are ongoing.

scholarly journals Cost-Effectiveness Analysis of Trastuzumab Emtansine as Second-Line Therapy for HER2 Positive Breast Cancer in China

2020 ◽  
Author(s):  
Huahua Zhang ◽  
Yandong Zhang ◽  
Chaonan Huang ◽  
Jiangfeng Wang
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Trastuzumab Emtansine ◽  
Second Line ◽  
Her2 Positive ◽  
Second Line Therapy ◽  
Her2 Positive Breast Cancer ◽  
Line Therapy ◽  
The Cost ◽  
Positive Breast Cancer

Abstract ObjectiveTo evaluate the cost-effectiveness of trastuzumab emtansine (T-DM1) as the second-line treatment for patients with human epidermal growth factor receptor-2 (HER2) positive breast cancer from the Chinese healthcare perspective. Capecitabine (Cap), capecitabine + lapatinib (Cap+Lap), capecitabine + trastuzumab (Cap+Tra), capecitabine + trastuzumab + pertuzumab (Cap+Tra+Pre) were selected as comparators.MethodsA three-state Markov simulation model was performed. The state transition probabilities were estimated based on the results of a published network meta-analysis, and utilities were derived from the published literature. The costs populated in the model were acquired from the local charge or previously published studies. Univariate sensitive analysis and probabilistic sensitivity analyses were performed to test the robustness of the results.ResultsTreatment with T-DM1 was estimated to increase the cost by $109,683.7, $106,003.7, $94,212.2, and $63,214.9, and yield a gain of 0.544 quality-adjusted life years (QALYs), 0.383 QALYs, 0.367 QALYs, 0.087 QALYs in comparison with Cap, Cap+Lap, Cap+Tra, and Cap+Tra+Pre, respectively. Corresponding incremental cost-effectiveness ratios (ICERs) were $201,624.4, $276,772.1, $256,709.0, and $726,608.0 per QALY. The probabilities of T-DM1 as the dominant option were 0% at the WTP threshold of $30,829.3/QALY.ConclusionsT-DM1, as second-line therapy in the treatment of HER2 positive breast cancer, is not a cost-effective option in China. Given the significant clinical efficacy, an appropriate price reduction of T-DM1 is required to benefit more HER2 positive breast cancer patients.

scholarly journals Nanotechnology approaches to addressing HER2-positive breast cancer

2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Bryan E. White ◽  
Molly K. White ◽  
Het Adhvaryu ◽  
Issam Makhoul ◽  
Zeid A. Nima ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Growth Factor Receptor ◽  
The United States ◽  
Breast Cancers ◽  
Specific Design ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Epidermal Growth ◽  
Growth Promoting ◽  
Positive Breast Cancer

Abstract Breast cancer is a major cause of cancer-associated deaths in the United States. It was estimated that 12% of women in the U.S. will develop invasive breast cancer in their lifetime. The human epidermal growth factor receptor (HER2/neu) is a growth-promoting protein that is overexpressed in 15–20% of breast cancers (HER2-positive breast cancer). HER2-positive breast cancer generally grows and spreads more quickly than other breast cancers, but it can be targeted therapeutically. Targeting drugs have been developed with a specific design to stop the growth and even the spread of cancer. These drugs include trastuzumab (Herceptin), pertuzumab (Perjeta), ado-trastuzumab emtansine (Kadcyla, or TDM-1), fam-trastuzumab deruxtecan, lapatinib, neratinib and tucatinib. However, the need for better targeted therapy and efficacy still exists. Nanotechnology could have major advantages in terms of detection, targeting, drug delivery, and destruction of cancer cells and tumors. Although a great deal of progress has been accomplished major challenges still need to be addressed. In this review, we examine the major areas of research in the area of nanotechnology and HER2-positive breast cancer.

Pertuzumab for the treatment of human epidermal growth factor receptor type 2-positive metastatic breast cancer

2013 ◽  
Vol 70 (18) ◽  
pp. 1579-1587 ◽  
Author(s):  
Clement Chung ◽  
Masha S. H. Lam
Keyword(s):  
Breast Cancer ◽  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Growth Factor Receptor ◽  
First Line ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Epidermal Growth ◽  
Positive Breast Cancer

Abstract Purpose The pharmacology, pharmacokinetics, clinical efficacy, safety, and administration of pertuzumab in patients with metastatic human epidermal growth factor receptor type 2 (HER2)-positive breast cancer are reviewed. Summary Disease progression in HER2-positive breast cancer is often due to resistance to or a lack of efficacy of trastuzumab-based anti-HER2 therapy. Pertuzumab is the first humanized monoclonal antibody in a new class of drugs, the HER dimerization inhibitors, approved by the Food and Drug Administration for the first-line treatment of patients with metastatic HER2-positive breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Since pertuzumab binds to a different epitope than trastuzumab, combination therapy with pertuzumab and trastuzumab results in a more complete blockade of HER2 signaling than trastuzumab monotherapy. The efficacy of adding pertuzumab to trastuzumab–docetaxel dual therapy was demonstrated in a pivotal randomized multicenter Phase III trial, which showed a significant benefit in terms of progression-free survival, with improved overall survival, in favor of the triple therapy as an initial regimen in treatment-naive patients with metastatic HER2-positive breast cancer. The combination of pertuzumab and trastuzumab has been found to have a tolerable toxicity profile. As clinical trials of pertuzumab for adjuvant, neoadjuvant, and metastatic-disease treatment continue, its role in the treatment of HER2-positive breast cancer will continue to evolve. Conclusion Pertuzumab, a novel HER2 dimerization inhibitor, has been shown to be effective in the treatment of metastatic HER2-positive breast cancer when used in combination with trastuzumab and docetaxel and is recommended for first-line therapy.

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