Palbociclib or Ribociclib in First-Line Treatment in Patients With Hormone Receptor–Positive/Human Epidermal Receptor 2–Negative Advanced or Metastatic Breast Cancer? A Perspective Based on Pharmacologic Costs
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Palbociclib
Lapatinib
We report the case of a 72‒year‒old woman with ER(+), PgR(+), HER2(-)metastatic breast cancer with liver involvement. The patient received palbociclib(125 mg daily po 3 weeks on/1 week off)and fulvestrant(500 mg im on days 1, 15, and 29, and once monthly thereafter)as second‒line endocrine therapy. Her metastatic liver lesions initially decreased in size and the tumor‒marker CA15‒3 level decreased. However, they progressed after seven months of therapy. She was subsequently switched to abemaciclib(150 mg twice/daily po)with fulvestrant as third‒line therapy, resulting in a decrease in the same liver lesions. She has continued treatment for 12 months. Based on this case, abemaciclib may be clinically useful for breast cancer that is not responsive or has become resistant to palbociclib, another selective CDK4/6 inhibitor.
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Upon disease progression on trastuzumab-based therapy, patients with HER-2 positive metastatic breast cancer (MBC) may switch to lapatinib or continue on trastuzumab. We aimed to assess the impact of both strategies on overall survival (OS) in all patients treated for HER-2 positive MBC at the Medical University Vienna from 1999 until 2009. A total of 201 patients were identified from a breast cancer data base. Of these 115 (57.2%) received multiple lines of trastuzumab-based therapy, whereas 58 (28.9%) were treated with a single line. A control group of 28 patients (13.9%) had never received trastuzumab as they were treated before 1999, when trastuzumab was registered. OS from diagnosis of metastatic disease was defined as primary study endpoint. Trastuzumab significantly prolonged OS in HER-2 positive MBC (41 versus 13 months; p < 0.001). Administration of multiple lines further improved OS; this, however, did not reach statistical significance (47 versus 28 months; p = 0.069). Positive estrogen receptor (ER) status (HR 1.6; 95% CI 1.13-2.27) was associated with better outcome compared to negative estrogen receptor status (p = 0.02). Addition of lapatinib did not improve OS significantly in patients with prior trastuzumab-based therapy (62 versus 47 months; p = n.s.). Patients receiving lapatinib after diagnosis of BM, however, experienced an improvement of OS (22 versus 5 months; p = 0.022). Trastuzumab improves OS in patients with HER-2 positive MBC with further nonsignificant improvement when administered in multiple lines. Lapatinib did not further improve OS in the entire population; however, lapatinib might improve OS in patients with BM.
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First-line therapy with lapatinib in the advanced/metastatic breast cancer setting was assessed in two phase III trials. Progression-free survival was improved by about 5 months in HER2 and hormone receptor positive women but similar data for gains in overall survival are still missing. Hence, it seems that the primary benefit of orally administered lapatinib is the potential of delaying more aggressive therapies with considerable toxicities in a well-defined hormone receptor/HER2 positive population.
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Lapatinib, an oral dual ErbB1/2 tyrosine kinase inhibitor, is effective in the treatment of metastatic breast cancer that has progressed after trastuzumab-based first-line chemotherapy. Moreover, lapatinib has been found to be effective in patients with metastatic brain involvement. Here we report the case of a 55-year-old woman with metastatic breast cancer and brain metastasis who achieved rapid symptom improvement and long-term disease control.
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Role of lapatinib in the first-line treatment of patients with metastatic breast cancer Catherine Oakman, Marta Pestrin, Elena Zafarana, Egidia Cantisani, Angelo Di Leo"Sandro Pitigliani" Medical Oncology Unit, Hospital of Prato, Istituto Toscano Tumori, Piazza Ospedale 2, 59100, Prato, ItalyAbstract: Lapatinib is a dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR/ErbB1) and human epidermal growth factor receptor 2 (HER2/ErbB2). EGFR and HER2 overexpression is associated with aggressive breast cancer with a high risk of disease relapse and death. Although lapatinib targets both EGFR and HER2, its effects on HER2 appear to be more critical. The role of lapatinib in the first-line setting remains unclear. A phase II first-line monotherapy lapatinib trial in HER2-therapy-naïve metastatic breast cancer (MBC) patients confirms efficacy in HER2-positive tumors. Retrospective analysis of a phase III, first-line MBC study confirmed incremental benefit from lapatinib and paclitaxel over paclitaxel alone in HER2-positive disease. A prospective phase III study confirms superiority of letrozole and lapatinib over letrozole alone in HER2-positive MBC. Further investigation is required to define the potential first-line role for lapatinib. Particular strengths appear to be its manageable toxicity profile, lack of cross resistance with trastuzumab, activity in central nervous system disease, and synergy in combination with other anticancer therapy. Current limitations are lack of dosing recommendations from early trials, lack of predictive biomarkers beyond HER2 status, and lack of large prospective phase III trials for HER2-positive disease in the first-line setting. The role of lapatinib in HER2-negative disease is unclear.Keywords: lapatinib, HER2, metastatic, first-line
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Fulvestrant
Exemestane
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According to the World Health Organization, breast cancer is the most common form of cancer in women worldwide.The steady increase in the prevalence of breast cancer, followed by an increase in the state budget expenditures on drug supply for this category of patients, determines the relevance of pharmacoeconomic evaluation of treatment of HER2-positive breast cancer using a combination of lapatinib and capecitabine and trastuzumab emtansine monotherapy.A subgroup analysis of the therapeutic outcomes in patients with HER2+ breast cancer conducted by the EMILIA study failed to find a statistically significant difference in median overall survival in patients receiving either trastuzumab emtansine or a combination of lapatinib and capecitabine as second-line treatment, or in patients with non-visceral metastases.Analysis of overall survival of the entire population of patients in the EMILIA study revealed that trastuzumab emtansine is more effective than a combination of lapatinib and capecitabine.Despite this, NICE does not recommend treatment with trastuzumab emtansine due to high cost of treatment.The EMILIA study results were used as a basis for pharmacoeconomic models for HER2+ breast cancer therapy, using such methods of pharmacoeconomic analysis as budget impact analysis, cost-effectiveness analysis, and costminimization analysis for these subgroups of patients.Result of budget impact analysis revealed that the use of the lapatinib and capecitabine combination can reduce health system expenditures by 3,985,271 rubles per patient per year or by 5,851,484 rubles over three years per one patient, which allows treating 4 additional patients given the fixed budget.Cost-effectiveness ratio of lapatinib + capecitabine equals to 869,705 rubles and 3,461,960 rubles with LYG and QALY as efficacy endpoints, respectively, which identifies this therapy as cost-effective in pharmacoeconomic terms.Cost-minimization analysis of lapatinib+capecitabine patient groups in the second-line treatment, and a group of patients with non-visceral metastases showed that the use of this treatment may reduce costs by 78% in comparison with trastuzumab emtansine.
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Lapatinib, an oral dual ErbB1/2 tyrosine kinase inhibitor, is effective in the treatment of metastatic breast cancer that has progressed after trastuzumab-based first-line chemotherapy. Moreover, lapatinib has been found to be effective in patients with metastatic brain involvement. Here we report the case of a 55-year-old woman with metastatic breast cancer and brain metastasis who achieved rapid symptom improvement and long-term disease control.
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Cyclin-dependent kinase 4
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