Women with a particularly aggressive form of early stage (primary) breast cancer may miss out on optimal treatment which may include chemotherapy and trastuzumab (Herceptin)
as a result of untimely or missing HER2-status test results, according
to doctors responding to the results from a North of England Cancer
Network audit of HER2-testing today.
Women with early stage HER2-positive breast cancer are at double the risk of their cancer returning during the first few years after diagnosis, when they do not receive adjuvant trastuzumab with their chemotherapy, according to trials involving over 13,000 women.[i],[ii],[iii],[iv] This risk is even higher when women with HER2-positive cancer do not receive chemotherapy treatment.
Only one quarter (26%) of 200 clinicians said that HER2 test results were routinely available at the time when a decision is being made about whether a patient will benefit from chemotherapy together with the HER2-targeted treatment trastuzumab (i.e. greater than 75% of the time) - during what is called the 'multi-disciplinary team meeting' (MDTM)[v], according to the results of the North of England Cancer Network audit. The results were presented at the 2008 annual conference of the National Cancer Research Institute.
Dr Mark Verrill, Consultant Oncologist, Newcastle General Hospital said, "For women with early stage HER2-positive breast cancer, chemotherapy with trastuzumab offers patients the best chance of a cure. Without failsafe mechanisms in place to ensure that HER2 status is known, there is a chance that women who may benefit from this treatment will not receive it, putting them at significantly greater risk of their cancer coming back during the first few years after diagnosis.''
Dr Alison Jones, Consultant Oncologist, Royal Free Hospital, London adds, ''Clinicians and patients must have access to all the information about their cancer in a timely fashion so that the best decision about treatment can be made for the patient. We must have the infrastructure in place to do this."
HER2-positive breast cancer is a distinct form of breast cancer that demands attention because HER2-positive tumours are fast growing and are associated with poor prognosis and a high chance of relapse. It is thought that about 1 in 5 women with breast cancer will have HER2-positive tumours.[vi]
The Department of Health estimates 1,000 patient lives will potentially be saved per year if all eligible patients with early stage (adjuvant) HER2-positive breast cancer are treated adjuvantly with trastuzumab.[vii]
It is almost three years to the day since former Health Secretary Patricia Hewitt announced that all women should receive a HER2 status test on diagnosis of breast cancer to identify in good time whether they are eligible for trastuzumab treatment. 7
Results from the North of England Cancer Network audit show that both oestrogen receptor (ER) and HER2 status of the tumour influence treatment decisions made by clinicians. 5
According to 79 percent of clinicians, ER status was routinely (i.e. greater than 75% of the time) available at the MDTM. 5 This compares to 26 per cent of clinicians reporting that HER2 status was routinely available.5
Thirty percent (30%) of clinicians said that HER2 status was rarely (less than 25% of the time) available and missing HER2 results led to extra out-patient visits in 46% of responses. 5
In 2005 more than 45,500 women were diagnosed with breast cancer in the UK.[viii] A recent update to recommendations for HER2 testing in the UK states that HER2 test results at diagnosis of breast cancer should be accurate, reliable, timely and available for the MDTM.[ix]
About treatment of early breast cancer
Women with early stage breast cancer are normally treated with surgery to remove the lump. Sometimes lymph notes in the armpit are also removed.
Radiotherapy is given to help prevent 'local recurrence' or the tumour coming back in the breast.
Chemotherapy (with trastuzumab for HER2-positive breast cancers) is recommended for all but the lowest risk patients to 'mop up' any cancer cells that may have already spread outside the breast.
About trastuzumab
Trastuzumab is the only HER2 targeted treatment with an overall survival benefit for women with HER2 positive breast cancer. Trastuzumab offers thousands of patients diagnosed each year with early stage HER2-positive breast cancer the best chance of a cure4 and enables women to live longer with secondary (metastatic) disease.[x] It has a licence and has been shown to be cost effective in both of these settings.[xi], [xii]
In trials, trastuzumab consistently reduced patient risk of death from early stage HER2- positive breast cancer by about one third4 and risk of the cancer coming back in women by up to a half.1,2,3,4
Like most treatments, trastuzumab is associated with side-effects, the most common of which are mild flu-like symptoms, such as chills and fever during its administration. A clinically important side-effect is the cardiac side-effect experienced by a small number (0.5-4.0%) of patients with early stage HER2 positive breast cancer. 1,3 In the majority of these patients, this effect is of short duration and reversible. Careful monitoring of heart function is recommended during treatment.
Trastuzumab is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. It has demonstrated efficacy in treating both early and advanced (metastatic) breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, trastuzumab has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2- positive breast cancer.
Trastuzumab received approval for use in the European Union for advanced (metastatic) HER2-positive breast cancer in 2000 and for early HER2-positive breast cancer in 2006. In advanced disease, trastuzumab is now approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of postmenopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. In early use, trastuzumab is approved for use following standard (adjuvant) chemotherapy.
Trastuzumab is recommended as a cost-effective option as part of the foundation of care by the National Institute for Health and Clinical Excellence (NICE) in all eligible patients with HER2-positive disease.11,12
Trastuzumab extends survival across all stages of HER2-positive breast cancer by activating the immune system and suppressing the HER2 receptor and preventing HER2 positive cells from growing and dividing.
Trastuzumab is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, trastuzumab has been used to treat more than 450,000 HER2-positive breast cancer patients worldwide.
About Roche in the UK
Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. For a copy of the trastuzumab Summary of Product Characteristics or to find out more please visit www.rocheuk.com.
Women with early stage HER2-positive breast cancer are at double the risk of their cancer returning during the first few years after diagnosis, when they do not receive adjuvant trastuzumab with their chemotherapy, according to trials involving over 13,000 women.[i],[ii],[iii],[iv] This risk is even higher when women with HER2-positive cancer do not receive chemotherapy treatment.
Only one quarter (26%) of 200 clinicians said that HER2 test results were routinely available at the time when a decision is being made about whether a patient will benefit from chemotherapy together with the HER2-targeted treatment trastuzumab (i.e. greater than 75% of the time) - during what is called the 'multi-disciplinary team meeting' (MDTM)[v], according to the results of the North of England Cancer Network audit. The results were presented at the 2008 annual conference of the National Cancer Research Institute.
Dr Mark Verrill, Consultant Oncologist, Newcastle General Hospital said, "For women with early stage HER2-positive breast cancer, chemotherapy with trastuzumab offers patients the best chance of a cure. Without failsafe mechanisms in place to ensure that HER2 status is known, there is a chance that women who may benefit from this treatment will not receive it, putting them at significantly greater risk of their cancer coming back during the first few years after diagnosis.''
Dr Alison Jones, Consultant Oncologist, Royal Free Hospital, London adds, ''Clinicians and patients must have access to all the information about their cancer in a timely fashion so that the best decision about treatment can be made for the patient. We must have the infrastructure in place to do this."
HER2-positive breast cancer is a distinct form of breast cancer that demands attention because HER2-positive tumours are fast growing and are associated with poor prognosis and a high chance of relapse. It is thought that about 1 in 5 women with breast cancer will have HER2-positive tumours.[vi]
The Department of Health estimates 1,000 patient lives will potentially be saved per year if all eligible patients with early stage (adjuvant) HER2-positive breast cancer are treated adjuvantly with trastuzumab.[vii]
It is almost three years to the day since former Health Secretary Patricia Hewitt announced that all women should receive a HER2 status test on diagnosis of breast cancer to identify in good time whether they are eligible for trastuzumab treatment. 7
Results from the North of England Cancer Network audit show that both oestrogen receptor (ER) and HER2 status of the tumour influence treatment decisions made by clinicians. 5
According to 79 percent of clinicians, ER status was routinely (i.e. greater than 75% of the time) available at the MDTM. 5 This compares to 26 per cent of clinicians reporting that HER2 status was routinely available.5
Thirty percent (30%) of clinicians said that HER2 status was rarely (less than 25% of the time) available and missing HER2 results led to extra out-patient visits in 46% of responses. 5
In 2005 more than 45,500 women were diagnosed with breast cancer in the UK.[viii] A recent update to recommendations for HER2 testing in the UK states that HER2 test results at diagnosis of breast cancer should be accurate, reliable, timely and available for the MDTM.[ix]
About treatment of early breast cancer
Women with early stage breast cancer are normally treated with surgery to remove the lump. Sometimes lymph notes in the armpit are also removed.
Radiotherapy is given to help prevent 'local recurrence' or the tumour coming back in the breast.
Chemotherapy (with trastuzumab for HER2-positive breast cancers) is recommended for all but the lowest risk patients to 'mop up' any cancer cells that may have already spread outside the breast.
About trastuzumab
Trastuzumab is the only HER2 targeted treatment with an overall survival benefit for women with HER2 positive breast cancer. Trastuzumab offers thousands of patients diagnosed each year with early stage HER2-positive breast cancer the best chance of a cure4 and enables women to live longer with secondary (metastatic) disease.[x] It has a licence and has been shown to be cost effective in both of these settings.[xi], [xii]
In trials, trastuzumab consistently reduced patient risk of death from early stage HER2- positive breast cancer by about one third4 and risk of the cancer coming back in women by up to a half.1,2,3,4
Like most treatments, trastuzumab is associated with side-effects, the most common of which are mild flu-like symptoms, such as chills and fever during its administration. A clinically important side-effect is the cardiac side-effect experienced by a small number (0.5-4.0%) of patients with early stage HER2 positive breast cancer. 1,3 In the majority of these patients, this effect is of short duration and reversible. Careful monitoring of heart function is recommended during treatment.
Trastuzumab is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. It has demonstrated efficacy in treating both early and advanced (metastatic) breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, trastuzumab has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2- positive breast cancer.
Trastuzumab received approval for use in the European Union for advanced (metastatic) HER2-positive breast cancer in 2000 and for early HER2-positive breast cancer in 2006. In advanced disease, trastuzumab is now approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of postmenopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. In early use, trastuzumab is approved for use following standard (adjuvant) chemotherapy.
Trastuzumab is recommended as a cost-effective option as part of the foundation of care by the National Institute for Health and Clinical Excellence (NICE) in all eligible patients with HER2-positive disease.11,12
Trastuzumab extends survival across all stages of HER2-positive breast cancer by activating the immune system and suppressing the HER2 receptor and preventing HER2 positive cells from growing and dividing.
Trastuzumab is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, trastuzumab has been used to treat more than 450,000 HER2-positive breast cancer patients worldwide.
About Roche in the UK
Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. For a copy of the trastuzumab Summary of Product Characteristics or to find out more please visit www.rocheuk.com.
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