NICE approves breakthrough breast cancer drugs

NICE confirms that it will recommend that breakthrough cancer drugs palbociclib and ribociclib be provided on the NHS for women with advanced breast cancer| story via OnMedica

There are around 45,000 new diagnosis of breast cancer each year in England and it is estimated that around 8,000 of these people would be eligible for treatment with either palbociclib or ribociclib.

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In draft guidance, NICE said breast cancer patients should have routine access to these two life extending drugs after a new deal with their manufacturing companies who agreed to lower the price and who gave more evidence for their effectiveness.

Palbociclib (Ibrance) from Pfizer and ribociclib (Kisqali) from Norvatis, are recommended for people with hormone receptor (HR) positive, HER2 negative locally advanced or secondary breast cancer.

NICE said that although there were some uncertainties on how long they extend the life expectancy of people with this type of breast cancer, these promising new drugs were found to stall the growth of cancer for an extra 10 months on average.

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Breast cancer can return 20 years after treatment

Risk of certain breast cancers coming back remains for at least 20 years after treatment | New England Journal of Medicine | Story via Cancer Research UK

Research, carried out by The Early Breast Cancer Trialists’ Collaborative Group collected data from more than 60,000 women who had been diagnosed with hormone sensitive breast cancer (usually called oestrogen receptor positive or ER+ breast cancer) between 1976 and 2011.

All of the patients were given a type of anti-oestrogen therapy for five years as part of their treatment. At the five year mark the women had no signs that their breast cancer had come back and treatment ended.

The figures, published in the New England Journal of Medicine show that out of the women included in the study, 11,000 had their cancer come back in another part of the body such as the bone, liver and lung in the 15 years after stopping treatment. They also showed that the risk of cancer coming back remained the same year on year from when they stopped taking the anti-oestrogen drugs to 15 years later.

Full story at Cancer Research UK

Full reference: Pan, H. et al. (2017) 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 YearsNew England Journal of Medicine.

 

Radiation risk with digital mammography in breast screening

This review estimates the risks and benefits of breast screening in terms of deaths due to radiation-induced cancers and lives saved by digital mammography in the NHS Breast Screening Programme in England.

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A radiation risk model, patient dose data and data from national screening statistics were used to estimate the number of deaths due to radiation induced breast cancers in the NHSBSP in England. The breast cancer mortality reduction in the invited population due to screening, and the percentage of women diagnosed with symptomatic breast cancer who die from that cancer, were collated from the literature. The number of lives saved due to screening was calculated.

The main findings are that:

  • the risk of a radiation-induced cancer for a woman attending full field digital mammographic screening (2 views) by the NHSBSP is between 1 in 49,000 to 1 in 98,000 per visit
  • if a woman attends all 7 screening examinations between the ages of 50 to 70, the risk of a radiation-induced cancer is between 1 in 7,000 to 1 in 14,000
  • it is estimated that about 400 to 800 cancers are detected by the NHSBSP for every cancer induced
  • the mortality benefit of screening exceeds the radiation-induced detriment by about 150:1 to 300:1
  • for the small proportion of women with breasts thicker than 90mm who receive higher radiation doses, the benefit will exceed the risk by about 100:1 to 200:1

Full report at Public Health England

Protocol: mHealth innovation for early detection of patient-reported symptom distress

Cancer patients are predominantly treated as out-patients and as they often experience difficult symptoms and side effects it is important to facilitate and improve patient-clinician communication to support symptom management and self-care | BMC Cancer

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Background: Although the number of projects within supportive cancer care evaluating mobile health is increasing, few evidence-based interventions are described in the literature and thus there is a need for good quality clinical studies with a randomised design and sufficient power to guide future implementations. An interactive information and communications technology platform, including a smartphone/computer tablet app for reporting symptoms during cancer treatment was created in collaboration with a company specialising in health care management. The aim of this paper is to evaluate the effects of using the platform for patients with breast cancer during neo adjuvant chemotherapy treatment and patients with locally advanced prostate cancer during curative radiotherapy treatment. The main hypothesis is that the use of the platform will improve clinical management, reduce costs, and promote safe and participatory care.

Method: The study is a prospective, randomised, controlled trial for each patient group and it is based on repeated measurements. Patients are consecutively included and randomised. The intervention groups report symptoms via the app daily, during treatment and up to three weeks after end of treatment, as a complement to standard care. Patients in the control groups receive standard care alone. Outcomes targeted are symptom burden, quality of life, health literacy (capacity to understand and communicate health needs and promote healthy behaviours), disease progress and health care costs. Data will be collected before and after treatment by questionnaires, registers, medical records and biomarkers. Lastly, participants will be interviewed about participatory and meaningful care.

Discussion: Results will generate knowledge to enhance understanding about how to develop person-centred care using mobile technology. Supporting patients’ involvement in their care to identify problems early, promotes more timely initiation of necessary treatment. This can benefit patients treated outside the hospital setting in regard to maintaining their safety.

Full reference: Langius-Eklöf, A. et al. (2017) Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer. BMC Cancer. 17:466

NICE set to approve trastuzumab emtansine for breast cancer

The NHS in England will soon be able to routinely fund the use of trastuzumab emtansine for people with certain categories of breast cancer, the National Institute for Health and Care Excellence (NICE) has announced in new draft guidance | OnMedica

NICE’s decision means that, by late summer, more than a thousand women and men could benefit from the drug.

HER2-positive breast cancer accounts for about a fifth of the roughly 41,500 women and 300 men who are diagnosed with breast cancer each year in England, but HER2-positive tumours are typically more aggressive than other types of breast cancer. The targeted treatment trastuzumab (Herceptin) is only effective for this type of breast cancer. Trastuzumab emtansine (Kadcyla) is licensed for the treatment of locally advanced or metastatic HER2-positive breast cancer, after trastuzumab and a taxane, taken either in combination or separately.

Currently, trastuzumab emtansine – which at full list price costs about £90,000 per patient – is only available on the NHS through the Cancer Drugs Fund (CDF). But NICE revealed yesterday afternoon that the drug’s manufacturer Roche had agreed a new commercial access arrangement with NHS England. When NICE factored this confidential agreement into a new clinical and cost-effectiveness analysis, also applying end-of-life criteria, it concluded that it can now recommend the drug as cost effective for routine use on the NHS.

New chemotherapy approach offers breast cancer patients a better quality of life

The chemotherapy drug capecitabine gives patients a better quality of life and is as effective at preventing breast cancer from returning as the alternative regimen called CMF, when given following epirubicin. | ScienceDaily | Cancer Research UK

Around 4,400 patients on the TACT2 clinical trial were treated with the chemotherapy drug epirubicin followed by either capecitabine or CMF, after surgery.

Researchers at The Institute of Cancer Research, London, and the Cancer Research UK Edinburgh Centre found that capecitabine resulted in patients experiencing fewer side effects and having a better quality of life, and it was as effective at preventing cancer’s return as CMF.

Most patients experienced some side effects regardless of the treatment they were given. But those taking CMF were more likely to experience severe side effects including early menopause, nausea, infection, thrombosis, and anemia.

During the trial, patients were followed up after 12, 18 and 24 months, and then yearly for at least 10 years, to see if their cancer had returned and to monitor side effects. More than 85 per cent of patients did not experience their cancer returning for at least five years.

More detail at

Link to the research:

Cameron, D., et al.  Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial. The Lancet Oncology.

Diet, nutrition, physical activity and breast cancer

The report analysed 119 studies and including data on 12 million women and 260,000 cases of breast cancer | World Cancer Research Fund

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Image source: WCRF

Many epidemiologic studies have classified breast cancer cases by menopausal status at time of diagnosis, and therefore in this report we chose to highlight associations between diet, weight, and physical activity separately in premenopausal and postmenopausal breast cancer, where possible.

Key findings: premenopausal breast cancer

There is strong evidence that:

  • consuming alcoholic drinks increases risk
  • undertaking vigorous physical activity decreases risk
  • being overweight or obese between the ages of about 18 and 30 years decreases risk
  • being overweight or obese in adulthood before the menopause decreases risk
  • developmental factors leading to greater linear growth (marked by adult attained height) increase risk
  • factors that lead to greater birthweight, or its consequences, increase risk
  • breastfeeding decreases risk (breast cancer type unspecified) in the mother
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Image Source: WCRF

Key findings: postmenopausal breast cancer

There is strong evidence that:

  • consuming alcoholic drinks increases risk
  • being physically active (including vigorous physical activity) decreases risk
  • being overweight or obese between the ages of about 18 and 30 years decreases risk
  • being overweight or obese throughout adulthood increases risk
  • greater weight gain in adulthood increases risk
  • developmental factors leading to greater linear growth (marked by adult attained height) increase risk
  • breastfeeding decreases risk (breast cancer type unspecified) in the mother
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Image source: WCRF