A potentially life-extending drug combination for some people with advanced breast cancer will now be available under the cancer drugs fund (CDF) following approval by NICE and publication of draft guidance
The draft guidance recommends ribociclib (also called Kisqali and made by Novartis) used with fulvestrant as an option for people with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer who have had previous endocrine therapy.
The positive recommendation follows an improved patient access scheme by the company as part of a commercial arrangement.
Clinical trial evidence suggests that, compared with fulvestrant alone, ribociclib with fulvestrant increases the length of time before the disease progresses. However, it is not known whether ribociclib increases the length of time people live, because the final trial results are not available yet.
The committee recognised that ribociclib with fulvestrant has the potential to be cost-effective, and therefore recommended it for use on the CDF. This will allow more evidence to be collected to address the uncertainties around overall survival and cost-effectiveness.
Full dtail at NICE
The NHS is preparing to fast-track the introduction of ‘game changing’ new cancer drugs that target tumours according to their genetic make-up rather than where they originate in the body | NHS England
The revolutionary treatments – known as ‘tumour agnostic’ drugs – can be used against a wide range of cancers and could offer hope to patients with rare forms of the disease that may previously have been untreatable.
The first of the new cancer drugs, which target genetic mutations that accelerate the growth of many types of tumours and have particular benefits for children, are set to come on to the market within months.
With such treatments, testing the tumour’s genes or other molecular features assists in deciding which treatments may be best for an individual with cancer, regardless of where the cancer is located or how it looks under the microscope. Molecular testing therefore becomes a first and essential element of treatment planning.
Around 850 patients a year could benefit from the frontrunners while many thousands a year are eventually expected to benefit from other tumour agnostic treatments on the horizon.
Full story at NHS England
University of Nottingham | May 2019 | Drugs for invasive breast cancer ‘could treat earliest stages of the disease’
Experts from the University of Nottingham’s School of Medicine have undertaken research that has found drugs used to target HER2-positive invasive breast cancer may also be successful in treating women in the first stages of the disease.
The HER2 gene is already closely associated with aggressive, invasive breast cancer and is already treated using the drug trastuzumab, more commonly known as Herceptin.
The Nottingham study looked at breast tissue from 776 women treated at Nottingham City Hospital between 1990 and 2012 for DCIS. It also collected information from 239 cases of DCIS and invasive breast cancer for comparison.
Following up on cases between two months and 20 years later, the team found that out of 308 patients treated with breast conserving surgery alone, the disease had reoccurred in 67 people (22 per cent). More than half of those (57 per cent) had gone on to develop aggressive, invasive breast cancer. Among the 93 cases treated with surgery and radiotherapy, the cancer came back in eight patients – two with invasive breast cancer and six with DCIS.
The researchers suggest that screening women with DCIS for HER2 may help to identify those at greater risk of developing more invasive forms of the disease.
Current treatments targeting HER2 could also potentially be extended to DCIS patients to reduce the chance of the cancer spreading and reduce the number of HER2-related deaths (Source: University of Nottingham).
Read the full, unabridged news story from the University of Nottingham
NICE | March 2019 | Promising lung cancer treatment approved for Cancer Drugs Fund
NICE has unveiled a promising lung cancer treatment has been approved for the Cancer Drugs Fund, as a result of a NICE recommendation. Today NICE has published draft final guidance.
Durvalumab helps the body’s immune system to find and attack cancer cells, by blocking the PD-L1 protein which disguises cancer.
In a clinical trial people taking it went for an average of around 2 years without the disease progressing, versus 6 months for those without. The committee agreed that it was plausible that between 27% and 40% of people taking durvalumab would have 5 years of progression-free survival.
The draft guidance is available from NICE
Read the full details from NICE
NICE Lung cancer: diagnosis and management
University of Newcastle Promising lung cancer treatment available on the NHS
University of Birmingham | June 2018 | Trial to test new treatment combination for children and adults with Leukaemia
A clinical trial testing a new treatment combination in patients with leukaemia launches through the Combinations Alliance, a joint initiative between Cancer Research UK and the Experimental Cancer Medicine Centres (ECMC) Network based at University of Birmingham.
Researchers want to discover whether pharmaceutical companies AstraZeneca and MSD’s experimental medicine, selumetinib (AZD6244, ARRY-142886), can be effective in combination with a treatment, dexamethasone, already used for several conditions including leukaemia.
This clinical trial, the first of its kind to include both adults and children is based at the Cancer Research UK Clinical Trials Unit at the University of Birmingham. This trial is planned to open in 23 centres throughout the UK and in 11 additional centres in 6 European countries, to help recruit 42 patients.
Professor Josef Vormoor, international clinical lead for the trial, said: ‘Although there are effective treatments for leukaemia, for some patients, the disease can return after they have been treated. If this combination is successful, it could give us an urgently needed new way to treat patients who have relapsed and have few treatment options left.’ (Source:University of Birmingham)
The full press release can be read at the University of Birmingham’s website
Further details on the clinical trial are available from Cancer Research
NHS England | June 2018 | NHS England strikes deal on new NICE recommended lung cancer immunotherapy drug
NHS England have announced it will make lung cancer drug pembrolizumab available for routine use on the NHS. Trial results show pembrolizumab extends life for certain adults with lung cancer for more than a year.
According to NHS England Pembrolizumab is the first drug to exceed the new budget impact threshold for new products costing more than £20 million a year. The drug, which is also called Keytruda, would have cost around £84,000 per patient at its full list price. NHS England and MSD have agreed a confidential arrangement for reimbursement which will enable NICE to recommend it be routinely available on the NHS (NHS England).
The full announcement is available at NHS England
University of Leeds | April 2018 |Women at increased cancer risk shun preventative tamoxifen therapy
A study published in Breast Cancer Research and Treatment shows that only 1 in 7 women who were offered Tamoxifen due to a familial history of cancer decided to take it. This new research sought to highlight that women eligible to take the drug were electing not to, it also aimed to explore the reasons behind such decisions. Researchers also found that patients consulted informal networks such as friends and family before making a decision about whether to take Tamoxifen (via University of Leeds) .
Whether the participants had children also had an impact on the decision, the scientists found those with children were more likely to take the drug. One participant explained that taking the drug might affect her ability to care for her children and parents, so decided not to take it.
The study was conducted in collaboration with scientists at the University Hospitals Southampton, University College London, Queen Mary University, University of Leeds and Northwestern University. The research was funded by Cancer Research UK and Yorkshire Cancer Research.
Purpose Uptake of preventive therapy for women at increased breast cancer risk in England is unknown following the introduction of UK clinical guidelines in 2013. Preventive therapy could create socioeconomic inequalities in cancer incidence if it is more readily accepted by particular socio-demographic groups. In this multicentre study, we investigated uptake of tamoxifen and evaluated socio-demographic and clinical factors associated with initiation. We explored women’s experiences of treatment decision-making using qualitative interview data.
Methods Between September 2015 and December 2016, women (n=732) attending an appointment at one of 20 centres in England to discuss breast cancer risk were approached to complete a survey containing socio-demographic details and nul-
liparity. Of the baseline survey respondents (n equal to 408/732, 55.7% response rate), self-reported uptake of tamoxifen at 3-month follow-up was reported in 258 (63.2%). Sixteen women participated in semi-structured interviews.
Results One in seven (38/258=14.7%) women initiated tamoxifen. Women who had children were more likely to report use of tamoxifen than those without children (OR=5.26; 95%CI: 1.13–24.49, p=0.035). Interview data suggested that women weigh up risks and benefits of tamoxifen within the context of familial commitments, with exposure to significant other’s beliefs and experiences of cancer and medication a basis for their decision.
Conclusions Uptake of tamoxifen is low in clinical practice. There were no socio-demographic differences in uptake, suggesting that the introduction of breast cancer preventive therapy is unlikely to create socioeconomic inequalities in cancer incidence. Women’s decision-making was influenced by familial priorities, particularly having children.
The full article can be downloaded here