NIHR Signal Common osteoporosis drugs may prevent breast cancer spreading to bone

NIHR Signal Common osteoporosis drugs may prevent breast cancer spreading to bone
          
Drugs commonly prescribed to prevent bone thinning probably help prevent the spread of early breast cancer to the bones in a few women, when taken in addition to standard cancer therapies. However, the overall benefits may be small, for example preventing spread to bone or death in about one extra woman in every 100 treated for about five years. This is a complex area because many of the treatments for breast cancer are known to worsen bone thinning, but there are other bone strengthening benefits to these drugs.
Published on 13 March 2018
Read full document at https://discover.dc.nihr.ac.uk/portal/article/4000967/common-osteoporosis-drugs-may-prevent-breast-cancer-spreading-to-bone

NICE Guidance Technology appraisal guidance TA509: Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer

Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer.

Evidence-based recommendations on pertuzumab (Perjeta) for treating HER2‑positive, locally recurrent or metastatic (secondary) breast cancer that has not been treated with chemotherapy or targeted HER‑2 therapy before, in adults.

Published March 2018
Next review: September 2022


Full guidance available at https://www.nice.org.uk/guidance/ta509

Fulvestrant for untreated locally advanced or metastatic oestrogen-receptor positive breast cancer [TA 503]

New:  Technology appraisal guidance


Fulvestrant is indicated for 'the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:

• not previously treated with endocrine therapy (licence extension under appraisal) or
• with disease relapse on or after adjuvant antioestrogen therapy, or disease progression on antioestrogen therapy' (appraised in NICE technology appraisal guidance on fulvestrant for the treatment of locally advanced or metastatic breast cancer).

The recommended dosage is 500 mg intramuscularly into the buttocks as 2×5‑ml injections (1 in each buttock) on days 1, 15 and 29, and then once monthly (until disease progression).

Intrabeam radiotherapy system for adjuvant treatment of early breast cancer [TA 501]

New: Technology appraisal guidance


The Intrabeam radiotherapy system (Carl Zeiss UK) is a mobile irradiation system. It is designed to deliver a single dose of targeted low-energy radiation (X‑rays) directly to the tumour bed, while limiting the exposure of healthy tissue to radiation. Because it delivers low energy radiation, it can be used in an ordinary operating theatre at the time of surgery. The Intrabeam radiotherapy system provides a source of 50 kV energy from a spherical applicator of between 1.5 cm and 5.0 cm diameter. The applicator is sutured to the tumour bed so that breast tissue at risk of local recurrence receives the prescribed dose while skin and deeper structures are protected. Radiation is delivered over 20 to 30 minutes.




The Intrabeam radiotherapy system was granted a CE (Conformité Européene) mark in 1999 for use in radiotherapy.
Intrabeam can be used as an intraoperative radiotherapy system given as the sole treatment or as a boost treatment followed by external beam radiotherapy (EBRT). When intraoperative radiotherapy is given as a boost treatment with Intrabeam and followed by EBRT, there is no need for further external boost treatment. Six NHS centres in the UK have used Intrabeam for adjuvant treatment of early breast cancer.

NICE consults on updated recommendations for the treatment and care of people with early breast cancer

NICE’s draft updated guideline on early and locally advanced breast cancer calls for extended hormonal therapy for some women after they’ve taken tamoxifen in order to reduce the risk of their breast cancer coming back.

The new recommendation is for women who have been through the menopause who have a type of breast cancer called ER-positive invasive breast cancer and who have been taking tamoxifen for 2 to 5 years. It reflects research showing that switching to an aromatase inhibitor after taking tamoxifen for 5 years improved disease-free survival compared with women who had only received tamoxifen for 5 years.

Breast screening: women wanting to attend service out of area

This guidance is aimed at breast screening providers and provides advice on dealing with requests from women who ask to be screened outside their area.

Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer [TA496]

New:  Technology appraisal guidance

Evidence-based recommendations on ribociclib (Kisqali) as initial endocrine-based therapy for hormone-receptor positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic (secondary) breast cancer in adults.

Marketing authorisation

Ribociclib in combination with an aromatase inhibitor is indicated for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy.

Palbociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer [TA495]

New technology appraisal guidance from NICE. Palbociclib (Ibrance) as initial endocrine-based therapy for hormone-receptor positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic (secondary) breast cancer in adults.

Recommendations:
Palbociclib, with an aromatase inhibitor, is recommended within its marketing authorisation, as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy in adults. Palbociclib is recommended only if the company provides it with the discount agreed in the patient access scheme.

Breast screening guidance

Public Health England has updated the following guidance:

Breast screening: guidance for breast screening mammographers

Guidance on the mammographic aspects (both clinical and technical) of breast screening QA and the quality control of radiographic procedures.

Breast screening: repeat mammograms
NHS breast screening programme procedures to collect, monitor and report repeat mammographic examinations.

Breast screening: women wanting to attend service out of area

Guidance for breast screening providers on dealing with requests from women who ask to be screened outside their area.

Diagnostic Assessment of Deep Learning Algorithms for Detection of Lymph Node Metastases in Women With Breast Cancer

JAMA. 2017 Dec 12;318(22):2199-2210. doi: 10.1001/jama.2017.14585.

In the setting of a challenge competition, some deep learning algorithms achieved better diagnostic performance than a panel of 11 pathologists participating in a simulation exercise designed to mimic routine pathology workflow; algorithm performance was comparable with an expert pathologist interpreting whole-slide images without time constraints. Whether this approach has clinical utility will require evaluation in a clinical setting.
UHCW Research: Rajpoot N

Taselisib in Combination with Fulvestrant for Advanced ER Positive, HER2-negative Breast Cancer – Second Line After Aromatase Inhibitor Therapy

Taselisib is investigated as a new oral treatment for ER+, HER2- type of breast cancer. It is being investigated as a medicine to work on a pathway regulating cell growth and cell survival. If taken in combination with an intramuscular injection of fulvestrant, which stops the effect of hormones altering the breast cells, taselisib has the potential to prolong survival. If licenced, this combination of treatments will offer an additional therapy option for those who have already had hormonal therapy but their cancer has relapsed.

From the NIHR Innovation Observatory.

Veliparib in Combination with Carboplatin and Paclitaxel for Breast Cancer – First to Third Line

Veliparib is a new oral drug that is being developed for patients with HER2- breast cancer that is advanced and cannot be removed completely through surgery.  The drug acts by targeting specific enzymes involved in the repair of damaged DNA that helps the body to kill cancer cells while allowing ordinary cells to survive. Veliparib is being developed to be used in combination with the chemotherapy drugs paclitaxel and carboplatin. If licenced, this combination will offer an additional treatment option for patients with HER2- metastatic or locally advanced unresectable BRCA-associated breast cancer.

From the NIHR Innovation Observatory

Alpelisib in Combination with Fulvestrant for Advanced HR Positive, HER2-negative Breast Cancer in Men and Postmenopausal Women

Alpelisib is a new drug that is being developed for patients with the HR+/HER2- type of advanced breast cancer. The drug is being developed to be given in combination with fulvestrant, a drug that is already in use for the treatment of advanced breast cancer. Alpelisib targets a very specific enzyme that transmits signals to cells, stopping the growth and survival of cancer cells. Alpelisib is taken orally while fulvestrant is given by injection. If approved, the combination of both drugs will offer additional treatment options for patients with advanced HR+/HER2- breast cancer that have not responded well to other drugs.

From the NIHR Innovation Observatory

Ribociclib and Fulvestrant and PI3K Inhibitor (Buparlisib or Alpelisib) for HR Positive, HER2 Negative Postmenopausal Breast Cancer – Second or Third Line

The combination of ribociclib, fulvestrant, and buparlisib or alpelisib is being developed for the treatment of HR+ and HER2- locally recurrent or advanced metastatic breast cancer. Ribociclib is given by mouth (capsules). It acts by helping to slow the progression of cancer by inhibiting two certain types of proteins that play a role in ensuring that cancer cells do not grow uncontrollably. Buparlisib and alpelisib are other types of drugs that act by reducing tumour cell growth and survival. Both are also given by mouth. Fulvestrant is a drug that is given by injection and is already in use for the treatment of advanced breast cancer. If licensed, the combination of ribociclib, fulvestrant, and buparlisib or alpelisib will offer an additional treatment option for postmenopausal women with HR+, HER2-negative locally recurrent or advanced metastatic breast cancer.

From the NIHR Innovation Observatory

Breast screening: interval cancers and duty of candour toolkit

Guidance from Public Health England on the role of breast screening and symptomatic services in identifying interval cancer and giving results to female patients.

Is Surgical Clip Placement Necessary in all Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy, and Could This Have Financial Implications for Local Trusts?

International Journal of Surgery , Volume 47 , S20 

Several studies have reported the benefits of surgical clip placement for all breast cancer patients undergoing neoadjuvant chemotherapy (NAC). The clips allow tumour localisation and maximise potential for breast-conserving surgery. We audited our data to determine if this approach is clinically necssary, and whether avoiding non-essential clips led to financial savings.

UHCW Research: S. Chambers, E. Griffin, L. Jenkins, S. Ayaani, H. Al-Omishy, S. Robertson, M. Sreenivas, A. Tomlins and K. McEvoy

Breast cancer patients to have routine access to two life extending drugs after new deal, say NICE in draft guidance

NICE has recommended palbociclib and ribociclib for routine funding after the companies lowered the prices and 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.

NHS England strikes new deals to make two new innovative treatments available routinely on the NHS

From 10 November hundreds of patients with Multiple Sclerosis are set to benefit from a new treatment option, Mavenclad, following a deal with drug company Merck.

NHS England and Roche have also reached a commercial agreement on the use of Pertuzumab, which unlocks the final stage of NICE’s appraisal and opens the way for continued access to this important treatment for breast cancer.

New genetic variants associated with breast cancer identified

"Do you have one of the 180 breast cancer genes? One in five women has a variant that raises her risk of the condition by a third" is the rather inaccurate headline in the Mail Online.

The story covers 2 new studies looking for genetic variations known as single nucleotide polymorphisms (SNPs).

These are small variations in our DNA, some of which are associated with an increased risk of developing a disease – in this case, breast cancer.

While the Mail Online's headline suggests the "breast cancer genes" have been pinpointed, this is not the case.

In most cases, the genetic variations identified by the researchers simply signpost regions in the DNA (loci) where the genes that affect breast cancer risk are likely to be located.

This is not the same as identifying specific genes or discovering why they increase the risk of breast cancer.

The individual variations identified are only associated with small increases in risk, and many women will carry them.

This is very different from the mutations in the BRCA1 or BRCA2 genes, which cause breast cancer – these are rare and have a bigger impact on risk.

These findings are useful steps towards understanding more about which genes influence breast cancer risk.

Radiation risk with digital mammography in breast screening

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