Six months of Herceptin could be as effective as 12 months for some women with HER2 positive breast cancer

May 17, 2018, University of Warwick

For women with HER2 positive early-stage breast cancer taking Herceptin for six months could be as effective as 12 months in preventing relapse and death, and can reduce side effects, finds new research.

The PERSEPHONE trial, a £2.6 million study which incorporated University of Warwick expertise, recruited more than 4,000 women and compared a six month course of of Herceptin with the current standard of 12 months for women with HER2-positive early-stage . Funded by the National Institute for Health Research (NIHR) with translational research funded by Cancer Research UK, this is the largest trial of its kind examining the impact of shortening the duration of Herceptin treatment.

The trial, which involved Warwick Clinical Trials, Warwick Medical School and was led by the University of Cambridge found that 89.4% of patients taking six months treatment were free of disease after four years compared with 89.8% of patients taking treatment for 12 months. These results show that taking Herceptin for six months is as effective as 12 months for many women. In addition, only 4% of women in the six month arm stopped taking the drug early because of heart problems, compared with 8% in the 12 month arm. Women also received chemotherapy (anthracycline-based, taxane-based or a combination of both) while enrolled in the trial.

Professor Janet Dunn, Deputy Director of Warwick Clinical Trials Unit, Warwick Medical School, said: "This is a very exciting result and we are delighted that Warwick Clinical Trials at Warwick Medical School was involved.

"There is still further research to be done, however there is now the possibility that women will now avoid longer treatment and the subsequent unnecessary side effects without losing any benefit. It is also good news for the NHS as a shorter duration of medication should help save vital funds."

Herceptin, has been a major breakthrough, prolonging and saving the lives of women with breast cancers that carry the HER2 receptor on the surface of their cancer cells. Around 15 out of every 100 women with early breast cancers have HER2 positive disease.

Herceptin is a targeted therapy that works by attaching to the HER2 receptors preventing the cancer cells from growing and dividing. It has rapidly become standard of care and based on clinical research a 12 month treatment course was adopted. Lead study author Professor Helena Earl, Professor of Clinical Cancer Medicine, University of Cambridge and Cancer Research UK Cambridge Centre, said: "The PERSEPHONE team, patient advocates who have worked with us on the study and our investigators are very excited by these results. We are confident that this will mark the first steps towards a reduction of Herceptin treatment to six months in many women with HER2-positive breast cancer. However, any proposed reduction in effective cancer treatment will always be complex and very challenging, and women currently taking the medication should not change their treatment without seeking advice from their doctor. There is more research to be done to define as precisely as possible the particular patients who could safely reduce their treatment duration. We are poised to do important translational research analysing blood and tissue samples collected within the trial to look for biomarkers to identify subgroups of different risk where shorter/longer durations might be tailored."

Professor Hywel Williams, Director of the NIHR Health Technology Assessment Programme that funded the PERSEPHONE study said: "This is a hugely important clinical trial that shows that more is not always better. Women will now have the potential to avoid unnecessary side effects of longer treatment without losing any benefit. In turn, this should help save vital funds for the NHS and prompt more studies in other situations where the optimum duration of treatment is not known. It is unlikely that research like this would ever be done by industry, so I am delighted that the NIHR are able to fund valuable research that has a direct impact on patients."

Maggie Wilcox, President of Independent Cancer patients Voice (ICPV) who is the patient lead for the PERSEPHONE trial, said "I am delighted to have been part of this landmark trial which is an important step to reduce the length of treatment whilst not changing effectiveness. Most trials add novel treatments to standard practice whilst this has set out to reduce duration of Herceptin. The collection of the patient reported experiences throughout the trial will greatly inform future practice and benefit patients. ICPV is working with the Persephone team to help disseminate these exciting results'.

Case Study—Sarah Stewart-Brown

In 2008 Sarah Stewart-Brown, Professor of Public Health at the University of Warwick's Warwick Medical School was diagnosed with breast cancer. She was told she had a tumour more than two centimetre in size and it was HER2 positive. This means the tumour had a higher than normal level of the protein HER2 on its surface, which stimulates tumours to grow. As a result one of the treatments she was advised to undergo was Herceptin which is designed to target and interfere with the processes in the cells that cause cancer. The tumour could have spread elsewhere but Sarah was lucky because there was no visible spread to her lymph nodes.

Professor Stewart-Brown underwent an operation to remove the tumour and was prescribed Herceptin. This was administered intravenously which meant a half-day visit to hospital every three weeks and this would have to continue for 12 months.

However three doses (nine weeks) into the treatment Sarah decided to stop her medication; she was developing allergy symptoms, which is a reported side effect of Herceptin, and after careful consideration of the research on Herceptin she started to question if the treatment was doing her more harm than good. She was offered steroids to dampen the allergy symptoms but she refused the medication.

She said: "As a medical professional with years of experience I was very aware that my body need to be working well to mount its own defence against the cancer and it wasn't reacting well to Herceptin. However I did take the hormone blocker Arimidex because my tumour was hormone sensitive and lowering the level of oestrogen can stop or slow the growth of these breast cancers."

"My cancer was an important life event for me in many positive ways. It started making me more aware of my health and the need to look after it. I started to take more notice of my digestive system and was careful to eat what suited me; I started to tackle my high stress levels and now practise mindfulness and various mindful movements like Qi Going. Until this point I had been less careful about my health and hadn't realised that my body needed me to take more care of it."

I didn't take the decision to reduce my Herceptin treatment lightly and wouldn't advise anyone to do so without understanding the pros and cons. However I believe, and there is research evidence to back this, that beginning to look after yourself better is a very important factor in not just surviving but thriving after . "

Studies that set out to reduce the amount and length of treatment are welcome. Persephone is one such study carried out at the Warwick Clinical Trials Unit at the University of Warwick that has shown that six months of Herceptin is as good as 12 months for those patients entered into the trial.

Sarah said: "I am delighted that the University of Warwick has carried out this important trial jointly with the University of Cambridge. Trials like Persephone are challenging but extremely important to patients and necessary to channel resources more efficiently within the NHS".

Explore further: Shorter drug treatment OK for many breast cancer patients

More information: PERSEPHONE—duration of trastuzumab study with chemotherapy in early breast cancer: six versus twelve months. www.journalslibrary.nihr.ac.uk … ammes/hta/0630398/#/

Related Stories

Shorter drug treatment OK for many breast cancer patients

May 16, 2018
Many women with a common and aggressive form of breast cancer that is treated with Herceptin can get by with six months of the drug instead of the usual 12, greatly reducing the risk of heart damage it sometimes can cause, ...

Study: Two drugs prevent heart problems in breast cancer patients

March 11, 2018
Data released today from a large multi-center study provides a view into the effectiveness of two drugs used to prevent heart problems resulting from breast cancer treatment.

Fewer breast cancer patients need radical surgery if they are pre-treated with targeted drugs

March 23, 2018
Extensive surgery involving mastectomy and removal of several lymph nodes can be safely avoided for more women with some types of breast cancer, if they receive targeted drugs before surgery, according to research presented ...

Herceptin plus taxol highly effective in lower-risk breast cancer patients

December 11, 2013
A remarkable 98.7 percent of certain lower-risk breast cancer patients were cancer free for at least three years after taking a combination of the drugs Herceptin and Taxol, a study has found.

Roche breast cancer drug 'helps patients live longer': study

September 29, 2014
A drug developed by Swiss giant Roche to treat an aggressive form of breast cancer has been shown to extend patients' lives by almost 16 months, researchers said Sunday.

Adjuvant Trastuzumab did not improve outcomes for patients with HER2-low breast cancer

December 6, 2017
Adding trastuzumab (Herceptin) to standard adjuvant chemotherapy did not improve invasive disease–free survival for patients with early-stage breast cancer found to have low levels of HER2, as defined as immunohistochemistry ...

Recommended for you

Scientists discover how breast cancer hibernates: study

May 22, 2018
Scientists have identified the mechanism that allows breast cancer cells to lie dormant in other parts of the body only to reemerge years later with lethal force, according to a study published Tuesday.

Researcher: Big data, networks identify cell signaling pathways in lung cancer

May 22, 2018
A team of scientists led by University of Montana cell biologist Mark Grimes has identified networks inside lung cancer cells that will help understand this cancer and fight it with drug treatments.

Resetting the epigenetic balance for cancer therapy

May 22, 2018
Though mutations in a gene called MLL3 are common across many types of cancers, their relationship to the development of the disease has been unclear. Now, a Northwestern Medicine study has identified an epigenetic imbalance ...

Downward-facing mouse: Stretching reduces tumor growth in mouse model of breast cancer

May 22, 2018
Many cancer patients seek out gentle, movement-based stretching techniques such as yoga, tai chi and qigong, but does stretching have an effect on cancer? While many animal studies have attempted to quantify the effects of ...

Compound in citrus oil could reduce dry mouth in head, neck cancer patients

May 21, 2018
A compound found in citrus oils could help alleviate dry mouth caused by radiation therapy in head and neck cancer patients, according to a new study by researchers at the Stanford University School of Medicine.

Ice cream funds research showing new strategy against thyroid cancer

May 21, 2018
Anaplastic thyroid cancer is almost uniformly fatal, with an average lifespan of about 5 months after diagnosis. And standard treatment for the condition includes 7 weeks of radiation, often along with chemotherapy.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.