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Targeted drugs beneficial to HER2 positive patients

Friday March 23rd, 2018

Women with HER2 positive breast cancer could avoid having extensive surgery involving mastectomy and removal of several lymph nodes by receiving targeted drugs before surgery, leading oncologists have heard.

Research presented at the 11th European Breast Cancer Conference in Barcelona yesterday (22 March 2018) revealed that most women with this type of aggressive cancer who were given standard chemotherapy and at least one anti-HER2 drug such as trastuzumab prior to surgery had a less extensive procedure.

Professor Isabel Rubio, co-chair of the 11th European Breast Cancer Conference and former head of the breast surgical oncology unit at the breast cancer centre at Vall d’Hebron University Hospital in Barcelona, Spain, led the research.

She said the development of new drugs that help to target receptors on the surface of cancer cells among women with HER2 positive breast cancer has shown positive results and her research wanted to establish if the known benefits of the targeted drugs could be extended to prevent women from radical surgery.

The researchers studied a group of 160 women with HER2 positive breast cancer who were being treated at Vall d’Hebron University Hospital between October 2007 and December 2016. Of these 129 (81%) were candidates for mastectomy based on the size of the tumour and other clinical characteristics.

They all received a drug treatment before surgery, including standard chemotherapy and at least one anti-HER2 drug such as trastuzumab, and 61 women (47.2%) who might otherwise have been offered mastectomy were instead treated with less extensive surgery.

Overall, 92 out of 160 women (57.5%) were treated with breast conserving surgery. The treatment also resulted in 71% of women having no signs of cancer in their lymph nodes, which meant they underwent less extensive surgery on their lymph nodes.

Professor Rubio told the conference: “This study shows us that treating HER2 positive breast cancer with a targeted drug before surgery can mean fewer women need to undergo mastectomy and removal of several lymph nodes. It also shows us that we can use biopsies to see which cancers are responding best to anti-HER2 treatments and therefore which patients can be safely treated with breast conserving surgery.

“Breast cancer treatments have advanced tremendously in recent years. What this means is that surgery should evolve too so that it is tailored to the individual patient and takes account of the effects of their particular treatment.”

Conference chair Professor Robert Mansel said: “This research provides more information on which patients are likely to benefit from radical surgery and which could be safely treated with breast conserving surgery, bringing potential benefits in patients’ of quality of life.”

Abstract no: 19.Breast and axillary conservative surgery after neoadjuvant treatment in HER 2 positive breast cancer patients: The time is now.

* Women with early breast cancer could avoid chemotherapy

The risk of relapse among women with small, low grade, well-defined breast tumours and a genetic profile showing they are at low risk of the cancer metastasising is so small that they could avoid chemotherapy and even radiotherapy after surgery, a conference will hear today.

Delegates at the 11th European Breast Cancer Conference, in Barcelona will hear today (23 March 2018) that these women have only a 1.4% risk of the cancer returning to the site of the original tumour or the nearby lymph nodes within five years.

The MINDACT (Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy) trial of nearly 7,000 patients revealed that the low risk of locoregional recurrence was seen whether or not the women had a mastectomy or breast conserving surgery followed by radiotherapy.

Professor Emiel Rutgers, of the Netherlands Cancer Institute, Amsterdam, says the findings mean that it is possible to identify women who can safely avoid chemotherapy after surgery and possibly radiotherapy.

He will tell delegates: “These findings show that, for these selected women, breast conservation is as good as mastectomy, and the risk of relapse is so low that we should look for ways of giving them less aggressive treatment.

“For instance, even though radiotherapy reduces the risk of locoregional recurrence two- to three-fold, can we do without it in some selected patients, such as these low risk women, and also in some women aged over 50 with small tumours, less than 2cms in diameter, who have a 1.4% risk of relapse within five years as well.”

A total of 6693 patients were enrolled in the MINDACT trial, 5470 (82%) of whom underwent breast conserving surgery, with 1223 (18%) having a mastectomy.

Decisions on how patient treatment were made based on tumour characteristics. Genetic make-up was also examined, using the MammaPrint 70-gene-signature test.

Women who were at low risk of a recurrence, based on these clinical and genomic factors, did not receive chemotherapy after surgery, while those who were at high risk, did. Women with a mixture of high and low risk factors were randomised to receive chemotherapy or not. Almost all women who had breast conserving surgery also had radiotherapy, but not all of the women who had a mastectomy.

Prof Rutgers and his colleagues also looked at the rate of locoregional recurrences five years after surgery and analysed them according to the clinical and genetic characteristics.

They found that women who had breast conserving surgery had an overall 2.1% risk of recurrence by five years, but if they had a low 70-gene signature score, the risk dropped to 1.4% compared with 3.6% among women who had a high score.

Among women who had a mastectomy, the overall risk of recurrence was 2.5%, but this dropped to 0.7% in those with a low genetic score and went up to 4.9% in those with a high score.

Full statistical analysis found that tumour grade and size were the only factors that were significantly associated with the risk of locoregional recurrences.

Prof Rutgers says: “The importance of this MINDACT analysis is that local and regional control, in which breast cancer does not come back in the preserved breast, or in the skin after mastectomy, or in the surrounding lymph nodes, is extremely good.

“Another important message from these findings is that well-performed breast conserving surgery in women with good indications is as good as mastectomy. Doing a mastectomy when you could very well perform breast conservation, will not add a day to the life of a breast cancer survivor. This is a wonderful trial that provides wonderful opportunities for further research.”

Conference chair Professor Robert Mansel said: “Professor Rutgers and colleagues have shown that there is a group of breast cancer patients who are low risk of locoregional recurrence and might be able to avoid radiotherapy and chemotherapy and the associated adverse side effects. I support his suggestion of a prospective trial to investigate this further in older, low-risk women.”

Abstract no: 2. Very low risk of locoregional breast cancer recurrence in the EORTC 10041/BIG 03-04 MINDACT trial: analysis of risk factors including the 70-gene signature.

* New results from IMPORT LOW trial revealed

Women report few adverse effects from partial or reduced breast radiotherapy, the results from a major UK trial will reveal today (23 March 2018).

Delegates at the 11th European Breast Cancer Conference in Barcelona will hear that the IMPORT LOW study of 2,016 women in 41 UK centres has already shown that partial breast and reduced dose radiotherapy was as effective as whole breast radiotherapy in controlling the cancer at five years.

However, these latest results, which focus predominantly on side-effects affecting the breast and also body image reported during the five years following radiotherapy, show that more than half of patients in the study did not report moderate or marked side-effects and that most side-effects reduced over time.

Dr Indrani Bhattacharya, a clinical research fellow at the Institute of Cancer Research’s Clinical Trials and Statistics Unit, London, will tell conference: “The findings from this study are reassuring for women who are offered either whole breast or partial breast radiotherapy using this technique of radiotherapy, which is simple to deliver and already available in centres worldwide.

“This new information will help doctors discuss the risks and benefits of this type of radiotherapy with patients and may improve shared decision-making, as well as enabling them to tailor treatment for individual patients.”

The IMPORT LOW study was a randomised trial in which women received one of three treatments: the control group had standard radiotherapy at a dose of 40 Gy to the whole breast, while others were given 36 Gy to the whole breast and 40 Gy to the part of the breast that contained the original tumour (reduced dose group). A third group received 40 Gy only to the site of the original tumour (partial breast group).

Hypofractionated intensity modulated radiotherapy (IMRT) was given, which can deliver an even dose of radiation.

Out of the total cohort, 1265 took part in a sub-study that looked at patient-reported outcomes (PROMs).

Most of the side-effects reported related to changes affecting the breast, and the most common reported side-effect was “overall change in breast appearance”.

The researchers found that younger women, those with larger breasts and those with a larger volume of tissue removed were more likely to report adverse side-effects. Women whose cancer had spread to any of their lymph nodes, and if they were feeling anxious or depressed at the start of the study were also likely to report side effects.

Dr Bhattacharya says: “Now that we can identify these patients who are at higher risk of reporting side-effects, this knowledge can be discussed with patients, may modify treatment and enable doctors to put in place more personalised and frequent monitoring if necessary.

“This new analysis shows that patients requiring whole breast radiotherapy can be reassured about the low risk of side-effects affecting the breast and body image. The technique of radiotherapy used in IMPORT LOW is easy to implement and deliver as the equipment and expertise is available in all centres worldwide.”

Conference co-chair Professor Isabel Rubio said: “These latest results from the IMPORT LOW trial provide important and reassuring information for clinicians and patients about side effects after partial or reduced dose radiotherapy, and will help them to make the best choices in each individual case.”

Abstract no: 3. A longitudinal analysis of patient reported outcomes over 5 years in the IMPORT LOW (partial breast radiotherapy after breast conservation surgery) phase III randomised controlled trial

Tags: Cancer | Europe | Pharmaceuticals | UK News | Women's Health & Gynaecology

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