A drug combination – of lapatinib and trastuzumab (Herceptin) – before surgery shrinks and may even destroy tumours in women with HER2 positive disease within 11 days. The results are from a Cancer Research UK-funded trial* being presented at the 10th European Breast Cancer Conference (EBCC10)(link is external) today.

The research may lead to fewer women needing chemotherapy.

The EPHOS B trial, led by researchers at The Institute of Cancer Research, London, the University of Manchester and University Hospital of South Manchester NHS Foundation Trust, studied 257 women with HER2 positive breast cancer in the short gap between initial diagnosis and surgery to remove their tumours.

In the trial, women were split into three groups and treated for 11 days before their surgery. Initially women were randomised to receive either trastuzamab, or lapatinib or no treatment – but halfway through the trial after evidence from other trials of the effectiveness of the combination the design was altered so that additional women allocated to the lapatinib group were also prescribed trastuzumab.

The trial set out to study the biological effects of the drug combination by measuring biological markers of cellular proliferation after 11 days of therapy. But when trying to measure this, the researchers discovered that in roughly a quarter of the 66 women who received both drugs the remaining tumour was too small for the second measurement of cell proliferation.

17 per cent of the women receiving both drugs had only minimal residual disease – defined as an invasive tumour smaller than 5mm in size – and 11 per cent had a pathological complete response – meaning no biological sign of invasive tumour could be found in the breast.

Three per cent of the women treated with trastuzumab only had residual disease or complete response.

HER2 positive breast cancer is more likely to come back after treatment than some other types of breast cancer. It is generally treated with surgery, chemotherapy, endocrine therapy and targeted anti-HER2 drugs.

Around 53,400 women are diagnosed with invasive breast cancer – with about 10-15 per cent of these characterised as HER2 positive breast cancer – and around 11,600 women die  from the disease in the UK every year.

Current treatments are effective, and complete response is common after three to four months, but the researchers say observing a disease response after 11 days was very surprising.

Trial co-leader Professor Judith Bliss, director of the Cancer Research UK-funded clinical trials and statistics unit at The Institute of Cancer Research, London, said: “Our trial set out to try to use the window between diagnosis and surgery to find clues that combined treatment with trastuzumab and lapatinib was having a biological effect on HER2 positive tumours. So it was unexpected to see quite such dramatic responses to the trastuzumab and lapatinib within 11 days.

“Our results are a strong foundation on which to build further trials of combination anti-HER2 therapies prior to surgery – which could reduce the number of women who require subsequent chemotherapy, which is also very effective but can lead to long-term side effects.”

Clinical chief investigator and trial co-leader Professor Nigel Bundred, professor of surgical oncology at The University of Manchester and clinical consultant at University Hospital of South Manchester NHS Foundation Trust, said: “These early and significant tumour regressions seen on dual anti-HER2 therapy suggest that we will be able to personalise treatment for these cancers on the basis of early response, allowing us to identify patients who in the future may avoid treatment morbidity or avoid chemotherapy”.

Professor Arnie Purushotham, senior clinical adviser at Cancer Research UK, said: “These results are very promising if they stand up in the long run and could be the starting step of finding a new way to treat HER2 positive breast cancers. This could mean some women can avoid chemotherapy after their surgery – sparing them the side-effects and giving them a better quality of life.”

Cancer Research UK scientists helped establish the link between some cancers and ‘growth factor receptor’ proteins on the surface of cells – a crucial early step in the development ofHerceptin. Cancer Research UK also funded the clinical trials unit where the research showing that Herceptin can improve survival for people with a certain type of breast cancer was completed.

www.cancerresearchuk.org/about-us/cancer-news/press-release/2016-03-10-drug-combination-shrinks-her2-positive-breast-cancers-within-11-days

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【治乳癌突破】結合兩種藥醫治 腫瘤最快11日消失

英國發現一種新的乳癌療法，在病人確診後立即給予兩種現有的藥物治療，最快可以在11天之內令腫瘤消失，有醫生甚至形容，未曾見過乳癌病人這麼快就對療程產生反應。

新療法由曼徹斯特大學和倫敦的癌症研究學院（Institute of Cancer Research）發現，研究團隊結合泰康達（Tyverb）及標靶藥Herceptin兩款乳癌藥物，向新確診病人立即用藥，原本是希望病人的腫瘤在手術前縮小，後來卻發現有些腫瘤在動手術前已消失。

研究在英國23間醫院進行，涉及257名新病人。接受新療法的66名患者中，87%對療法有反應，腫瘤停止產生更多癌細胞，令癌細胞數目下降。11%的患者的腫瘤更已經消失，另外17%病人的腫瘤明顯縮小至直徑少於5毫米。而病人的腫瘤原本直徑達3厘米。

帶領研究的曼徹斯特大學癌症外科醫生邦德雷德（Nigel Bundred）非常興奮，稱：「實體腫瘤在11天之內消失是聞所未聞，這些都是令人難以置信的結果。」研究的詳情在阿姆斯特丹的歐洲乳癌會議上公佈。

這個療法是針對難纏的HER2型乳癌，雖然患病女性仍需要接受手術確保癌細胞全部消失，但醫生希望這個方法可以令她們免卻化療之苦。

英國《每日郵報》/《每日電訊報》

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