Bridging the Gap to Reimbursement for New Therapies

Imagine this scenario: A wealthy Australian woman is diagnosed with early breast cancer. She has her tumour removed but there is some uncertainty as to whether she will benefit from chemotherapy. Her doctor recommends she pays for a breast cancer genomic test that will reveal specific information about her own cancer to help determine whether chemotherapy will make any difference, or whether she can be safely treated with hormone therapy alone.

The test – known as the Oncotype DX^® Breast Recurrence Score test – is not reimbursed by the Government, but this patient comfortably pays $5000 to get the result. Like most women who have this test (around 70%), it reveals that she is safe to be treated with hormone therapy alone.

On the other side of town is another woman with the same type of breast cancer. She hasn’t got $5000 for an Oncotype DX test, so her doctor decides to err on the side of caution and prescribes chemotherapy, just to be safe. For this woman, it means up to six months of treatment and potentially, debilitating side effects including fatigue, nausea and hair loss. Some effects – like nerve damage – may be permanent. It might be too hard for her to keep working. Her family life and income may be severely impacted.

It doesn’t sound fair that two women have the same cancer, but one has a treatment path that is far more gruelling – simply because she could not afford the test that might help her avoid the more onerous path.

Unfortunately, this happens every day in Australia.

I am the CEO and founder of Australia’s largest independent pharmaceutical company, Specialised Therapeutics Australia, which provides the Oncotype DX test to Australian women under license from a US partner.

Our company has tried unsuccessfully six times to have this test reimbursed by the government for all Australian women – as it is for early breast cancer patients in many other developed countries – including the US, UK, Canada, Germany, Italy and France. The Oncotype DX test is recommended by the world’s and Australia’s most renowned breast cancer specialists as the “preferred” genomic test, because of the strong clinical evidence underpinning it.

There is no question about the Oncotype DX test’s safety, efficacy or utility. Australia’s peak regulatory authority – the Therapeutic Goods Administration – has approved use of this technology in Australia, and every international breast cancer treatment guideline recommends its use. It is prescribed by leading surgeons and breast cancer specialising oncologists every day. This is simply a question of cost. Some might say we should just lower the price, but it’s not that simple. This test is under license from an international partner and already Australian women are offered the lowest price in the world to access the technology. International governments pay more per test for their residents to have it – because they know it offer women with breast cancer an informed choice to avoid 6 months of toxic chemotherapy, and will ultimately save the health budget significant sums in chemotherapy costs.

We realise that the health budget is a finite resource, particularly given the impact the Covid-19 pandemic, and that not everything can be reimbursed by the government.

It is for this reason that Australians, including consumers, industry and governments – must find new ways for Australians to finance access to new innovative therapies and technologies that are not yet reimbursed.

I was still bruised from MSAC’s most recent rejection of Oncotype DX when I found myself in a large retail outlet. Surrounded by signs about interest-free payment plans for everyday items, the idea struck me: If Australians can purchase almost anything for the home via this type of arrangement, why not important health-related purchases that their doctor would like to prescribe, but cannot because they are not yet funded by the government?

With this in mind, we approached third party finance providers – Latitude Finance – to help us find a workable payment solution for the Oncotype DX test and potentially, other prescription healthcare items.

It has taken many months to negotiate, but we are pleased to advise that from March 15 this year, Australian women will be able to undertake an interest-free payment plan over a nominated period of up to two years to more manageably afford this test.

We believe this is a first for the pharmaceutical industry but expect we won’t be the last. This will pave the way for other companies to assist patients in this way, because the gap between availability of new therapies and technologies and reimbursement must be bridged without the need for patients to find lump sums that entail tapping into their super or home mortgage equity.

Patients are falling through the gaps as they await affordable access to new treatments or technologies that might improve their prospects, or overall outcome.

While this new finance option is a good short-term outcome for Oncotype DX, the big picture solution must be reimbursement.

STA remains committed to progressing discussions regarding Oncotype DX with the Federal Government to ensure that cost is not an issue for any eligible woman. We know that even a monthly payment plan will render the test inaccessible for some. It is a technology that should be freely and readily accessed and funded by the Federal purse.

The irony here is that reimbursing Oncotype DX will actually save the federal budget and the taxpayer all the associated costs of a woman having chemotherapy treatment – not only the cost of the therapy itself, but potentially time off work and long-term health and economic consequences.

We all recognise that the Federal health budget is not a bottomless pit. But personal health is priceless, and offering more avenues to access these returns control to the patient. Healthcare must be affordable and accessible. Payment plans are one way to help achieve this. If patients, customers and consumers can make an informed decision to spend several thousand dollars to buy a couch or a television and pay later, it’s only fair that they can make the same informed decision with their healthcare practitioner to access the latest therapies and medical technologies not yet reimbursed by the government.

Meet the Specialist: Dr Aminudin Rahman Bin Mohd Mydin

“Too often, patients are seeking information early on from social media and from the internet and they may be being provided with misinformation about unproven therapies. If they wait too long to seek medical care, then their cancer might not be curable.”

Malaysian sarcoma specialist Dr Aminudin Rahman Bin Mohd Mydin, Consultant Clinical Oncologist from KPJ Damansara Specialist Hospital, believes novel immunotherapy agents may one day change outcomes for difficult to treat sarcomas, with “promising responses” recorded in some of his own patients. While there is no phase 3 evidence yet supporting the use of immunotherapy in these cancers, patients can have hope that ongoing research efforts will continue to make a difference, as will the emergence of targeted agents to enable more durable disease control. As Specialised Therapeutics Asia prepares to reintroduce a global sarcoma therapy to the region, Dr Aminudin outlined his vision.

What is your reaction to the reintroduction of a global sarcoma therapy in South East Asia?

This is an exciting new development and will provide a new treatment option for many of our sarcoma patients. Essentially it means we have another option for these patients who are affected by these rare tumours. Sarcomas represent about 1% of adult cancers in Malaysia and in the region, but unfortunately, most patients present at advanced stage, when their disease has metastasised. This is a significant problem. Results are poor with current therapies, so any additional options are very welcome.

What is the incidence of sarcoma in South East Asia and what are the median survival outcomes?

Data in Malaysia suggests there are just over 200 cases of sarcoma per year in this country alone (Malaysian National Cancer Registry Report 2012-2016). About one-quarter of these would be liposarcoma or leiomyosarcoma, which are another sarcoma subset.

Almost half – around 40% – of patients who present with sarcoma in Malaysia are already at Stage 4 disease, with about 20% presenting at stage 3.

When they are stage 4, they are incurable, and the median survival is about 14 – 20 months. That is why there is this need for new therapies. With standard induction therapies, the response in these patients is not that great – patients would typically not receive a very durable, long term response. So, what we need is a maintenance therapy that can be introduced after induction therapy. This is typically the treatment scenario we would see with other advanced cancers, like lung, breast and ovarian cancers

What are the early symptoms of sarcoma and are there any known causes?

Early symptoms of sarcoma might be when a patient develops a painless mass or a lump, usually on the upper or lower limbs, although they can arise anywhere in the body. A lump in the abdomen may cause back pain, abdominal pain and so forth. Some of the possible causes can be previous radiation exposure or radiotherapy treatment. Some patients have had this kind of therapy many years earlier and can later develop a sarcoma at the site. In other cases, there may be a genetic abnormality that can predispose someone to sarcoma.

But generally, these cancers are rare and a cause for the vast majority of sarcomas is unknown.

What is your sarcoma vision for 2030?

It is my hope that by 2030, sarcomas are diagnosed at earlier stage when they are curable and I think to do that here in Malaysia, we will need a cultural shift.

Too often, patients are seeking information early on from social media and from the internet and they may be being provided with misinformation about unproven therapies. If they wait too long to seek medical care, then their cancer might not be curable.

There is certainly hope for patients and the signs are good. It is a long journey, but we are learning more all the time about genetics and molecular biology, which is helping us develop more targeted therapies. In other cancers like metastatic non-small cell lung cancer for example, one in three patients are now alive at five years post-diagnosis with effective treatment. This was unheard of 10 or 20 years ago. We can also replicate that in sarcoma, but there is a lot of work to do, and we have not reached that level yet. Sarcoma is a very heterogenous group of diseases, so we need to better understand the disease at a molecular and genetic level and translate that understanding into new therapies.

When it comes to immunotherapy, there are also some promising signs, although there is no phase 3 data yet. Trials in small groups have shown this kind of treatment to be effective, although it is not an approved therapy platform yet in sarcoma. I have used it and have seen some response. I expect there will be a significant role for immunotherapy in the future.

As a clinician, what inspires you about working with sarcoma patients?

I was not born into a family of doctors, but I was inspired by doctors treating our family growing up. I decided to do oncology after graduation – it is the contact with patients and their families that inspires me most. I have learned so much from many of them.

From a scientific perspective, oncology is an exciting field as there are always new developments. It is important that our fascination with the science doesn’t mean we forget there is a patient and a family in front of us and they are all impacted by the disease. Cancer impacts a whole family and a whole society.

Being an oncologist is challenging, time consuming and exhausting. But it is ultimately satisfying to treat and support the patients and their families through the journey.

*May 2021

Purple: Pancreatic Cancer Conversations Issue #1

Click on the cover image to see inside Purple, a magazine produced by Specialised Therapeutics for pancreatic cancer patients. Thanks to all patients, families and clinicians who provided their stories and insights.

Australian Financial Review: 15 March, 2021

Australian Financial Review

By Carrie LaFrenz 15 March 2021

Latitude Offers Payment Plans for $5000 Breast Cancer Test

When Carlo Montagner – the founder of Australia’s largest independent specialist pharmaceutical company – was buying a new sofa at Harvey Norman he saw a Latitude Financial Group sign, and it sparked an idea.

A year on, his company, Specialised Therapeutics Australia, has signed a new deal with the IPO hopeful, which will provide interest-free payment plans for up to two years for a genomic test for breast cancer that costs $5000.

Carlo Montagner, founder of Specialised Therapeutics Australia, says the company has been rejected six times by the federal government after seeking reimbursement for a commonly prescribed genomic breast cancer test. Arsineh Houspian

The multi-gene test, known as the Oncotype DX Breast Cancer Assay, predicts a patient’s likely benefit from chemotherapy and the overall risk of breast cancer recurrence. It is able to determine whether an early breast cancer patient needs chemo, or whether she can be safely treated with hormone therapy alone. Without this test, many women might go though chemo unnecessarily.

“I thought if people can spend $4000 or $5000, or even $7000 purchasing sofas or a barbecue – everyday items – why can’t they take advantage of a similar interest-free payment plan for an item that is going to benefit their health, which is far more important,” Mr Montagner told The Australian Financial Review.

STA has been rejected six times by the federal government after seeking reimbursement for this commonly prescribed test, approved by the TGA. Mr Montagner said as a result, he had to seek novel ways for women to finance this assay.

After seeing the Latitude sign in the home and electronics retailer, Mr Montagner contracted several possible lenders, including buy now, pay later players Zip and Afterpay, which do offer dental plans.

“We are entering uncharted territory here. Zip and Afterpay had a cap of $2000, and they were risk averse,” Mr Montagner said.

“This is a pilot, exclusive arrangement with Latitude for a breast cancer assay that helps women make that decision, whether they should or shouldn’t have chemotherapy. If this goes well, then we would like to advance this into our other cancer therapies.”

Australia an ‘outlier’

Credit plans in oncology have always been a tricky space due to the perceived risk associated with cancer patients. But the women who are eligible for Oncotype DX are typically “healthy” apart from breast cancer diagnosis; have been diagnosed early and are typically under 65 years old.

Only about 300 women a year in Australia are accessing this test, but 3000 out of the 18,000 women a year diagnosed with breast cancer should be getting it.

Mr Montagner added some women seeking the genomic test but who did not have the disposable income to cover it, would be willing to pay by credit card, break into their superannuation or dip into the equity of their home.

Mr Montagner is still trying to get federal Health Minister Greg Hunt’s attention on the matter (he has also spoken to his local member, Treasurer Josh Frydenberg).

“This test is reimbursed on every international cancer treatment guideline around the world,” Mr Montagner said. “Australia is an absolute outlier here. This is being prescribed by cancer experts in Australia every day.”

STA pays a sliding merchant service fee based on the payment plans women choose from six, 12, 18 or 24 months. No fee is paid by the oncologist, but there is a $99 annual card fee paid by the patient.

As a new customer with Latitude, the women would have to go through traditional credit history checks. This is a regulated product under the Credit Act. Patients will pay no interest, provided monthly repayments of up to $208 are met.

Latitude’s instalment payments product has done well, thanks to the growth in sales at retailers such as Harvey Norman, but the pair have been criticised for pushing a credit card with an eye-watering interest rate of 22.74 per cent.

Latitude, which is owned by buyout group KKR, alternative investor Varde, Deutsche Bank and now Japan’s Shinsei Bank, declined to comment. The group already provides payment plans in audiology, cosmetics and dental segments.

This agreement is a first in oncology and expected to pave the way for other pharma companies to follow suit and find alternate ways for patients to access new therapies and technologies that are not yet reimbursed via the PBS.

STA is an independent pharma company supplying specialty medicines (mostly in oncology and haematology) in Australia, New Zealand and south-east Asia.

The company was founded 12 years ago by Mr Montagner and his wife Bozena Zembrzuski, who brought a chemo medicine called Abraxane to Australia that has since become one of the most successful chemotherapies commercialised here.

Breast Cancer Patients Can Access New Interest-Free Payment Plan for Genomic Test That May Help Them Avoid Chemotherapy

Melbourne, Australia, 15 March 2021: BREAST cancer patients who wish to have a genomic test that may help them to avoid chemotherapy can now take out interest-free payment plans of up to two years to pay for the test, following an exclusive arrangement between independent pharmaceutical company Specialised Therapeutics Australia (STA) and Latitude Finance.

This partnership represents what is believed to be the first time an Australian pharmaceutical company has engaged with a third-party financial institution to help patients fund access to a breast cancer technology like the Oncotype DX^® test, but is expected to pave the way for similar opportunities due to a lack of Federal Government funding for many therapies commonly available in other countries.

Under the terms of the new agreement, Australian women who decide to take an Oncotype DX Breast Recurrence Score test can now use an interest-free two-year payment plan to help afford the $5000 one-off test, which has been shown in large randomised clinical studies published in leading medical journals to identify the majority of breast cancer patients who do not benefit from chemotherapy.1,2 Patients will pay no interest, provided monthly repayments of up to ~$208.00 are met.

STA Chief Executive Officer Mr Carlo Montagner said the new finance option followed six “frustrating” attempts to have the Oncotype DX test reimbursed by the Federal Government for all eligible breast cancer patients, as is the case in many countries around the world.

“We have tried on multiple occasions to have this test reimbursed for Australian women. These efforts are ongoing, but we trust that in the interim, this new third-party finance arrangement will help many breast cancer patients afford this important technology which in turn, may help them to avoid chemotherapy,” he said.

“Avoiding chemotherapy when there is no proven benefit to be derived can spare many women from experiencing six months of aggressive treatment, which can be traumatic and debilitating. In some cases, it can result in permanent side effects.

“It is unfortunate for Australian women with breast cancer that the Oncotype DX test is not reimbursed as it is in many other developed countries, including the US, UK, Canada, Germany and other European territories.

“In those countries, it is widely used. The Oncotype DX test is recommended by the leading international cancer treatment guidelines as a test to help guide decisions about whether a woman actually needs chemotherapy or whether she can be treated with hormone therapy alone.”3-6

An Oncotype DX test currently costs Australian women $5,000. It is marketed by STA under exclusive license from US-based Exact Sciences and is appropriate for women who have been diagnosed with early breast cancer, whose cancer is hormone receptor-positive, HER2 negative and has up to three positive lymph nodes.1,2

However, the lack of reimbursement has placed it out of reach for many women, who have gone on to endure chemotherapy – sometimes unnecessarily.

Mr Montagner added: “Without Federal Government funding and without accessible personal savings, hundreds of Australian women have been unable to afford this important test.

“As a company and a community, we must find new ways for all Australians to access new therapies and technologies that are recommended by their specialist doctors but are not reimbursed. This is a step in the right direction. STA is proud to partner with Latitude Finance, which has an established presence in healthcare and is now extending its offering in this space due to strong patient demand.”

Women who opt for an Oncotype DX test have a tumour sample taken during their first breast cancer surgery, which is sent to a US specialist laboratory for analysis. The sample is screened for 21 specific genes and this information has been proven to accurately inform a woman’s long-term risk of a breast cancer recurrence, as well as the likely benefit of chemotherapy treatment, over and above standard hormone therapy alone.^1,2

Interest-free payment plans to access the Oncotype DX Breast Cancer Recurrence Score Test will be available from 15 March.

Ends.

Further Enquiries

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com

About Specialised Therapeutics Asia

Specialised Therapeutics is an international biopharmaceutical company established to commercialise new therapies and technologies for patients in Australia, New Zealand and across South East Asia. ST and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. Additional information can be found at www.stbiopharma.com

About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early stage, hormone-positive, HER2- invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score® test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score® test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com (US website).

NOTE: Oncotype DX, Oncotype DX Breast Recurrence Score, Oncotype DX Breast DCIS Score, and Oncotype DX Genomic Prostate Score, and Oncotype DX AR-V7 Nucleus Detect are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.

• The Oncotype DX Breast Recurrence Score^® Test now able to be funded via 6 to 24 month interest-free payment plans
• First time an Australian pharmaceutical company has engaged with private financial provider to fund a global standard of care healthcare product
• Specialised Therapeutics Australia to facilitate new interest-free payment plan following six unsuccessful submissions to the Federal Government for reimbursement – despite being reimbursed in many other developed countries

Melbourne, Australia, 15 March 2021:

References:

1. Sparano JA et al. N Engl J Med. 2018; ;379(2):111-121
2. Kalinsky K et al, San Antonio Breast Cancer Symposium 2020 Presentation GS3-00
3. NCCN Guidelines Insights: Breast Cancer, version 3.2018
4. IQWIG Press Release, September 2018
5. NICE Diagnostics Guidance DG34 December 2018
6. Burstein et al. Ann Oncol. 2019 ; 30(10) : 1541-1557

Oncotype DX Breast Recurrence Score Test^® and Oncotype DX^® are registered trademarks of Exact Sciences, Inc. Oncotype DX^® is under license from Exact Science Inc.

Pharma Dispatch: 15 March, 2021

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BioPharma Dispatch

15 March 2021

Australians Will Need to ‘Reconcile Themselves to this New Reality’

STA’s Carlo Montagner says the company’s finance arrangement with Latitude Finance to support patient access to a cancer recurrence diagnostic is unfortunate but that Australians need to “reconcile themselves to this new reality” while government funding remains such a challenge.

Specialised Therapeutics Australia (STA) has announced the arrangement with Latitude Finance under which breast cancer patients can access interest-free payment plans of up to two years to pay for the Oncotype DX genomic test.

The profiling test analyses 21 genes in a breast cancer tumour sample. The test can help predict the risk that a woman’s breast cancer may recur and the likely benefit chemotherapy may have in reducing that risk.

Results from the TAILORx clinical trial showed women diagnosed with hormone receptor-positive, HER2-negative, node-negative early breast cancer may be able to avoid chemotherapy if they undergo the OncotypeDX test and receive a mid-range recurrence score.

The unreimbursed test currently costs Australian women $5,000 putting it out of reach for many women who have gone on to endure chemotherapy – sometimes unnecessarily.

STA CEO Carlo Montagner said the new finance option followed six “frustrating” attempts to have the Oncotype DX test reimbursed by the federal government for all eligible breast cancer patients, as is the case in many countries around the world.

The last rejection by the Medical Services Advisory Committee was marked by an evaluation process in which a competitor made a submission just days before it was due to consider Oncotype DX. STA was not informed of the submission, let alone given an opportunity to respond, and it was only revealed through a Freedom of Information request.

Mr Montagner said he believes the partnership with Latitude Finance is the first time an Australian pharmaceutical company has engaged with a third-party financial institution to help patients fund access to a technology like the Oncotype DX test.

He told BioPharmaDispatch the arrangement “is a pity but what was the alternative?”

“Australians may have to reconcile themselves to this new reality. If decision-making does not change, these arrangements will be the natural consequence of no access or very delayed access.”

He said, “This will pave the way for similar outcomes due to a lack of federal government funding for many therapies and treatments commonly available in other countries.”

Under the terms of the agreement, Australian women who decide to take an Oncotype DX Breast Recurrence Score test can now use an interest-free two-year payment plan to pay for the one-off $5,000 test. Patients will pay no interest, provided monthly repayments of up to $208.00 are met.

Mr Montagner added, “Without Federal Government funding and without accessible personal savings, hundreds of Australian women have been unable to afford this important test.

Pharma in Focus: 15 March, 2021

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PHARMA IN FOCUS

By Nick Lush 15 March 2021

Is This a Funding Breakthrough?

With the Zimmerman inquiry being told the PBAC is not up to scratch on delivering medicines to Australian patients, a ‘thinking outside the square’ option being pioneered by local pharmaSpecialised Therapeutics (STA) appears to be blazing a new funding trail.

STA has today announced that, after “six frustrating attempts” to secure government reimbursement for a cancer diagnostic without success, it has won backing from the private sector that will support patients financially while it continues to seek public funding.

The company has struck an agreement with Latitude Finance so breast cancer patients can access the Oncotype DX test, “which has been shown in large randomised clinical studies published in leading medical journals to identify the majority of breast cancer patients who do not benefit from chemotherapy”.

“Under the terms of the new agreement, Australian women who decide to take an Oncotype DX Breast Recurrence Score test can now use an interest-free two-year payment plan to help afford the $5000 one-off test,” STA said.

“As a company and a community, we must find new ways for all Australians to access new therapies and technologies that are recommended by their specialist doctors but are not reimbursed.

This is a step in the right direction. STA is proud to partner with Latitude Finance, which has an established presence in healthcare and is now extending its offering in this space due to strong patient demand,” Montagner added.

The Oncotype DX test is marketed in Australia by STA under exclusive license from US-based Exact Sciences and is appropriate for women who have been diagnosed with early breast cancer, whose cancer is hormone receptor positive, HER2 negative and has up to three positive lymph nodes, STA said.

“Without federal government funding and without accessible personal savings, hundreds of Australian women have been unable to afford this important test,” Montagner said.

Interest-free payment plans to access the Oncotype DX Breast Cancer Recurrence Score Test become available from today, STA said.

Suzanne Lombardo – International Women’s Day

This International Women’s Day, we celebrate all women – particularly those who are facing a breast cancer diagnosis as well as those striving to make a difference.

STA oncology liaison Suzanne Lombardo understands both perspectives. In this piece, she explains how her own experience with the disease has changed the way she now approaches her work.

“I was diagnosed with breast cancer just over two years ago, when I was 61. I am pretty fit and healthy, and I had made a decision to have breast reduction surgery. It was something I just wanted to do for myself and it has saved my life.

Three days after my operation I returned to the hospital to get my drains removed. My appointment was to see the nurse however when I arrived, I was told that my surgeon wanted to see me. As I sat down he said, ‘I have good and bad news’. This was very unexpected.

He was holding a pathology report. Not all plastic surgeons have the breast tissue examined by a pathologist but thankfully, mine did. The surgeon told me that while he had seen nothing during the operation at all, the pathology had revealed two small malignant tumours in my left breast.

He showed me the report which he had written ‘WOW” over as to be diagnosed like this is very unusual. I was stunned, as a mammogram only four weeks prior to surgery had showed nothing.

He immediately contacted one of the best Breast Oncology Surgeons in NSW and I was booked to see him at 7.30 the next morning. I expected to be told that they would monitor me, as basically I had already undergone surgery and the tumours were now excised with clear margins. Because of this expectation, and as I had kept my surgery private, I attended the appointment alone.

But I was then told I could still need a full double mastectomy, depending on the results of additional tests. Attending the appointment alone was a mistake, as I was so shocked I did not ask any questions.

I am a registered nurse, but I am the world’s biggest sook and some of the tests were quite confronting – with one of them, I had five needles inserted around the nipple and they injected a dye. The MRI scans were also really claustrophobic. After these tests I had lymph node biopsies.

It was determined that I had invasive lobular carcinoma, that was hormone positive and HER2-. It had not spread to my lymph nodes, thankfully.

I did not need chemotherapy, but I had six weeks of radiation treatment every day. I was due to start hormone therapy, but the overall benefit to me was going to be small, so in consultation with my medical oncologist I opted not to because of the possibility of experiencing an associated side effect. As a result, I must be very vigilant, and I have a regular MRI scan to keep an eye on things.

I coped very well with the radiation, although I crashed a bit about three weeks after finishing when I felt quite depressed.

I think it is because you are so busy when you are first diagnosed and all of a sudden, the ‘busyness’ stops, and you have time to think.

You do go through a grieving process after being diagnosed with breast cancer because it makes you face your mortality. Our breasts are strongly tied to our identity and you don’t give them up easily.

I am really thankful I had my breast reduction surgery. Without it, it would have been another year before my next mammogram and my doctor has said it would have been a totally different ball game.

Everybody associated with my diagnosis and treatment was so kind and supportive and open with the treatment pathway and benefits. Everyone’s pathway is different.

How has my own diagnosis influenced my work? I have always been passionate about being a voice for patients and ensuring that doctors know about new therapies that can make a difference.

One of the products we market is the Oncotype DX Breast Recurrence Score test. This test basically determines whether women with my type of cancer really need chemotherapy, or whether they can be safely treated with hormone therapy alone and avoid chemo.

Despite the best efforts of my employer, this test is still not reimbursed for Australian women. It costs $5000 to have this test, but it is reimbursed in most other parts of the world and is considered a standard of care.

I did not have this test at the time of my own diagnosis, because of the cost. Having it would have put my mind at ease about whether chemotherapy would make a difference to my long -term outcome, based on my own tumour biology. Breast cancer is not a ‘one size fits all’. I know of women who have had the same diagnosis as me and had a recurrence even though standard pathology might have indicated their own risk of recurrence was small.

The thought of recurrence does play on your mind. In all my dealings now with breast cancer oncologists, I always remember there is someone like me who will ultimately benefit if I can provide doctors with all relevant information about new therapies or technologies like Oncotype DX.

For the patient, being armed with all the right information is empowering. While I no longer work directly with patients, I am working for them. I really love my work and I am really grateful that my own health is good.”

*March 2021.

Introducing GIST and Sarcoma Specialist Dr Richard Quek

Dr Richard Quek says he has “the best job in the world”.

The Singapore based specialist in both GIST and sarcoma cancers believes it is a great privilege to care for patients during what is often a difficult cancer journey. “I enjoy the deep interactions I have with my patients and I am honored that they come to me and entrust me with their treatment, health and life,” he reflects.

As STA prepares to launch a new GIST therapy in South East Asia, Dr Quek generously shared his insights about the disease, which “most people have never heard of” before they are diagnosed. “Patients should ultimately know there are good treatments available for GIST, even for those patients whose disease has spread,” Dr Quek said. “The median survival rate is now more than five years and we have several lines of therapy for patients – so when one drug becomes ineffective, there are other options we can turn to. Patients who are diagnosed with GIST should have hope.”

Firstly, what is a GIST tumour and who do these tumours affect?

A gastrointestinal stromal tumor – or GIST – is the most common type of soft tissue tumor in the gastrointestinal (GI) tract. GIST is thought to arise from the Interstitial Cells of Cajal (ICC), which are the pacemaker cells of the GI tract.
Within the GI tract, the stomach is the most common primary location for a GIST, followed by the small bowels. GIST is also known to arise in the rectum.
GIST tends to affect adults, and typically, people are diagnosed in their sixties. There are however, some rare and specific forms of GIST that affect young children. A proportion of these are familiar in nature (i.e. heritable diseases).

1. What makes a GIST tumour different to other cancers?

GIST differs from other cancers in several aspects. GIST arises from the mesenchymal layer (connective tissue) of the human body while most other solid tumors arise in the epithelial layer (which lines the internal organs). As such, GIST is usually grouped under the umbrella of sarcoma instead of carcinoma.

GIST is molecularly heterogeneous. Most GISTs are driven by a mutation in either the KIT or PDGFRA gene, resulting in uncontrolled cell growth and metastasis (spread). While the minority of GIST are driven by a whole host of other genes, including NTRK, SDH, BRAF, NF1 etc. In some cases, we do not detect any driver mutations, we call them wild type GIST. But wild type GIST represents fewer than 10% of all GIST cases. Very rarely, GIST can affect young children and in the pediatric population, two cohorts exist. The first is familial GIST where there is a mutation in the blood line and the driver mutation is heritable. Some of these heritable genetic mutations include NF1 and KIT. Other cases of paediatric GISTs involve non-blood line mutations in SDH genes.

2. How common is the incidence of GIST in South East Asia and particularly, in Singapore?

GIST is a rare tumor and most patients have not heard of GIST prior to their own diagnosis. While we do not have exact incidence figures of GIST in Singapore and South East Asia, the incidence is believed to be similar to that in the west, which is approximately 15 cases per million population per year. However, autopsy data of incidentally detected GIST suggest the incidence of GIST to be higher than previously estimated.

3. What are the early symptoms of these tumours?

Symptoms are variable. Some patients may have an asymptomatic lesion that is found by chance, while others might present with massive lesions that are causing significant symptoms.

Symptoms also depend on where in the GI tract the tumor arises from and/or where it has spread to.

Common symptoms include:

Abdominal bloating,
Early satiety (feeling full easily after a small meal)
Symptoms of anemia (low red blood cell count)
Pain (in cases of tumor perforation)
Rectal symptoms including feeling of incomplete bowel evacuation, blood in stools
Urinary symptoms (when the rectal GIST irritates the urinary passage). Symptoms resemble those of an enlarged prostate and include urinary frequency, poor urinary flow, or a sense of incomplete urination

4. What are the next treatment paradigms for GIST?

Treatment of GIST involves a multi-disciplinary approach.

In cases of localised disease, where the disease has not yet spread, treatment will involve surgery with or without adjuvant (preventive) systemic treatment. If the tumor is easily resectable, surgery is advised. Patients are then risk stratified based on tumor size, site, mitosis per 50 high-power field (HPF) and presence/absence of tumor rupture. Patients with low and very low risk GIST are best observed post-surgery. Patients with high-risk GIST are advised to commence on extended adjuvant systemic therapy with imatinib. Currently, the duration of extended adjuvant imatinib is three years. For patients with intermediate risk GIST, the data is less clear and the clinical situation calls for shared decision making with the patient.

In cases of localised GIST where surgery is potentially morbid e.g. rectal GIST involving an abdomino-perineal resection and permanent colostomy, one can consider pre-operative systemic therapy to downsize the tumor prior to surgery.

In cases of metastatic GIST, treatment is palliative. Having said that, the field has made many significant advances since the early 2000s. We now have four lines of approved tyrosine kinase inhibitors (TKIs) for use in advanced GIST including imatinib, sunitinib, regorafenib and now, ripretinib.

Notably, the response to each type of drug also depends on the molecular profile. Some GIST harbour mutations which respond very well to certain drugs while others do not. Making things even more complicated, some specific subtypes of mutations within the same gene respond differently to the same drug. For example, in KIT-mutant GISTs, patients with KIT exon 11 respond well to imatinib while those with KIT exon? respond less well.

5. What is the five-year survival rate for GIST cancers?

With the development of effective drugs, median survival of patients with advanced/ metastatic GIST is now more than five years.

Most clinicians and pathologists are now familiar with diagnosis and initial management of GISTs. The potential blind spots could be molecular testing at initial diagnosis and potentially at time of resistance. Knowing this information may help tailor our choice of drug use.

6. What could the availability of new drugs mean for advanced GIST patients? Why is there a need for new therapies for these cancers? What would you like patients to know about the available treatments for GIST?

Effective treatment delays cancer worsening, prolongs period of disease control and potentially, survival.

There is clearly a need to discover new therapies because while we have many treatments available, advanced/ metastatic GIST is still considered incurable.

I would like patients to know there are many effective lines of treatment even in the advanced/ metastatic setting.

There is good treatment available for GIST and availability of specialised care for this rare cancer here in Singapore. Patients can be heartened by this.

7. On a personal level, what do you love about your job? What has inspired you to work with GIST cancers and sarcoma in particular?

This is the best job in the world!

I enjoy the deep interactions I have with my patients as they go through their difficult cancer journey. I am honored that they come to me and entrust me with their treatment, health (and life).

Sub-specialsing in GIST and sarcoma is a little serendipitous. Prior to joining the private sector, I had trained and worked at the National Cancer Centre Singapore. At the time of completion of my medical oncology fellowship, I had noticed a service gap in my centre, namely in the area of bone and soft tissue sarcoma and GIST. That got me thinking and before I knew it, I was at the Dana-Faber Cancer Institute in Boston doing a two-year clinical research fellowship in GIST and sarcoma . This has been followed by a wonderful career thus far dedicated to sarcoma, GIST and general oncology. I am very much enjoying what I do!

8. What are the research areas offering hope to patients impacted by these cancers? Do newer immunotherapy agents currently play a role in GIST or would you like to see more research and development in this area?

Isolating the mechanisms of resistance and developing new drugs for resistance offers hope to patients.

The role of immunotherapy is currently more limited in GIST. Cancers which are addicted to specific genetic mutations like GIST may have a lower mutational burden and do not respond well to single agent immunotherapy (check point inhibitors).
Moving forward, we eagerly await new data surrounding novel agents, drug combinations, immunotherapy-TKI combinations in GIST. There is definitely hope for continuing to improve outcomes for these cancers.

*February 2021.

Channel 10 News: December 2020

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The following stories appeared on Channel 10 News and other news outlets nationally. Click on the thumbnails below to view them.

Breast Surgeon Dr Jane O’Brien on Channel 10 News

Breast Cancer Surgeon Dr Chantel Thornton on ABC News

Breast Cancer Surgeon Dr Chantel Thornton on 7 News

Breast Surgeon Dr Jane O’Brien on Channel 7 News