Door opens to expensive liver cancer Tx in SA

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More cancer patients in South Africa with inoperable liver tumours may now have access to a one-off radiation treatment option paid for by medical aid – at a cost of up to R250,000 – to extend their lives by a few months reports Business Day.

New research shows that SIR-Spheres Y-90 resin microspheres, a permanent, single-use, implanted medical device used in selective internal radiation therapy, could shrink liver tumours sufficiently to make surgery an option, even a cure. The device was developed by Australian company Sirtex Medical.

The report says Discovery Health Medical Scheme has indicated it may approve more reimbursements in “appropriately selected patients” after reviewing the evidence. Fedhealth said it would review funding of the treatment method “on a case-by-case basis, and then make a reimbursement decision”.

The treatment is now available at more than 950 sites globally including more than 300 centres in the US. In South Africa, its use has been limited by a high rate (80%) of medical-aid reimbursement rejection. The Steve Biko Academic Hospital at the University of Pretoria was the first in South Africa to treat liver tumours with SIR-Spheres microspheres in 2012.

The report says the procedure is now available only at the Wits Donald Gordon Medical Centre in Johannesburg, the Rondebosch Oncology Centre in Cape Town, and the Life Entabeni Hospital and Rainbow Oncology Centre in Durban.

Some cancer specialists welcomed Discovery Health’s move, saying it gives more patients access to a technology that can prolong life and has “great potential in management of other cancers involving the liver”. They hope other schemes will follow.

The report says that in South Africa, primary liver cancer is a leading cause of death. It is diagnosed in about 3,500 patients annually, according to the University of Pretoria’s department of nuclear medicine website. The university reported that about 85% of these cases will be inoperable.

Durban interventional radiologist Gareth Bydawell has treated about 30 patients with SIR-Spheres at Entabeni Hospital and says costs vary, depending on “the amount of consumables during the process”. Because treatment is one-off, the cost is “comparable to certain chemotherapy medications which are required on a regular basis”.

The report says because SIR-Spheres can shrink tumours, patients with previously inoperable tumours may “well become eligible for surgery in some cases”. The risk profile is “very small, with careful work-up before the treatment and with safe technique” and the risk of systemic side effects is reduced. “Being able to offer a patient more time is priceless,” Bydawell says.

Discovery Health CEO Jonathan Broomberg says the decision to reimburse was taken after a review showing evidence “sufficient to demonstrate positive net health benefits in carefully selected patients who may undergo treatment in specialised hepato-biliary centres”. Evidence suggests SIR-Spheres can add “significant and meaningful value to patients who would otherwise have no other treatment option at this stage of their disease”. Broomberg says in one cancer type, treatment may increase life expectancy up to 22 months instead of untreated patients dying within six months.

Bydawell says suitability for treatment all depends on the patient’s particular disease profile. There are contra-indications. Bydawell says he would not prescribe SIR-Spheres for patients with malignant disease outside the liver, or if liver function were compromised significantly.

Patients with a blood clot blocking or narrowing the portal vein that brings blood to the liver from the intestines, or who have “abnormal vascular anatomy” that would result in significant reflux of hepatic arterial blood to the stomach, pancreas, or bowel, are “not ideal candidates”, he is quoted in the report as saying.

 

Sirtex has also announced that the UK National Institute for Health and Care Excellence (NICE) has issued a new Medtech Innovation Briefing (MIB) stating that NHS doctors and commissioners may consider SIR-Spheres Y-90 resin microspheres as an alternative to standard therapy with trans-arterial chemo-embolisation (TACE) or sorafenib in the treatment of patients with inoperable primary liver cancer (hepatocellular carcinoma or HCC).

The new NICE MIB states that patients with inoperable HCC have a poor prognosis and limited effective treatment options, and that existing clinical research evidence suggests that SIR-Spheres Y-90 resin microspheres are as effective as both TACE and sorafenib.
One of the MIB specialist commentators noted that SIR-Spheres Y-90 resin microspheres are also better tolerated than TACE, with fewer incidences of post-embolisation syndrome and shorter in-patient hospital stays.

The new MIB also explains that unlike TACE, which requires multiple procedures, or sorafenib, a medication that must be taken daily, most patients treated with SIR-Spheres Y-90 resin microspheres usually require only a single treatment. SIR-Spheres Y-90 resin microspheres are an innovative form of local radiotherapy typically delivering 30-40 million tiny radioactive beads directly to liver tumours via the bloodstream, which permits a uniform distribution of radioactivity around the tumour sites whilst sparing normal liver cells. In a few patients with inoperable HCC, treatment with SIR-Spheres Y-90 resin microspheres has sufficiently reduced the size of liver tumours to allow potentially curative surgery with liver resection, ablation or transplantation.

Professor Daniel Palmer of the University of Liverpool and Clatterbridge Cancer Centre said that, “this NICE MIB is welcomed, as it opens the door for UK HCC patients to have access to SIR-Spheres Y-90 resin microspheres as a well-tolerated alternative to other standard therapies. Whilst exciting further research with this technology is already well along the way to completion, the new NICE MIB advice may be particularly important now for our patients who cannot tolerate TACE or sorafenib, or are ineligible for these treatments.”

Patient advocate Andrew Langford, CEO of the British Liver Trust, stated: “For many years, patients with inoperable HCC have had access to only two effective therapy options. Now, with the publication of the NICE MIB, NHS patients will have a further option in the form of SIR-Spheres Y-90 resin microspheres. This form of local radiotherapy is well-tolerated and convenient for the patient.”

SIR-Spheres Y-90 resin microspheres are a medical device used in an interventional radiology procedure known as selective internal radiation therapy (SIRT), or radioembolisation, which targets high doses of radiation directly to liver tumours. The treatment consists of tens of millions of radioactive Y-90 resin particles coated with the radionuclide ytrrium-90 (Y-90), each no bigger in diameter than a human hair. Interventional radiologists inject these resin particles, or microspheres, into the hepatic artery via a catheter inserted into the femoral artery through an incision in the groin. SIR-Spheres Y-90 resin microspheres become lodged in the capillaries that surround liver tumours, where they deliver a high dose of short-range (mean 2.5 mm; maximum 11 mm) beta radiation to the liver tumours, while sparing healthy liver tissue. The low specific gravity of Y-90 resin microspheres allows the blood flow to evenly distribute the radioactivity within and around the liver tumours.

SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumours in Australia, the EU (CE Mark), Argentina (ANMAT), Brazil and several countries in Asia such as Turkey, India, and Singapore. The product is also supplied for this use in countries such as Hong Kong, Israel, Malaysia, New Zealand, Taiwan and Thailand. SIR-Spheres Y-90 resin microspheres are approved in the US (FDA PMA approval) for the treatment of non-resectable metastatic liver tumours from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine.

 

Meanwhile, a new analysis of the MORE data on 606 mCRC patients treated with SIR-Spheres Y-90 resin microspheres at 11 US medical centres, published late last year, confirms that patient age is not a barrier to appropriate treatment with the microspheres.

“The analysis of the data from the MORE study confirmed that age alone should not exclude patients from being considered for, or receiving, SIR-Spheres® Y-90 resin microspheres treatment,” said principal study author, Dr Andrew S Kennedy, director, radiation oncology research, Sarah Cannon Research Institute. “Because older mCRC patients tend to receive less intense systemic therapy, local liver tumour control with selective internal radiation therapy, or radio-embolisation, may provide added benefits to this population. We look forward to continuing our research in this field to determine the most effective treatments for this patient population and improve outcomes.”

The new MORE analysis divided the 606-patient population into two groups, 446 patients under age 70 years at the time of treatment and 160 patients age 70 years or older when treated. Researchers also separately analysed the data for 90 very elderly patients who were age 75 and above. Mean ages in the younger, elderly, and very elderly groups were 55.9 +/- 9.4 years, 77.2 +/- 4.8 years, and 80.2 +/- 3.8 years, respectively. The researchers found that regardless of their age, the patients tended to have similar baseline characteristics.

However, the elderly patients were more likely (P < 0.001) to have liver metastases that did not occur at the same time as their primary tumour (metachronous tumours) or to have undergone previous surgery for their primary tumour (P = 0.009). Elderly patients also tended to have received fewer lines of chemotherapy treatment (P = 0.036) or no previous chemotherapy (P < 0.001) at all and were likely to have experienced a longer period of time between diagnosis and radio-embolisation (P = 0.011). In addition, the older patients were less likely to have received more than one radio-embolisation procedure.

Overall survival was statistically the same (P = 0.335) between the older (9.3 months) and younger patients (9.7 months). There were also no age-related differences for any grade of adverse event (P = 0.433), including the more serious or grade 3+ events (P = 0.482) within 90 days of treatment. Of note, gastrointestinal side effects were reported less frequently in elderly patients than in younger ones.

Similar profiles were also observed in comparisons between patients 75 years and older and those who were younger than 75 years old. Median overall survival was 9.3 months compared to 9.6 months (P = 0.987), respectively, and there were no significant differences in either grade 3+ adverse events (P = 0.398) or any adverse event (P = 0.158) within 90 days of treatment.

Abstract
Background: The effects of advancing age on clinical outcomes after radioembolization (RE) in patients with unresectable liver-dominant metastatic colorectal cancer (mCRC) are largely unknown.
Patients and Methods: This study was a retrospective analysis of 160 elderly (≥ 70 years) and 446 younger (< 70 years) consecutive patients from 11 US centers who received RE using ytrrium-90 (90Y) resin microspheres (90Y radioembolization [90Y-RE]) between July 2002 and December 2011. A further analysis was conducted in 98 very elderly patients (≥ 75 years). Statistical analyses of safety, tolerability, and overall survival were conducted.
Results: Mean ages (± standard deviation) in the younger (< 70 years), elderly (≥ 70 years), and very elderly (≥ 75 years) cohorts were 55.9 ± 9.4 years, 77.2 ± 4.8 years, and 80.2 ± 3.8 years, respectively. Overall survival was similar between elderly and younger patients: 9.3 months (95% confidence interval [CI], 8.0-12.1) and 9.7 months (95% CI, 9.0-11.4) (P = .335). There were no differences between cohorts for any grade adverse events (P = .433) or grade 3+ events (P = .482). Analysis of patients ≥ 75 years and < 75 years confirmed similar overall survival (median, 9.3 months vs. 9.6 months, respectively; P = .987) and grade 3+ events (P = .398) or any adverse event (P = .158) within 90 days of RE.
Conclusion: For patients with unresectable liver-dominant mCRC who meet eligibility criteria for RE, 90Y-RE microspheres appear to be effective and well-tolerated, regardless of age. Criteria for selecting patients for RE should not include age for exclusion from this potentially beneficial intervention.

Authors
Andrew S. Kennedy, David S. Ball, Steven J. Cohen, Michael Cohn, Douglas Coldwell, Alain Drooz, Eduardo Ehrenwald, Samir Kanani, Steven C. Rose, Charles W. Nutting, Fred M. Moeslein, Michael A. Savin, Sabine Schirm, Samuel G. Putnam III, Navesh K. Sharma, Eric A. Wang

Full Business Day report
Sirtex Medical material
Sarah Cannon Research Institute material
Clinical Colorectal Cancer abstract

 


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