麻豆传媒

Over the last 20 years, standard-of-care therapies for metastatic renal cell carcinoma (mRCC) have progressed from cytokines and vascular endothelial growth factor-tyrosine kinase inhibitors (VEGF-TKIs) to immune checkpoint inhibition (ICI)–based treatment. The availability of these , however, can vary worldwide.

A new study in analyzed the use of novel treatments for mRCC in Canada. The results show that in spite of having a publicly funded healthcare system, Canada increased its use of ICI-based treatments between 2011 and 2021, reflecting global patterns.

"The use of therapies after doublet ICI has mostly shifted toward VEGF-TKIs that were previously used in first line with subsequent treatments reflecting approved and available agents after previous VEGF-TKI," wrote Aly-Khan A. Lalani, MD, of the Juravinski Cancer Center of McMaster University in Hamilton, Ontario, and colleagues.

The retrospective analysis of data from 4,107 patients with mRCC enrolled in the Canadian Kidney Cancer Information System (CKCis) showed that 2,752 (67%) received systemic therapy. Overall, clinical trial participation among these patients was 18% in the first-line setting, 21% in the second line, and 24% in the third line.

Most patients gained access through participation in government-funded clinical trials and compassionate access programs, the researchers noted. "In an evolving therapeutic landscape, ongoing advocacy is required to continue to facilitate patient access to efficacious therapies."

Lalani discussed the findings in greater detail in the following interview.

How is this research unique?

Lalani: This study is the first foray into the use of systemic treatments for RCC in Canada using CKCis. This web-based national registry produces a regular on the management of advanced kidney cancer, and most recently, recommended ICI-based regimens as preferred treatment options in the first-line setting. It also feeds into the IMDC [International mRCC Database Consortium] database.

The drug approval and reimbursement processes associated with publicly funded healthcare systems can complicate timely access to novel therapies. Did you find this to be the case in Canada?

Lalani: We did not, even though routine access to systemic therapies for RCC requires several steps.

Regulatory approval granted by Health Canada for new oncology drugs can take anywhere from 180 to 300 days. Following approval, new agents undergo review by the Canadian Agency for Drugs and Technologies in Health (), which makes funding and reimbursement recommendations to provinces and territories. This requires up to 150 business days.

Are there regional differences in public funding of systemic therapy for mRCC in Canada?

Lalani: Yes. There are significant inequalities in access to new cancer treatments as a result of variations in the reimbursement criteria and approval timelines between provinces and territories. In fact, a recent showed that for mRCC treatments, there was a median lag between first and last provincial approval of 20.5 months.

Despite these processes and their respective timelines, utilization of systemic therapies in Canada, including novel agents, has largely mirrored global standard of care. This is due in part to leveraging government-funded treatment, clinical trials, compassionate drug access programs, and ongoing physician advocacy for timely access to life-prolonging therapies.

How would you characterize the experience of oncologists managing patients with mRCC within the Canadian healthcare system?

Lalani: We feel fortunate to be part of a cohesive, motivated, multidisciplinary group of physicians and researchers focused on advancing the care for every patient with RCC. We work closely with patient advocacy groups to make sure that highly desired clinical trials, both industry- and investigator-sponsored, are available to our patients.

This has a ripple effect. We gain access to the most promising new therapies and can draw attention to the needs of RCC patients in ways that influence funding decisions.

Do your findings have implications for patient access to tailored treatment for other renal tumors, such as non–clear cell RCC?

Lalani: Our analysis showed that in a real-world setting, 25% of participants had variant histology -- aka, non–clear cell RCC -- a finding that will help us tailor therapy. Ultimately, standard first-line therapies for clear-cell RCC can be extrapolated to the non-clear cell setting if indicated or appropriate.

In addition, mechanisms that would allow case-by-case review for reimbursement through unique care plans are accessible globally. This could have implications for improving the management of rare histologies, such as renal medullary carcinoma.

What's next for your research?

Lalani: We will continue to assess emerging front-line and next-line options as approvals are anticipated for RCC across untreated and pretreated scenarios.

We are also keen to describe and understand the outcomes of our patients with variant histology RCC, such as non-clear cell RCC. This may help us focus on ongoing clinical trials and drug development collaboration.

Read the study here.