Cabo-POLARIS : A Trial to Evaluate Cabozantinib Among Haemodialysied Patients
Status:
Not yet recruiting
Trial end date:
2027-03-01
Target enrollment:
Participant gender:
Summary
Among patients with renal cell carcinoma (RCC), 2.7 to 4.7 % of patients are at risk of
progressing to dialysis or transplantation after partial and radical nephrectomy
respectively. Of note, similar risk factors can be seen in both disease: RCC and renal
impairment leading to dialysis. Currently, three types of systemic therapies (ST) are mainly
used among patients with metastatic renal cell carcinoma (mRCC): anti-angiogenics (mostly
tyrosine kinase inhibitors and bevacizumab), mTOR inhibitors and immune checkpoint inhibitor.
ST prescription for patients undergoing HD may be more dangerous than in other patients. This
is partially explained by the fact that several adverse events can be induced by both the ST
and HD e.g. thromboembolic disease, or hypertension.
Patients in HD are usually excluded from major clinical trials and available data concerning
safety and activity of ST in this specific population are lacking. In most cases, drugs'
label is driven by the eligibility criteria of large randomized phase 3 trials that exclude
this type of patients. The main source of information for these patients comes from academic
publications of patients' cases or small cohorts, but they are not included within the drug
label. Moreover, no clear guidelines are given by savant societies regarding those patients.
It is known that patients with HD are at high risk of specific adverse events that can
sometimes overlap with the safety profile of anti-cancer drugs: thromboembolic complications,
cardio-vascular comorbidities, hematologic and metabolic abnormalities.
Having a dedicated clinical trial to this particular population would definitely help the
community to improve the care of HD patients by getting prospective data in order to increase
the level of evidence and therefore to optimize anticancer drug use in this specific
population.