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.
Documented histological diagnosis of advanced or metastatic renal cell cancer with a clear-cell or papillary component.
Must have received at least one prior line of systemic therapy.
Undergoing haemodialysis for more than 3 months without major complications that might confound the results of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Recovery to baseline or ≤ Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless AE(s) are considered clinically nonsignificant by the investigator and/or stable on supportive therapy.
Prior treatment with cabozantinib.
Kidney cancer without clear-cell or papillary component.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before cabozantinib initiation.
Receipt of any type of anticancer antibody within 2 weeks before randomization. For investigational antibody the delay is 4 weeks.
Single group
Cabozantinib
DrugCabozantinib will be prescribed following its Marketing Authorization with an initiation at a reduced dose of 40 mg per day. The dose will be adjusted according to safety. At the end of the first cycle, patients may be eligible for an increase in the dose of cabozantinib (up to 60 mg per day) if the following criteria are met: no adverse effects of grade 3 or 4 cabozantinib-related, no dose reduction or interruption for safety reasons, no long-lasting grade 2 cabozantinib-related adverse effects requiring maximum supportive care. Continuation to 40 mg per day or reduction to 20 mg per day are the other alternatives depending on the safety profile.
Blood sample
Biological/Vaccinebiomonitoring and pharmacokinetics
Questionnaires of quality of life
Other interventionFKSI-19 and FKSI-DRS and EUROQOL EQ-5D-5L
rate of patients permanently discontinuing for any reason cabozantinib at 6 months after initiation of treatment
rate of patients permanently discontinuing cabozantinib at 6 months after initiation of treatment due to toxicity
progression free survival
Absolute and relative frequency of dose reductions and temporary or permanent discontinuation of cabozantinib
total duration of treatment with cabozantinib
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