Observational studyInternational journal of urology : official journal of the Japanese Urological Association2026
Post-Marketing Surveillance of the Safety and Effectiveness of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma.
Observational study in International journal of urology : official journal of the Japanese Urological Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
objectivesThis post-marketing surveillance study evaluated the real-world safety and effectiveness of cabozantinib in Japanese patients with advanced renal cell carcinoma (aRCC).
methodsThis prospective, observational study enrolled patients with histologically or cytologically confirmed aRCC across 102 sites in Japan. Patients received cabozantinib as monotherapy or in combination with nivolumab according to approved label regimens and were monitored for 26 weeks. The primary outcome was the incidence of adverse drug reactions (ADRs) related to hepatic failure/dysfunction and pancreatitis. Secondary outcomes included grade 3 or higher ADRs, treatment discontinuation due to ADRs, and investigator-assessed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
resultsOf 388 enrolled patients, 385 were included in the analysis (median age, 71.0 years; 70.1% men). Patients receiving monotherapy (n = 322) and those receiving combination therapy (n = 63) reported ADRs related to hepatic failure/dysfunction (16.15% and 25.40%), pancreatitis-related ADRs (2.80% and 4.76%), grade 3 or higher ADRs (24.84% and 38.10%), and ADRs leading to treatment discontinuation (13.98% and 30.16%), respectively. The most common grade 3 or higher ADRs were hypertension (3.73%), reduced appetite (3.11%), and hand-foot syndrome (3.11%) in the monotherapy group, and diarrhea (4.76%) in the combination therapy group. The ORR was 32.9% for patients receiving monotherapy and 41.3% for those receiving combination therapy.
conclusionsCabozantinib, as monotherapy or in combination with nivolumab, demonstrated safety and effectiveness in Japanese patients with aRCC in real-world settings, consistent with previous literature. No new safety concerns were identified. These findings support the use of cabozantinib-based regimens in Japanese clinical practice. TRAIL REGISTRATION: Japan Registry of Clinical Trials (JRCT), registration number: jRCT2031210003.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.