Observational studyInternational journal of clinical oncology2022
Real-world safety and effectiveness of nivolumab for advanced renal cell carcinoma in Japan: a post-marketing surveillance.
Observational study in International journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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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.
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Who cites it
4 citing papers in PubMed, 4 citations in OpenAlex.
- Real-world safety and effectiveness of nivolumab in patients with cancer of unknown primary: results from a nationwide post-marketing surveillance in Japan.International journal of clinical oncology · 2026Observational
- Real-world safety of nivolumab in patients with malignant pleural mesothelioma in Japan: post-marketing surveillance study.Japanese journal of clinical oncology · 2024Article
- Safety of nivolumab monotherapy in five cancer types: pooled analysis of post-marketing surveillance in Japan.International journal of clinical oncology · 2024Article
- Post-marketing surveillance of the safety and effectiveness of nivolumab for classic Hodgkin lymphoma in Japan.International journal of hematology · 2024Observational
Corrections and comments
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Authors and funding
6 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis all-case post-marketing surveillance (PMS) evaluated the real-world safety and effectiveness of nivolumab monotherapy in Japanese patients with un-resectable or metastatic renal cell carcinoma (RCC).
methodsThis multicenter, open-label, non-interventional, observational PMS study (registered from August 2016 to January 2017) was conducted in patients who were newly initiated on nivolumab monotherapy. Assessments included treatment-related adverse events (TRAEs) of special interest, patient characteristics affecting safety, and effectiveness over 12 months.
resultsOverall, 580 patients were enrolled; 555 and 554 patients comprised the safety and effectiveness analysis sets, respectively. The median (range) age of the population was 66 (14-90) years. Nivolumab was initiated as 1st-, 2nd-, and ≥ 3rd-line treatment in 0.2%, 42.0%, and 57.8% of patients, respectively. TRAEs were reported in 275 (49.5%) patients. The most common TRAEs of special interest included thyroid dysfunction (9.5%), hepatic dysfunction (8.6%), and interstitial lung disease (6.7%). The incidence of TRAEs was significantly higher in elderly patients (≥ 65 vs < 65 years; ≥ 75 vs < 75 years); patients with lower C-reactive protein levels (< 5 vs ≥ 5 mg/dL); and patients with vs without a past medical history, including hepatic, thyroid, and autoimmune diseases. The 6- and 12-month survival rates were 71.8% and 57.9%, respectively.
conclusionThe safety profile of nivolumab monotherapy in Japanese patients with advanced RCC was similar to that in the phase 3 CheckMate 025 trial. No new safety signals were observed in this study.
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