Evidence map›Paper›PMID 24793747›Full record

Trial reportMedical oncology (Northwood, London, England)2014

Assessment of efficacy, safety and quality of life of 110 patients treated with sunitinib as first-line therapy for metastatic renal cell carcinoma: experience in real-world clinical practice in Japan.

Hideaki Miyake, Akira Miyazaki, Ken-Ichi Harada, Masato Fujisawa

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Medical oncology (Northwood, London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
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1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Hideaki MiyakeDivision of Urology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan, hideakimiyake@hotmail.com.
Akira Miyazaki
Ken-Ichi Harada
Masato Fujisawa

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective of this study was to comprehensively evaluate the clinical outcomes of 110 consecutive Japanese patients who received at least two cycles of sunitinib as first-line therapy for metastatic renal cell carcinoma (mRCC) in a routine clinical setting. Initially, 50 mg of sunitinib was administered once daily on a 4 weeks on, followed by 2 weeks off dosing schedule; however, dose modification was required in 102 patients, and the relative dose intensity was 62.6 % throughout this series. As the best responses to sunitinib, 2, 28, 65 and 15 were judged to show a complete response, partial response, stable disease and progressive disease, respectively. The median progression-free survival (PFS) and overall survival (OS) following the treatment with sunitinib were 7.8 and 33.2 months, respectively. Multivariate analyses of several factors identified the following independent predictors of PFS and OS: Memorial Sloan Kettering Cancer Center (MSKCC) classification and C-reactive protein (CRP) level for PFS and liver metastasis, MSKCC classification and CRP level for OS. The common adverse events related to sunitinib corresponding to ≥grade 3 were thrombocytopenia in 59, leukopenia in 23, fatigue in 22, hand-foot syndrome in 15 and hypertension in 12. Quality of life (QOL) analysis using 36-Item Short Form revealed no significant differences in any scale scores between surveys performed before and 3 months after the treatment with sunitinib. Collectively, these findings suggest that the introduction of sunitinib as a first-line agent can lead to favorable disease control with acceptable tolerability, resulting in improvement in the prognosis and QOL of Japanese patients with mRCC.

Indexed as

Quality of LifeAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Renal CellC-Reactive ProteinDisease-Free SurvivalFemaleHumansIndolesJapanKidney NeoplasmsLiver NeoplasmsMaleMiddle AgedAntineoplastic AgentsC-Reactive ProteinIndolesPyrrolesSunitinib

Identifiers

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Registered trials

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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.