Evidence map›Paper›PMID 26089686›Full record

ArticleOncoTargets and therapy2015

Axitinib versus sorafenib as a second-line therapy in Asian patients with metastatic renal cell carcinoma: results from a randomized registrational study.

Shukui Qin, Feng Bi, Jie Jin, Ying Cheng, Jun Guo, Xiubao Ren, Yiran Huang, Jamal Tarazi, Jie Tang, Connie Chen and 2 more

Open access · goldAbstract read
In one paragraph

Article in OncoTargets and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
3.1field-weighted citation impact, top 8% of its field
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

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2020
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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

12 authors at 4 institutions in 2 countries.

Shukui QinDepartment of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital, Nanjing, Jiangsu, People's Republic of China.
Feng BiDepartment of Medical Oncology, West China Hospital of Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
Jie JinDepartment of Urology, Peking University First Hospital, Beijing, People's Republic of China.
Ying ChengDepartment of Oncology, Jilin Provincial Cancer Hospital, Changchun, Jilin Province, People's Republic of China.
Jun GuoDepartment of Renal Cancer and Melanoma, Peking University Cancer Hospital/Institute, Beijing, People's Republic of China.
Xiubao RenDepartment of Biology Treatment, Tianjin Oncology Hospital, Tianjin, People's Republic of China.
Yiran HuangDepartment of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Jamal TaraziClinical Development, Pfizer Oncology, San Diego, CA, USA.
Jie TangGlobal Outcomes Research, Pfizer Inc., New York, NY, USA.
Connie ChenGlobal Outcomes Research, Pfizer Inc., New York, NY, USA.
Sinil KimClinical Development, Pfizer Oncology, San Diego, CA, USA.
Dingwei YeDepartment of Urology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Pfizer (United States) · USFudan University Shanghai Cancer Center · CNPeking University · CNShanghai Jiao Tong University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis registrational trial evaluated the efficacy, safety, and patient-reported outcomes of axitinib versus sorafenib as a second-line treatment in Asian patients with clear-cell metastatic renal cell carcinoma (mRCC).

methodsIn this open-label, multicenter study, previously treated Asian patients with clear-cell mRCC were stratified by Eastern Cooperative Oncology Group performance status and prior therapy and randomized in a 2:1 ratio to receive axitinib (5 mg twice daily) or sorafenib (400 mg twice daily). The primary end point was progression-free survival (PFS) assessed by a masked independent review committee.

resultsA total of 204 Asian patients received axitinib (n=135) or sorafenib (n=69). Median PFS (95% confidence interval [CI]) was 6.5 (4.7-9.1) months with axitinib versus 4.8 (3.0-6.5) months with sorafenib (hazard ratio, 0.731; 95% CI, 0.506-1.058; one-sided P=0.0531). The objective response rate (95% CI) was 23.7% (16.8%-31.8%) with axitinib versus 10.1% (4.2%-19.8%) with sorafenib. Common, grade ≥3, all-causality adverse events were hypertension (19.3%), weight decrease (5.2%), and proteinuria (5.2%) with axitinib and hypertension (8.7%) and palmar-plantar erythrodysesthesia (7.2%) with sorafenib. In a time-to-deterioration composite end point of death, progression, and worsening of Functional Assessment of Cancer Therapy Kidney Symptom Index score, patients treated with axitinib demonstrated a 17%-24% risk reduction compared with sorafenib-treated patients.

conclusionAxitinib is clinically active and well tolerated in previously treated Asian patients with mRCC, consistent with the results from the global Phase III trial. These results establish axitinib as a second-line treatment option for Asian patients with mRCC.

Indexed as

axitinibrenal cell carcinomasorafenibvascular endothelial growth factor receptor inhibitor

Identifiers

PMID26089686
PMCPMC4467642
OpenAlexW1486016839

What OpenQuestion holds

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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.