Evidence map›Paper›PMID 36470258›Full record

Observational studyCancer research and treatment2023

Real-World Study Evaluating Safety and Effectiveness of Axitinib in Korean Patients with Renal Cell Carcinoma after Failure of One Prior Systemic Therapy.

Sang Joon Shin, Jae Lyun Lee, Tae Gyun Kwon, Byoung Young Shim, Ho Seok Chung, Sang-Hee Kim, Se Hoon Park

Open access · diamondAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Cancer research and treatment, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 39% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Review
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

7 authors at 7 institutions in 1 country.

Sang Joon ShinDivision of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Jae Lyun LeeDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Tae Gyun KwonDepartment of Urology, School of Medicine Kyungpook National University, Daegu, Korea.
Byoung Young ShimDepartment of Medical Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
Ho Seok ChungDepartment of Urology, Chonnam National University Medical School, Gwangju, Korea.
Sang-Hee KimOncology Medical Affair, Pfizer Pharmaceuticals Korea Ltd., Seoul, Korea.
Se Hoon ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Chonnam National University Hospital · KRKorea Pharma (South Korea) · KRKyungpook National University · KRSungkyunkwan University · KRThe Catholic University of Korea St. Vincent's Hospital · KRUlsan College · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis post-marketing surveillance (PMS) study was conducted to monitor the usage of axitinib (Inlyta) in clinical practice of Korean patients with advanced renal cell carcinoma (RCC) with disease progression during or after a prior systemic therapy in real world. Materials and Methods: In this multicenter, observational study, patients indicated for oral axitinib 5 mg twice daily as second-line therapy for advanced RCC were followed up under routine clinical practices, and their safety and effectiveness outcomes were collected.

resultsBetween 2012 and 2021, 125 patients were enrolled, and data from 111 patients were analyzed. Median age was 65 years (range, 30 to 84 years), 81% was male, and 110 (99%) had clear cell RCC. The median daily dose of axitinib was 10 mg (range, 4.36 to 15.95 mg) with a median administration period of 5.6 months (range, 15 to 750 days). Eighty-three percentage of patients experienced any grade of adverse events, 71% of which were related to study treatment, including diarrhea (36%), hypertension (21%), stomatitis (17%), decreased appetite (14%), palmar-plantar erythrodysesthesia syndrome (12%), and asthenia (11%). Most adverse events were generally well tolerated and manageable, with 13% of grade ≥ 3. Axitinib dose reduction was required in 20% of the adverse events and discontinuation in 8%. Median progression-free survival was 12.4 months (95% confidence interval [CI], 9.6 to 18.9). Objective responses were observed in 30% of patients (95% CI, 21 to 39) with 4% of complete response and 26% of partial response.

conclusionNo new safety signal was found in the present PMS study of Korean RCC patients. Axitinib showed consistent outcomes in terms of effectiveness and safety confirming that the drug is a valid option for second-line therapy in patients with advanced RCC in a real-world setting.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAgedAxitinibHumansIndazolesMaleRepublic of KoreaTreatment OutcomeAxitinibIndazolesAxitinibCarcinomaPost marketing surveillanceRenal Cell

Identifiers

PMID36470258
PMCPMC10101802
OpenAlexW4310263728

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.