Evidence map›Paper›PMID 29888205›Full record

ArticleLiver cancer2018

Regional Differences in Efficacy, Safety, and Biomarkers for Second-Line Axitinib in Patients with Advanced Hepatocellular Carcinoma: From a Randomized Phase II Study.

Masatoshi Kudo, Yoon-Koo Kang, Joong-Won Park, Shukui Qin, Yoshitaka Inaba, Eric Assenat, Yoshiko Umeyama, Maria José Lechuga, Olga Valota, Yosuke Fujii and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Liver cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01210495 (A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.7field-weighted citation impact, top 28% 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.

NCT01210495 phase2completednot on this map

A multicenter, global, randomized, double-blind study of axitinib plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma following failure of one prior antiangiogenic therapy

TypeinterventionalSponsorPfizerRan2010 to 2016Enrolled224ConditionsHepatocellular CarcinomaArmsAxitinib (AG-013736), Best Supportive Care, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Towards a tailored systemic therapy for liver cancer.Annals of translational medicine · 2020
    Article
  9. Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 6 countries.

Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
Yoon-Koo KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Joong-Won ParkCenter for Liver Cancer, National Cancer Center, Goyang, Republic of Korea.
Shukui QinDepartment of Medical Oncology, Nanjing Bayi Hospital, Nanjing, China.
Yoshitaka InabaDepartment of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan.
Eric AssenatDepartment of Medical Oncology, Hôpital Saint Eloi, Montpellier, France.
Yoshiko UmeyamaPfizer Japan Inc., Tokyo, Japan.
Maria José LechugaPfizer Srl, Milan, Italy.
Olga ValotaPfizer Srl, Milan, Italy.
Yosuke FujiiPfizer Japan Inc., Tokyo, Japan.
Jean-Francois MartiniPfizer Inc., San Diego, CA, USA.
J Andrew WilliamsPfizer Inc., San Diego, CA, USA.
Shuntaro ObiDepartment of Hepatology, Sasaki Foundation Kyoundo Hospital, Tokyo, Japan.
Pfizer (Italy) · ITPfizer (Japan) · JPPfizer (United States) · US81th Hospital of PLA · CNAichi Cancer Center · JPHôpital Saint Eloi · FRKindai University · JPNational Cancer Center · KRSasaki Institute · JPUlsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn unmet need exists for treatment of patients with advanced hepatocellular carcinoma (HCC) who progress on or are intolerant to sorafenib. A global randomized phase II trial (ClinicalTrial.gov No. NCT01210495) of axitinib, a vascular endothelial growth factor receptor 1-3 inhibitor, in combination with best supportive care (BSC) did not prolong overall survival (OS) over placebo/BSC, but showed improved progression-free survival in some patients. Subgroup analyses were conducted to identify potential predictive/prognostic factors.

methodsThe data from this phase II study were analyzed for the efficacy and safety of axitinib/BSC in patients from Asia versus non-Asia versus Asian subgroups (Japan, Korea, or mainland China/Hong Kong/Taiwan) and predictive/prognostic values of baseline microRNAs and serum soluble proteins, using the Cox proportional hazards model.

resultsOf 202 patients, 78 were from non-Asia and 124 from Asia (37 Japanese, 36 Korean, and 51 Chinese). No significant differences in OS were found between axitinib/BSC and placebo/BSC in non-Asians, Asians, or Asian subgroups. However, in an exploratory analysis, axitinib/BSC showed favorable OS in Asians, especially Japanese, when patients intolerant to prior antiangiogenic therapy were excluded from the data set. Axitinib/BSC was well tolerated by non-Asians and Asians alike. The presence of 4 circulating microRNAs, including miR-5684 and miR-1224-5p, or a level lower than or equal to the median protein level of stromal cell-derived factor 1 at baseline was significantly associated with longer OS in axitinib/BSC-treated Asians or non-Asians.

conclusionsAxitinib/BSC did not prolong survival over placebo/BSC in non-Asians, Asians, or Asian subgroups, but favorable OS with axitinib/BSC was observed in a subset of Japanese patients. A patient population that excludes sorafenib-intolerant patients might potentially be more suitable for clinical trials of new agents in advanced HCC. Since these results are very preliminary, further investigation is warranted. The potential predictive/prognostic value of several baseline microRNAs and soluble proteins identified in this study would require validation in prospective studies on a large cohort of patients.

Indexed as

AsianAxitinibBiomarkersHepatocellular carcinomaMicroRNAs

Identifiers

PMID29888205
PMCPMC5985413
OpenAlexW2775115258

What OpenQuestion holds

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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.