Evidence map›Paper›PMID 20461441›Full record

Trial reportInvestigational new drugs2011

Phase II study of sunitinib as second-line treatment for advanced gastric cancer.

Yung-Jue Bang, Yoon-Koo Kang, Won K Kang, Narikazu Boku, Hyun C Chung, Jen-Shi Chen, Toshihiko Doi, Yan Sun, Lin Shen, Shukui Qin and 6 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Investigational new drugs, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

88 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
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  6. Pooled it
  7. An application study of low-dose computed tomography perfusion imaging for evaluation of the efficacy of neoadjuvant chemotherapy for advanced gastric adenocarcinoma.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2018
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  9. Regorafenib for the Treatment of Advanced Gastric Cancer (INTEGRATE): A Multinational Placebo-Controlled Phase II Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
    Trial
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  11. Article
  12. Review
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28 more citing papers are in PubMed but not listed here.

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

16 authors.

Yung-Jue BangDepartment of Internal Medicine, Seoul National University College of Medicine, Yongon-Dong 28, Chongno-Gu, Seoul, 110-799, Republic of Korea. bangyj@snu.ac.kr
Yoon-Koo Kang
Won K Kang
Narikazu Boku
Hyun C Chung
Jen-Shi Chen
Toshihiko Doi
Yan Sun
Lin Shen
Shukui Qin
Wai-Tong Ng
Jennifer M Tursi
Maria J Lechuga
Dongrui Ray Lu
Ana Ruiz-Garcia
Alberto Sobrero

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis phase II, open-label, multicenter study assessed the oral, multitargeted, tyrosine kinase inhibitor sunitinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma who had received prior chemotherapy. EXPERIMENTAL

designPatients received sunitinib 50 mg/day on Schedule 4/2 (4 weeks on treatment, followed by 2 weeks off treatment). The primary endpoint was objective response rate; secondary endpoints included clinical benefit rate, duration of response, progression-free survival (PFS), overall survival (OS), pharmacokinetics, pharmacodynamics, safety and tolerability, and quality of life.

resultsOf 78 patients enrolled, most had gastric adenocarcinoma (93.6%) and metastatic disease (93.6%). All were evaluable for safety and efficacy. Two patients (2.6%) had partial responses and 25 patients (32.1%) had a best response of stable disease for ≥6 weeks. Median PFS was 2.3 months (95% confidence interval [CI], 1.6-2.6 months) and median OS was 6.8 months (95% CI, 4.4-9.6 months). Grade ≥ 3 thrombocytopenia and neutropenia were reported in 34.6% and 29.4% of patients, respectively, and the most common non-hematologic adverse events were fatigue, anorexia, nausea, diarrhea, and stomatitis. Pharmacokinetics of sunitinib and its active metabolite were consistent with previous reports. There were no marked associations between baseline soluble protein levels, or changes from baseline, and measures of clinical outcome.

conclusionsThe progression-delaying effect and manageable toxicity observed with sunitinib in this study suggest that although single-agent sunitinib has insufficient clinical value as second-line treatment for advanced gastric cancer, its role in combination with chemotherapy merits further study.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic AgentsDisease-Free SurvivalEsophagogastric JunctionFemaleHumansIndolesMaleMiddle AgedProtein Kinase InhibitorsPyrrolesQuality of LifeStomach NeoplasmsSunitinibAntineoplastic AgentsIndolesProtein Kinase InhibitorsPyrrolesSunitinib

Identifiers

PMID20461441
PMCPMC3171673

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.