ArticleMedical oncology (Northwood, London, England)2012
Phase I clinical trial of continuous infusion of tyroserleutide in patients with advanced hepatocellular carcinoma.
Article in Medical oncology (Northwood, London, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.
- Health-related quality of life as an endpoint in oncology phase I trials: a systematic review.BMC cancer · 2019Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Hepatocellular carcinoma (HCC) is usually diagnosed in advanced stage, which causes difficulty of using surgical treatment. Previous studies demonstrated that tyroserleutide (YSL), an immunologically active tripeptide compound, could suppress the proliferation and tumor formation of some liver cancer cell lines. We aimed to investigate the feasibility and toxicity of continuous administration of YSL by a portable infusion pump to patients with advanced HCC and its biologically effective but non-toxic doses used in outpatient setting. Forty patients (12 in stage 1, 28 in stage 2, total 10 treated in each dose cohort) were treated with YSL 6, 12, 18, or 24 mg/day lasting for 5 days. No treatment-related mortality was observed. The overall response rates were 25% (3/12) and 7.2% (2/28) in stages 1 and 2, respectively. The median 6-month overall survival (OS) in stage 1 was 75, 64, and 41 days for 6, 18, and 24 mg/day groups, respectively; all patients survived in the 12 mg/day group. The median OS in stage 2 was 68, 72, and 60 days for 12, 18, and 24 mg/day groups, respectively; all survived in the 6 mg/day group. The most common adverse reactions were abnormal liver function (59/107) and hemogram (22/107). The dose-limiting toxicities of 24 mg/day group contained abdominal distention (1/10), sicchasia (1/10), hyponatremia (1/10), myocardiac ischemia (1/10), and abnormal hemogram (6/10). We conclude that the continuous administration of YSL by portable infusion pump was well tolerated. Treatment responses of doses 6 and 12 mg/day were better than other two groups. Further studies of continuous infusion of YSL to determine its efficacy are warranted.
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