Evidence map›Paper›PMID 20941597›Full record

ArticleCancer chemotherapy and pharmacology2011

Phase I clinical trial of hepatic arterial infusion of paclitaxel in patients with advanced cancer and dominant liver involvement.

Apostolia M Tsimberidou, Katherine Letourneau, Siqing Fu, David Hong, Aung Naing, Jennifer Wheler, Cynthia Uehara, Stephen E McRae, Sijin Wen, Razelle Kurzrock

Abstract readClinical Trial, Phase I
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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

8 citing papers in PubMed.

  1. Article
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  6. Review
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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

10 authors.

Apostolia M TsimberidouPhase I Program, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Unit 455, 1515 Holcombe Boulevard, Houston, TX 77030, USA. atsimber@mdanderson.org
Katherine Letourneau
Siqing Fu
David Hong
Aung Naing
Jennifer Wheler
Cynthia Uehara
Stephen E McRae
Sijin Wen
Razelle Kurzrock

Funding

U OF TEXAS HLTH SCI CTR HOUSTON CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUL1RR024148 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2010
$27.9M
NCRR NIH HHS RR024148NCRR NIH HHS UL1 RR024148
6 · The paper itself

Abstract

purposeThe survival of patients with liver metastases from solid tumors is poor. We conducted a phase I study of hepatic arterial infusion (HAI) paclitaxel in patients with advanced cancer and predominant liver involvement.

methodsPatients were treated with HAI paclitaxel 150-275 mg/m(2) (and 15,000 IU heparin intraarterially) every 28 days. A "3 + 3" study design was used.

resultsTwenty-six patients were treated (median age, 59 years). Diagnoses were colorectal cancer (n = 10), breast cancer (n = 7), and other (n = 9). The median number of prior therapies was four (range, 0-10). The maximum tolerated dose (MTD) was HAI paclitaxel 225 mg/m(2). Dose-limiting toxicities (DLTs) included Grade 3 neuropathy (1 of 5 patients) at HAI paclitaxel 275 mg/m(2) and Grade 4 thrombocytopenia and neutropenia, and Grade 3 mucositis (1 of 4 patients) at 250 mg/m(2). None of the eight patients treated with HAI paclitaxel 225 mg/m(2) experienced a DLT. The most common toxicities were nausea and peripheral neuropathy. Of 22 patients evaluable for response, 3 (13.6%) patients had SD for ≥4 months (colorectal cancer, n = 1; thyroid cancer, n = 1; and hepatocellular carcinoma, n = 1; duration of response was 4 months, 7.1 months, and 22.2+ months, respectively).

conclusionThe MTD of HAI paclitaxel was 225 mg/m(2). This regimen was well tolerated and had antitumor activity in selected patients.

Indexed as

AdultAgedAntineoplastic Agents, PhytogenicDisease-Free SurvivalFemaleHepatic ArteryHumansInfusions, Intra-ArterialLiver NeoplasmsMaleMaximum Tolerated DoseMiddle AgedPaclitaxelSurvival RateTreatment OutcomeAntineoplastic Agents, PhytogenicPaclitaxel

Identifiers

PMID20941597
PMCPMC3410641

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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.