Evidence map›Paper›PMID 18534250›Full record

Trial reportGynecologic oncology2008

Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial.

Martee L Hensley, John A Blessing, Robert Mannel, Peter G Rose

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00101127 (A Phase II Evaluation of Docetaxel), which is not on this map. Cited by 130 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 3 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.

NCT00101127 phase2completednot on this map

A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

TypeinterventionalSponsorGynecologic Oncology GroupRan2003ConditionsSarcomaArmsfilgrastim, pegfilgrastim, docetaxel, gemcitabine hydrochloride
3 · Its place in the literature

Who cites it

130 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  18. Phase II study of sorafenib in patients with metastatic or recurrent sarcomas.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009
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  20. Observational

70 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

4 authors.

Martee L HensleyMemorial Sloan-Kettering Cancer Center, New York, NY 10065, USA. gynbreast@mskcc.org
John A Blessing
Robert Mannel
Peter G Rose

Funding

GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
NCI NIH HHS CA27469NCI NIH HHS CA 37517NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517
6 · The paper itself

Abstract

objectivesFixed-dose rate gemcitabine plus docetaxel is active as second-line therapy for metastatic uterine leiomyosarcoma. We sought to determine the activity of this regimen as first-line treatment.

methodsEligible women with advanced uterine leiomyosarcoma were treated with gemcitabine 900 mg/m(2) over 90 min, on days one and eight, plus docetaxel 100 mg/m(2) on day eight, with granulocyte growth factor support on day nine of a 21-day cycle. Patients with prior pelvic radiation received lower doses. Patients were treated until progression or unacceptable toxicity. Response was assessed every other cycle by RECIST.

resultsForty-two women enrolled, with 39 evaluable for response. Objective responses were observed in 15 of 42 patients (35.8% overall; complete response 4.8%, partial response 31%, 90% confidence interval 23.5 to 49.6%), with an additional 11 (26.2%) having stable disease. Nineteen of 38 (50%) received six or more cycles of study treatment. Myelosuppression was the major toxicity: neutropenia grade 3 in 5%, grade 4 in 12%; anemia grade 3 in 24%; thrombocytopenia grade 3 in 9.5%, grade 4 in 5%. One patient had a grade 3 allergic reaction, 17% had grade 3 fatigue. One possibly-related grade 4 pulmonary toxicity was observed. The median progression-free survival (PFS) was 4.4 months (range 0.4 to 37.2+ months). Among 15 women with objective response, median response duration was 6 months (range 2.1 to 33.4+ months). Median overall survival was 16+ months (range:.4-41.3 months).

conclusionFixed-dose rate gemcitabine plus docetaxel achieves high objective response rates as first-line therapy in metastatic uterine leiomyosarcoma.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineDisease-Free SurvivalDocetaxelFemaleGemcitabineHumansLeiomyosarcomaMiddle AgedTaxoidsUterine NeoplasmsDeoxycytidineDocetaxelGemcitabineTaxoids

Identifiers

PMID18534250
PMCPMC2504727

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.