Evidence map›Paper›PMID 18394689›Full record

Trial reportGynecologic oncology2008

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

Martee L Hensley, John A Blessing, Koen Degeest, Ovadia Abulafia, Peter G Rose, Howard D Homesley

Open access · greenAbstract 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. Cited by 95 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 4 pooled it
20.7field-weighted citation impact, top 1% 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.

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

95 citing papers in PubMed, 4 syntheses or guidelines pooled it, 362 citations in OpenAlex.

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  17. 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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35 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

6 authors at 6 institutions in 1 country.

Martee L HensleyMemorial Sloan-Kettering Cancer Center, Department of Medical Oncology, 1275 York Avenue, New York, NY 10021, USA. hensleym@mskcc.org
John A Blessing
Koen Degeest
Ovadia Abulafia
Peter G Rose
Howard D Homesley
Cleveland Clinic · USGynecologic Oncology Group · USMemorial Sloan Kettering Cancer Center · USRoswell Park Comprehensive Cancer Center · USSUNY Downstate Health Sciences University · USUniversity of Iowa Hospitals and Clinics · US

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

objectiveDoxorubicin-based treatment is standard therapy for metastatic uterine leiomyosarcoma. There is no standard second-line therapy. We determined activity of fixed-dose rate gemcitabine plus docetaxel as second-line treatment for metastatic uterine leiomyosarcoma.

methodsEligible women with unresectable uterine leiomyosarcoma progressing after prior cytotoxic therapy were treated with gemcitabine 900 mg/m(2) days one and eight over 90 min, plus docetaxel 100 mg/m(2) on day 8 of a 21-day cycle with granulocyte growth factor. Patients with prior pelvic radiation received lower doses. Response Evaluation Criteria in Solid Tumors (RECIST) response was assessed by computed tomography (CT).

resultsForty-eight of 51 women were evaluable for response (one wrong histology, two never treated). Prior therapy was doxorubicin-based in 90%, and ifosfamide-based in 6%. The overall objective response rate is 27%, with complete response in 6.3% (3/48), and partial response in 20.8% (10/48). An additional 50% (24/48) had stable disease (median duration 5.4 months). The median number of cycles per patient was 5.5 (range 1-22); 73% of patients remained progression-free at 12 weeks and 52% at 24 weeks. The predominant toxicity was uncomplicated myelosuppression: thrombocytopenia grade 3 (29%), grade 4 (10.4%); neutropenia grade 3 (12.5%), grade 4 (8.3%) anemia grade 3 (20.8%), grade 4 (4.2%). While pulmonary toxicity was reported, no patient had drug-related pneumonitis/hypoxia-type toxicity. Median progression-free survival (PFS) was 5.6+ months (range 0.7-27+ months). The median duration of objective response was 9+ months (range 3.9-24.5+ months).

conclusionFixed-dose rate gemcitabine plus docetaxel is active second-line therapy for uterine leiomyosarcoma.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineDisease-Free SurvivalDocetaxelFemaleGemcitabineHumansLeiomyosarcomaMiddle AgedNeoplasm Recurrence, LocalTaxoidsUterine NeoplasmsDeoxycytidineDocetaxelGemcitabineTaxoids

Identifiers

PMID18394689
PMCPMC2692926
OpenAlexW2136309235

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.