A phase II trial to assess the activity of gemcitabine and docetaxel as first line chemotherapy treatment in patients with ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-12

AUTHORS

Beatrice Seddon, Michelle Scurr, Robin L Jones, Zoe Wood, Cerys Propert-Lewis, Cyril Fisher, Adrienne Flanagan, Jonanthan Sunkersing, Roger A’Hern, Jeremy Whelan, Ian Judson

ABSTRACT

BACKGROUND: Gemcitabine and docetaxel have been shown to be active in pre-treated relapsed leiomyosarcoma. This study investigated the combination as first line treatment in patients with unresectable locally advanced/metastatic leiomyosarcoma. METHODS: Patients received gemcitabine 900 mg/m(2) days 1 and 8, and docetaxel 100 mg/m(2) day 8, administered 3-weekly for up to 8 cycles, with GCSF support on days 9-15. Patients who had received previous radiotherapy were treated at 75% dose. Patients were evaluated for response by RECIST 1.0 after cycles 2, 4, 6 and 8, and 3-monthly after completing treatment. RESULTS: Forty-four patients were evaluable for response. Eligible patients had histologically proven leiomyosarcoma of the uterus (54.5%) or other sites (45.5%). Thirty-nine patients (84.4%) had metastatic disease, and 5 (15.6%) had locally advanced disease. Six patients (13.6%) had grade 1 disease, and 23 (75%) had grade 2/3 disease. All patients had demonstrated disease progression prior to trial entry. Responses were as follows: partial response 11 (25.0%), stable disease (confirmed) 16 (36.6%), stable disease (unconfirmed) 7 (15.9%), progressive disease 10 (22.7%). Median progression-free survival and overall survival were 7.1 months (95% CI 5.7-8.3) and 17.9 months (95% CI 10.6-25.2), respectively. Progression free rates at 3 and 6 months were 70.5% (95% CI 56.7-84.2%) and 59.1% (95% CI 44.3-73.9%). CONCLUSIONS: This study demonstrates gemcitabine and docetaxel to be active in locally advanced/metastatic leiomyosarcoma in the first line setting. Further investigation comparing with current standard therapies for leiomyosarcoma is warranted. More... »

PAGES

13

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13569-015-0029-8

DOI

http://dx.doi.org/10.1186/s13569-015-0029-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1007269393

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/25987978


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