Gemcitabine-based chemotherapy in sarcomas: A systematic review of published trials. (February 2016)

• Record Type: Journal Article
• Authors: Ducoulombier, Agnès; Cousin, Sophie; Kotecki, Nuria; Penel, Nicolas
• Is Part Of: Critical reviews in oncology/hematology. Volume 98(2016)
• Page Start: 73
• Page End: 80
• Publication Date: 2016-02
• Subjects: Dacarbazine -- Docetaxel -- Gemcitabine -- Leiomyosarcoma -- Uterine sarcoma; Oncology -- Periodicals; Hematology -- Periodicals; 616.994
• DOI: 10.1016/j.critrevonc.2015.10.020
• Languages: English
• ISSNs: 1040-8428

Abstract

Highlights: In everyday practice, gemcitabine is largely used in management of advanced sarcoma despite limited evidence of activity. Phase II trials suggest that gemcitabine +/− docetaxel is an active regimen in pretreated leiomyosarcoma. Phase II trials suggest that gemcitabine + dacarbzaine is an active regimen is pretreated adult soft tissue sarcoma. Nevertheless confirmatory phase III trials are warranted when phase II trials suggest some preliminary activity. Abstract: Gemcitabine is largely used in the management of sarcomas. We have systematically reviewed all of the fully published trials that investigated a gemcitabine-based regimen in the management of sarcomas and then provided a grade of recommendations and a level of evidence for every recommendation. Because of conflicting results from successive non-randomized phase II trials, gemcitabine activity alone in unselected pretreated soft tissue sarcomas could not be properly assessed. Gemcitabine alone and gemcitabine-docetaxel appeared to both be active in pretreated uterine and non-uterine leiomyosarcoma (1B;I). Gemcitabine–dacarbazine appeared to be active in pretreated unselected soft tissue sarcomas (1B;I). According the GeDDIS phase III trial (not yet fully published), gemcitabine-docetaxel appeared slightly less active than doxorubicine and more toxic than doxorubicine in chemo-naïve metastatic soft tissue sarcoma patients. Because of the absence of controlled randomized trials, the benefit of gemcitabine-docetaxel as an adjuvant treatment in high-grade uterine leiomyosarcoma could not be appropriately assessed. The level of activity of gemcitabine/docetaxel in bone sarcomas cannot be ascertained with the available data. The level of evidence supporting the use of gemcitabine-based regimens in sarcoma management is limited. Confirmatory phase III trials are warranted when phase II trials suggest some preliminary activity.