title: Gemcitabine-based chemotherapy in sarcomas: A systematic review of published trials.
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.
authors.affiliation: Medical Oncology Department, Centre Oscar Lambret, Lille, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Ducoulombier
authors.affiliation: Medical Oncology Department, Centre Oscar Lambret, Lille, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Cousin
authors.affiliation: Medical Oncology Department, Centre Oscar Lambret, Lille, France.
authors.forename: Nuria
authors.initials: N
authors.lastname: Kotecki
authors.affiliation: Medical Oncology Department, Centre Oscar Lambret, Lille, France; Methodological Platform of the SIRIC OncoLille Consortium, Lille, France. Electronic address: n-penel@o-lambret.fr.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Penel
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D007890:Leiomyosarcoma / Q000188:drug therapy; D012516:Osteosarcoma / Q000188:drug therapy; D012509:Sarcoma / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000093542:Gemcitabine
keywords: Dacarbazine; Docetaxel; Gemcitabine; Leiomyosarcoma; Uterine sarcoma