title: Efficacy and toxicity of gemcitabine plus docetaxel combination as a second line therapy for patients with advanced stage soft tissue sarcoma.
abstract: OBJECTIVE
  To assess the safety and efficacy of a gemcitabine plus docetaxel regimen as a second line therapy for patients with advanced soft tissue sarcoma (STS) resistant to doxorubicin and ifosfamide-based therapy.
  
  
  METHODS
  Medical records of 64 patients with advanced STS who received gemcitabine plus docetaxel regimen as a second line treatment between May 2006 and June 2011 were examined. All patients had been previously treated with doxorubicin plus ifosfamide-based regimen at first line setting. Patients received gemcitabine 900 mg/m2 on days one and eight intravenously over 90 minutes, followed by docetaxel 75 mg/m2 on day eight intravenously over one hour. Cycles were repeated every 3 weeks.
  
  
  RESULTS
  The male-to-female ratio was 37/27 and the median age was 44 years (range; 19-67 years). Objective responses were observed in 13 (20.3%) patients (2 CR, 11 PR) and stable disease in 21 (32.8%). Total clinical benefit (CR+PR+SD) was observed in 34 (53.1%). Median overall survival (OS) was 18 months (95% confidence interval (CI):12.1-23.9) and Median time to progression (TTP) was 4.8 months (95% CI: 3.6-6). A total of 243 cycles of chemotherapy were administered. The median number of cycle was 3 (range; 1-11). The most common grade 3-4 hematologic toxicity was neutropenia (35.9%). The most common nonhematologic toxicities consisted of nausea/vomiting (37.5%), mucositis (32.8%), peripheral neuropathy (29.7%), and fatigue (26%). There was no toxicity-related death.
  
  
  CONCLUSIONS
  The combination of gemcitabine plus docetaxel is an active and tolerable regimen as a second line therapy for patients with advanced soft tissue sarcoma who have failed doxorubicin and ifosfamide-based therapy.
authors.affiliation: Department of Medical Oncology, Bakirkoy Dr Sadi Konuk Training and Research Hospital, İstanbul, Turkey. aosmankaya@gmail.com
authors.forename: Ali Osman
authors.initials: AO
authors.lastname: Kaya
authors.forename: Süleyman
authors.initials: S
authors.lastname: Büyükberber
authors.forename: Metin
authors.initials: M
authors.lastname: Ozkan
authors.forename: Necati
authors.initials: N
authors.lastname: Alkiş
authors.forename: Alper
authors.initials: A
authors.lastname: Sevinc
authors.forename: Nuriye Yildirim
authors.initials: NY
authors.lastname: Ozdemir
authors.forename: Suleyman
authors.initials: S
authors.lastname: Alici
authors.forename: Onur
authors.initials: O
authors.lastname: Esbah
authors.forename: Veli
authors.initials: V
authors.lastname: Berk
authors.forename: Celalettin
authors.initials: C
authors.lastname: Camci
authors.forename: Arife
authors.initials: A
authors.lastname: Ulas
authors.forename: Uğur
authors.initials: U
authors.lastname: Coskun
authors.forename: Mustafa
authors.initials: M
authors.lastname: Benekli
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D011379:Prognosis; D012189:Retrospective Studies; D016879:Salvage Therapy; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine