title: [Efficacy and safety of fixed dose rate gemcitabine infusion in combination with docetaxel in patients with relapsed/refractory soft tissue sarcoma].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of fixed dose rate (FDR) gemcitabine infusion in combination with docetaxel in patients with relapsed/refractory soft tissue sarcoma.
  
  
  METHODS
  Clinicopathological data of 28 patients with relapsed/refractory soft tissue sarcoma treated in our hospital from April 2008 to August 2013 were reviewed in this study. The patients received 900 mg/m² gemcitabine with a FDR infusion (10 mg/m²/min) in a total dose of 900 mg/m² on days 1 and 8, and 75 mg/m² docetaxel intravenously over 60 min on day 8 of a 21-day cycle. When irradiation was conducted before drug therapy, the dose of gemcitabine was reduced to 675 mg/m² on days 1 and 8. The clinicopathological characteristics, short-term response, long-term survival status and toxicity were analyzed retrospectively.
  
  
  RESULTS
  The 28 patients received a total of 118 cycles of therapy (range 1-8 cycles, median 4 cycles per patient). No patient achieved complete response (CR), 4 partial responses (PR) and 11 stable diseases (SD), with an overall response rate (ORR) of 14.3% and clinical benefit rate (CBR) of 53.6%. The median progression-free survival (PFS) was 3.2 months and the median overall survival (OS) was 8.5 months. PFS and OS were correlated with the response to this treatment regimen (P < 0.0001). Patients with clinical benefit had significantly better PFS and OS than the patients with progressive disease (P < 0.05 for all). The ORR, CBR, PFS and OS were better in patients with leiomyosarcoma than in patients with other histological subtypes in this study, but the differences were not significant (P > 0.05 for all). Grade 3-4 neutropenia, anemia and thrombocytopenia were 50.0%, 17.9% and 14.3%, respectively. Only one patient (3.6%) had febrile neutropenia. Grade 3 non-hematologic toxicities were nausea/vomiting (3.6%) and mucositis (3.6%). No grade 4 non-hematologic toxicities were observed. Almost all non-hematologic toxicities were grade 1-2 and manageable.
  
  
  CONCLUSIONS
  The fixed dose rate (FDR) gemcitabine infusion in combination with docetaxel is an effective treatment regimen for patients with relapsed/refractory soft tissue sarcoma, and with tolerable adverse reactions.
authors.affiliation: Department of Medical Oncology, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.
authors.forename: Zhihua
authors.initials: Z
authors.lastname: Yao
authors.affiliation: Department of Medical Oncology, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.
authors.forename: Shujun
authors.initials: S
authors.lastname: Yang
authors.affiliation: Department of Medical Oncology, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Department of Medical Oncology, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.
authors.forename: Shuna
authors.initials: S
authors.lastname: Yao
authors.affiliation: Department of Medical Oncology, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.
authors.forename: Hongqiang
authors.initials: H
authors.lastname: Guo
authors.affiliation: Department of Medical Oncology, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China. Email: liuyanyan4827@yahoo.com.
authors.forename: Yanyan
authors.initials: Y
authors.lastname: Liu
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D006801:Humans; D007890:Leiomyosarcoma / Q000188:drug therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009503:Neutropenia; D012189:Retrospective Studies; D012509:Sarcoma / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine