title: Meta-analysis of phase III trials of docetaxel alone or in combination with chemotherapy in metastatic breast cancer.
abstract: OBJECTIVE
  Whether combination chemotherapy offers an advantage over sequential therapy in metastatic breast cancer (MBC) is still an unsettled issue. Polychemotherapy regimens containing taxanes has been shown to increase overall survival (OS), time to tumor progression (TTP), and overall response rate (ORR) when compared with regimens that did not contain a taxanes, while taxane-based doublets have a statistically significant benefit over single-agent taxane only for progression-free survival. However, the term "taxanes" generally includes both paclitaxel and docetaxel, drugs with different clinical activity. Aim of this work is to compare OS, TTP, and ORR in patients with MBC receiving docetaxel alone or in combination with chemotherapy using a formal meta-analysis.
  
  
  METHODS
  We performed a systematic review of all published trials comparing docetaxel alone or in combination with other chemotherapeutic agents in MBC.
  
  
  RESULTS
  Three randomized clinical trials including 1,313 patients were retrieved. A significant reduction of risk ratio was found in TTP (P ≤ 0.0001) but not in OS (P = 0.48) or ORR (P = 0.10) for patients treated with a chemotherapy agent plus docetaxel compared with docetaxel alone. Treatment with docetaxel alone is associated with a lower incidence of grade 3 diarrhea and stomatitis (diarrhea, P = 0.011; stomatitis, P = 0.0004).
  
  
  CONCLUSIONS
  Combination chemotherapy regimens with docetaxel show a statistically significant advantage for TTP, but not for OS and ORR in MBC. This review confirms that it is unlikely that any single agent or combination chemotherapy regimen will emerge as superior in MBC, due to its heterogeneous nature.
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Via Nazionale 8/A, Santa Maria Imbaro, Chieti, Italy. belfiglio@negrisud.it
authors.forename: Maurizio
authors.initials: M
authors.lastname: Belfiglio
authors.forename: Caterina
authors.initials: C
authors.lastname: Fanizza
authors.forename: Nicola
authors.initials: N
authors.lastname: Tinari
authors.forename: Corrado
authors.initials: C
authors.lastname: Ficorella
authors.forename: Stefano
authors.initials: S
authors.lastname: Iacobelli
authors.forename: Clara
authors.initials: C
authors.lastname: Natoli
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017326:Clinical Trials, Phase III as Topic; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis; D016032:Randomized Controlled Trials as Topic; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D043823:Taxoids; D000077143:Docetaxel
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