title: Neoadjuvant Chemotherapy with Gemcitabine plus Cisplatin in Patients with Locally Advanced Bladder Cancer.
abstract: BACKGROUND
  Neoadjuvant chemotherapy with methotrexate-vinblastine-doxorubicin-cisplatin (MVAC) is the standard of care for muscle-invasive urothelial bladder cancer. Gemcitabine plus cisplatin (GC) shows similar efficacy with less toxicity in the metastatic setting and has therefore often been used interchangeably with MVAC. We report on the efficacy and safety of neoadjuvant GC in patients with locally advanced urothelial cancer.
  
  
  METHODS
  We prospectively evaluated 87 patients in 2 centers. Their median age was 68 years. Treatment consisted of 3× GC prior to radical cystectomy. The primary endpoint was pathologic response. The secondary endpoints were safety, progression-free survival (PFS), and overall survival (OS).
  
  
  RESULTS
  In all, 83 patients finished chemotherapy; 80 patients were evaluable for the primary endpoint. Pathologic complete response (pCR) was achieved in 22.5% and near pCR was seen in 33.7% of the patients. The 1-year PFS rate was 79.5% among those patients achieving ≤pT2 versus 100% among those patients achieving pCR or near pCR (p = 0.041). Five-year OS was 61.8% (95% CI 67.6 to NA). GC was well tolerated. Grade 3/4 toxicities occurred in 38% of the patients. There was no grade 3/4 renal toxicity, febrile neutropenia, or death.
  
  
  CONCLUSIONS
  Neoadjuvant GC is a well-tolerated regimen. Although the pathologic response is lower than that reported with MVAC, our data support GC as a feasible option in the absence of a prospective randomized comparison, particularly for older patients, since its toxicity is lower than that of MVAC.
authors.affiliation: Department of Medicine I, Center for Oncology, Haematology and Palliative Care, Wilhelminenspital, Vienna, Austria.
authors.forename: Dora
authors.initials: D
authors.lastname: Niedersüss-Beke
authors.forename: Thomas
authors.initials: T
authors.lastname: Puntus
authors.forename: Thomas
authors.initials: T
authors.lastname: Kunit
authors.forename: Birgit
authors.initials: B
authors.lastname: Grünberger
authors.forename: Michael
authors.initials: M
authors.lastname: Lamche
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Loidl
authors.forename: Reinhard
authors.initials: R
authors.lastname: Böhm
authors.forename: Nicole
authors.initials: N
authors.lastname: Kraischits
authors.forename: Stefan
authors.initials: S
authors.lastname: Kudlacek
authors.forename: Paul
authors.initials: P
authors.lastname: Schramek
authors.forename: Johannes G
authors.initials: JG
authors.lastname: Meran
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011446:Prospective Studies; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine
keywords: Bladder cancer; Cisplatin and gemcitabine; Neoadjuvant chemotherapy