title: Use of low-dose combined therapy with gemcitabine and paclitaxel for advanced urothelial cancer patients with resistance to cisplatin-containing therapy: a retrospective analysis.
abstract: OBJECTIVE
  The prognosis of patients with advanced and recurrent urothelial cancer (UC) is poor. Although cisplatin (CDDP)-containing chemotherapy is the most effective regimen in these patients, there is no other established chemotherapeutic regimen. We administered combination therapy with low-dose gemcitabine (GEM) and paclitaxel (PTX), named low-dose gemcitabine-paclitaxel (LD-GP) therapy, as salvage therapy for these patients. The aim was to evaluate the anti-tumoral effects, relief of pain, and toxicity of LD-GP therapy in patients with resistance to CDDP-containing therapy.
  
  
  METHODS
  Thirty-five patients with advanced UC, previously treated with CDDP-containing regimens, were treated with LD-GP therapy (GEM, 700 mg/m(2) + PTX, 70 mg/m(2) on day 1 and 8, repeated every 28 days). Pain was measured on a visual analog scale before and after treatment. Pain relief and survival were compared between this and other treatment regimens.
  
  
  RESULTS
  None of the patients had complete response to LD-GP therapy. Partial response and stable disease were seen in 25.7 and 62.9 % of patients, respectively. Kaplan-Meier curves showed better survival in patients with LD-GP therapy than with others (p = 0.034). Twenty-eight patients (80.0 %) had adequate pain relief, and only two patients needed to increase their analgesics. Other regimens demonstrated pain relief in 30.4 % of patients. Common toxicities included leukopenia, with five patients requiring granular colony-stimulating factor therapy (14.3 %). The most common non-hematologic toxicity was fatigue (n = 7, 17.1 %).
  
  
  CONCLUSIONS
  LD-GP therapy is feasible and well tolerated as salvage therapy in patients with advanced UC with resistance to CDDP-containing therapy.
authors.affiliation: Department of Nephro-Urology, Nagasaki University Graduate School of Biomedical Science, Japan. int.doc.miya@m3.dion.ne.jp
authors.forename: Yasuyoshi
authors.initials: Y
authors.lastname: Miyata
authors.forename: Koichiro
authors.initials: K
authors.lastname: Nomata
authors.forename: Kojiro
authors.initials: K
authors.lastname: Ohba
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Matsuo
authors.forename: Yuji
authors.initials: Y
authors.lastname: Sagara
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kanetake
authors.forename: Hideki
authors.initials: H
authors.lastname: Sakai
mesh_terms: D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D019008:Drug Resistance, Neoplasm; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D012189:Retrospective Studies; D016879:Salvage Therapy / Q000379:methods; D016896:Treatment Outcome; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D019459:Urothelium / Q000473:pathology*; D000093542:Gemcitabine
chemical_list: D000700:Analgesics; D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine