title: Gemcitabine treatment in pretreated cutaneous T-cell lymphoma: experience in 44 patients.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of gemcitabine, a novel pyrimidine antimetabolite with a low-toxicity profile and activity in several solid tumors, in patients with relapsed or refractory cutaneous T-cell lymphomas.
  
  
  METHODS
  Between May 1997 and February 1999, 44 previously treated patients with mycosis fungoides (MF; n = 30) and peripheral T-cell lymphoma unspecified (PTCLU) with exclusive skin involvement (n = 14) were enrolled onto a two-institution, phase II trial and treated with gemcitabine. This drug was given on days 1, 8, and 15 of a 28-day schedule at a dose of 1,200 mg/m(2) intravenously over 30 minutes for a total of three courses.
  
  
  RESULTS
  Of the 44 patients, five (11. 5%) achieved complete responses (CRs), 26 (59%) partial responses (PRs), and the remaining 13 showed no benefit from the treatment. Two of the CRs were histologically confirmed. The CR and PR rates were the same for patients with MF and those with PTCLU, respectively. No difference in terms of overall response rate was observed between relapsed and refractory patients. The median durations of CR and PR were 15 months (range, 6 to 22 months) and 10 months (range, 2 to 15 months), respectively. Treatment was well tolerated; hematologic toxicity was mild, and no nausea/vomiting or organ toxicity was recorded.
  
  
  CONCLUSIONS
  The results of the present phase II study show activity of gemcitabine as a single agent in patients with pretreated cutaneous T-cell lymphoma. Further studies that use gemcitabine alone or in combination with other drugs in earlier stages of the disease are needed.
authors.affiliation: Institute of Hematology and Medical Oncology "Seràgnoli," University of Bologna, and Institute of Dermatology "Immacolata," Rome, Italy. plzinzo@med.unibo.it
authors.forename: P L
authors.initials: PL
authors.lastname: Zinzani
authors.forename: G
authors.initials: G
authors.lastname: Baliva
authors.forename: M
authors.initials: M
authors.lastname: Magagnoli
authors.forename: M
authors.initials: M
authors.lastname: Bendandi
authors.forename: G
authors.initials: G
authors.lastname: Modugno
authors.forename: F
authors.initials: F
authors.lastname: Gherlinzoni
authors.forename: G F
authors.initials: GF
authors.lastname: Orcioni
authors.forename: S
authors.initials: S
authors.lastname: Ascani
authors.forename: R
authors.initials: R
authors.lastname: Simoni
authors.forename: S A
authors.initials: SA
authors.lastname: Pileri
authors.forename: S
authors.initials: S
authors.lastname: Tura
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine