title: Gemcitabine, dexamethasone, and cisplatin in patients with recurrent or refractory aggressive histology B-cell non-Hodgkin lymphoma: a Phase II study by the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG).
abstract: BACKGROUND
  Gemcitabine has been shown to have activity as a single agent in lymphoma and, when combined with cisplatin, is effective therapy for a number of solid tumors. The authors wished to determine the response rate and toxicity of gemcitabine, dexamethasone, and cisplatin for recurrent or refractory non-Hodgkin lymphoma (NHL).
  
  
  METHODS
  Patients with recurrent or refractory diffuse large B-cell NHL or variants (REAL classification), measurable disease, and one previous chemotherapy regimen were eligible. Treatment consisted of gemcitabine 1000 mg/m(2) intravenously (i.v.) on Days 1 and 8, dexamethasone 40 mg orally on Days 1-4, and cisplatin 75 mg/m(2) i.v. on Day 1 (GDP), every 21 days as an outpatient. The primary end point was a response after two cycles. Patients could then proceed to stem cell transplantation (SCT) or receive up to six treatment cycles.
  
  
  RESULTS
  Fifty-one eligible patients were evaluable for toxicity and response. The median age of the patients was 57 years (range, 18-84 years) and most had diffuse large-cell lymphoma. After 2 cycles, there were 8 complete responses (CR; 16%) and 17 partial responses (PR; 33%). There was an overall response rate (RR) of 49% (95% confidence interval = 37-63%). The RR afer completion of all protocol chemotherapy (including those who received > 2 cycles of GDP) was 53% (11 CR, 16 PR). Grade 3 and 4 neutropenia occurred in 33% and 39% of patients, respectively. Grade 3 and 4 thrombocytopenia occurred in 24% and 4% of patients, respectively. Seven patients (14%) experienced febrile neutropenia. Of the 35 patients < 66 years, 22 (63%) proceeded to SCT.
  
  
  CONCLUSIONS
  GDP is an active regimen in B-cell NHL and can be administered with acceptable toxicity to outpatients. A Phase III trial comparing GDP with standard cisplatin-based chemotherapy is now ongoing through the National Cancer Institute of Canada Clinical Trials Group.
authors.affiliation: National Cancer Institute of Canada-Clinical Trials Group, Kingston, Ontario, Canada. michael.crump@uhn.on.ca
authors.forename: Michael
authors.initials: M
authors.lastname: Crump
authors.forename: Tara
authors.initials: T
authors.lastname: Baetz
authors.forename: Stephen
authors.initials: S
authors.lastname: Couban
authors.forename: Andrew
authors.initials: A
authors.lastname: Belch
authors.forename: Deborah
authors.initials: D
authors.lastname: Marcellus
authors.forename: Kang
authors.initials: K
authors.lastname: Howson-Jan
authors.forename: Kevin
authors.initials: K
authors.lastname: Imrie
authors.forename: Robert
authors.initials: R
authors.lastname: Myers
authors.forename: Grenfell
authors.initials: G
authors.lastname: Adams
authors.forename: Keyue
authors.initials: K
authors.lastname: Ding
authors.forename: Nancy
authors.initials: N
authors.lastname: Paul
authors.forename: Lois
authors.initials: L
authors.lastname: Shepherd
authors.forename: Jose
authors.initials: J
authors.lastname: Iglesias
authors.forename: Ralph
authors.initials: R
authors.lastname: Meyer
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D016879:Salvage Therapy; D033581:Stem Cell Transplantation; D016896:Treatment Outcome
chemical_list: D003841:Deoxycytidine; D003907:Dexamethasone; D002945:Cisplatin