title: Efficacy and safety of gemcitabine, carboplatin, dexamethasone, and rituximab in patients with relapsed/refractory lymphoma: a prospective multi-center phase II study by the Puget Sound Oncology Consortium.
abstract: We conducted a multi-center phase II trial of gemcitabine (G), carboplatin (C), dexamethasone (D), and rituximab (R) in order to examine its safety and efficacy as an outpatient salvage regimen for lymphoma. Fifty-one patients received 2-4 21-day cycles of G (1000 mg/m(2), days 1 and 8), C (AUC = 5, day 1), D (40 mg, daily days 1-4), and R (375 mg/m(2), day 8 for CD20-positive disease) and were evaluable for response. Characteristics included: median age 58 years (19-79 years), stage III/IV 88%, elevated LDH 33%, median prior therapies 2, prior stem cell transplant 12%, chemoresistant 62%, median prior remission duration 2.5 months. The overall and complete response rates were 67% (95% confidence interval [CI] 54-80%) and 31% (95% CI 19-44%), respectively, with activity seen in a broad variety of histologies. Responses occurred in 16 of 17 (94%, 95% CI 83-100%) transplant-eligible patients and 15 of 28 (54%, 95% CI 34-71%) with chemoresistant disease. The median CD34 yield in patients attempting peripheral blood stem cell (PBSC) collection following this regimen was 10.9 x 10(6) CD34+ cells/kg (range 5.0-24.1 x 10(6)). Hematologic toxicity was common, but febrile neutropenia (2.5%) and grade 4 non-hematologic adverse events (n = 2) were rare, with no treatment-related deaths. GCD(R) is a safe and effective outpatient regimen for relapsed lymphoma, and successfully mobilizes PBSCs.
authors.affiliation: University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA, USA. agopal@u.washington.edu
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Gopal
authors.forename: Oliver W
authors.initials: OW
authors.lastname: Press
authors.forename: Andrei R
authors.initials: AR
authors.lastname: Shustov
authors.forename: Stephen H
authors.initials: SH
authors.lastname: Petersdorf
authors.forename: Ted A
authors.initials: TA
authors.lastname: Gooley
authors.forename: Jasmine T
authors.initials: JT
authors.lastname: Daniels
authors.forename: Mitchell A
authors.initials: MA
authors.lastname: Garrison
authors.forename: George F
authors.initials: GF
authors.lastname: Gjerset
authors.forename: Matthew
authors.initials: M
authors.lastname: Lonergan
authors.forename: Anne E
authors.initials: AE
authors.lastname: Murphy
authors.forename: Julie C
authors.initials: JC
authors.lastname: Smith
authors.forename: John M
authors.initials: JM
authors.lastname: Pagel
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003907:Dexamethasone / Q000008:administration & dosage; D019008:Drug Resistance, Neoplasm; D005260:Female; D019650:Hematopoietic Stem Cell Mobilization; D006801:Humans; D008223:Lymphoma / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy*; D036102:Peripheral Blood Stem Cell Transplantation; D011446:Prospective Studies; D012074:Remission Induction; D000069283:Rituximab; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D003841:Deoxycytidine; D000069283:Rituximab; D003907:Dexamethasone; D016190:Carboplatin; D000093542:Gemcitabine