title: Salvage chemotherapy of gemcitabine, dexamethasone, and cisplatin (GDP) for patients with relapsed or refractory peripheral T-cell lymphomas: a consortium for improving survival of lymphoma (CISL) trial.
abstract: There is no standard salvage chemotherapy for relapsed or refractory peripheral T-cell lymphomas (PTCLs). Gemcitabine combined with cisplatin has been known as an effective regimen for lymphoma treatment in the salvage setting. We investigated the efficacy and toxicity of gemcitabine, dexamethasone, and cisplatin (GDP) for relapsed or refractory PTCLs in search of a more effective and less toxic therapy. Patients with relapsed or refractory PTCLs with more than one previous 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 70 mg/m(2) i.v. on day 1, and then every 21 days. Patients could proceed to autologous stem cell transplantation (ASCT) after four cycles of GDP or receive up to six treatment cycles. Twenty-five eligible patients were evaluated for toxicity and response. The diagnoses of participants included 14 cases of PTCL-not otherwise specified (NOS) (56 %) and four cases of angioimmunoblastic T-cell lymphoma (16 %) among others. The median age of the patients was 59 years (range 20-75 years). After treatments with GDP, which delivered a median of four GDP cycles, there were 12 patients with complete responses (CR; 48 %) and six with partial responses (PR; 24 %). The overall response rate (RR) was 72 %. Four patients preceded to ASCT, and three patients finally achieved CR. The median progression free survival was 9.3 months (95 % confidence interval (CI); 4.1-14.6) with a median follow-up duration of 27.1 months. In a total of 86 cycles of GDP, grade 3 or 4 neutropenia and thrombocytopenia occurred in 16.3 and 12.8 % of cycles, respectively. Three patients (3.3 %) experienced febrile neutropenia. GDP is a highly effective and optimal salvage regimen for relapsed or refractory PTCLs and can be administered with acceptable toxicity.
authors.affiliation: Division of Hematology/Oncology, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
authors.forename: Byeong-Bae
authors.initials: BB
authors.lastname: Park
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, School of Medicine, Sungkyunkwan University, 50 Ilwon-dong, Kangnam-gu, Seoul, 135-710, Republic of Korea. wskimsmc@skku.edu.
authors.forename: Won Seog
authors.initials: WS
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.
authors.forename: Cheolwon
authors.initials: C
authors.lastname: Suh
authors.affiliation: Division of Hematology/Oncology, Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical sciences, Seoul, Korea.
authors.forename: Dong-Yeop
authors.initials: DY
authors.lastname: Shin
authors.affiliation: Division of Hematology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, Catholic University of Korea, Suwon, Korea.
authors.forename: Jeong-A
authors.initials: JA
authors.lastname: Kim
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, School of Medicine, Gyeongsang National University, Jinju, Korea.
authors.forename: Hoon-Gu
authors.initials: HG
authors.lastname: Kim
authors.affiliation: Division of Hematology, Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.
authors.forename: Won Sik
authors.initials: WS
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003907:Dexamethasone / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D016879:Salvage Therapy / Q000009:adverse effects / Q000379:methods*; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003841:Deoxycytidine; D003907:Dexamethasone; D002945:Cisplatin
keywords: Gemcitabine; Peripheral T-cell lymphoma; Salvage therapy