title: Gemcitabine, vinorelbine and prednisone for refractory or relapsed aggressive lymphoma, results of a phase II single center study.
abstract: The optimum therapy for patients with relapsed or refractory aggressive non-Hodgkin's lymphomas (NHL) not qualifying for platinum-based and/or high-dose chemotherapy is not known. We conducted a prospective phase II study evaluating a regimen consisting of gemcitabine (1 g/m2, days 1 and 8), vinorelbine (30 mg/m2, days 1 and 8) and prednisone (100 mg/day, days 1-8) (GVP) given every 21 days. Fifteen patients with a median age of 68 years and a median of three previous therapies were enrolled. Diagnoses included B lymphoblastic (n=1), diffuse large B cell (n=10), anaplastic large T cell (n=2) and peripheral T-cell NHL (n=2). The median international prognostic index score was 3 (six patients with a score of 4 or 5). Five patients achieved a complete remission and three patients a partial remission. The median overall survival was 13.8 months, and the median time to next treatment was 4.4 months. Haematological toxicities of World Health Organisation grades 3/4 were leucopenia in 58%, thrombocytopenia in 33% and anaemia in 17% of all courses. Three patients had grade 3 infections. There was no treatment-related mortality. GVP shows substantial activity in poor prognosis relapsed or refractory aggressive lymphomas and is generally well tolerated, but haematological toxicity is dose limiting.
authors.affiliation: Klinik für Hämatologie, Universitätsklinikum Essen, Hufelandstrasse 55, 45122, Essen, Germany. m-beissenhirtz@uni-essen.de
authors.forename: Hannes
authors.initials: H
authors.lastname: Müller-Beissenhirtz
authors.forename: Christoph
authors.initials: C
authors.lastname: Kasper
authors.forename: Holger
authors.initials: H
authors.lastname: Nückel
authors.forename: Ulrich
authors.initials: U
authors.lastname: Dührsen
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006086:Graft vs Host Disease / Q000209:etiology / Q000401:mortality; D006801:Humans; D007239:Infections / Q000209:etiology / Q000401:mortality; D007970:Leukopenia / Q000209:etiology / Q000401:mortality; D008228:Lymphoma, Non-Hodgkin / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D013921:Thrombocytopenia / Q000209:etiology / Q000401:mortality; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D011241:Prednisone; D000093542:Gemcitabine