title: A multicentre phase II trial of gemcitabine for the treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03.
abstract: Mantle cell lymphoma (MCL) has a poor prognosis with often short and incomplete remissions. We aimed to test the efficacy and tolerability of gemcitabine in treating MCL. Gemcitabine was given in doses of 1000 mg/m(2) as a 30 min infusion on days 1 and 8 of each 3 week cycle for a maximum of nine cycles. Eighteen patients with a median age of 70 years were recruited. MCL was newly diagnosed in half of patients and relapsed in the remainder. Fifteen patients had Ann Arbor stage IV. The best-recorded responses were 1 CR (complete remission), 4 PRs (partial responses), 8 SDs (stable diseases) and 4 PDs (diseases progression). The response rate (RR) (CR + PR) was 5 (28%; 95% confidence interval: 7.1, 48.5). The patient achieving a CR had stage IV disease. Most haematological adverse events occurred during the first chemotherapy cycle. Three patients developed non-haematological serious adverse events: dyspnea, glomerular microangiopathy with haemolytic uremic syndrome (HUS) and hyperglycaemia. The median time-to-progression and treatment response duration (TRD) was 8.0 (95% confidence interval: 5.5, 9.3) and 10.6 (95% confidence interval: 5.5, 10.9) months, respectively. We conclude that Gemcitabine is well tolerated, moderately active and can induce disease stabilization in patients with MCL.
authors.affiliation: Kantonsspital St. Gallen, 9007 St. Gallen, Switzerland. felicitas.hitz@kssg.ch
authors.forename: F
authors.initials: F
authors.lastname: Hitz
authors.forename: G
authors.initials: G
authors.lastname: Martinelli
authors.forename: E
authors.initials: E
authors.lastname: Zucca
authors.forename: R
authors.initials: R
authors.lastname: von Moos
authors.forename: W
authors.initials: W
authors.lastname: Mingrone
authors.forename: M
authors.initials: M
authors.lastname: Simcock
authors.forename: J
authors.initials: J
authors.lastname: Peterson
authors.forename: S B
authors.initials: SB
authors.lastname: Cogliatti
authors.forename: F
authors.initials: F
authors.lastname: Bertoni
authors.forename: D R
authors.initials: DR
authors.lastname: Zimmermann
authors.forename: M
authors.initials: M
authors.lastname: Ghielmini
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects* / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine