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

F. Hitz, G. Martinelli, E. Zucca, R. Von Moos, W. Mingrone, M. Simcock, J. Peterson, S. B. Cogliatti, F. Bertoni, D. R. Zimmermann, M. Ghielmini

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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.

Original languageEnglish
Pages (from-to)154-159
Number of pages6
JournalHematological Oncology
Volume27
Issue number3
DOIs
Publication statusPublished - Sep 2009

Keywords

  • Elderly patients
  • Gemcitabine
  • Mantle cell lymphoma
  • SAKK

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Hitz, F., Martinelli, G., Zucca, E., Von Moos, R., Mingrone, W., Simcock, M., Peterson, J., Cogliatti, S. B., Bertoni, F., Zimmermann, D. R., & Ghielmini, M. (2009). 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. Hematological Oncology, 27(3), 154-159. https://doi.org/10.1002/hon.891