BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients

Giuseppe Visani, Lara Malerba, Pietro Maria Stefani, Saveria Capria, Piero Galieni, Francesco Gaudio, Giorgina Specchia, Giovanna Meloni, Filippo Gherlinzoni, Claudio Giardini, Sadia Falcioni, Francesca Cuberli, Marco Gobbi, Barbara Sarina, Armando Santoro, Felicetto Ferrara, Marco Rocchi, Enrique M. Ocio, Maria Dolores Caballero, Alessandro Isidori

Research output: Contribution to journalArticle

72 Citations (Scopus)

Abstract

We designed a phase 1-2 study to evaluate the safety and the efficacy of increasing doses of bendamustine (160 mg/m 2, 180 mg/m 2, and 200 mg/m 2 given on days -7 and -6) coupled with fixed doses of etoposide, cytarabine, and melphalan (BeEAM regimen) as the conditioning regimen to autologous stem cell transplantation for resistant/relapsed lymphoma patients. Forty-three patients (median age, 47 years) with non-Hodgkin (n = 28) or Hodgkin (n = 15) lymphoma were consecutively treated. Nine patients entered the phase 1 study; no patients experienced a dose-limiting toxicity. Thirty-four additional patients were then treated in the phase 2. A median number of 6 × 10 6 CD34 + cells/kg (range, 2.4-15.5) were reinfused. All patients engrafted, with a median time to absolute neutrophil count > 0.5 × 10 9/L of 10 days. The 100-day transplantation-related mortality was 0%. After a median follow-up of 18 months, 35 of 43 patients (81%) are in complete remission, whereas 6 of 43 relapsed and 2 of 43 did not respond. Disease type (non-Hodgkin lymphomas vs Hodgkin disease) and disease status at transplantation (chemosensitive vs chemoresistant) significantly influenced DFS (P = .01; P = .007). Remarkably, 4 of 43 (9%) patients achieved the first complete remission after receiving the high-dose therapy with autologous stem cell transplantation. In conclusion, the new BeEAM regimen is safe and effective for heavily pretreated lymphoma patients. The study was registered at European Medicines Agency (EudraCT number 2008-002736-15).

Original languageEnglish
Pages (from-to)3419-3425
Number of pages7
JournalBlood
Volume118
Issue number12
DOIs
Publication statusPublished - Sep 22 2011

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Melphalan
Cytarabine
Stem Cell Transplantation
Etoposide
Stem cells
Lymphoma
Medicine
Toxicity
Hodgkin Disease
Non-Hodgkin's Lymphoma
Transplantation
Bendamustine Hydrochloride
Neutrophils
Safety
Mortality

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

Cite this

BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. / Visani, Giuseppe; Malerba, Lara; Stefani, Pietro Maria; Capria, Saveria; Galieni, Piero; Gaudio, Francesco; Specchia, Giorgina; Meloni, Giovanna; Gherlinzoni, Filippo; Giardini, Claudio; Falcioni, Sadia; Cuberli, Francesca; Gobbi, Marco; Sarina, Barbara; Santoro, Armando; Ferrara, Felicetto; Rocchi, Marco; Ocio, Enrique M.; Caballero, Maria Dolores; Isidori, Alessandro.

In: Blood, Vol. 118, No. 12, 22.09.2011, p. 3419-3425.

Research output: Contribution to journalArticle

Visani, G, Malerba, L, Stefani, PM, Capria, S, Galieni, P, Gaudio, F, Specchia, G, Meloni, G, Gherlinzoni, F, Giardini, C, Falcioni, S, Cuberli, F, Gobbi, M, Sarina, B, Santoro, A, Ferrara, F, Rocchi, M, Ocio, EM, Caballero, MD & Isidori, A 2011, 'BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients', Blood, vol. 118, no. 12, pp. 3419-3425. https://doi.org/10.1182/blood-2011-04-351924
Visani, Giuseppe ; Malerba, Lara ; Stefani, Pietro Maria ; Capria, Saveria ; Galieni, Piero ; Gaudio, Francesco ; Specchia, Giorgina ; Meloni, Giovanna ; Gherlinzoni, Filippo ; Giardini, Claudio ; Falcioni, Sadia ; Cuberli, Francesca ; Gobbi, Marco ; Sarina, Barbara ; Santoro, Armando ; Ferrara, Felicetto ; Rocchi, Marco ; Ocio, Enrique M. ; Caballero, Maria Dolores ; Isidori, Alessandro. / BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. In: Blood. 2011 ; Vol. 118, No. 12. pp. 3419-3425.
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AU - Visani, Giuseppe

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AU - Stefani, Pietro Maria

AU - Capria, Saveria

AU - Galieni, Piero

AU - Gaudio, Francesco

AU - Specchia, Giorgina

AU - Meloni, Giovanna

AU - Gherlinzoni, Filippo

AU - Giardini, Claudio

AU - Falcioni, Sadia

AU - Cuberli, Francesca

AU - Gobbi, Marco

AU - Sarina, Barbara

AU - Santoro, Armando

AU - Ferrara, Felicetto

AU - Rocchi, Marco

AU - Ocio, Enrique M.

AU - Caballero, Maria Dolores

AU - Isidori, Alessandro

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N2 - We designed a phase 1-2 study to evaluate the safety and the efficacy of increasing doses of bendamustine (160 mg/m 2, 180 mg/m 2, and 200 mg/m 2 given on days -7 and -6) coupled with fixed doses of etoposide, cytarabine, and melphalan (BeEAM regimen) as the conditioning regimen to autologous stem cell transplantation for resistant/relapsed lymphoma patients. Forty-three patients (median age, 47 years) with non-Hodgkin (n = 28) or Hodgkin (n = 15) lymphoma were consecutively treated. Nine patients entered the phase 1 study; no patients experienced a dose-limiting toxicity. Thirty-four additional patients were then treated in the phase 2. A median number of 6 × 10 6 CD34 + cells/kg (range, 2.4-15.5) were reinfused. All patients engrafted, with a median time to absolute neutrophil count > 0.5 × 10 9/L of 10 days. The 100-day transplantation-related mortality was 0%. After a median follow-up of 18 months, 35 of 43 patients (81%) are in complete remission, whereas 6 of 43 relapsed and 2 of 43 did not respond. Disease type (non-Hodgkin lymphomas vs Hodgkin disease) and disease status at transplantation (chemosensitive vs chemoresistant) significantly influenced DFS (P = .01; P = .007). Remarkably, 4 of 43 (9%) patients achieved the first complete remission after receiving the high-dose therapy with autologous stem cell transplantation. In conclusion, the new BeEAM regimen is safe and effective for heavily pretreated lymphoma patients. The study was registered at European Medicines Agency (EudraCT number 2008-002736-15).

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