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

Abstract

We designed a phase 1-2 study to evaluate the safety and the efficacy of increasing doses of bendamustine (160 mg/m², 180 mg/m², and 200 mg/m² 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 × 10⁶ CD34(+) cells/kg (range, 2.4-15.5) were reinfused. All patients engrafted, with a median time to absolute neutrophil count > 0.5 × 10⁹/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).

• Authors: 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
• Journal: Blood (Blood) Vol. 118 Issue 12 Pg. 3419-25 (Sep 22 2011) ISSN: 1528-0020 [Electronic] United States
• PMID: 21816830 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Nitrogen Mustard Compounds
• Cytarabine
• Etoposide
• Bendamustine Hydrochloride
• Melphalan

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Bendamustine Hydrochloride
• Cytarabine (administration & dosage, therapeutic use)
• Drug Resistance, Neoplasm
• Etoposide (administration & dosage, therapeutic use)
• Female
• Follow-Up Studies
• Graft Survival
• Hematopoietic Stem Cell Transplantation
• Hodgkin Disease (immunology, pathology, therapy)
• Humans
• Lymphoma, Non-Hodgkin (immunology, pathology, therapy)
• Male
• Melphalan (administration & dosage, therapeutic use)
• Middle Aged
• Nitrogen Mustard Compounds (administration & dosage, therapeutic use)
• Recurrence
• Remission Induction
• Salvage Therapy (methods)
• Transplantation Conditioning (methods)
• Transplantation, Autologous