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 language | English |
|---|---|
| Pages (from-to) | 3419-3425 |
| Number of pages | 7 |
| Journal | Blood |
| Volume | 118 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - Sep 22 2011 |
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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 journal › Article
}
TY - JOUR
T1 - BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients
AU - Visani, Giuseppe
AU - Malerba, Lara
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
PY - 2011/9/22
Y1 - 2011/9/22
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).
AB - 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).
UR - http://www.scopus.com/inward/record.url?scp=80053185604&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=80053185604&partnerID=8YFLogxK
U2 - 10.1182/blood-2011-04-351924
DO - 10.1182/blood-2011-04-351924
M3 - Article
C2 - 21816830
AN - SCOPUS:80053185604
VL - 118
SP - 3419
EP - 3425
JO - Blood
JF - Blood
SN - 0006-4971
IS - 12
ER -