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

Bendamustine, Etoposide, Cytarabine and Melphalan (BeEAM) Followed By Autologous Stem Cell Transplantation Produce a 3-Year Progression-Free Survival Of 75% In Heavily Pre-Treated Hodgkin and Non-Hodgkin Lymphoma

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  • Medientyp: E-Artikel
  • Titel: Bendamustine, Etoposide, Cytarabine and Melphalan (BeEAM) Followed By Autologous Stem Cell Transplantation Produce a 3-Year Progression-Free Survival Of 75% In Heavily Pre-Treated Hodgkin and Non-Hodgkin Lymphoma
  • Beteiligte: Visani, Giuseppe; Stefani, Pietro Maria; Capria, Saveria; Malerba, Lara; Galieni, Piero; Gaudio, Francesco; Specchia, Giorgina; Meloni, Giovanna; Gherlinzoni, Filippo; Giardini, Claudio; Falcioni, Sadia; Gonella, Roberta; Cuberli, Francesca; Gobbi, Marco; Sarina, Barbara; Santoro, Armando; Ferrara, Felicetto; Rocchi, Marco; Ocio, Enrique M.; Caballero, Maria Dolores; Picardi, Paola; Ricciardi, Teresa; Loscocco, Federica; Isidori, Alessandro
  • Erschienen: American Society of Hematology, 2013
  • Erschienen in: Blood
  • Sprache: Englisch
  • DOI: 10.1182/blood.v122.21.2134.2134
  • ISSN: 0006-4971; 1528-0020
  • Schlagwörter: Cell Biology ; Hematology ; Immunology ; Biochemistry
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>We previously demonstrated (Visani et al, Blood 2011) the safety of a new conditioning regimen with bendamustine, etoposide, cytarabine, and melphalan (BeEAM) prior to autologous stem cell transplant (ASCT) in resistant/relapsed lymphoma patients (EUDRACTnumber2008-002736-15). Furthermore, this regimen showed significant anti-lymphoma activity (80% CR). At the time of publication (2011), disease type (NHL versus HL) and disease status at transplant (chemosensitive versus chemoresistant) were the only statistically significant variables influencing PFS (p=0.01; p=0.007). However, median follow-up for surviving patients was short (18 months), therefore, it was not possible to draw final conclusions on the efficacy.</jats:p> </jats:sec> <jats:sec> <jats:title>Aims</jats:title> <jats:p>We evaluated the efficacy of the BeEAM regimen in terms of disease-free (DFS) and overall survival (OS) after a median follow-up of 41 months.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>Forty-three patients (median age 47 years, range 18-70) with resistant/relapsed NHL (28) or Hodgkin lymphoma (HL, 15) were consecutively enrolled in the study. Twenty-one patients had primary refractory disease, whereas 22 had relapsed disease, 5 of whom where in second or subsequent relapse, at the time of enrolment.</jats:p> <jats:p>The study was designed according to Fleming’s method. The primary objective of the study was to determine the 36-months event free survival rate. We fixed the lowest acceptable rate as 40% and the successful rate as 60%, with a significance level a=0.05 and a power 1-b =0.80. At the time of publication, the median follow-up was 18 months, and therefore it was not possible to establish if we had met the primary end-point of the study.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>we updated the follow-up at 41 months after transplant. Thirty-one out of 43 patients are still in CR (72%), as documented by both PET and CT scan. Two patients with HL were refractory and rapidly died, whereas 10/43 patients (23%) relapsed after a median time of 7.5 months (range:3-23) from transplant. Five patients died (3 NHL, 2 HL), whereas 5 patients are still alive after relapse. Median PFS and OS were still not reached.</jats:p> <jats:p>Conversely, 3-year PFS was 75%, allowing our study to met its primary end-point. Interestingly, disease type (HL versus NHL) at transplant is no longer influencing PFS (p=0.7), and still does not influence OS (p=0.1). On the other hand, disease status at transplant (chemosensitive vs chemoresistant) is still a strong predictor of both PFS and OS (p=0.03 and p=0.009, respectively). At present, one patient developed myelodisplasia after transplant. No other late effects were observed up to now.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>The new BeEAM regimen met the primary end-point of the study and confirms its safety, after 41 months of follow-up. Interestingly, NHL and HL were not statistically different in terms of both PFS and OS at 41 months of observation.</jats:p> <jats:p>These data confirm the high efficacy of this regimen in heavily pretreated non-Hodgkin, as well as Hodgkin lymphoma.</jats:p> </jats:sec> <jats:sec> <jats:title>Acknowledgments</jats:title> <jats:p>supported in part by AIL Pesaro Onlus.</jats:p> </jats:sec> <jats:sec> <jats:title>Disclosures:</jats:title> <jats:p>Ocio: Onyx: Consultancy, Research Funding; Novartis: Consultancy; Array Biopharma: Consultancy, Research Funding; Bristol Myers Squibb: Consultancy; Celgene: Consultancy, Research Funding.</jats:p> </jats:sec>
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