Phase ii study of bendamustine in relapsed and refractory hodgkin lymphoma

Alison J. Moskowitz, Paul A. Hamlin, Miguel Angel Perales, John Gerecitano, Steven M. Horwitz, Matthew J. Matasar, Ariela Noy, Maria Lia Palomba, Carol S. Portlock, David J. Straus, Tricia Graustein, Andrew D. Zelenetz, Craig Moskowitz

Research output: Contribution to journalArticle

110 Citations (Scopus)

Abstract

Purpose Limited data exist regarding the activity of bendamustine in Hodgkin lymphoma (HL). This phase II study evaluated the efficacy of bendamustine in relapsed and refractory HL. Patients and Methods Patients with relapsed and refractory HL who were ineligible for autologous stem-cell transplantation (ASCT), or for whom this treatment failed, received bendamustine 120 mg/m2 as a 30-minute infusion on days 1 and 2 every 28 days with growth factor support. The primary end point was overall response rate (ORR). A secondary end point was referral rate to allogeneic stem-cell transplantation (alloSCT) for patients deemed eligible for alloSCT at the time of enrollment. Results Of the 36 patients enrolled, 34 were evaluable for response. Patients had received a median of four prior treatments, and 75% had relapsed after ASCT. The ORR by intent-to-treat analysis was 53%, including 12 complete responses (33%) and seven partial responses (19%). The response rate among evaluable patients was 56%. Responses were seen in patients with prior refractory disease, prior ASCT, and prior alloSCT; however, no responses were seen in patients who relapsed within 3 months of ASCT. The median response duration was 5 months. Five patients (20% of those eligible) proceeded to alloSCT after treatment with bendamustine. Grade ≥ 3 adverse events were infrequent and most commonly included thrombocytopenia (20%), anemia (14%), and infection (14%). Conclusion This study confirms the efficacy of bendamustine in heavily pretreated patients with HL. These results support current and future studies evaluating bendamustine combinations in relapsed and refractory HL.

Original languageEnglish (US)
Pages (from-to)456-460
Number of pages5
JournalJournal of Clinical Oncology
Volume31
Issue number4
DOIs
StatePublished - Feb 1 2013
Externally publishedYes

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Hodgkin Disease
Stem Cell Transplantation
Bendamustine Hydrochloride
Thrombocytopenia
Anemia
Intercellular Signaling Peptides and Proteins
Therapeutics
Referral and Consultation
Infection

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Moskowitz, A. J., Hamlin, P. A., Perales, M. A., Gerecitano, J., Horwitz, S. M., Matasar, M. J., ... Moskowitz, C. (2013). Phase ii study of bendamustine in relapsed and refractory hodgkin lymphoma. Journal of Clinical Oncology, 31(4), 456-460. https://doi.org/10.1200/JCO.2012.45.3308

Phase ii study of bendamustine in relapsed and refractory hodgkin lymphoma. / Moskowitz, Alison J.; Hamlin, Paul A.; Perales, Miguel Angel; Gerecitano, John; Horwitz, Steven M.; Matasar, Matthew J.; Noy, Ariela; Palomba, Maria Lia; Portlock, Carol S.; Straus, David J.; Graustein, Tricia; Zelenetz, Andrew D.; Moskowitz, Craig.

In: Journal of Clinical Oncology, Vol. 31, No. 4, 01.02.2013, p. 456-460.

Research output: Contribution to journalArticle

Moskowitz, AJ, Hamlin, PA, Perales, MA, Gerecitano, J, Horwitz, SM, Matasar, MJ, Noy, A, Palomba, ML, Portlock, CS, Straus, DJ, Graustein, T, Zelenetz, AD & Moskowitz, C 2013, 'Phase ii study of bendamustine in relapsed and refractory hodgkin lymphoma', Journal of Clinical Oncology, vol. 31, no. 4, pp. 456-460. https://doi.org/10.1200/JCO.2012.45.3308
Moskowitz AJ, Hamlin PA, Perales MA, Gerecitano J, Horwitz SM, Matasar MJ et al. Phase ii study of bendamustine in relapsed and refractory hodgkin lymphoma. Journal of Clinical Oncology. 2013 Feb 1;31(4):456-460. https://doi.org/10.1200/JCO.2012.45.3308
Moskowitz, Alison J. ; Hamlin, Paul A. ; Perales, Miguel Angel ; Gerecitano, John ; Horwitz, Steven M. ; Matasar, Matthew J. ; Noy, Ariela ; Palomba, Maria Lia ; Portlock, Carol S. ; Straus, David J. ; Graustein, Tricia ; Zelenetz, Andrew D. ; Moskowitz, Craig. / Phase ii study of bendamustine in relapsed and refractory hodgkin lymphoma. In: Journal of Clinical Oncology. 2013 ; Vol. 31, No. 4. pp. 456-460.
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abstract = "Purpose Limited data exist regarding the activity of bendamustine in Hodgkin lymphoma (HL). This phase II study evaluated the efficacy of bendamustine in relapsed and refractory HL. Patients and Methods Patients with relapsed and refractory HL who were ineligible for autologous stem-cell transplantation (ASCT), or for whom this treatment failed, received bendamustine 120 mg/m2 as a 30-minute infusion on days 1 and 2 every 28 days with growth factor support. The primary end point was overall response rate (ORR). A secondary end point was referral rate to allogeneic stem-cell transplantation (alloSCT) for patients deemed eligible for alloSCT at the time of enrollment. Results Of the 36 patients enrolled, 34 were evaluable for response. Patients had received a median of four prior treatments, and 75{\%} had relapsed after ASCT. The ORR by intent-to-treat analysis was 53{\%}, including 12 complete responses (33{\%}) and seven partial responses (19{\%}). The response rate among evaluable patients was 56{\%}. Responses were seen in patients with prior refractory disease, prior ASCT, and prior alloSCT; however, no responses were seen in patients who relapsed within 3 months of ASCT. The median response duration was 5 months. Five patients (20{\%} of those eligible) proceeded to alloSCT after treatment with bendamustine. Grade ≥ 3 adverse events were infrequent and most commonly included thrombocytopenia (20{\%}), anemia (14{\%}), and infection (14{\%}). Conclusion This study confirms the efficacy of bendamustine in heavily pretreated patients with HL. These results support current and future studies evaluating bendamustine combinations in relapsed and refractory HL.",
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T1 - Phase ii study of bendamustine in relapsed and refractory hodgkin lymphoma

AU - Moskowitz, Alison J.

AU - Hamlin, Paul A.

AU - Perales, Miguel Angel

AU - Gerecitano, John

AU - Horwitz, Steven M.

AU - Matasar, Matthew J.

AU - Noy, Ariela

AU - Palomba, Maria Lia

AU - Portlock, Carol S.

AU - Straus, David J.

AU - Graustein, Tricia

AU - Zelenetz, Andrew D.

AU - Moskowitz, Craig

PY - 2013/2/1

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N2 - Purpose Limited data exist regarding the activity of bendamustine in Hodgkin lymphoma (HL). This phase II study evaluated the efficacy of bendamustine in relapsed and refractory HL. Patients and Methods Patients with relapsed and refractory HL who were ineligible for autologous stem-cell transplantation (ASCT), or for whom this treatment failed, received bendamustine 120 mg/m2 as a 30-minute infusion on days 1 and 2 every 28 days with growth factor support. The primary end point was overall response rate (ORR). A secondary end point was referral rate to allogeneic stem-cell transplantation (alloSCT) for patients deemed eligible for alloSCT at the time of enrollment. Results Of the 36 patients enrolled, 34 were evaluable for response. Patients had received a median of four prior treatments, and 75% had relapsed after ASCT. The ORR by intent-to-treat analysis was 53%, including 12 complete responses (33%) and seven partial responses (19%). The response rate among evaluable patients was 56%. Responses were seen in patients with prior refractory disease, prior ASCT, and prior alloSCT; however, no responses were seen in patients who relapsed within 3 months of ASCT. The median response duration was 5 months. Five patients (20% of those eligible) proceeded to alloSCT after treatment with bendamustine. Grade ≥ 3 adverse events were infrequent and most commonly included thrombocytopenia (20%), anemia (14%), and infection (14%). Conclusion This study confirms the efficacy of bendamustine in heavily pretreated patients with HL. These results support current and future studies evaluating bendamustine combinations in relapsed and refractory HL.

AB - Purpose Limited data exist regarding the activity of bendamustine in Hodgkin lymphoma (HL). This phase II study evaluated the efficacy of bendamustine in relapsed and refractory HL. Patients and Methods Patients with relapsed and refractory HL who were ineligible for autologous stem-cell transplantation (ASCT), or for whom this treatment failed, received bendamustine 120 mg/m2 as a 30-minute infusion on days 1 and 2 every 28 days with growth factor support. The primary end point was overall response rate (ORR). A secondary end point was referral rate to allogeneic stem-cell transplantation (alloSCT) for patients deemed eligible for alloSCT at the time of enrollment. Results Of the 36 patients enrolled, 34 were evaluable for response. Patients had received a median of four prior treatments, and 75% had relapsed after ASCT. The ORR by intent-to-treat analysis was 53%, including 12 complete responses (33%) and seven partial responses (19%). The response rate among evaluable patients was 56%. Responses were seen in patients with prior refractory disease, prior ASCT, and prior alloSCT; however, no responses were seen in patients who relapsed within 3 months of ASCT. The median response duration was 5 months. Five patients (20% of those eligible) proceeded to alloSCT after treatment with bendamustine. Grade ≥ 3 adverse events were infrequent and most commonly included thrombocytopenia (20%), anemia (14%), and infection (14%). Conclusion This study confirms the efficacy of bendamustine in heavily pretreated patients with HL. These results support current and future studies evaluating bendamustine combinations in relapsed and refractory HL.

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