Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged ≥60 years with HL

Jonathan W. Friedberg, Andres Forero-Torres, Rodolfo E. Bordoni, Vivian J.M. Cline, Dipti Patel-Donnelly, Patrick J. Flynn, Gregg Olsen, Robert Chen, Abraham Fong, Yinghui Wang, Christopher A. Yasenchak

Research output: Contribution to journalArticle

Abstract

Patients aged ≥60 years with treatment-naive Hodgkin lymphoma (HL) have few treatment options and inferior survival due to treatment-related toxicities and comorbidities. This phase 2, nonrandomized, open-label study evaluated brentuximab vedotin (BV) monotherapy (results previously reported), BV plus dacarbazine (DTIC), and BV plus bendamustine. Patients had classical HL and were ineligible for or declined frontline chemotherapy. Twenty-two patients received 1.8 mg/kg BV and 375 mg/m2 DTIC for up to 12 cycles, and 20 more patients received 1.8 mg/kg BV plus 90 or 70 mg/m2 bendamustine for up to 6 cycles (dose reduced due to toxicity). Subsequent BV monotherapy was allowed. Approximately 30 patients were to receive BV plus bendamustine; however, the incidence of serious adverse events (65%) and 2 deaths on study led to discontinuation of bendamustine and cessation of enrollment. Most patients had stage III/IV disease, and approximately half had ≥3 comorbidities or were impaired in ≥1 aspect that significantly interfered with quality of life. For BV plus DTIC, the objective response rate (ORR) was 100% and the complete remission (CR) rate was 62%. To date, the median progressionfree survival (PFS) is 17.9 months. ForBVplusbendamustine, theORRwas 100%and theCRrate was88%. Neither the medianPFSnor overall survival was reached. For elderly patients with HL, BV plus DTIC may be a frontline option based on tolerability and response duration. Despite activity, BV plus bendamustine is not a tolerable regimen in these patients. This trial was registered at www. clinicaltrials.gov as #NCT01716806.

Original languageEnglish (US)
Pages (from-to)2829-2837
Number of pages9
JournalBlood
Volume130
Issue number26
DOIs
StatePublished - Dec 28 2017
Externally publishedYes

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Dacarbazine
Hodgkin Disease
Survival
Toxicity
Comorbidity
Bendamustine Hydrochloride
cAC10-vcMMAE
Chemotherapy
Labels
Therapeutics
Quality of Life
Drug Therapy

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Friedberg, J. W., Forero-Torres, A., Bordoni, R. E., Cline, V. J. M., Patel-Donnelly, D., Flynn, P. J., ... Yasenchak, C. A. (2017). Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged ≥60 years with HL. Blood, 130(26), 2829-2837. https://doi.org/10.1182/blood-2017-06-787200

Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged ≥60 years with HL. / Friedberg, Jonathan W.; Forero-Torres, Andres; Bordoni, Rodolfo E.; Cline, Vivian J.M.; Patel-Donnelly, Dipti; Flynn, Patrick J.; Olsen, Gregg; Chen, Robert; Fong, Abraham; Wang, Yinghui; Yasenchak, Christopher A.

In: Blood, Vol. 130, No. 26, 28.12.2017, p. 2829-2837.

Research output: Contribution to journalArticle

Friedberg, JW, Forero-Torres, A, Bordoni, RE, Cline, VJM, Patel-Donnelly, D, Flynn, PJ, Olsen, G, Chen, R, Fong, A, Wang, Y & Yasenchak, CA 2017, 'Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged ≥60 years with HL', Blood, vol. 130, no. 26, pp. 2829-2837. https://doi.org/10.1182/blood-2017-06-787200
Friedberg, Jonathan W. ; Forero-Torres, Andres ; Bordoni, Rodolfo E. ; Cline, Vivian J.M. ; Patel-Donnelly, Dipti ; Flynn, Patrick J. ; Olsen, Gregg ; Chen, Robert ; Fong, Abraham ; Wang, Yinghui ; Yasenchak, Christopher A. / Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged ≥60 years with HL. In: Blood. 2017 ; Vol. 130, No. 26. pp. 2829-2837.
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abstract = "Patients aged ≥60 years with treatment-naive Hodgkin lymphoma (HL) have few treatment options and inferior survival due to treatment-related toxicities and comorbidities. This phase 2, nonrandomized, open-label study evaluated brentuximab vedotin (BV) monotherapy (results previously reported), BV plus dacarbazine (DTIC), and BV plus bendamustine. Patients had classical HL and were ineligible for or declined frontline chemotherapy. Twenty-two patients received 1.8 mg/kg BV and 375 mg/m2 DTIC for up to 12 cycles, and 20 more patients received 1.8 mg/kg BV plus 90 or 70 mg/m2 bendamustine for up to 6 cycles (dose reduced due to toxicity). Subsequent BV monotherapy was allowed. Approximately 30 patients were to receive BV plus bendamustine; however, the incidence of serious adverse events (65{\%}) and 2 deaths on study led to discontinuation of bendamustine and cessation of enrollment. Most patients had stage III/IV disease, and approximately half had ≥3 comorbidities or were impaired in ≥1 aspect that significantly interfered with quality of life. For BV plus DTIC, the objective response rate (ORR) was 100{\%} and the complete remission (CR) rate was 62{\%}. To date, the median progressionfree survival (PFS) is 17.9 months. ForBVplusbendamustine, theORRwas 100{\%}and theCRrate was88{\%}. Neither the medianPFSnor overall survival was reached. For elderly patients with HL, BV plus DTIC may be a frontline option based on tolerability and response duration. Despite activity, BV plus bendamustine is not a tolerable regimen in these patients. This trial was registered at www. clinicaltrials.gov as #NCT01716806.",
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AU - Cline, Vivian J.M.

AU - Patel-Donnelly, Dipti

AU - Flynn, Patrick J.

AU - Olsen, Gregg

AU - Chen, Robert

AU - Fong, Abraham

AU - Wang, Yinghui

AU - Yasenchak, Christopher A.

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N2 - Patients aged ≥60 years with treatment-naive Hodgkin lymphoma (HL) have few treatment options and inferior survival due to treatment-related toxicities and comorbidities. This phase 2, nonrandomized, open-label study evaluated brentuximab vedotin (BV) monotherapy (results previously reported), BV plus dacarbazine (DTIC), and BV plus bendamustine. Patients had classical HL and were ineligible for or declined frontline chemotherapy. Twenty-two patients received 1.8 mg/kg BV and 375 mg/m2 DTIC for up to 12 cycles, and 20 more patients received 1.8 mg/kg BV plus 90 or 70 mg/m2 bendamustine for up to 6 cycles (dose reduced due to toxicity). Subsequent BV monotherapy was allowed. Approximately 30 patients were to receive BV plus bendamustine; however, the incidence of serious adverse events (65%) and 2 deaths on study led to discontinuation of bendamustine and cessation of enrollment. Most patients had stage III/IV disease, and approximately half had ≥3 comorbidities or were impaired in ≥1 aspect that significantly interfered with quality of life. For BV plus DTIC, the objective response rate (ORR) was 100% and the complete remission (CR) rate was 62%. To date, the median progressionfree survival (PFS) is 17.9 months. ForBVplusbendamustine, theORRwas 100%and theCRrate was88%. Neither the medianPFSnor overall survival was reached. For elderly patients with HL, BV plus DTIC may be a frontline option based on tolerability and response duration. Despite activity, BV plus bendamustine is not a tolerable regimen in these patients. This trial was registered at www. clinicaltrials.gov as #NCT01716806.

AB - Patients aged ≥60 years with treatment-naive Hodgkin lymphoma (HL) have few treatment options and inferior survival due to treatment-related toxicities and comorbidities. This phase 2, nonrandomized, open-label study evaluated brentuximab vedotin (BV) monotherapy (results previously reported), BV plus dacarbazine (DTIC), and BV plus bendamustine. Patients had classical HL and were ineligible for or declined frontline chemotherapy. Twenty-two patients received 1.8 mg/kg BV and 375 mg/m2 DTIC for up to 12 cycles, and 20 more patients received 1.8 mg/kg BV plus 90 or 70 mg/m2 bendamustine for up to 6 cycles (dose reduced due to toxicity). Subsequent BV monotherapy was allowed. Approximately 30 patients were to receive BV plus bendamustine; however, the incidence of serious adverse events (65%) and 2 deaths on study led to discontinuation of bendamustine and cessation of enrollment. Most patients had stage III/IV disease, and approximately half had ≥3 comorbidities or were impaired in ≥1 aspect that significantly interfered with quality of life. For BV plus DTIC, the objective response rate (ORR) was 100% and the complete remission (CR) rate was 62%. To date, the median progressionfree survival (PFS) is 17.9 months. ForBVplusbendamustine, theORRwas 100%and theCRrate was88%. Neither the medianPFSnor overall survival was reached. For elderly patients with HL, BV plus DTIC may be a frontline option based on tolerability and response duration. Despite activity, BV plus bendamustine is not a tolerable regimen in these patients. This trial was registered at www. clinicaltrials.gov as #NCT01716806.

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