Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma

Scott D. Ramsey, Auayporn Nademanee, T. Masszi, Jerzy Holowiecki, Muneer Abidi, Andy Chen, Patrick Stiff, Simonetta Viviani, John W. Sweetenham, John Radford, Yanyan Zhu, Vijayveer Bonthapally, Elizabeth Thomas, Akshara Richhariya, Naomi N. Hunder, Jan Walewski, Craig H. Moskowitz

Research output: Article

10 Citations (Scopus)

Abstract

Brentuximab vedotin (BV) significantly improved progression-free survival in a phase 3 study in patients with relapsed or refractory Hodgkin lymphoma (RR-HL) post-autologous-haematopoietic stem cell transplant (auto-HSCT); we report the impact of BV on quality of life (QOL) from this trial. The European Quality of Life five dimensions questionnaire was administered at the beginning of each cycle, end of treatment, and every 3 months during follow-up; index value scores were calculated using the time trade-off (TTO) method for UK-weighted value sets. Questionnaire adherence during the trial was 87·5% (N = 329). In an intent-to-treat analysis, compared with placebo, TTO scores in the BV arm did not exceed the minimally important difference (MID) of 0·08 except at month 15 (-0·084; 95% confidence interval, -0·143 to -0·025). On-treatment index scores were similar between arms and did not reach the MID at any time point; mixed-effect modelling showed that BV treatment effect was not significant (P = 0·2127). BV-associated peripheral neuropathy did not meaningfully impact QOL. Utility scores for patients who progressed declined compared with those who did not; TTO scores between these patients exceeded the MID beginning at month 15. In conclusion, QOL decreased modestly with BV consolidation treatment in patients with RR-HL at high risk of relapse after auto-HSCT.

Original languageEnglish
JournalBritish Journal of Haematology
DOIs
Publication statusAccepted/In press - 2016

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Hematopoietic Stem Cells
Hodgkin Disease
Quality of Life
Transplants
Arm
Peripheral Nervous System Diseases
Therapeutics
Disease-Free Survival
cAC10-vcMMAE
Placebos
Confidence Intervals
Recurrence

ASJC Scopus subject areas

  • Hematology

Cite this

Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma. / Ramsey, Scott D.; Nademanee, Auayporn; Masszi, T.; Holowiecki, Jerzy; Abidi, Muneer; Chen, Andy; Stiff, Patrick; Viviani, Simonetta; Sweetenham, John W.; Radford, John; Zhu, Yanyan; Bonthapally, Vijayveer; Thomas, Elizabeth; Richhariya, Akshara; Hunder, Naomi N.; Walewski, Jan; Moskowitz, Craig H.

In: British Journal of Haematology, 2016.

Research output: Article

Ramsey, SD, Nademanee, A, Masszi, T, Holowiecki, J, Abidi, M, Chen, A, Stiff, P, Viviani, S, Sweetenham, JW, Radford, J, Zhu, Y, Bonthapally, V, Thomas, E, Richhariya, A, Hunder, NN, Walewski, J & Moskowitz, CH 2016, 'Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma', British Journal of Haematology. https://doi.org/10.1111/bjh.14316
Ramsey, Scott D. ; Nademanee, Auayporn ; Masszi, T. ; Holowiecki, Jerzy ; Abidi, Muneer ; Chen, Andy ; Stiff, Patrick ; Viviani, Simonetta ; Sweetenham, John W. ; Radford, John ; Zhu, Yanyan ; Bonthapally, Vijayveer ; Thomas, Elizabeth ; Richhariya, Akshara ; Hunder, Naomi N. ; Walewski, Jan ; Moskowitz, Craig H. / Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma. In: British Journal of Haematology. 2016.
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AU - Ramsey, Scott D.

AU - Nademanee, Auayporn

AU - Masszi, T.

AU - Holowiecki, Jerzy

AU - Abidi, Muneer

AU - Chen, Andy

AU - Stiff, Patrick

AU - Viviani, Simonetta

AU - Sweetenham, John W.

AU - Radford, John

AU - Zhu, Yanyan

AU - Bonthapally, Vijayveer

AU - Thomas, Elizabeth

AU - Richhariya, Akshara

AU - Hunder, Naomi N.

AU - Walewski, Jan

AU - Moskowitz, Craig H.

PY - 2016

Y1 - 2016

N2 - Brentuximab vedotin (BV) significantly improved progression-free survival in a phase 3 study in patients with relapsed or refractory Hodgkin lymphoma (RR-HL) post-autologous-haematopoietic stem cell transplant (auto-HSCT); we report the impact of BV on quality of life (QOL) from this trial. The European Quality of Life five dimensions questionnaire was administered at the beginning of each cycle, end of treatment, and every 3 months during follow-up; index value scores were calculated using the time trade-off (TTO) method for UK-weighted value sets. Questionnaire adherence during the trial was 87·5% (N = 329). In an intent-to-treat analysis, compared with placebo, TTO scores in the BV arm did not exceed the minimally important difference (MID) of 0·08 except at month 15 (-0·084; 95% confidence interval, -0·143 to -0·025). On-treatment index scores were similar between arms and did not reach the MID at any time point; mixed-effect modelling showed that BV treatment effect was not significant (P = 0·2127). BV-associated peripheral neuropathy did not meaningfully impact QOL. Utility scores for patients who progressed declined compared with those who did not; TTO scores between these patients exceeded the MID beginning at month 15. In conclusion, QOL decreased modestly with BV consolidation treatment in patients with RR-HL at high risk of relapse after auto-HSCT.

AB - Brentuximab vedotin (BV) significantly improved progression-free survival in a phase 3 study in patients with relapsed or refractory Hodgkin lymphoma (RR-HL) post-autologous-haematopoietic stem cell transplant (auto-HSCT); we report the impact of BV on quality of life (QOL) from this trial. The European Quality of Life five dimensions questionnaire was administered at the beginning of each cycle, end of treatment, and every 3 months during follow-up; index value scores were calculated using the time trade-off (TTO) method for UK-weighted value sets. Questionnaire adherence during the trial was 87·5% (N = 329). In an intent-to-treat analysis, compared with placebo, TTO scores in the BV arm did not exceed the minimally important difference (MID) of 0·08 except at month 15 (-0·084; 95% confidence interval, -0·143 to -0·025). On-treatment index scores were similar between arms and did not reach the MID at any time point; mixed-effect modelling showed that BV treatment effect was not significant (P = 0·2127). BV-associated peripheral neuropathy did not meaningfully impact QOL. Utility scores for patients who progressed declined compared with those who did not; TTO scores between these patients exceeded the MID beginning at month 15. In conclusion, QOL decreased modestly with BV consolidation treatment in patients with RR-HL at high risk of relapse after auto-HSCT.

KW - Autologous-haematopoietic stem cell transplant

KW - Brentuximab vedotin

KW - CD30

KW - Hodgkin lymphoma

KW - Quality of life

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