Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study

Reinhard Dummer; Henry M Prince; Sean Whittaker; Steven M Horwitz; Youn H Kim; Julia Scarisbrick; Pietro Quaglino; Pier Luigi Zinzani; Pascal Wolter; Herbert Eradat; Lauren Pinter-Brown; Jose A Sanches; Pablo L Ortiz-Romero; Oleg E Akilov; Larisa Geskin; Auris Huen; Jan Walewski; Yinghui Wang; Julie Lisano; Akshara Richhariya; Joseph Feliciano; Yanyan Zhu; Veronica Bunn; Meredith Little; Erin Zagadailov; Mehul R Dalal; Madeleine Duvic

doi:10.1016/j.ejca.2020.04.010

Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study

Eur J Cancer. 2020 Jul:133:120-130. doi: 10.1016/j.ejca.2020.04.010. Epub 2020 Jun 2.

Authors

Reinhard Dummer¹, Henry M Prince², Sean Whittaker³, Steven M Horwitz⁴, Youn H Kim⁵, Julia Scarisbrick⁶, Pietro Quaglino⁷, Pier Luigi Zinzani⁸, Pascal Wolter⁹, Herbert Eradat¹⁰, Lauren Pinter-Brown¹¹, Jose A Sanches¹², Pablo L Ortiz-Romero¹³, Oleg E Akilov¹⁴, Larisa Geskin¹⁵, Auris Huen¹⁶, Jan Walewski¹⁷, Yinghui Wang¹⁸, Julie Lisano¹⁹, Akshara Richhariya²⁰, Joseph Feliciano²¹, Yanyan Zhu²², Veronica Bunn²³, Meredith Little²⁴, Erin Zagadailov²⁵, Mehul R Dalal²⁶, Madeleine Duvic²⁷

Affiliations

¹ Universitäts Spital Zürich, Rämistrasse 100, Zürich 8091, Switzerland. Electronic address: [email protected].
² Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, Victoria 8066, Australia. Electronic address: [email protected].
³ Division of Genetics and Molecular Medicine, Faculty of Life Sciences and Medicine, Kings College London & Guys and St Thomas NHS Foundation Trust, London, UK. Electronic address: [email protected].
⁴ Memorial Hospital, 1275 York Avenue, Between 67th and 68th Streets, New York, NY 10065, USA. Electronic address: [email protected].
⁵ Stanford Clinical Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. Electronic address: [email protected].
⁶ Nuffield House, Dermatology - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham B15 2TH, UK. Electronic address: [email protected].
⁷ University of Turin, Turin, Italy. Electronic address: [email protected].
⁸ Institute of Hematology "Seràgnoli", University of Bologna, Via Massarenti 9, Bologna 40138, Italy. Electronic address: [email protected].
⁹ University Hospitals Leuven, Leuven, Belgium. Electronic address: [email protected].
¹⁰ Hematology Oncology, UCLA Lymphoma Program, Bone Marrow Transplant Program, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: [email protected].
¹¹ Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA. Electronic address: [email protected].
¹² Division of Clinical Dermatology, Hospital Das Clinicas, FMUSP, Department of Dermatology, University of Sao Paulo Medical School, Brazil. Electronic address: [email protected].
¹³ University Hospital 12 de Octubre, Institute i+12, Medical School, Universidad Complutense, Madrid, Spain. Electronic address: [email protected].
¹⁴ University of Pittsburgh School of Medicine, Biomedical Science Tower, Room E1157, 200 Lothrop Street, Pittsburgh, PA 15261-2109, USA. Electronic address: [email protected].
¹⁵ Department of Dermatology, Columbia University and CUMC, 161 Fort Washington Ave, 12th Floor, New York, NY 10032, USA. Electronic address: [email protected].
¹⁶ University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: [email protected].
¹⁷ Maria Sklodowska-Curie National Research Institute of Oncology, 5 WK Roentgen Str, Warszawa 02-781, Poland. Electronic address: [email protected].
¹⁸ Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: [email protected].
¹⁹ Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: [email protected].
²⁰ Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: [email protected].
²¹ Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: [email protected].
²² Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: [email protected].
²³ Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: [email protected].
²⁴ Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: [email protected].
²⁵ Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: [email protected].
²⁶ Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: [email protected].
²⁷ University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: [email protected].

PMID: 32502876
DOI: 10.1016/j.ejca.2020.04.010

Abstract

Background: Brentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/kg once every 3 weeks; ≤16 cycles) versus physician's choice (methotrexate/bexarotene; ≤48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined.

Methods: QoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires.

Results: Mean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (-27.96 versus -8.62); the difference, -18.9 (95% confidence interval -26.6, -11.2; adjusted p < 0.001), exceeded the study-defined minimally important difference (9.0-12.3). Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29). EQ-5D changes were also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was -35.54 versus -11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores.

Conclusions: In summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients.

Clinical trial registration: NCT01578499.

Keywords: Brentuximab vedotin; CD30; Clinical trial; Cutaneous T-cell lymphoma; Phase III; Quality of life.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Aged, 80 and over
Brentuximab Vedotin / therapeutic use*
Drug Resistance, Neoplasm / drug effects
Female
Humans
Lymphoma, T-Cell, Cutaneous / drug therapy*
Lymphoma, T-Cell, Cutaneous / epidemiology
Lymphoma, T-Cell, Cutaneous / pathology
Lymphoma, T-Cell, Cutaneous / psychology
Male
Middle Aged
Neoplasm Recurrence, Local / drug therapy
Neoplasm Recurrence, Local / epidemiology
Neoplasm Recurrence, Local / psychology
Patient Reported Outcome Measures
Psychometrics / methods
Quality of Life*
Skin Neoplasms / drug therapy*
Skin Neoplasms / epidemiology
Skin Neoplasms / pathology
Skin Neoplasms / psychology
Surveys and Questionnaires
Treatment Outcome
Young Adult

Substances

Brentuximab Vedotin

Associated data

ClinicalTrials.gov/NCT01578499

Grants and funding

P30 CA008748/CA/NCI NIH HHS/United States