Journal article

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

  • Dummer R Universitäts Spital Zürich, Rämistrasse 100, Zürich 8091, Switzerland. Electronic address: reinhard.dummer@usz.ch.
  • Prince HM Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, Victoria 8066, Australia. Electronic address: miles.prince@petermac.org.
  • Whittaker S 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: sean.whittaker@gstt.nhs.uk.
  • Horwitz SM Memorial Hospital, 1275 York Avenue, Between 67th and 68th Streets, New York, NY 10065, USA. Electronic address: horwitzs@MSKCC.ORG.
  • Kim YH Stanford Clinical Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. Electronic address: younkim@stanford.edu.
  • Scarisbrick J Nuffield House, Dermatology - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham B15 2TH, UK. Electronic address: Julia.Scarisbrick@uhb.nhs.uk.
  • Quaglino P University of Turin, Turin, Italy. Electronic address: Pietro.quaglino@unito.it.
  • Zinzani PL Institute of Hematology "Seràgnoli", University of Bologna, Via Massarenti 9, Bologna 40138, Italy. Electronic address: pierluigi.zinzani@unibo.it.
  • Wolter P University Hospitals Leuven, Leuven, Belgium. Electronic address: pascalwolter@hotmail.com.
  • Eradat H Hematology Oncology, UCLA Lymphoma Program, Bone Marrow Transplant Program, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: Heradat@mednet.ucla.edu.
  • Pinter-Brown L Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA. Electronic address: lpinterb@uci.edu.
  • Sanches JA Division of Clinical Dermatology, Hospital Das Clinicas, FMUSP, Department of Dermatology, University of Sao Paulo Medical School, Brazil. Electronic address: jasanchesjr@gmail.com.
  • Ortiz-Romero PL University Hospital 12 de Octubre, Institute i+12, Medical School, Universidad Complutense, Madrid, Spain. Electronic address: portiz.hdoc@salud.madrid.org.
  • Akilov OE University of Pittsburgh School of Medicine, Biomedical Science Tower, Room E1157, 200 Lothrop Street, Pittsburgh, PA 15261-2109, USA. Electronic address: akilovoe@upmc.edu.
  • Geskin L Department of Dermatology, Columbia University and CUMC, 161 Fort Washington Ave, 12th Floor, New York, NY 10032, USA. Electronic address: ljg2145@cumc.columbia.edu.
  • Huen A University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: aohuen@mdanderson.org.
  • Walewski J Maria Sklodowska-Curie National Research Institute of Oncology, 5 WK Roentgen Str, Warszawa 02-781, Poland. Electronic address: jan.walewski@coi.pl.
  • Wang Y Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: ywang@seagen.com.
  • Lisano J Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: jlisano@seagen.com.
  • Richhariya A Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: arichhariya@seagen.com.
  • Feliciano J Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: felicianojoseph1@gmail.com.
  • Zhu Y Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Yanyan.Zhu@takeda.com.
  • Bunn V Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Veronica.Bunn@takeda.com.
  • Little M Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: meredith.little@takeda.com.
  • Zagadailov E Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: erin.zagadailov@gmail.com.
  • Dalal MR Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: mehul.dalal@takeda.com.
  • Duvic M University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: mduvic@mdanderson.org.
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  • 2020-06-06
Published in:
  • European journal of cancer (Oxford, England : 1990). - 2020
English 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.
Language
  • English
Open access status
hybrid
Identifiers
Persistent URL
https://sonar.ch/global/documents/4965
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