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. 1. Universitäts Spital Zürich, Rämistrasse 100, Zürich 8091, Switzerland. Electronic address: reinhard.dummer@usz.ch. 2. Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, Victoria 8066, Australia. Electronic address: miles.prince@petermac.org. 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: sean.whittaker@gstt.nhs.uk. 4. Memorial Hospital, 1275 York Avenue, Between 67th and 68th Streets, New York, NY 10065, USA. Electronic address: horwitzs@MSKCC.ORG. 5. Stanford Clinical Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. Electronic address: younkim@stanford.edu. 6. 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. 7. University of Turin, Turin, Italy. Electronic address: Pietro.quaglino@unito.it. 8. Institute of Hematology "Seràgnoli", University of Bologna, Via Massarenti 9, Bologna 40138, Italy. Electronic address: pierluigi.zinzani@unibo.it. 9. University Hospitals Leuven, Leuven, Belgium. Electronic address: pascalwolter@hotmail.com. 10. 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. 11. Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA. Electronic address: lpinterb@uci.edu. 12. Division of Clinical Dermatology, Hospital Das Clinicas, FMUSP, Department of Dermatology, University of Sao Paulo Medical School, Brazil. Electronic address: jasanchesjr@gmail.com. 13. University Hospital 12 de Octubre, Institute i+12, Medical School, Universidad Complutense, Madrid, Spain. Electronic address: portiz.hdoc@salud.madrid.org. 14. University of Pittsburgh School of Medicine, Biomedical Science Tower, Room E1157, 200 Lothrop Street, Pittsburgh, PA 15261-2109, USA. Electronic address: akilovoe@upmc.edu. 15. Department of Dermatology, Columbia University and CUMC, 161 Fort Washington Ave, 12th Floor, New York, NY 10032, USA. Electronic address: ljg2145@cumc.columbia.edu. 16. University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: aohuen@mdanderson.org. 17. Maria Sklodowska-Curie National Research Institute of Oncology, 5 WK Roentgen Str, Warszawa 02-781, Poland. Electronic address: jan.walewski@coi.pl. 18. Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: ywang@seagen.com. 19. Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: jlisano@seagen.com. 20. Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: arichhariya@seagen.com. 21. Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: felicianojoseph1@gmail.com. 22. Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Yanyan.Zhu@takeda.com. 23. Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Veronica.Bunn@takeda.com. 24. Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: meredith.little@takeda.com. 25. Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: erin.zagadailov@gmail.com. 26. Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: mehul.dalal@takeda.com. 27. University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: mduvic@mdanderson.org.
Abstract
BACKGROUND:Brentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with priorsystemic 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.
RCT Entities:
BACKGROUND:Brentuximabvedotin 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 brentuximabvedotin (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 brentuximabvedotin 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 brentuximabvedotin and physician's choice (0.15 versus -2.29). EQ-5D changes were also comparable between arms. Among brentuximabvedotin-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, brentuximabvedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximabvedotin-treated patients. CLINICAL TRIAL REGISTRATION: NCT01578499.
Authors: Steven M Horwitz; Julia J Scarisbrick; Reinhard Dummer; Sean Whittaker; Madeleine Duvic; Youn H Kim; Pietro Quaglino; Pier Luigi Zinzani; Oliver Bechter; Herbert Eradat; Lauren Pinter-Brown; Oleg E Akilov; Larisa Geskin; Jose A Sanches; Pablo L Ortiz-Romero; Michael Weichenthal; David C Fisher; Jan Walewski; Judith Trotman; Kerry Taylor; Stephane Dalle; Rudolf Stadler; Julie Lisano; Veronica Bunn; Meredith Little; H Miles Prince Journal: Blood Adv Date: 2021-12-14
Authors: Edgar Dippel; Chalid Assaf; Jürgen C Becker; Michael von Bergwelt-Baildon; Sophie Bernreiter; Antonio Cozzio; Hans T Eich; Khaled Elsayad; Markus Follmann; Stephan Grabbe; Uwe Hillen; Wolfram Klapper; Claus-Detlev Klemke; Carmen Loquai; Frank Meiss; Christina Mitteldorf; Ulrike Wehkamp; Dorothee Nashan; Jan P Nicolay; Ilske Oschlies; Max Schlaak; René Stranzenbach; Rose Moritz; Christoph Stoll; Tibor Vag; Michael Weichenthal; Marion Wobser; Rudolf Stadler Journal: J Dtsch Dermatol Ges Date: 2022-04 Impact factor: 5.231
Authors: Van To; Vera J Evtimov; Graham Jenkin; Aleta Pupovac; Alan O Trounson; Richard L Boyd Journal: Front Immunol Date: 2022-08-18 Impact factor: 8.786