Scientific publications
Health-Related Quality of Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma
Stewart AK (1), Dimopoulos MA (2), Masszi T (2), Špička I (2), Oriol A (2), Hájek R (2), Rosiñol L (2), Siegel DS (2), Niesvizky R (2), Jakubowiak AJ (2), San-Miguel JF (2), Ludwig H (2), Buchanan J (2), Cocks K (2), Yang X (2), Xing B (2), Zojwalla N (2), Tonda M (2), Moreau P (2), Palumbo A (2).
(1) A. Keith Stewart, Mayo Clinic, Scottsdale, AZ; Meletios A. Dimopoulos, Alexandra Hospital, Athens, Greece; Tamás Masszi, St. István and St. László Hospital, Semmelweis University, Budapest, Hungary; Ivan Špička, General University Hospital in Prague, Prague; Roman Hájek, University Hospital Brno and University of Ostrava, Brno, Czech Republic; Albert Oriol, Institut Català d'Oncologia, Institut Josep Carreras, Hospital Germans Trias i Pujol; Laura Rosiñol, Hospital Clínic de Barcelona, Barcelona; Jesus F. San-Miguel, Clinica Universidad de Navarra/El Centro de Investigacíon Médica Aplicada, Instituto de Investigacíon Sanitaria de Navarra, Pamplona, Spain; David S. Siegel, John Theurer Cancer Center at Hackensack University, Hackensack, NJ; Ruben Niesvizky, Weill Cornell Medical College, New York, NY; Andrzej J. Jakubowiak, University of Chicago Medicine, Chicago, IL; Heinz Ludwig, Wilhelminen Cancer Research Institute, Wilheminenspital, Vienna, Austria; Jacqui Buchanan, Xinqun Yang, Biao Xing, Naseem Zojwalla, and Margaret Tonda, Onyx Pharmaceuticals, South San Francisco, CA; Kim Cocks, KCStats Consultancy, Leeds, United Kingdom; Philippe Moreau, University of Nantes, Nantes, France; and Antonio Palumbo, University of Torino, Torino, Italy. stewart.keith@mayo.edu.
(2) A. Keith Stewart, Mayo Clinic, Scottsdale, AZ; Meletios A. Dimopoulos, Alexandra Hospital, Athens, Greece; Tamás Masszi, St. István and St. László Hospital, Semmelweis University, Budapest, Hungary; Ivan Špička, General University Hospital in Prague, Prague; Roman Hájek, University Hospital Brno and University of Ostrava, Brno, Czech Republic; Albert Oriol, Institut Català d'Oncologia, Institut Josep Carreras, Hospital Germans Trias i Pujol; Laura Rosiñol, Hospital Clínic de Barcelona, Barcelona; Jesus F. San-Miguel, Clinica Universidad de Navarra/El Centro de Investigacíon Médica Aplicada, Instituto de Investigacíon Sanitaria de Navarra, Pamplona, Spain; David S. Siegel, John Theurer Cancer Center at Hackensack University, Hackensack, NJ; Ruben Niesvizky, Weill Cornell Medical College, New York, NY; Andrzej J. Jakubowiak, University of Chicago Medicine, Chicago, IL; Heinz Ludwig, Wilhelminen Cancer Research Institute, Wilheminenspital, Vienna, Austria; Jacqui Buchanan, Xinqun Yang, Biao Xing, Naseem Zojwalla, and Margaret Tonda, Onyx Pharmaceuticals, South San Francisco, CA; Kim Cocks, KCStats Consultancy, Leeds, United Kingdom; Philippe Moreau, University of Nantes, Nantes, France; and Antonio Palumbo, University of Torino, Torino, Italy.
PURPOSE:
To determine the effects of carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) on health-related quality of life (HR-QoL) in the Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone for the Treatment of Patients With Relapsed Multiple Myeloma (ASPIRE) trial.
METHODS:
Patients with relapsed multiple myeloma were randomly assigned to receive KRd or Rd. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and myeloma-specific module were administered at baseline; day 1 of cycles 3, 6, 12, and 18; and after treatment.
The Global Health Status/Quality of Life (GHS/QoL) scale and seven subscales (fatigue, nausea and vomiting, pain, physical functioning, role functioning, disease symptoms, and adverse effects of treatment) were compared between groups using a mixed model for repeated measures. The percentages of responders with ≥ 5- or 15-point GHS/QoL improvement at each cycle were compared between groups.
RESULTS:
Baseline questionnaire compliance was excellent (94.1% of randomly assigned patients). KRd patients had higher GHS/QoL scores versus Rd patients over 18 treatment cycles (two-sided P < .001). The minimal important difference was met at cycle 12 (5.6 points) and approached at cycle 18 (4.8 points).
There was no difference between groups for the other prespecified subscales from ASPIRE. A higher proportion of KRd patients met the GHS/QoL responder definition (≥ 5-point improvement) with statistical differences at cycle 12 (KRd v Rd patients, 25.5% v 17.4%, respectively) and 18 (KRd v Rd patients, 24.2% v 12.9%, respectively).
CONCLUSION:
KRd improves GHS/QoL without negatively affecting patient-reported symptoms when compared with Rd. These data further support the benefit of KRd in patients with relapsed multiple myeloma.
CITATION J Clin Oncol. 2016 Sep 6. pii: JCO669648
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