Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory
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ORIGINAL ARTICLE – CLINICAL ONCOLOGY
Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results Saad Z. Usmani1 · Maria‑Victoria Mateos2 · Vania Hungria3 · Shinsuke Iida4 · Nizar J. Bahlis5 · Hareth Nahi6 · Hila Magen7 · Michele Cavo8 · Cyrille Hulin9 · Darrell White10 · Valerio De Stefano11 · John Fastenau12 · Mary Slavcev12 · Christoph Heuck13 · Xiang Qin13 · Huiling Pei13 · Tara Masterson13 · Kristen Lantz13 · Katharine S. Gries12 Received: 26 June 2020 / Accepted: 18 August 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Purpose The phase III COLUMBA study evaluated daratumumab (DARA) intravenous (IV) and subcutaneous (SC) in patients with relapsed or refractory multiple myeloma. Here, we report patient-reported satisfaction with therapy (SWT) in COLUMBA. Methods DARA IV or DARA SC was administered weekly (cycles 1–2), every 2 weeks (cycles 3–6), and every 4 weeks (cycles 7 +). Patients completed a modified version of the Cancer Therapy Satisfaction Questionnaire (CTSQ) at weekly (cycles 1–2) and monthly (cycles 3 +) intervals and at the end of treatment. Results for each item and the SWT domain score were summarized using descriptive statistics. The distribution of responses for individual items was calculated for each assessment. The proportion of patients for whom SWT domain score change from first assessment met or exceeded the minimally important difference (MID) of 5.9 points was calculated at each assessment time point. Results Two-hundred fifty-nine patients were randomized to DARA IV and 263 to DARA SC. Mean scores for SWT domain questions were high and largely positive during treatment. Responses indicating positive perceptions of therapy were given by a numerically greater proportion of patients in the DARA SC group than the DARA IV group for most questions. Changes from the first assessment in SWT domain scores met or exceeded the MID for an average of ~ 40% of patients. Conclusion In COLUMBA, modified CTSQ results suggest patients in the DARA SC group were more satisfied with their cancer therapy than those in the DARA IV group. Trial registration ClinicalTrials.gov identifier NCT03277105. Registered September 8, 2107. Keywords Relapsed/refractory multiple myeloma · Daratumumab · Subcutaneous · Patient satisfaction · Patient-reported outcomes
Introduction In phase 3 randomized clinical trials, the anti-CD38 monoclonal antibody daratumumab (DARA) has shown efficacy as monotherapy and in combination with other agents for Prior presentation: presented in part at the 17th international myeloma workshop (IMW), September 12–15, 2019, Boston, MA, USA. * Saad Z. Usmani [email protected] Extended author information available on the last page of the article
the treatment of newly diagnosed (Facon et al. 2019; Mateos et al. 2018; Moreau et al. 2019) and relapsed/refractory multiple myeloma (RRMM) (Dimopoulos et al. 2016; Palumbo et al. 2016). Based on
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