4.6 Article

Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results

Journal

JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY
Volume 147, Issue 2, Pages 619-631

Publisher

SPRINGER
DOI: 10.1007/s00432-020-03365-w

Keywords

Relapsed; refractory multiple myeloma; Daratumumab; Subcutaneous; Patient satisfaction; Patient-reported outcomes

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Funding

  1. Janssen Research & Development, LLC
  2. Janssen Global Services, LLC

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In the COLUMBA study, patients receiving daratumumab subcutaneously had higher satisfaction with their cancer therapy compared to those receiving it intravenously. Around 40% of patients experienced changes in satisfaction domain scores exceeding the minimally important difference.
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 similar to 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.

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