Plasma Cell Disorders Division, Clinical Research for Hematologic Malignancies, Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.
University Hospital of Salamanca/IBSAL, Salamanca, Spain.
J Cancer Res Clin Oncol. 2021 Feb;147(2):619-631. doi: 10.1007/s00432-020-03365-w. Epub 2020 Aug 27.
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.
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.
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.
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.
ClinicalTrials.gov identifier NCT03277105. Registered September 8, 2107.
III 期 COLUMBA 研究评估了达雷妥尤单抗（DARA）静脉（IV）和皮下（SC）给药在复发/难治性多发性骨髓瘤患者中的疗效。本研究报告了 COLUMBA 中患者报告的治疗满意度（SWT）。
DARA IV 或 DARA SC 每周（第 1-2 周期）、每 2 周（第 3-6 周期）和每 4 周（第 7 周期及以后）给药。患者在每周（第 1-2 周期）和每月（第 3 周期及以后）间隔以及治疗结束时完成了癌症治疗满意度问卷（CTSQ）的修订版。使用描述性统计方法总结了每个项目和 SWT 域评分的结果。对于每个评估，计算了各个项目的响应分布。在每个评估时间点，计算了 SWT 域评分变化大于或等于 5.9 分的最小临床重要差异（MID）的患者比例。
259 例患者随机分配至 DARA IV 组，263 例患者随机分配至 DARA SC 组。在治疗期间，SWT 域问题的平均得分较高且大部分为正性。对于大多数问题，DARA SC 组中给予治疗有积极看法的患者比例大于 DARA IV 组。SWT 域评分的变化从第一次评估开始，平均有~40%的患者达到或超过 MID。
在 COLUMBA 中，修订后的 CTSQ 结果表明，与 DARA IV 组相比，DARA SC 组的患者对癌症治疗的满意度更高。
ClinicalTrials.gov 标识符 NCT03277105。注册于 2017 年 9 月 8 日。
