Skalicky Anne, Bennett Bryan, Raimbourg Judith, Lonardi Sara, Correll Julia, Lugowska Iwona, Dixon Matthew, Sargalo Nashmel, Martin Mona L
Evidera, Seattle, WA, United States.
Bristol Myers Squibb, Uxbridge, United Kingdom.
Front Pharmacol. 2024 Mar 27;15:1310546. doi: 10.3389/fphar.2024.1310546. eCollection 2024.
A better understanding of patient experience of intravenous (IV) or subcutaneous (SC) routes of administration is fundamental to providing optimal administration of medical therapies to oncology patients. The objective of this study was to examine patient experiences of IV and SC treatment with nivolumab and confirm the relevance of item concepts in the Patient Experience and Preference Questionnaire (PEPQ). The PEPQ is a clinical outcomes' assessment instrument developed to obtain patient-centric data and understand the experience with IV and SC treatment administration. Embedded qualitative interviews were conducted with a subset of participants from three treatment cohorts with metastatic non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), unresectable or advanced metastatic melanoma, hepatocellular carcinoma (HCC), or colorectal cancer (CRC) from the CA209-8KX clinical trial. Concept elicitation interviews were conducted within 14 days of the initial treatment cycle and patient experiences with IV and SC treatment administration were assessed. Concepts from interviews were mapped to the PEPQ version 1.0 questions to assess relevance and convergence of concepts. : Interviews were conducted with 43 trial participants from clinical sites opting to participate from six countries (Argentina, France, the Netherlands, Poland, Spain, and New Zealand). The mean age of sub-study participants was 66 ± 11.3 years (range 24-80 years), and 67.4% ( = 29) were male. Sub-study participants with experience of SC most frequently reported symptoms or signs of injection-related redness (27.9%), itching (14.0%), and pain (of needle), and described the pain as pricking, stinging, or tingling (11.0% each). The amount of pain and time burden were widely endorsed as important factors for satisfaction and related to the route of medication administration. For 11 sub-study participants with experience with both IV and SC treatments, 10 (90.9%) preferred SC over IV treatment administration. This study summarizes the experience and satisfaction of receiving IV or SC treatment and confirms the relevance of the PEPQ in a subgroup of CA209-8KX clinical trial participants with metastatic NSCLC, RCC, melanoma, HCC, and CRC. Participant treatment experience and satisfaction with the route of medication mapped to the PEPQ question content support the relevance of PEPQ v2.0 in clinical trials as a self-report measure.
更好地了解患者对静脉注射（IV）或皮下注射（SC）给药途径的体验，对于为肿瘤患者提供最佳药物治疗至关重要。本研究的目的是调查患者接受纳武单抗IV和SC治疗的体验，并确认患者体验与偏好问卷（PEPQ）中项目概念的相关性。PEPQ是一种临床结局评估工具，旨在获取以患者为中心的数据，并了解IV和SC治疗给药的体验。对来自CA209 - 8KX临床试验的三个治疗队列（转移性非小细胞肺癌（NSCLC）、肾细胞癌（RCC）、不可切除或晚期转移性黑色素瘤、肝细胞癌（HCC）或结直肠癌（CRC））的部分参与者进行了嵌入式定性访谈。在初始治疗周期的14天内进行概念引出访谈，并评估患者对IV和SC治疗给药的体验。将访谈中的概念映射到PEPQ 1.0版问题，以评估概念的相关性和一致性。对来自六个国家（阿根廷、法国、荷兰、波兰、西班牙和新西兰）选择参与的临床站点的43名试验参与者进行了访谈。亚研究参与者的平均年龄为66±11.3岁（范围24 - 80岁），67.4%（n = 29）为男性。有SC治疗体验的亚研究参与者最常报告的与注射相关的症状或体征为发红（27.9%）、瘙痒（14.0%）和疼痛（针刺样），并将疼痛描述为刺痛、灼痛或刺痛感（各占11.0%）。疼痛程度和时间负担被广泛认可为影响满意度以及与给药途径相关的重要因素。对于11名有IV和SC两种治疗体验的亚研究参与者，10名（90.9%）更喜欢SC治疗而非IV治疗。本研究总结了接受IV或SC治疗的体验和满意度，并确认了PEPQ在CA209 - 8KX临床试验中转移性NSCLC、RCC、黑色素瘤、HCC和CRC亚组参与者中的相关性。参与者的治疗体验以及对映射到PEPQ问题内容的给药途径的满意度，支持了PEPQ v2.0作为临床试验中自我报告测量方法的相关性。
