背景:转移性乳腺癌(MBC)通常是不可治愈的,大多数 MBC 患者仍将继续接受治疗。根据临床试验结果,患者通常以 FDA 批准标签上的推荐起始剂量(RSD)开始新的治疗。然而,病人在现实世界中耐受 RSD 的能力可能与临床试验中不同。虽然患者报告结果的重要性已得到承认,但尚缺乏从病人的视角了解耐受性,并且患者的意愿关于讨论 MBC 治疗的个体化剂量也未被评估过。 Background: Met
背景:转移性乳腺癌(MBC)通常是不可治愈的,大多数 MBC 患者仍将继续接受治疗。根据临床试验结果,患者通常以 FDA 批准标签上的推荐起始剂量(RSD)开始新的治疗。然而,病人在现实世界中耐受 RSD 的能力可能与临床试验中不同。虽然患者报告结果的重要性已得到承认,但尚缺乏从病人的视角了解耐受性,并且患者的意愿关于讨论 MBC 治疗的个体化剂量也未被评估过。
Background: Metastatic breast cancer (MBC) is generally incurable and the majority of patients with MBC will remain on treatment indefinitely. Patients usually begin each new treatment at the Recommended Starting Dose (RSD) on the FDA-approved label based on results from clinical trials. However, patients’ ability to tolerate the RSD in the real-world may differ from the clinical trial setting. While the importance of patient reported outcomes is recognized, understanding tolerability from the patient’s perspective is lacking and patients’ willingness to discuss individualized doses for MBC therapy has not been evaluated.
方法:以患者为中心的给药倡议的患者倡导者通过社交媒体团体、组织通讯和在线支持论坛向MBC 患者分发了一份在线调查。这项调查是由病人和医学肿瘤学家制定的,以确定病人的患病率和与治疗相关的副作用的影响、医患沟通的质量、副作用的管理以及在开始新的治疗或出现不良副作用时对 RSD 替代方法的兴趣。
Methods: Patient advocates from the Patient-Centered Dosing Initiative distributed a confidential online survey to patients with MBC via social media groups, organizational newsletters, and online support forums. The survey was developed by patients and medical oncologists to ascertain the prevalence and impact of patients’ treatment-related side effects, quality of patient-physician communication, management of side effects, and interest in alternative approaches to the RSD when a new treatment is initiated or adverse side effects are experienced.
结果:1221 例 MBC 患者在 15 天内完成调查。MBC 治疗线数的中位数为 2.5(范围 1-≥5),46%(n=564)的患者在接受调查的两年内诊断为 MBC。86%(n=1051)报告至少经历了一次显著的治疗相关副作用,其中 20%(n=213)到急诊室/医院就诊,43%(n=454)至少错过了一次治疗。98%(n=1026)有副作用的患者与医生讨论,82%(n=838)的患者得到了医生的帮助。最常见的(非排他性)缓解策略是减少剂量(66%,n=556)和处方药(59%,n=494)。在 556 名减少剂量的患者中,83%(n=459)的患者感觉好些。值得注意的是,92%(n=1127)的患者表示愿意根据其个人特点和个人偏好与医生讨论替代给药方案。
Results: 1,221 patients with MBC completed the survey within 15 days. The median number of lines of MBC therapy was 2.5 (range 1 - ≥5) and 46% (n = 564) of patients received their MBC diagnosis within two years of taking the survey. 86% (n = 1,051) reported experiencing at least one significant treatment-related side effect, and of these, 20% (n = 213) visited the Emergency Room/hospital and 43% (n = 454) missed at least one treatment. 98% (n = 1,026) of patients with side effects discussed them with their doctors and 82% (n = 838) were helped by their physicians. The most common (non-exclusive) mitigation strategies were dosage reductions (66%, n = 556) and prescription medications (59%, n = 494). Of the 556 patients given a dosage reduction, 83% (n = 459) reported feeling better. Notably, 92% (n = 1,127) of patients expressed willingness to discuss alternative dosing options with their physicians based upon their personal characteristics and individual preferences.
结论:考虑到 86%的 MBC 患者经历了至少一次显著的治疗相关副作用,83%的患者在剂量减少后有所改善,因此创新的剂量相关策略是维持生活质量的保证。在患者与医生的讨论中,医生定期评估患者的身体状态和情况,可以帮助在治疗开始时和治疗结束后为患者确定合适的剂量,绝大多数患者会接受这种讨论。
Conclusions: Given that 86% of patients with MBC experienced at least one significant treatment-related side effect and 83% improved after dosage reduction, innovative dosage-related strategies are warranted to sustain Quality of Life. Patient-physician discussions in which the patient’s physical attributes and circumstances are periodically assessed may determine the right dose for the patient upon treatment initiation and afterwards, and the vast majority of patients would be receptive to such discussions.
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