背景：轉移性乳腺癌（MBC）通常是不可治愈的，大多數 MBC 患者仍將繼續接受治療。根據臨床試驗結果，患者通常以 FDA 批準標簽上的推薦起始劑量（RSD）開始新的治療。然而，病人在現實世界中耐受 RSD 的能力可能與臨床試驗中不同。雖然患者報告結果的重要性已得到承認，但尚缺乏從病人的視角了解耐受性，並且患者的意願關於討論 MBC 治療的個體化劑量也未被評估過。
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：以患者為中心的給藥倡議的患者倡導者通過社交媒體團體、組織通訊和在線支持論壇向MBC 患者分發了一份在線調查。這項調查是由病人和醫學腫瘤學家製定的，以確定病人的患病率和與治療相關的副作用的影響、醫患溝通的質量、副作用的管理以及在開始新的治療或出現不良副作用時對 RSD 替代方法的興趣。
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.
結果：1221 例 MBC 患者在 15 天內完成調查。MBC 治療線數的中位數為 2.5（範圍 1-≥5），46%（n=564）的患者在接受調查的兩年內診斷為 MBC。86%（n=1051）報告至少經曆了一次顯著的治療相關副作用，其中 20%（n=213）到急診室/醫院就診，43%（n=454）至少錯過了一次治療。98%（n=1026）有副作用的患者與醫生討論，82%（n=838）的患者得到了醫生的幫助。最常見的（非排他性）緩解策略是減少劑量（66%，n=556）和處方藥（59%，n=494）。在 556 名減少劑量的患者中，83%（n=459）的患者感覺好些。值得注意的是，92%（n=1127）的患者表示願意根據其個人特點和個人偏好與醫生討論替代給藥方案。
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.
結論：考慮到 86%的 MBC 患者經曆了至少一次顯著的治療相關副作用，83%的患者在劑量減少後有所改善，因此創新的劑量相關策略是維持生活質量的保證。在患者與醫生的討論中，醫生定期評估患者的身體狀態和情況，可以幫助在治療開始時和治療結束後為患者確定合適的劑量，絕大多數患者會接受這種討論。
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.
