The Patient-Centered Dosing Initiative, a patient-led effort advocating for a paradigm shift in determining cancer drug dosing strategies, pioneers a departure from traditional oncology drug dosing practices. Historically, oncology drug dosing relies on identifying the maximum tolerated dose through phase 1 dose escalation methodology, favoring higher dosing for greater efficacy, often leading to higher toxicity. However, this approach is not universally applicable, especially for newer treatments like targeted therapies and immunotherapies. Patient-Centered Dosing Initiative challenges this “more is better” ethos, particularly as metastatic breast cancer patients themselves, as they not only seek longevity but also a high quality of life since most metastatic breast cancer patients stay on treatment for the rest of their lives. Surveying 1221 metastatic breast cancer patients and 119 oncologists revealed an evident need for flexible dosing strategies, advocating personalized care discussions based on patient attributes. The survey results also demonstrated an openness toward flexible dosing and a willingness from both patients and clinicians to discuss dosing as part of their care. Patient-centered dosing emphasizes dialogue between clinicians and patients, delving into treatment efficacy-toxicity trade-offs. Similarly, clinical trial advocacy for multiple dosing regimens encourages adaptive strategies, moving away from strict adherence to maximum tolerated dose, supported by recent research in optimizing drug dosages. Recognizing the efficacy-effectiveness gap between clinical trials and real-world practice, Patient-Centered Dosing Initiative underscores the necessity for patient-centered dosing strategies. A focus on individual patient attributes aligns with initiatives like Project Optimus and Project Renewal, aiming to optimize drug dosages for improved treatment outcomes at both the pre- and post-approval phases. Patient-Centered Dosing Initiative’s efforts extend to patient education, providing tools to initiate dosage-related conversations with physicians. In addition, it emphasizes physician-patient dialogues and post-marketing studies as essential in determining optimal dosing and refining drug regimens. A dose-finding paradigm prioritizing drug safety, tolerability, and efficacy benefits all stakeholders, reducing emergency care needs and missed treatments for patients, aligning with oncologists’ and patients’ shared goals. Importantly, it represents a win-win scenario across healthcare sectors. In summary, the Patient-Centered Dosing Initiative drives transformative changes in cancer drug dosing, emphasizing patient well-being and personalized care, aiming to enhance treatment outcomes and optimize oncology drug delivery.

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患者对抗癌治疗剂量优化的看法：癌症药物剂量的新时代——挑战“越多越好”的教条

以患者为中心的剂量倡议是一项由患者主导的努力，倡导确定癌症药物剂量策略的范式转变，开创了传统肿瘤药物剂量实践的背离。从历史上看，肿瘤药物剂量依赖于通过第一阶段剂量递增方法确定最大耐受剂量，有利于更高剂量以获得更大疗效，但通常会导致更高的毒性。然而，这种方法并不普遍适用，特别是对于靶向疗法和免疫疗法等较新的治疗方法。以患者为中心的剂量倡议挑战了这种“越多越好”的理念，特别是对于转移性乳腺癌患者本身，因为他们不仅寻求长寿，而且还追求高质量的生活，因为大多数转移性乳腺癌患者在余生中都在接受治疗。对 1221 名转移性乳腺癌患者和 119 名肿瘤科医生的调查显示，显然需要灵活的剂量策略，提倡根据患者属性进行个性化护理讨论。调查结果还表明，患者和临床医生对灵活剂量持开放态度，并且愿意将剂量作为其护理的一部分进行讨论。以患者为中心的剂量强调临床医生和患者之间的对话，深入研究治疗效果与毒性的权衡。同样，临床试验提倡多种给药方案，鼓励采取适应性策略，摆脱严格遵守最大耐受剂量的做法，这得到了最近优化药物剂量研究的支持。认识到临床试验与现实世界实践之间的疗效差距，以患者为中心的剂量倡议强调了以患者为中心的剂量策略的必要性。对个体患者属性的关注与“Optimus 项目”和“Project Renewal 项目”等举措相一致，旨在优化药物剂量，以改善批准前和批准后阶段的治疗结果。以患者为中心的剂量倡议的努力延伸到患者教育，提供工具来启动与医生的剂量相关对话。此外，它强调医患对话和上市后研究对于确定最佳剂量和完善药物治疗方案至关重要。优先考虑药物安全性、耐受性和疗效的剂量探索范式有利于所有利益相关者，减少患者的紧急护理需求和错过的治疗，与肿瘤学家和患者的共同目标保持一致。重要的是，它代表了医疗保健行业的双赢局面。总之，以患者为中心的剂量倡议推动了癌症药物剂量的变革，强调患者福祉和个性化护理，旨在提高治疗效果并优化肿瘤药物输送。