Background: Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment by providing durable survival gains, but understanding their effects on patient health-related quality of life (HRQL) is critical. Methods: We performed a narrative review of cross-sectional surveys, early-phase trials, and large-scale phase II and III randomized controlled clinical trials assessing FDA-approved ICIs, including programmed cell death protein 1 (PD-1) inhibitors, programmed death ligand 1 (PD-L1) inhibitors, and cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) inhibitors, with emphasis on patient-reported HRQL. Validated HRQL instruments were summarized, and for pivotal trials, the positioning of HRQL outcomes as primary, secondary, or exploratory endpoints was taken from original protocols or primary manuscripts. Results: ICIs generally preserved or improved HRQL in patients with various malignancies compared with chemotherapy, targeted therapies, or observation. PD-1/PD-L1 inhibitors maintained global health and function and delayed symptom progression in patients with lung cancer, melanoma, and renal cell carcinoma. Regimens combining CTLA-4 blockade and PD-1/PD-L1 inhibition (e.g., nivolumab + ipilimumab, durvalumab + tremelimumab) are associated with HRQL outcomes similar or superior to those of targeted therapies. Overall, most immune-related adverse effects were short-term and did not diminish HRQL benefits. Conclusions: ICIs extend survival while preserving, and often enhancing, patient HRQL. These medications represent a shift in oncology, offering not just longer life but also better daily well-being. Continued long-term patient-reported outcome monitoring is essential to guide survivorship care in the immunotherapy era.
背景：免疫检查点抑制剂通过提供持久的生存获益，已彻底改变了癌症治疗模式，但理解其对患者健康相关生活质量的影响至关重要。方法：我们对评估美国食品药品监督管理局批准的免疫检查点抑制剂的横断面调查、早期试验及大规模II/III期随机对照临床试验进行了叙述性综述，涵盖程序性细胞死亡蛋白1抑制剂、程序性死亡配体1抑制剂及细胞毒性T淋巴细胞相关抗原4抑制剂，重点关注患者报告的健康相关生活质量指标。研究总结了经过验证的健康相关生活质量评估工具，并依据原始研究方案或主要文献，明确了关键试验中健康相关生活质量结果作为主要、次要或探索性终点的定位。结果：与化疗、靶向治疗或观察等待相比，免疫检查点抑制剂在多种恶性肿瘤患者中普遍维持或改善了健康相关生活质量。PD-1/PD-L1抑制剂在肺癌、黑色素瘤和肾细胞癌患者中保持了整体健康状态与功能，并延缓了症状进展。CTLA-4阻断剂联合PD-1/PD-L1抑制剂的治疗方案（如纳武利尤单抗+伊匹木单抗、度伐利尤单抗+替西木单抗）产生的健康相关生活质量结果与靶向治疗相当或更优。总体而言，大多数免疫相关不良反应具有短期性，并未削弱健康相关生活质量的获益。结论：免疫检查点抑制剂在延长生存期的同时，能够维持并经常提升患者的健康相关生活质量。这类药物代表了肿瘤治疗模式的转变，不仅延长生命，更改善了患者的日常生存状态。在免疫治疗时代，持续开展长期患者报告结局监测对于指导癌症生存照护至关重要。
肿瘤(癌症)患者之家