目的：免疫檢查點抑制劑 (Immune checkpoint inhibitors, ICIs) 已成為固態腫瘤治療的重要藥物之一，然而其會引發免疫相關不良事件 (Immune-related adverse events, irAE)，癌末患者使用ICIs 的風險還不清楚。對於臺灣末期癌症病人，接受ICIs 治療的預後生物標記物的研究仍相對匱乏。本研究旨在透過ICIs 處方型態進行使用評估，預測癌症末期病人接受治療的風險。
方法：本研究為回溯性觀察研究，收集2018 至2021 年間臺灣某區域教學醫院使用ICIs 治療癌症末期病人的基本資料及治療前各項指標，比較病人的存活時間及短期死亡率（≤ 90 天）。統計分析包括存活分析和Cox 模型分析，以計算危險比值及信賴區間。
結果：共納入222 位癌症末期病人，ECOG PS、白蛋白數值和嗜中性白血球與淋巴球數目的比值 (neutrophil to lymphocyte ratio, NLR) 對ICIs 治療的預後有顯著影響 (HR = 1.449，95% CI: 1.184–1.773, p < 0.001; HR = 0.499, 95% CI: 0.355–0.700，p < 0.001; HR = 1.033, 95% CI: 1.013–1.052, p = 0.001)。在所有死亡的病人中，短期死亡組和非短期死亡組在首次給藥前的ECOG PS、白蛋白值、NLR 值和血小板與淋巴球數目的比值 (platelet to lymphocyte ratio, PLR) 等方面均有顯著差異 (p < 0.05)。
結論：在癌症末期患者接受ICIs 治療前，ECOG PS、血液中的白蛋白數值和NLR 值可被視為預後生物標記。臨床醫師可透過這些生物標記來評估治療風險，以提供個別化治療和醫病共享決策。未來研究可擴大樣本數，驗證這些生物標記的適用性，以提高治療效果和減少不良事件的發生率。

 

Objective: Immune checkpoint inhibitors (ICIs) have become a key treatment for solid tumors; however, they can cause immune-related adverse events (irAE). The risks for end-stage cancer patients using ICIs are unclear. Research on prognostic biomarkers for immune checkpoint inhibitor treatment in advanced cancer patients in Taiwan remains scarce. This study aims to assess ICIs prescription patterns and predict treatment risks for end-stage cancer patients.
Methods: This retrospective observational study collected data from a regional teaching hospital in Taiwan between 2018 and 2021, including patients’ baseline information and pre-treatment indicators. Survival time and short-term mortality rate (≤ 90 days) were compared. Statistical analyses included survival and Cox model analyses to calculate hazard ratios (HR) and confidence intervals (CI).
Results: A total of 222 end-stage cancer patients were included. Eastern Cooperative Oncology Group Performance Status (ECOG PS), serum albumin levels, and neutrophil-to-lymphocyte ratio (NLR) had a significant impact on the prognosis of ICIs treatment (HR = 1.449, 95% CI: 1.184–1.773, p < 0.001; HR = 0.499, 95% CI: 0.355–0.700, p < 0.001; HR = 1.033, 95% CI: 1.013–1.052, p = 0.001). Among deceased patients, there were notable differences between the shortterm mortality group and the non-short-term mortality group in terms of ECOG PS, albumin levels, NLR, and platelet-to-lymphocyte ratio (PLR) values prior to the initiation of treatment (p < 0.05).
Conclusions: ECOG PS, serum albumin, and NLR are prognostic biomarkers before ICIs treatment in end-stage cancer patients. These markers aid clinicians in risk assessment, personalized treatment, and shared decisionmaking. Future research could expand sample size, validating biomarker applicability, and enhancing treatment efficacy while reducing adverse events. 

 

 

Submitted for publication: 2023.2.2; Accepted for publication: 2023.8.9