Department of Clinical Pharmaceutics & Therapeutics, Faculty of Pharmaceutical Sciences, Hokkaido University of Science, 4-1, Maeda 7-jo 15-chome, Teine-ku, Sapporo, 006-8585, Japan.
Department of Pharmacy, Hokkaido University Hospital, Kita 14-jo, Nishi 5-chome, Kita-ku, Sapporo, 060-8648, Japan.
BMC Cancer. 2024 Oct 21;24(1):1301. doi: 10.1186/s12885-024-13070-3.
Docetaxel (DOC) and ramucirumab (RAM) is one of the most effective regimens for advanced non-small cell lung cancer (NSCLC) treatment. In our previous study, baseline anemia was identified as a preventive factor against the development of severe adverse effects during the first treatment cycle. It was hypothesized that anemia directly promotes tumor angiogenesis, leading to the elevation of RAM efficacy with increased DOC delivery to tumors, while reducing DOC delivery to other organs, potentially mitigating severe adverse effects. If this hypothesis is correct, patients with baseline anemia may have better clinical outcomes than those with normal hemoglobin levels. In this study, we aimed to investigate the effect of baseline anemia on the efficacy of DOC + RAM in treating advanced NSCLC in a real-word setting.
Patients with advanced NSCLC receiving DOC + RAM (n = 72) were retrospectively assessed. They were categorized into a control group with normal baseline hemoglobin levels and an anemia group with baseline anemia. The primary endpoint was progression-free survival (PFS) evaluation.
Patients in the anemia group had a significantly shorter PFS than that of patients in the control group (median PFS: 3.2 and 6.2 months; 95% confidence interval [CI]: 2.2-4.8 and 4.3-9.9 months, respectively;P = 0.008). In addition, the disease control rate in the anemia group was 65.8%, which was significantly lower than that in the control group (93.6%; P = 0.007). Overall survival tended to be shorter in patients with anemia than in controls, although the difference was not statistically significant (P = 0.07). Multivariate Cox hazard analysis suggested that baseline anemia was a singular risk factor for poor PFS (adjusted hazard ratio 1.84, 95% CI 1.08-3.13; P = 0.02). The incidence of severe adverse effects did not differ between the two groups.
This study suggests that the PFS of patients with anemia treated with DOC + RAM for advanced NSCLC is shorter than that of those without the symptoms.
多西他赛（DOC）和雷莫芦单抗（RAM）是治疗晚期非小细胞肺癌（NSCLC）最有效的方案之一。在我们之前的研究中，基线贫血被确定为预防第一个治疗周期发生严重不良反应的因素。假设贫血直接促进肿瘤血管生成，从而提高 RAM 的疗效，增加肿瘤中 DOC 的输送，同时减少 DOC 向其他器官的输送，从而减轻严重不良反应。如果这一假设是正确的，那么基线贫血的患者可能比血红蛋白水平正常的患者有更好的临床结局。在这项研究中，我们旨在研究基线贫血对真实环境中晚期 NSCLC 患者接受 DOC+RAM 治疗效果的影响。
回顾性评估了 72 例接受 DOC+RAM 治疗的晚期 NSCLC 患者。他们被分为血红蛋白水平正常的对照组和基线贫血的贫血组。主要终点是无进展生存期（PFS）评估。
贫血组患者的 PFS 明显短于对照组（中位 PFS：3.2 个月和 6.2 个月；95%置信区间[CI]：2.2-4.8 和 4.3-9.9 个月；P=0.008）。此外，贫血组的疾病控制率为 65.8%，明显低于对照组（93.6%；P=0.007）。尽管差异无统计学意义（P=0.07），但贫血组患者的总生存期似乎比对照组短。多变量 Cox 风险分析表明，基线贫血是 PFS 不良的单一危险因素（调整后的危险比 1.84，95%CI 1.08-3.13；P=0.02）。两组严重不良事件的发生率无差异。
本研究表明，接受 DOC+RAM 治疗的晚期 NSCLC 伴贫血患者的 PFS 短于无贫血患者。
