在正在接受外束放射治疗（RT）的患者中评估聚乙二醇脂质体丝裂霉素C脂质前药（PL-MLP）的配方。对于需要RT进行疾病控制或症状缓解的转移性疾病或无法手术的原发性实体肿瘤的患者，在21天的时间间隔内接受两个疗程的PL-MLP（1.25，1.5或1.8 mg/kg），以及10个传统RT治疗或5个SBRT分数，始于第一次PL-MLP剂量后的1-3天，并在2周内完成。治疗安全性在6周内得到监测，并在此后每6周重新评估疾病状况。每次PL-MLP输注后1小时和24小时分析MLP水平。 总体上，共有19名转移性（18）或无法手术（1）的患者接受了联合治疗，其中18/19完成了完整的方案。大多数患者（16）被诊断为晚期胃肠道癌症。报告了一起可能与研究治疗相关的4级中性粒细胞减少事件；其他不良事件均为轻度或中度。在18个可评估的患者中，有16个在首次重新评估时没有放疗靶病灶进展。整个患者人群的中位生存期为63.3周。血清MLP水平与剂量增加相关，并且在放疗前后观察到类似的长循环曲线。PL-MLP与RT联合治疗可安全使用，具有较高的肿瘤控制率。放射therapy不会影响药物清除。 PL-MLP在化学放疗中可能是一种有吸引力的选择，值得在姑息性和治愈性环境中进一步评估随机研究。版权所有©2023 Elsevier Inc.发表。

To evaluate a formulation of pegylated liposomal mitomycin C lipidic prodrug (PL-MLP) in patients concomitantly undergoing external beam radiotherapy (RT).Patients with metastatic disease or inoperable primary solid tumors requiring RT for disease control or symptom relief, were treated with two courses of PL-MLP (1.25, 1.5 or 1.8 mg/kg) at 21-day intervals, along with 10 fractions of conventional RT or 5 SBRT fractions initiated 1-3 days after the first PL-MLP dose and completed within 2 weeks. Treatment safety was monitored for 6 weeks, and disease status was reevaluated at 6 week-intervals thereafter. MLP levels were analyzed 1h and 24h after each PL-MLP infusion.Overall, 19 patients with metastatic (18) or inoperable (1) disease, received combination treatment, with 18/19 completing the full protocol. Most patients (16) were diagnosed with advanced gastrointestinal tract cancer. One grade 4 neutropenia event possibly related to study treatment was reported; other adverse events were mild or moderate. Of the 18 evaluable patients, 16 were free of radiotherapy target lesion progression at first re-evaluation. Median survival of the entire patient population was 63.3 weeks. Serum MLP level correlated with dose increases and similar long circulating profiles were observed before and after RT.PL-MLP up to 1.8 mg/kg in combination with RT treatment is safe, with a high rate of tumor control. Drug clearance is not affected by radiation. PL- MLP is potentially an attractive option for chemoradiotherapy that warrants further evaluation in randomized studies in the palliative and the curative settings.Copyright © 2023. Published by Elsevier Inc.