Impact of Renal Function on S-1 + Radiotherapy for Locally Advanced Pancreatic Cancer: An Integrated Analysis of Data From 2 Clinical Trials
Impact of Renal Function on S-1 + Radiotherapy for Locally Advanced Pancreatic Cancer: An Integrated Analysis of Data From 2 Clinical Trials
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肾功能对局部晚期胰腺癌 S-1 放射治疗的影响：两项临床试验数据的综合分析
DOI：
10.1097/mpa.0000000000001879
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发表时间：
2021
期刊：
影响因子：
2.9
通讯作者：
Furuse J.
中科院分区：
文献类型：
--
作者：
Kobayashi S;Ueno M;Ogawa G;Fukutomi A;Ikeda M;Okusaka T;Sato T;Ito Y;Kadota T;Ioka T;Sugimori K;Sata N;Nakamori S;Shimizu K;Mizuno N;Ishii H;Furuse J.
目的：1单药联合放疗（RT）是局部晚期胰腺癌（LAPC）患者的标准治疗方法。虽然肾功能不全会增加S-1单药治疗的毒性，但其对S-1并发RT的影响尚不清楚。我们评估了肾功能对S-1联合RT治疗LAPC安全性的影响。方法：我们对2项前瞻性研究（JCOG1106和LAPC- s1rt）的数据进行了综合探索性事后分析，其中LAPC患者接受RT （50.4 Gy/28分数，持续5.5周）和S-1（每剂量40 mg/ m2，照射当天每天两次）。我们将患者分为高肌酸酐清除率组（CCr≥80 mL/min）和低肌酸酐清除率组（< 80 mL/min），并比较结果以确定治疗安全性。结果高、低CCr组中位数分别为97.5（范围：80.0 ~ 194.6）、64.4（范围：50.0 ~ 78.3）mL/min。低CCr组出现3级及以上不良反应（ARs）和2级及以上胃肠道不良反应（ARs）的比例高于高CCr组（30.8% vs 15.8%, 51.9% vs 36.8%）。结论低CCr患者伴有S-1和RT的ARs发生率增高；因此，在此类患者中应适当考虑ARs。
ObjectivesS-1 monotherapy with concurrent radiotherapy (RT) is a standard of care for patients with locally advanced pancreatic cancer (LAPC). Although renal dysfunction increases S-1 monotherapy toxicity, its effect in S-1 with concurrent RT remains unknown. We evaluated the effect of renal function on the safety of S-1 with RT for LAPC.MethodsWe performed an integrated exploratory post hoc analysis of data from 2 prospective studies (JCOG1106 and LAPC-S1RT), where patients with LAPC received RT (50.4 Gy/28 fraction for 5.5 weeks) and concurrent S-1 (40 mg/m 2 per dose, twice daily on the day of irradiation). We split the patients into high creatinine clearance (CCr;≥ 80 mL/min) and low CCr (< 80 mL/min) groups and compared the findings to determine treatment safety.ResultsThe high and low CCr groups showed a median of 97.5 (range, 80.0–194.6) and 64.4 (range, 50.0–78.3) mL/min, respectively. The low CCr group presented more adverse reactions (ARs) of grade 3 or higher and gastrointestinal ARs of grade 2 or higher than the high CCr group (30.8% vs 15.8% and 51.9% vs 36.8%).ConclusionsThe incidence of ARs associated with concurrent S-1 and RT increases in patients with low CCr; therefore, ARs should be duly considered in such patients.