| 张雁山,李小军,张一贺,等.碳离子放射治疗肌层浸润性膀胱癌Ⅰ/Ⅱ期临床研究的初步疗效观察[J].中华放射医学与防护杂志,2022,42(9):664-670.Zhang Yanshan,Li Xiaojun,Zhang Yihe,et al.Preliminary efficacy observation of carbon ion radiotherapy in the treatment of muscle-invasive bladder cancer in phase Ⅰ/Ⅱ clinical trials[J].Chin J Radiol Med Prot,2022,42(9):664-670 |
| 碳离子放射治疗肌层浸润性膀胱癌Ⅰ/Ⅱ期临床研究的初步疗效观察 |
| Preliminary efficacy observation of carbon ion radiotherapy in the treatment of muscle-invasive bladder cancer in phase Ⅰ/Ⅱ clinical trials |
| 投稿时间：2022-05-08 |
| DOI：10.3760/cma.j.cn112271-20220508-00197 |
| 中文关键词: 碳离子放疗 肌层浸润性膀胱癌 临床研究 疗效观察 不良反应 |
| 英文关键词:Carbon ion radiotherapy Muscle invasive bladder cancer (MIBC) Clinical trial Efficacy observation Adverse reactions |
| 基金项目:甘肃省科技重点研发计划项目(19YF3FH001);甘肃省科技厅创新基地和人才计划项目(21JR7RH896) |
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| 中文摘要: |
| 目的 评估Ⅰ/Ⅱ期临床研究中碳离子放疗(CIRT)治疗肌层浸润性膀胱癌的可行性和安全性。方法 研究对象为2020年3月至2022年1月就诊甘肃省武威肿瘤医院的9例肌层浸润性膀胱癌患者(不伴远处转移),临床分期为T2~3。治疗包括3分次,由12 Gy增加到24 Gy的局部照射和11分次44 Gy的全膀胱照射。碳离子照射剂量均为相对生物学有效性(RBE)为3.0时的剂量。膀胱肿瘤总剂量为56~68 Gy,分14次。主要观察终点包括肿瘤的治疗相关不良反应和剂量限制毒性(DLT)、局部控制率(LC)。次要终点为无进展生存期(PFS)。结果 9例患者完成了试验研究中各剂量段CIRT,剂量递增至68 Gy。未发生DLT和≥3级的急性放疗不良反应和生存期内的晚期放疗不良反应。肿瘤剂量达到68 Gy时,出现2例2级急性泌尿生殖道反应,1例急性下消化道症状;62 Gy以上剂量组观察到3例1级晚期放射性膀胱反应,表现为尿频和镜下血尿。所有病例治疗结束时血尿均消失,排尿不畅缓解,尿红细胞值显著下降。治疗后3个月、6个月局部控制率分别为100%和88.9%,客观缓解率均为88.9%。1例患者在治疗后6个月出现局部复发,采用挽救性手术治疗。结论 碳离子放射治疗肌层浸润性膀胱癌初步疗效观察,未见剂量限制性毒性,安全可行,近期疗效显著,症状缓解明显,患者耐受性好。 |
| 英文摘要: |
| Objective To evaluate the feasibility and safety of carbon ion radiotherapy (CIRT) in the treatment of muscle-invasive bladder cancer in phase Ⅰ/Ⅱ clinical trials.Methods Clinical stage T2-3 patients with muscle-invasive bladder cancer (without distant metastasis) were studied.A three-fraction treatment was applied,including the local irradiation with the dose from 12 Gy to 24 Gy and 11 fractions of whole-bladder irradiation with a dose of 44 Gy.The carbon ion irradiation dose is determined with relative biological effectiveness (RBE) of 3.0.The total dose for bladder tumor was 56-68 Gy in 14 fractions.The primary endpoints included tumor treatment-related side effects,dose-limiting toxicity (DLT) responses,and local control (LC) rate,and the secondary endpoints included progression-free survival (PFS).Results Nine patients received CIRT of various doses in the clinical trials,with the dose gradually increasing to 68 Gy.The patients did not suffer from DLT response,acute adverse effects of radiation therapy of grade ≥ 3,and late radiation adverse reactions during follow-up.When the dose to the tumor reached 68 Gy,there were 2 cases of grade 2 acute urogenital tract reaction and 1 case of acute lower gastrointestinal tract symptom.For the group with a dose above 62 Gy,three cases of grade 1 late radiation bladder reaction were observed and their symptoms included urinary frequency and microscopic hematuria.At the end of treatment,hematuria disappeared,dysuria was relieved,and urine red blood cell value significantly decreased for all the patients.Three months and six months after treatment,the LC rates were 100% and 88.9%,respectively,and the objective response rates were both 88.9%.One patient developed local recurrence and was treated with salvage surgery six months after treatment.Conclusions The preliminary efficacy observation of CIRT in the treatment of muscle-invasive bladder cancer showed significant short-term efficacy,obvious symptom relief,and good tolerability for patients,without DLT.Therefore,CIRT is safe and feasible. |
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