Phase I Dose-Escalation Study of Stereotactic Body Radiotherapy in Patients With Hepatic Metastases
Phase I Dose-Escalation Study of Stereotactic Body Radiotherapy in Patients With Hepatic Metastases
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DOI：
10.1245/s10434-010-1405-5
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发表时间：
2011-04-01
影响因子：
3.7
通讯作者：
Cho, L. Chinsoo
中科院分区：
文献类型：
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作者：
Rule, William;Timmerman, Robert;Cho, L. Chinsoo
为确定5次立体定向体部放射治疗肝转移瘤的耐受剂量和有效剂量，患者被纳入3个剂量递增队列：30戈伊3次，50戈伊5次，60戈伊5次。符合条件的患者有1 - 5个肝转移，能够保留700 ml的临界肝体积（接受< 21戈伊的体积），足够的基线肝功能，没有同时接受放射治疗，Karnofsky性能评分为千分之一日元60。剂量限制性毒性包括胃肠道、肝胆/胰腺和代谢/实验室类别中的治疗相关3级毒性。任何可归因于治疗的4级或5级事件均定义为剂量限制性毒性。评估局部控制（LC）和完全加部分缓解率。27例患者，每个队列9例，37个病灶入选并接受治疗：17例男性和11例女性;中位年龄62岁（范围48-86）;最常见的原发病部位为结直肠（44.4%）。中位随访时间为20（范围4-53）个月。没有4级或5级毒性或治疗相关的3级毒性。30-、50-和60-戈伊队列的精算24个月LC率分别为56%、89%和100%。60-和30-戈伊队列之间的LC存在统计学显著差异（P = 0.009），但60-和50-戈伊队列之间（P = 0.56）或50-和30-戈伊队列之间（P = 0.091）无统计学显著差异。60戈伊分5次照射对肝转移瘤患者是安全的，只要考虑到临界肝体积。剂量为60戈伊，分5次给药，可产生良好的LC水平。
To identify a tolerable and effective dose for 5-fraction stereotactic body radiotherapy for hepatic metastases.Patients were enrolled onto three dose-escalation cohorts: 30 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 5 fractions. Eligible patients had one to five hepatic metastases, ability to spare a critical hepatic volume (volume receiving < 21 Gy) of 700 ml, adequate baseline hepatic function, no concurrent antineoplastic therapy, and a Karnofsky performance score of a parts per thousand yen60. Dose-limiting toxicity included treatment-related grade 3 toxicity in the gastrointestinal, hepatobiliary/pancreas, and metabolic/laboratory categories. Any grade 4 or 5 event attributable to therapy was defined as a dose-limiting toxicity. Local control (LC) and complete plus partial response rates were assessed.Twenty-seven patients, 9 in each cohort, with 37 lesions were enrolled and treated: 17 men and 11 women; median age 62 (range 48-86) years; most common site of primary disease, colorectal (44.4%). Median follow-up was 20 (range 4-53) months. There was no grade 4 or 5 toxicity or treatment-related grade 3 toxicity. Actuarial 24-month LC rates for the 30-, 50-, and 60-Gy cohorts were 56%, 89%, and 100%, respectively. There was a statistically significant difference for LC between the 60- and 30-Gy cohorts (P = 0.009) but not between the 60- and 50-Gy cohorts (P = 0.56) or the 50- and 30-Gy cohorts (P = 0.091). The maximum tolerated dose was not reached.A dose of 60 Gy in 5 fractions can be safely delivered to selected patients with hepatic metastases as long as the critical liver volume is respected. A dose of 60 Gy in 5 fractions yields an excellent level of LC.