Definitive radiotherapy in lieu of systemic therapy for oligometastatic renal cell carcinoma: a single-arm, single-centre, feasibility, phase 2 trial
Definitive radiotherapy in lieu of systemic therapy for oligometastatic renal cell carcinoma: a single-arm, single-centre, feasibility, phase 2 trial
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DOI：
10.1016/s1470-2045(21)00528-3
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发表时间：
2021-11-29
期刊：
影响因子：
51.1
通讯作者：
Tannir, Nizar M.
中科院分区：
文献类型：
--
作者：
Tang, Chad;Msaouel, Pavlos;Tannir, Nizar M.
背景放疗在转移性肾细胞癌中的作用存在争议。我们前瞻性地测试了放疗延迟肾细胞癌患者全身治疗的可行性和有效性。该单臂2期可行性试验在美国的一个中心进行（MD Anderson Cancer Center, Houston， TX， USA）。患者（年龄>= 18岁）有5个或更少的转移灶，东部肿瘤合作组状态为0-2，既往不超过一次全身治疗（如果该治疗在入组前至少1个月停止），无肾细胞癌组织学限制，符合纳入条件。患者接受立体定向体放疗（定义为每分数= 7 Gy）治疗所有病变，并维持全身治疗。当病灶位置排除安全立体定向放疗时，患者接受低分割调强放疗方案，包括60-70 Gy的10个部分或52.5-67.5 Gy的15个部分。允许对后续进展部位进行额外的放射治疗。共同主要终点是可行性(定义为所有计划放疗完成的
Background The role of radiotherapy in metastatic renal cell carcinoma is controversial. We prospectively tested the feasibility and efficacy of radiotherapy to defer systemic therapy for patients with oligometastatic renal cell carcinoma.Methods This single-arm, phase 2, feasibility trial was done at one centre in the USA (The MD Anderson Cancer Center, Houston, TX, USA). Patients (aged >= 18 years) with five or fewer metastatic lesions, an Eastern Cooperative Oncology Group status of 0-2, and no more than one previous systemic therapy (if this therapy was stopped at least 1 month before enrolment) without limitations on renal cell carcinoma histology were eligible for inclusion. Patients were treated with stereotactic body radiotherapy (defined as = 7 Gy per fraction) to all lesions and maintained off systemic therapy. When lesion location precluded safe stereotactic body radiotherapy, patients were treated with hypofractionated intensity-modulated radiotherapy regimes consisting of 60-70 Gy in ten fractions or 52.5-67.5 Gy in 15 fractions. Additional rounds of radiotherapy were allowed to treat subsequent sites of progression. Co-primary endpoints were feasibility (defined as all planned radiotherapy completed with