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立体定向体部放疗治疗肺部寡转移瘤:一项 2 期研究。

Stereotactic body radiation therapy for oligometastases to the lung: a phase 2 study.

机构信息

Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.

Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.

出版信息

Int J Radiat Oncol Biol Phys. 2015 Feb 1;91(2):337-43. doi: 10.1016/j.ijrobp.2014.10.021.

DOI:10.1016/j.ijrobp.2014.10.021
PMID:25636758
Abstract

PURPOSE

To assess, in a phase 2 study, the efficacy and toxicity of stereotactic body radiation therapy for oligometastases to the lung in inoperable patients.

METHODS AND MATERIALS

Patients with lung metastases were included in this study if (1) the primary tumor was controlled; (2) patients were ineligible for or refused surgery and chemotherapy; and (3) patients had 5 or fewer metastatic lesions in no more than 2 organs. Large peripheral tumors were treated with a dose of 60 Gy (3 fractions), small peripheral tumors with 30 Gy (1 fraction), central tumors received 60 Gy (5 fractions), and mediastinal tumors or tumors close to the esophagus received 56 Gy (7 fractions).

RESULTS

Thirty patients with 57 metastatic lung tumors from various primary cancers were analyzed. The median follow-up was 36 months (range, 4-60 months). At 2 years, local control for the 11 central tumors was 100%, for the 23 peripheral tumors treated to 60 Gy it was 91%, and for the 23 tumors treated in a single 30-Gy fraction it was 74% (P=.13). This resulted in an overall local control rate at 1 year of 79%, with a 2-sided 80% confidence interval of 67% to 87%. Because the hypothesized value of 70% lies within the confidence interval, we cannot reject the hypothesis that the true local control rate at 1 year is ≤70%, and therefore we did not achieve the goal of the study: an actuarial local control of the treated lung lesions at 1 year of 90%. The 4-year overall survival rate was 38%. Grade 3 acute toxicity occurred in 5 patients. Three patients complained of chronic grade 3 toxicity, including pain, fatigue, and pneumonitis, and 3 patients had rib fractures.

CONCLUSIONS

The local control was promising, and the 4-year overall survival rate was 38%. The treatment was well tolerated, even for central lesions.

摘要

目的

在一项 2 期研究中评估立体定向体放射治疗不能手术的肺寡转移瘤的疗效和毒性。

方法和材料

患有肺转移瘤的患者符合以下条件可纳入本研究:(1)原发肿瘤得到控制;(2)患者不适合或拒绝手术和化疗;(3)患者的转移灶不超过 2 个器官,且数量不超过 5 个。大的外周肿瘤采用 60Gy(3 次分割),小的外周肿瘤采用 30Gy(1 次分割),中央肿瘤采用 60Gy(5 次分割),纵隔肿瘤或靠近食管的肿瘤采用 56Gy(7 次分割)。

结果

对 30 例来自不同原发肿瘤的 57 个肺部转移瘤患者进行了分析。中位随访时间为 36 个月(范围 4-60 个月)。2 年时,11 个中央肿瘤的局部控制率为 100%,23 个接受 60Gy 治疗的外周肿瘤局部控制率为 91%,23 个单次 30Gy 治疗的肿瘤局部控制率为 74%(P=.13)。因此,1 年时的总局部控制率为 79%,双侧 80%置信区间为 67%至 87%。由于假设的 70%值在置信区间内,我们不能拒绝 1 年时的真实局部控制率≤70%的假设,因此我们没有达到研究的目标:即 1 年时治疗肺部病变的实际局部控制率为 90%。4 年总生存率为 38%。5 例患者出现 3 级急性毒性。3 例患者出现慢性 3 级毒性,包括疼痛、疲劳和肺炎,3 例患者出现肋骨骨折。

结论

局部控制效果令人鼓舞,4 年总生存率为 38%。该治疗方法耐受性良好,即使是中央病变也是如此。

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