Department of Radiotherapy and Radiosurgery, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089 Milan, Rozzano, Italy.
Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Milan, Pieve Emanuele, Italy.
Curr Oncol. 2022 Oct 17;29(10):7858-7867. doi: 10.3390/curroncol29100621.
We report the mature toxicity data of a phase II non-randomized trial on the use of SBRT for lung and liver oligometastases.
Oligometastatic patients from breast cancer were treated with SBRT for up to five lung and/or liver lesions. Inclusion criteria were: age > 18 years, ECOG 0-2, diagnosis of breast cancer, less than five lung/liver lesions (with a maximum diameter <5 cm), metastatic disease confined to the lungs and liver or extrapulmonary or extrahepatic disease stable or responding to systemic therapy. Various dose-fractionation schedules were used. Then, a 4D-CT scan and FDG-CTPET were acquired for simulation and fused for target definition.
From 2015 to 2021, 64 patients and a total of 90 lesions were irradiated. Treatment was well tolerated, with no G 3-4 toxicities. No grade ≥3 toxicities were registered and the coprimary endpoint of the study was met. Median follow-up was 19.4 months (range 2.6-73.1).
The co-primary endpoint of this phase II trial was met, showing excellent tolerability of SBRT for lung and liver oligometastatic in breast cancer patients. Until efficacy data will mature with longer follow-up, SBRT should be regarded as an opportunity for oligometastatic breast cancer patients.
我们报告了一项针对肺和肝寡转移瘤 SBRT 应用的 II 期非随机试验的成熟毒性数据。
来自乳腺癌的寡转移患者接受了最多 5 个肺和/或肝病变的 SBRT 治疗。纳入标准为:年龄>18 岁,ECOG 0-2,乳腺癌诊断,肺/肝病变少于 5 个(最大直径<5cm),转移性疾病局限于肺和肝,或肺外或肝外疾病稳定或对全身治疗有反应。使用了各种剂量分割方案。然后,进行 4D-CT 扫描和 FDG-CTPET 扫描,以进行模拟并融合以确定靶区。
2015 年至 2021 年,共 64 例患者的 90 个病灶接受了放疗。治疗耐受性良好,无 G3-4 级毒性。未登记任何≥3 级毒性,且该研究的主要终点达到。中位随访时间为 19.4 个月(范围 2.6-73.1)。
该 II 期试验的主要终点达到,表明 SBRT 治疗乳腺癌肺和肝寡转移的耐受性极好。在更长的随访中疗效数据成熟之前,SBRT 应被视为寡转移乳腺癌患者的一个机会。