Arcidiacono Fabio, Anselmo Paola, Casale Michelina, Zannori Cristina, Ragusa Mark, Mancioli Francesco, Marchetti Giovanni, Loreti Fabio, Italiani Marco, Bracarda Sergio, Maranzano Ernesto, Trippa Fabio
Radiotherapy Oncology Centre.
Radiotherapy Oncology Centre.
Int J Radiat Oncol Biol Phys. 2023 Mar 15;115(4):886-896. doi: 10.1016/j.ijrobp.2022.10.025. Epub 2022 Oct 24.
This is a single arm phase 2 trial (Clinical trials.gov NCT05291780) to assess local control (LC) and safety of SAbR in patients with unresectable locally advanced non-small cell lung cancer (LA-NSCLC) unfit for concurrent chemo-radiation therapy (ChT-RT).
Neoadjuvant ChT was prescribed in fit patients. The tumor volume included primary tumor and any regionally positive node/s. The coprimary study endpoints were LC and safety.
Between December 31, 2015, and December 31, 2020, 50 patients with LA-NSCLC were enrolled. Histology was squamous cell carcinoma and adenocarcinoma (ADC) in 52% and 48%, respectively. Forty (80%) patients had ultracentral tumor. Twenty-seven (54%) received neoadjuvant ChT and 7 (14%) adjuvant durvalumab. Median prescribed dose was 45 Gy (range, 35-55) and 40 Gy (35-45) in 5 daily fractions to tumor and node/s, respectively. After a median follow-up of 38 months (range, 12-80), 19 (38%) patients had experienced local recurrence (LR) at a median time of 13 months (range, 7-34). The median LR-free survival (FS) was not reached (95% confidence interval [CI], 28 to not reached). The 1-, 2-, and 3-year LR-FS rates were 86% ± 5%, 66% ± 7%, and 56% ± 8%, respectively. At last follow-up, 33 (66%) patients were alive. Median overall survival (OS) was 55 months (95% CI, 43-55 months). The 1-, 2-, and 3-year OS rates were 94% ± 3%, 79% ± 6%, and 72% ± 7%, respectively. No patients developed ≥ grade (G) 3 toxicity. ADC (hazard ratio [HR], 3.61; 95% CI, 1.15-11.35) was a significant predictor of better LC, while OS was significantly conditioned by smaller planning target volumes (HR, 1.004; 95% CI, 1.001-1.010) and tumor, node, and metastasis stage (HR, 4.8; 95% CI, 1.34-17).
Patients with LA-NSCLC treated with SABR had optimal LC and promising OS in absence of ≥G3 toxicity. Our early outcomes would suggest the feasibility of using this approach in patients with LA-NSCLC unfit for concurrent ChT-RT.
这是一项单臂2期试验（临床试验.gov标识符：NCT05291780），旨在评估立体定向消融放疗（SAbR）对不适合同步放化疗（ChT-RT）的不可切除局部晚期非小细胞肺癌（LA-NSCLC）患者的局部控制（LC）情况和安全性。
适合的患者接受新辅助化疗。肿瘤体积包括原发肿瘤和任何区域阳性淋巴结。共同主要研究终点为局部控制和安全性。
在2015年12月31日至2020年12月31日期间，纳入了50例LA-NSCLC患者。组织学类型分别为鳞状细胞癌和腺癌（ADC），各占52%和48%。40例（80%）患者有超中央型肿瘤。27例（54%）接受新辅助化疗，7例（14%）接受辅助度伐利尤单抗治疗。肿瘤和淋巴结的中位处方剂量分别为45 Gy（范围35 - 55）和40 Gy（35 - 45），分5次每日给予。中位随访38个月（范围12 - 80个月）后，19例（38%）患者出现局部复发（LR），中位时间为13个月（范围7 - 34个月）。未达到中位无局部复发生存期（FS）（95%置信区间[CI]，28至未达到）。1年、2年和3年无局部复发生存率分别为86%±5%、66%±7%和56%±8%。在最后一次随访时，33例（66%）患者存活。中位总生存期（OS）为55个月（95% CI，43 - 55个月）。1年、2年和3年总生存率分别为94%±3%、79%±6%和72%±7%。没有患者出现≥3级毒性反应。ADC（风险比[HR]，3.61；95% CI，1.15 - 11.35）是更好的局部控制的显著预测因素，而总生存期受较小的计划靶体积（HR，1.004；95% CI，1.001 - 1.010）和肿瘤、淋巴结及转移分期（HR，4.8；95% CI，1.34 - 17）的显著影响。
接受SABR治疗的LA-NSCLC患者在无≥3级毒性的情况下具有最佳的局部控制和有前景的总生存期。我们的早期结果表明，对于不适合同步放化疗的LA-NSCLC患者，采用这种方法是可行的。
