立体定向体部放射治疗早期非小细胞肺癌：一项前瞻性II期研究的四年结果
Stereotactic body radiation therapy for early-stage non-small-cell lung carcinoma: four-year results of a prospective phase II study.
作者信息
Fakiris Achilles J, McGarry Ronald C, Yiannoutsos Constantin T, Papiez Lech, Williams Mark, Henderson Mark A, Timmerman Robert
机构信息
Department of Radiation Oncology, Indiana University School of Medicine, 535 Barnhill Drive, Indianapolis, IN 46202, USA.
出版信息
Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):677-82. doi: 10.1016/j.ijrobp.2008.11.042. Epub 2009 Feb 27.
PURPOSE
The 50-month results of a prospective Phase II trial of stereotactic body radiation therapy (SBRT) in medically inoperable patients are reported.
METHODS AND MATERIALS
A total of 70 medically inoperable patients had clinically staged T1 (34 patients) or T2 (36 patients) (< or =7 cm), N0, M0, biopsy-confirmed non-small-cell lung carcinoma (NSCLC) and received SBRT as per our previously published reports. The SBRT treatment dose of 60-66 Gy was prescribed to the 80% isodose volume in three fractions.
RESULTS
Median follow-up was 50.2 months (range, 1.4-64.8 months). Kaplan-Meier local control at 3 years was 88.1%. Regional (nodal) and distant recurrence occurred in 6 (8.6%) and 9 (12.9%) patients, respectively. Median survival (MS) was 32.4 months and 3-year overall survival (OS) was 42.7% (95% confidence interval [95% CI], 31.1-54.3%). Cancer-specific survival at 3 years was 81.7% (95% CI, 70.0-93.4%). For patients with T1 tumors, MS was 38.7 months (95% CI, 25.3-50.2) and for T2 tumors MS was 24.5 months (95% CI, 18.5-37.4) (p = 0.194). Tumor volume (< or =5 cc, 5-10 cc, 10-20 cc, >20 cc) did not significantly impact survival: MS was 36.9 months (95% CI, 18.1-42.9), 34.0 (95% CI, 16.9-57.1), 32.8 (95% CI, 21.3-57.8), and 21.4 months (95% CI, 17.8-41.6), respectively (p = 0.712). There was no significant survival difference between patients with peripheral vs. central tumors (MS 33.2 vs. 24.4 months, p = 0.697). Grade 3 to 5 toxicity occurred in 5 of 48 patients with peripheral lung tumors (10.4%) and in 6 of 22 patients (27.3%) with central tumors (Fisher's exact test, p = 0.088).
CONCLUSION
Based on our study results, use of SBRT results in high rates of local control in medically inoperable patients with Stage I NSCLC.
目的
报告立体定向体部放射治疗（SBRT）用于医学上无法手术的患者的前瞻性II期试验的50个月结果。
方法与材料
共有70例医学上无法手术的患者，临床分期为T1（34例）或T2（36例）（≤7 cm），N0，M0，经活检确诊为非小细胞肺癌（NSCLC），并按照我们之前发表的报告接受SBRT治疗。SBRT治疗剂量为60 - 66 Gy，分三次给予80%等剂量体积。
结果
中位随访时间为50.2个月（范围1.4 - 64.8个月）。3年时的Kaplan - Meier局部控制率为88.1%。区域（淋巴结）和远处复发分别发生在6例（8.6%）和9例（12.9%）患者中。中位生存期（MS）为32.4个月，3年总生存率（OS）为42.7%（95%置信区间[95%CI]，31.1 - 54.3%）。3年癌症特异性生存率为81.7%（95%CI，70.0 - 93.4%）。对于T1期肿瘤患者，MS为38.7个月（95%CI，25.3 - 50.2），对于T2期肿瘤患者，MS为24.5个月（95%CI，18.5 - 37.4）（p = 0.194）。肿瘤体积（≤5 cc、5 - 10 cc、10 - 20 cc、>20 cc）对生存率无显著影响：MS分别为36.9个月（95%CI，18.1 - 42.9）、34.0个月（95%CI，16.9 - 57.1）、32.8个月（95%CI，21.3 - 57.8）和21.4个月（95%CI，17.8 - 41.6）（p = 0.712）。周围型与中央型肿瘤患者的生存率无显著差异（MS分别为33.2个月和24.4个月，p = 0.697）。48例周围型肺肿瘤患者中有5例（10.4%）发生3 - 5级毒性反应，22例中央型肿瘤患者中有6例（27.3%）发生3 - 5级毒性反应（Fisher精确检验，p = 0.088）。
结论
基于我们的研究结果，SBRT用于医学上无法手术的I期NSCLC患者可获得较高的局部控制率。
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