Stereotactic body radiation therapy for inoperable early stage lung cancer.
Stereotactic body radiation therapy for inoperable early stage lung cancer.
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DOI：
10.1001/jama.2010.261
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发表时间：
2010-03-17
影响因子：
120.7
通讯作者：
Choy, Hak
中科院分区：
文献类型：
--
作者：
Timmerman, Robert;Paulus, Rebecca;Galvin, James;Michalski, Jeffrey;Straube, William;Bradley, Jeffrey;Fakiris, Achilles;Bezjak, Andrea;Videtic, Gregory;Johnstone, David;Fowler, Jack;Gore, Elizabeth;Choy, Hak
早期但医学上无法手术的肺癌患者在目前的治疗下，原发肿瘤控制率较低（30-40%），死亡率较高（3年生存率20-35%）。评估立体定向全身放射治疗对早期但医学上无法手术的肺癌高危人群的毒性和疗效。北美 2 期多中心研究，对象为经活检证实为直径小于 5 厘米的外周 T1-T2、N0、M0 非小细胞肿瘤且身体状况不允许进行手术治疗的患者。处方剂量为每次分次 18 Gy 乘以 1.5-2 周内递送的 3 次分次（总计 54 Gy）。该研究于2004年5月26日开始，并于2006年10月13日结束；数据分析截至2009年8月31日。主要终点是主要肿瘤控制，总体生存率、无病生存率、不良事件、受累肺叶、区域和播散性复发作为次要终点。共有 59 名患者入组，其中 55 名可评估（44 名 T1 肿瘤和 11 名 T2 肿瘤），中位随访时间为 34.4 个月（范围为 4.8 至 49.9 个月）。仅 1 名患者出现原发性肿瘤衰竭；预计 3 年原发肿瘤控制率为 97.6%（95% 置信区间 [CI]、84.3%、99.7%）。 3 名患者在受累肺叶内出现复发； 3年原发肿瘤和受累肺叶（局部）控制率为90.6%（95% CI，76.0%，96.5%）。两名患者出现局部衰竭；局部区域控制率为87.2%（95%CI，71.0%，94.7%）。 11 名患者出现播散性复发； 3 年播散性失败率为 22.1%（95% CI、12.3%、37.8%）。 3 年无病生存率和总生存率分别为 48.3%（95% CI，34.4%、60.8%）和 55.8%（95% CI，41.6%、67.9%）。中位总生存期为 48.1 个月（95% CI，29.6% 未达到）。 7 名患者报告了方案指定的与治疗相关的 3 级不良事件（12.7%；95% CI，9.6%，15.8%）； 2 名患者报告了 4 级事件（3.6%；95%CI，2.7%，4.5%）。未报告 5 级不良事件。接受立体定向全身放射治疗的无法手术的非小细胞肺癌患者的3年生存率为55.8%，局部肿瘤控制率高，治疗相关发病率中等。
Patients with early stage but medically inoperable lung cancer patients have a poor rate of primary tumor control (30-40%) and a high rate of mortality (3-year survival 20-35%) with current management. To evaluate the toxicity and efficacy of stereotactic body radiation therapy in a high risk population of patients with early stage but medically inoperable lung cancer. Phase 2 North American multicenter study of patients with biopsy-proven peripheral T1-T2, N0, M0 non-small cell tumors less than 5 cm in diameter and medical conditions precluding surgical treatment. The prescription dose was 18 Gy per fraction times 3 fractions (54 Gy total) delivered in 1½-2 weeks. The study opened May 26, 2004, and closed October 13, 2006; data were analyzed through August 31, 2009. The primary endpoint was primary tumor control with overall survival, disease free survival, adverse events, involved lobe, regional, and disseminated recurrence as secondary endpoints. A total of 59 patients accrued, of which 55 were evaluable (44 T1 and 11 T2 tumors) with a median follow-up of 34.4 months (range, 4.8 to 49.9 months). Only 1 patient had a primary tumor failure; the estimated 3-year primary tumor control rate was 97.6% (95% confidence interval [CI], 84.3%, 99.7%). Three patients had recurrence within the involved lobe; the 3-year primary tumor and involved lobe (local) control rate was 90.6% (95% CI, 76.0%, 96.5%). Two patients experienced regional failure; the local-regional control rate was 87.2% (95%CI, 71.0%, 94.7%). Eleven patients experienced disseminated recurrence; the 3-year rate of disseminated failure was 22.1% (95% CI, 12.3%, 37.8%). The rates of disease-free and overall survival at 3 years were 48.3% (95% CI, 34.4%, 60.8%) and 55.8% (95% CI, 41.6%, 67.9%), respectively. The median overall survival was 48.1 months (95% CI, 29.6% to not reached). Protocol specified treatment-related grade 3 adverse events were reported in 7 patients (12.7%; 95% CI, 9.6%, 15.8%); grade 4 events were reported in 2 patients (3.6%; 95%CI, 2.7%, 4.5%). No grade 5 adverse events were reported. Patients with inoperable non-small cell lung cancer who received stereotactic body radiation therapy had a survival rate of 55.8% at 3 years, high rates of local tumor control, and moderate treatment-related morbidity.
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DOI：
10.1016/j.ijrobp.2008.11.019
发表时间：
2009-03-15
影响因子：
7
作者：
Xiao, Ying;Papiez, Lech;Paulus, Rebecca;Timmerman, Robert;Straube, William L.;Bosch, Wailter R.;Michalski, Jeff;Galvin, James M.
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DOI：
10.1016/0360-3016(93)90373-4
发表时间：
1993-10-20
影响因子：
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