Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas.
Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas.
JAMA Oncol. 2018 Sep 1;4(9):1263-1266. doi: 10.1001/jamaoncol.2018.1251.
Stereotactic body radiation therapy (SBRT) has become a standard treatment for patients with medically inoperable early-stage lung cancer. However, its effectiveness in patients medically suitable for surgery is unclear.
To evaluate whether noninvasive SBRT delivered on an outpatient basis can safely eradicate lung cancer and cure selected patients with operable lung cancer, obviating the need for surgical resection.
DESIGN, SETTING, AND PARTICIPANTS: Single-arm phase 2 NRG Oncology Radiation Therapy Oncology Group 0618 study enrolled patients from December 2007 to May 2010 with median follow-up of 48.1 months (range, 15.4-73.7 months). The setting was a multicenter North American academic and community practice cancer center consortium. Patients had operable biopsy-proven peripheral T1 to T2, N0, M0 non-small cell tumors no more than 5 cm in diameter, forced expiratory volume in 1 second (FEV1) and diffusing capacity greater than 35% predicted, arterial oxygen tension greater than 60 mm Hg, arterial carbon dioxide tension less than 50 mm Hg, and no severe medical problems. The data analysis was performed in October 2014.
The SBRT prescription dose was 54 Gy delivered in 3 18-Gy fractions over 1.5 to 2.0 weeks.
Primary end point was primary tumor control, with survival, adverse events, and the incidence and outcome of surgical salvage as secondary end points.
Of 33 patients accrued, 26 were evaluable (23 T1 and 3 T2 tumors; 15 [58%] male; median age, 72.5 [range, 54-88] years). Median FEV1 and diffusing capacity of the lung for carbon monoxide at enrollment were 72.5% (range, 38%-136%) and 68% (range, 22%-96%) of predicted, respectively. Only 1 patient had a primary tumor recurrence. Involved lobe failure, the other component defining local failure, did not occur in any patient, so the estimated 4-year primary tumor control and local control rate were both 96% (95% CI, 83%-100%). As per protocol guidelines, the single patient with local recurrence underwent salvage lobectomy 1.2 years after SBRT, complicated by a grade 4 cardiac arrhythmia. The 4-year estimates of disease-free and overall survival were 57% (95% CI, 36%-74%) and 56% (95% CI, 35%-73%), respectively. Median overall survival was 55.2 months (95% CI, 37.7 months to not reached). Protocol-specified treatment-related grade 3, 4, and 5 adverse events were reported in 2 (8%; 95% CI, 0.1%-25%), 0, and 0 patients, respectively.
As given, SBRT appears to be associated with a high rate of primary tumor control, low treatment-related morbidity, and infrequent need for surgical salvage in patients with operable early-stage lung cancer.
ClinicalTrials.gov Identifier: NCT00551369.
立体定向体部放射治疗（SBRT）已成为无法手术的早期肺癌患者的标准治疗方法。然而，对于适合手术的患者，其疗效尚不清楚。
评估在门诊基础上进行非侵入性 SBRT 是否可以安全地根除肺癌，并治愈选定的具有可操作性的肺癌患者，从而避免手术切除的需要。
设计、地点和参与者：NRG 肿瘤学放射治疗肿瘤学组 0618 单臂 2 期研究于 2007 年 12 月至 2010 年 5 月期间招募患者，中位随访时间为 48.1 个月（范围，15.4-73.7 个月）。该研究在一个多中心北美学术和社区实践癌症中心联盟进行。患者为经活检证实的外周 T1 至 T2、N0、M0 非小细胞肿瘤，肿瘤直径不超过 5 厘米，用力呼气量（FEV1）和一氧化碳弥散量大于预测值的 35%，动脉血氧分压大于 60mmHg，动脉二氧化碳分压小于 50mmHg，且无严重的医疗问题。数据分析于 2014 年 10 月进行。
SBRT 处方剂量为 54Gy，分 3 次给予，每次 18Gy，每周 1.5-2.0 次。
主要终点为原发性肿瘤控制，生存、不良事件以及手术挽救的发生率和结果为次要终点。
共纳入 33 例患者，其中 26 例可评估（23 例 T1 肿瘤和 3 例 T2 肿瘤；15 例男性；中位年龄为 72.5[范围，54-88]岁）。入组时，中位 FEV1 和一氧化碳弥散量分别为预计值的 72.5%（范围，38%-136%）和 68%（范围，22%-96%）。仅有 1 例患者出现原发性肿瘤复发。局部失败（定义为局部肿瘤控制失败的另一个组成部分）未在任何患者中发生，因此，估计 4 年原发性肿瘤控制率和局部控制率均为 96%（95%CI，83%-100%）。根据方案指南，1 例局部复发患者在 SBRT 后 1.2 年接受了挽救性肺叶切除术，伴有 4 级心律失常。无病生存率和总生存率的 4 年估计值分别为 57%（95%CI，36%-74%）和 56%（95%CI，35%-73%）。中位总生存期为 55.2 个月（95%CI，37.7 个月至未达到）。按照方案规定，报告了 2 例（8%；95%CI，0.1%-25%）、0 例和 0 例患者分别发生了 3 级、4 级和 5 级治疗相关不良事件。
根据研究结果，SBRT 似乎与较高的原发性肿瘤控制率、较低的治疗相关发病率以及较少需要手术挽救相关，适用于可手术的早期肺癌患者。
ClinicalTrials.gov 标识符：NCT00551369。
