Division of Thoracic Surgery, Washington University School of Medicine, St. Louis, MO 63110, USA.
J Thorac Cardiovasc Surg. 2013 Mar;145(3):692-9. doi: 10.1016/j.jtcvs.2012.10.038. Epub 2012 Nov 20.
The purpose of the present study was to compare the selection criteria and short-term outcomes among 3 prospective clinical trials using stereotactic body radiotherapy (Radiation Therapy Oncology Group [RTOG] trial 0236), sublobar resection (American College of Surgeons Oncology Group [ACOSOG] trial Z4032), and radiofrequency ablation (ACOSOG trial Z4033).
The selection criteria and outcomes were compared among RTOG 0236 (n = 55), ACOSOG Z4032 (n = 211), and ACOSOG Z4033 (n = 51). Age, Eastern Cooperative Oncology Group performance status, percentage of predicted forced expiratory volume in 1 second, and percentage of predicted carbon monoxide diffusing capacity of the lung were used to perform a propensity-matched analysis among patients with clinical stage 1A in RTOG 0236 and ACOSOG Z4032.
The patients in ACOSOG Z4033 undergoing radiofrequency ablation were older (75.6 ± 7.5 years) than those in RTOG 0236 (72.5 ± 8.8 years) and ACOSOG Z4032 (70.2 ± 8.5 years; P = .0003). The pretreatment percentage of predicted forced expiratory volume in 1 second was 61.3% ± 33.4% for RTOG 0236, 53.8% ± 19.6% for ACOSOG Z4032, and 48.8% ± 20.3% for ACOSOG Z4033 (P = .15). The pretreatment percentage of predicted carbon monoxide diffusing capacity of the lung was 61.6% ± 30.2% for RTOG 0236, 46.4% ± 15.6% for ACOSOG Z4032, and 43.7% ± 18.0% for ACOSOG Z4033 (P = .001). The overall 90-day mortality for stereotactic body radiotherapy, surgery, and radiofrequency ablation was 0%, 2.4% (5/211), and 2.0% (1/51), respectively (P = .5). Overall, the unadjusted 30-day grade 3+ adverse events were more common with surgery than with stereotactic body radiotherapy (28% vs 9.1%, P = .004), although no difference was between the 2 groups at 90 days. Among the patients with clinical stage IA in ACOSOG Z4032, 29.3% had a more advanced pathologic stage at surgery. A propensity-matched comparison showed no difference between stereotactic body radiotherapy and surgery for 30-day grade 3+ adverse events (odds ratio, 2.37; 95% confidence interval, 0.75-9.90; P = .18).
Among appropriately matched patients, no difference was seen in early morbidity between sublobar resection and stereotactic body radiotherapy. These results underscore the need for a randomized trial to delineate the relative survival benefit of each modality and to help stratify patients considered high risk.
本研究旨在比较使用立体定向体部放射治疗（放射治疗肿瘤学组[RTOG]试验 0236）、亚肺叶切除术（美国外科医师学院肿瘤学组[ACOSOG]试验 Z4032）和射频消融术（ACOSOG 试验 Z4033）的 3 项前瞻性临床试验的选择标准和短期结果。
比较 RTOG 0236（n=55）、ACOSOG Z4032（n=211）和 ACOSOG Z4033（n=51）的选择标准和结果。使用年龄、东部合作肿瘤学组体能状态、1 秒用力呼气容积预测百分比和一氧化碳弥散量预测百分比进行倾向评分匹配分析，以比较 RTOG 0236 和 ACOSOG Z4032 中临床分期为 1A 的患者。
ACOSOG Z4033 中接受射频消融术的患者年龄（75.6±7.5 岁）大于 RTOG 0236（72.5±8.8 岁）和 ACOSOG Z4032（70.2±8.5 岁；P=0.0003）。RTOG 0236、ACOSOG Z4032 和 ACOSOG Z4033 的治疗前 1 秒用力呼气容积预测百分比分别为 61.3%±33.4%、53.8%±19.6%和 48.8%±20.3%（P=0.15）。RTOG 0236、ACOSOG Z4032 和 ACOSOG Z4033 的治疗前一氧化碳弥散量预测百分比分别为 61.6%±30.2%、46.4%±15.6%和 43.7%±18.0%（P=0.001）。立体定向体部放疗、手术和射频消融术的 90 天总死亡率分别为 0%、2.4%（5/211）和 2.0%（1/51）（P=0.5）。总体而言，手术组的 30 天 3 级以上不良事件未经调整发生率高于立体定向体部放疗组（28%比 9.1%，P=0.004），但两组在 90 天时无差异。在 ACOSOG Z4032 中临床分期为 1A 的患者中，29.3%的患者在手术后存在更晚期的病理分期。倾向评分匹配比较显示，30 天 3 级以上不良事件的立体定向体部放疗和手术之间无差异（比值比，2.37；95%置信区间，0.75-9.90；P=0.18）。
在适当匹配的患者中，亚肺叶切除术和立体定向体部放疗的早期发病率无差异。这些结果强调需要进行随机试验来阐明每种治疗方式的相对生存获益，并帮助分层考虑高风险的患者。
