Rusthoven Kyle E, Kavanagh Brian D, Burri Stuart H, Chen Changhu, Cardenes Higinia, Chidel Mark A, Pugh Thomas J, Kane Madeleine, Gaspar Laurie E, Schefter Tracey E
University of Colorado Denver, Department of Radiation Oncology and Medical Oncology, Aurora, CO 80045, USA.
J Clin Oncol. 2009 Apr 1;27(10):1579-84. doi: 10.1200/JCO.2008.19.6386. Epub 2009 Mar 2.
To evaluate the efficacy and tolerability of high-dose stereotactic body radiation therapy (SBRT) for the treatment of patients with one to three lung metastases.
Patients with one to three lung metastases with cumulative maximum tumor diameter smaller than 7 cm were enrolled and treated on a multi-institutional phase I/II clinical trial in which they received SBRT delivered in 3 fractions. In phase I, the total dose was safely escalated from 48 to 60 Gy. The phase II dose was 60 Gy. The primary end point was local control. Lesions with at least 6 months of radiographic follow-up were considered assessable for local control. Secondary end points included toxicity and survival.
Thirty-eight patients with 63 lesions were enrolled and treated at three participating institutions. Seventy-one percent had received at least one prior systemic regimen for metastatic disease and 34% had received at least two prior regimens (range, zero to five). Two patients had local recurrence after prior surgical resection. There was no grade 4 toxicity. The incidence of any grade 3 toxicity was 8% (three of 38). Symptomatic pneumonitis occurred in one patient (2.6%). Fifty lesions were assessable for local control. Median follow-up for assessable lesions was 15.4 months (range, 6 to 48 months). The median gross tumor volume was 4.2 mL (range, 0.2 to 52.3 mL). Actuarial local control at one and two years after SBRT was 100% and 96%, respectively. Local progression occurred in one patient, 13 months after SBRT. Median survival was 19 months.
This multi-institutional phase I/II trial demonstrates that high-dose SBRT is safe and effective for the treatment of patients with one to three lung metastases.
评估大剂量立体定向体部放射治疗（SBRT）对一至三个肺转移瘤患者的疗效及耐受性。
纳入一至三个肺转移瘤且累积最大肿瘤直径小于7 cm的患者，在一项多机构I/II期临床试验中接受治疗，该试验中患者接受分3次给予的SBRT。在I期，总剂量从48 Gy安全递增至60 Gy。II期剂量为60 Gy。主要终点为局部控制。具有至少6个月影像学随访的病灶被视为可评估局部控制情况。次要终点包括毒性反应和生存率。
38例患者共63个病灶在三个参与机构入组并接受治疗。71%的患者此前至少接受过一种转移性疾病的全身治疗方案，34%的患者此前至少接受过两种治疗方案（范围为零至五种）。两名患者在先前手术切除后出现局部复发。无4级毒性反应。任何3级毒性反应的发生率为8%（38例中的3例）。1例患者（2.6%）出现症状性肺炎。50个病灶可评估局部控制情况。可评估病灶的中位随访时间为15.4个月（范围为6至48个月）。中位肿瘤总体积为4.2 mL（范围为0.2至52.3 mL）。SBRT后1年和2年的精算局部控制率分别为100%和96%。1例患者在SBRT后13个月出现局部进展。中位生存期为19个月。
这项多机构I/II期试验表明，大剂量SBRT治疗一至三个肺转移瘤患者是安全有效的。
