Extracranial stereotactic radioablation - Results of a phase I study in medically inoperable stage I non-small cell lung cancer
Extracranial stereotactic radioablation - Results of a phase I study in medically inoperable stage I non-small cell lung cancer
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DOI：
10.1378/chest.124.5.1946
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发表时间：
2003-11-01
期刊：
影响因子：
9.6
通讯作者：
Williams, M
中科院分区：
文献类型：
--
作者：
Timmerman, R;Papiez, L;Williams, M
简介：手术切除是I期非小细胞肺癌（NSCLC）患者的标准治疗，然而，许多患者在医学上无法手术。我们着手调查一种新的治疗类似于脑放射外科称为颅外立体定向放射消融术（ESR）在第一阶段trial.Patients和方法：符合条件的患者包括那些临床分期T1或T2（肿瘤大小，小于或等于7厘米）NOMO活检证实非小细胞肺癌。所有患者都有排除开胸手术的合并症。中位年龄为75岁，中位Karnofsky体能状态为80。ESR在2周内分三个单独的部分给药。在每个剂量队列中，3至5名患者接受治疗，从800 cGy/次（总剂量，2,400 cGy）开始，随后连续剂量递增200 cGy/次（每个队列总剂量增加600 cGy）。在剂量队列之间存在等待期以观察毒性。T1与T2肿瘤患者进行了单独的独立剂量escalations.Results：自2000年2月以来，共37例患者参加。1例患者发生3级肺炎，另1例患者发生3级缺氧。对于整个人群，通过症状、体格检查、吸氧需求、肺功能检查、动脉血气测定或定期胸部成像测量，心肺功能没有明显下降。两个T分期组最终达到并耐受了每次2,000 cGy，共三次（总共6,000 cGy）。该疗法在任何T分期组中的最大耐受剂量尚未达到。87%的患者对治疗有反应（完全反应，27%）。经过中位随访期为15.2个月，6例患者出现局部失败，所有这些人都收到了剂量< 1,800 cGy每fraction.Conclusions：非常高的辐射剂量治疗耐受在这个人口的医学上不能手术的患者与I期非小细胞肺癌使用ESR技术。
Introduction: Surgical resection is standard therapy for patients with stage I non-small cell lung cancer (NSCLC), however, many patients are medically inoperable. We set out to investigate a new therapy akin to brain radiosurgery called extracranial stereotactic radioablation (ESR) in a phase I trial.Patients and methods: Eligible patients included those with clinically staged T1 or T2 (tumor size, less than or equal to 7 cm) NOMO biopsy confirmed NSCLC. All patients had comorbid medical problems that precluded thoracotomy. The median age was 75 years, and the median Karnofsky performance status was 80. ESR was administered in three separate fractions over 2 weeks. Three to five patients were treated within each dose cohort starting at 800 cGy per fraction (total, 2,400 cGy) followed by successive dose escalations of 200 cGy per fraction (total increase per cohort, 600 cGy). Waiting periods occurred between dose cohorts to observe toxicity. Patients with T1 vs T2 tumors underwent separate independent dose escalations.Results: A total of 37 patients were enrolled since February 2000. One patient experienced grade 3 pneumonitis, and another patient had grade 3 hypoxia. For the entire population, there was no appreciable decline in cardiopulmonary function as measured by symptoms, physical examination, need for oxygen supplementation, pulmonary function testing, arterial blood gas determinations, or regular chest imaging. Both T-stage groups ultimately reached and tolerated 2,000 cGy per fraction for three fractions (total, 6,000 cGy). The maximum tolerated dose for this therapy in either T-stage group has yet to be reached. Tumors responded to treatment in 87% of patients (complete response, 27%). After a median follow-up period of 15.2 months, six patients experienced local failure, all of whom had received doses of < 1,800 cGy per fraction.Conclusions: Very high radiation dose treatments were tolerated in this population of medically inoperable patients with stage I NSCLC using ESR techniques.