Response to radiofrequency ablation of pulmonary tumours: a prospective, intention-to-treat, multicentre clinical trial (the RAPTURE study)
Response to radiofrequency ablation of pulmonary tumours: a prospective, intention-to-treat, multicentre clinical trial (the RAPTURE study)
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DOI：
10.1016/s1470-2045(08)70155-4
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发表时间：
2008-07-01
期刊：
影响因子：
51.1
通讯作者：
Mussi, Alfredo
中科院分区：
文献类型：
--
作者：
Lencioni, Riccardo;Crocetti, Laura;Mussi, Alfredo
背景放射性消融是非手术治疗肝癌患者的一种公认治疗方法。方法2001年7月1日至2005年12月10日，对106例肺恶性肿瘤患者的183个直径小于或等于3.5cm的肺肿瘤进行经皮射频消融治疗，观察其安全性、有效性和可行性。（平均1.7 cm [SD 1.3]）入组一项来自欧洲、美国和澳大利亚7个中心的前瞻性、意向治疗、单臂、多中心临床试验。所有患者均通过活检获得恶性肿瘤的证据。诊断包括非小细胞肺癌（NSCLC）33例，结直肠癌转移53例，其他原发性恶性肿瘤转移20例。治疗医生认为所有患者都不适合手术，也不适合放疗或化疗。患者按照CT引导肺活检的标准规则进行射频消融，然后随访长达2年。主要终点为技术成功（定义为消融器械正确置入所有肿瘤靶点，并完成计划的消融方案）、安全性（包括识别治疗相关并发症和肺功能变化）和确认的肿瘤完全缓解（根据改良的实体瘤缓解评价标准）。次要终点是总生存期、癌症特异性生存期和生活质量。该试验在ClinicalTrials.gov注册，编号NCT 00690703。结果106例患者中有105例（99%）在完成计划治疗方案的情况下将消融器械正确置入靶肿瘤是可行的。1例患者的技术故障是由于无法将器械置入小肿瘤内所致。在137例消融术中没有发生手术相关死亡。主要并发症包括气胸（n=27）或胸腔积液（n=4），需要引流。未观察到肺功能显著恶化。在85例可评估患者中，75例（88%）证实靶肿瘤完全缓解持续至少1年。在NSCLC或肺转移患者之间未观察到缓解差异。总生存率为70%（95% CI 51-83%），2年时为48%（30-65%），结直肠转移患者1年时为89%（70 - 95%），2年时为66%（53-79%），其他转移瘤患者1年时为92%（65-99%），2年时为64%（43-82%）。NSCLC患者1年和2年的癌症特异性生存率分别为92%（78-98%）和73%（54-86%），结直肠转移患者1年和2年的癌症特异性生存率分别为91（78-96%）和68%（54-80%），其他转移瘤患者1年时为93%（67-99%），2年时为67%（48-84%）。I期NSCLC患者（n=13）的2年总生存率为75%（45-92%），2年癌症特异性生存率为92%（66-99%）。经皮射频消融术在适当选择的肺部恶性肿瘤患者中产生高比例的持续完全缓解，并且与可接受的发病率相关。比较射频消融与标准非手术治疗选择的随机对照试验是必要的。
Background Radiofrequency ablation is an accepted treatment for non-surgical patients with liver cancer. The purpose of this study was to identify the feasibility, safety, and effectiveness of percutaneous radiofrequency ablation of malignant lung tumours.Methods Between July 1, 2001, and Dec 10, 2005, a series of 106 patients with 183 lung tumours that were 3.5 cm in diameter or smaller (mean 1.7 cm [SD 1.3]) were enrolled in a prospective, intention-to-treat, single-arm, multicentre clinical trial from seven centres in Europe, the USA, and Australia. Proof of malignancy was obtained by biopsy in all patients. Diagnoses included non-small-cell lung cancer (NSCLC) in 33 patients, metastasis from colorectal carcinoma in 53 patients, and metastasis from other primary malignancies in 20 patients. All patients were considered by the treating physician to be unsuitable for surgery and unfit for radiotherapy or chemotherapy. Patients underwent radiofrequency ablation in accordance with standard rules for CT-guided lung biopsy and were then followed for up to 2 years. Primary endpoints were technical success (defined as correct placement of the ablation device into all tumour targets with completion of the planned ablation protocol), safety (including identification of treatment-related complications and changes in pulmonary function), and confirmed complete response of tumours (according to modified Response Evaluation Criteria in Solid Tumors). Secondary endpoints were overall survival, cancer-specific survival, and quality of life. This trial is registered with ClinicalTrials.gov, number NCT00690703.Findings Correct placement of the ablation device into the target tumour with completion of the planned treatment protocol was feasible in 105 (99%) of 106 patients. The technical failure in one patient was caused by the inability to place the device inside a small tumour. No procedure-related deaths occurred in any of the 137 ablation procedures. Major complications consisted of pneumothorax (n=27) or pleural effusion (n=4), which needed drainage. No significant worsening of pulmonary function was noted. A confirmed complete response of target tumours lasting at least 1 year was shown in 75 (88%) of 85 assessable patients. No differences in response were noted between patients with NSCLC or lung metastases. Overall survival was 70% (95% CI 51-83%) at 1 year and 48% (30-65%) at 2 years in patients with NSCLC, 89% (7095%) at 1 year and 66% (53-79%) at 2 years in patients with colorectal metastases, and 92% (65-99%) at 1 year and 64% (43-82%) at 2 years in patients with other metastases. Cancer-specific survival was 92% (78-98%) at 1 year and 73% (54-86%) at 2 years in patients with NSCLC, 91 do (78-96%) at 1 year and 68% (54-80%) at 2 years in patients with colorectal metastases, and 93% (67-99%) at 1 year and 67% (48-84%) at 2 years in patients with other metastases. Patients with stage I NSCLC (n=13) had a 2-year overall survival of 75% (45-92%) and a 2-year cancer-specific survival of 92% (66-99%).Interpretation Percutaneous radiofrequency ablation yields high proportions of sustained complete responses in properly selected patients with pulmonary malignancies, and is associated with acceptable morbidity. Randomised controlled trials comparing radiofrequency ablation with standard non-surgical treatment options are warranted.