Fast track — ArticlesResponse to radiofrequency ablation of pulmonary tumours: a prospective, intention-to-treat, multicentre clinical trial (the RAPTURE study)
Introduction
Lung cancer is the leading cause of cancer death in both men and women.1 Non-small-cell lung cancer (NSCLC) constitutes about 80% of primary malignant tumours in the lung.2 Surgical resection is the standard of care for early-stage NSCLC and offers 5-year survival in excess of 50% for all non-small-cell histological groups.2, 3 Careful preoperative assessment of the patient's overall medical condition, especially the pulmonary reserve and the associated comorbidities, is crucial for considering the benefits of surgery.4, 5 Patients with early-stage disease who are medically unfit for surgery, but who have sufficient pulmonary reserve, might be candidates for radiotherapy with curative intent.6 In two large radiotherapy series, patients ineligible for surgery who were treated with definitive radiotherapy achieved a 5-year survival of 10% and 27%.7, 8
The lungs are the second most frequent site of metastatic disease. Many series have documented survival benefits of surgical resection in selected patients with pulmonary metastases of favourable histology—especially colorectal carcinoma.9, 10 Unfortunately, only a few patients are suitable candidates for resection because of the associated extrapulmonary disease, the extent and location of lesions in the lungs, or concurrent medical conditions. Moreover, the high risk of recurrence and the need to remove functioning lung tissue along with the lesions restricts indications for surgery.11
Percutaneous image-guided radiofrequency ablation is a minimally invasive technique used to treat solid tumours. Because of its ability to produce large volumes of coagulation necrosis in a controlled fashion, this technique has gained acceptance as a viable therapeutic option for unresectable liver malignancies.12, 13 Recently, single-institution case series have suggested that radiofrequency ablation can be a valuable treatment option for patients with unresectable or medically inoperable lung malignancies.14, 15, 16 However, to our knowledge, this technique has never been tested in the setting of a large, intention-to-treat clinical trial. In 2001, we designed a multicentre clinical trial aimed at assessing the feasibility, safety, and effectiveness of percutaneous CT-guided radiofrequency ablation in the treatment of NSCLC and pulmonary metastases.
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Patients
This study was designed as a prospective, intention-to-treat, single-arm, multicentre clinical trial. Inclusion criteria were: age greater than 18 years; biopsy-proven NSCLC or lung metastasis; patients rejected for surgery and considered unfit for radiotherapy or chemotherapy; up to three tumours per lung, each 3·5 cm or smaller in greatest diameter, detected by CT; tumours located at least 1 cm from trachea, main bronchi, oesophagus, aorta, aortic arch branches, main, right, or left pulmonary
Results
Between July 1, 2001, and Dec 10, 2005, 106 patients (36 women and 70 men; median age 66 years [range 29–85]; mean 64·9 years [SD 11·6]) with 183 malignant lung tumours were enrolled in seven centres in Europe, the USA, and Australia. Median tumour size was 1·5 cm (range 0·5–3·4; mean 1·7 cm [SD 0·8]). Proof of malignancy for at least one lesion was obtained in all patients. Diagnoses included NSCLC in 33 patients, metastasis from colorectal adenocarcinoma in 53 patients, and metastasis from
Discussion
Our study shows that percutaneous CT-guided radiofrequency ablation yields high proportions of sustained CR in properly selected patients with primary or secondary lung malignancies, and is associated with acceptable morbidity.
The aim of radiofrequency ablation is to induce thermal injury to the target tumour by electromagnetic energy deposition. The patient is part of a closed-loop circuit, that includes the radiofrequency generator, an active electrode placed inside the tumour, and a large
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