CT- guided Interstitial 3D After-loading Radiotherapy in Combination with Regional Positive Lymph Nodes Intensity Modulated Radiotherapy(IMRT) in Patients with Locally Advanced Peripheral Non-small cell Lung Cancer(NSCLC): A Phase I Clinical Trail
Mené en Chine sur 26 patients atteints d'un cancer non à petites cellules et de stade localement avancé de la région périphérique du poumon (durée médiane de suivi : 28 mois), cet essai de phase I évalue la sécurité et la faisabilité d'un traitement combinant une curiethérapie interstitielle à haut débit de dose guidée par tomographie numérique et une radiothérapie avec modulation d'intensité ciblant les ganglions régionaux atteints
Purpose : To assess the technical safety, complications, and efficacy of computed tomography (CT)-guided interstitial high-dose-rate (HDR) brachytherapy in combination with regional positive lymph node intensity-modulated radiotherapy in patients with locally advanced peripheral non-small cell lung cancer (NSCLC). Methods and Materials : Twenty-six patients with histologically confirmed NSCLC were enrolled in a prospective, officially approved phase I trial. Primary tumors were treated via HDR brachytherapy. A single 30 Gy dose was delivered to the 90% isodose line of the gross lung tumor volume. A total dose of at least 70 Gy was administered to the 95% isodose line of the planning target volume of malignant lymph nodes using 6-MV X-rays. The patients received concurrent or sequential chemotherapy. We assessed treatment efficacy, complications, and radiation toxicity. Results : The median follow-up was 28 months (range, 7–44 months). There were three cases of mild pneumothorax, but no cases of hemothorax, dyspnea, or pyothorax, after the procedure. Grade 3 or 4 acute hematologic toxicity was observed in five patients. During follow-up, mild fibrosis around the puncture point was observed on the CT scans of two patients, but both were asymptomatic. The overall response rates (complete and partial) for the primary mass and positive lymph nodes were 100% and 92.3%, respectively. The 1-year and 2-year overall survival (OS) rates were 90.9% and 67%, respectively, with a median OS of 22.5 months. Conclusion : Our findings suggest that HDR brachytherapy is safe and feasible for peripheral locally advanced NSCLC, justifying a phase II clinical trial.
http://www.redjournal.org/article/S0360-3016(15)00419-8/abstract 2015