title: Computed Tomography-Guided Interstitial High-Dose-Rate Brachytherapy in Combination With Regional Positive Lymph Node Intensity-Modulated Radiation Therapy in Locally Advanced Peripheral Non-Small Cell Lung Cancer: A Phase 1 Clinical Trial.
abstract: OBJECTIVE
  To assess the technical safety, adverse events, and efficacy of computed tomography (CT)-guided interstitial high-dose-rate (HDR) brachytherapy in combination with regional positive lymph node intensity modulated radiation therapy in patients with locally advanced peripheral non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Twenty-six patients with histologically confirmed NSCLC were enrolled in a prospective, officially approved phase 1 trial. Primary tumors were treated with 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, adverse events, and radiation toxicity.
  
  
  RESULTS
  The median follow-up time was 28 months (range, 7-44 months). There were 3 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 5 patients. During follow-up, mild fibrosis around the puncture point was observed on the CT scans of 2 patients, but both patients 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.
  
  
  CONCLUSIONS
  Our findings suggest that HDR brachytherapy is safe and feasible for peripheral locally advanced NSCLC, justifying a phase 2 clinical trial.
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Li
authors.initials: L
authors.lastname: Xiang
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Jian-Wen
authors.initials: JW
authors.lastname: Zhang
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Sheng
authors.initials: S
authors.lastname: Lin
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Hui-Qun
authors.initials: HQ
authors.lastname: Luo
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Qing-Lian
authors.initials: QL
authors.lastname: Wen
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Li-Jia
authors.initials: LJ
authors.lastname: He
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Chang-Ling
authors.initials: CL
authors.lastname: Shang
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Pei-Rong
authors.initials: PR
authors.lastname: Ren
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Hong-Ru
authors.initials: HR
authors.lastname: Yang
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Hao-Wen
authors.initials: HW
authors.lastname: Pang
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Yang
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China.
authors.forename: Huai-Lin
authors.initials: HL
authors.lastname: He
authors.affiliation: Department of Nuclear Medicine, Affiliated Hospital of Luzhou Medical College, Luzhou, China. Electronic address: chenyue5523@126.com.
authors.forename: Yue
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Oncology, Affiliated Hospital of Luzhou Medical College, Luzhou, China. Electronic address: wjb6147@163.com.
authors.forename: Jing-Bo
authors.initials: JB
authors.lastname: Wu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011030:Pneumothorax / Q000209:etiology; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D061089:Radiotherapy, Image-Guided / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D012074:Remission Induction; D012449:Safety; D015996:Survival Rate; D013997:Time Factors
chemical_list: D005047:Etoposide; D017239:Paclitaxel; D002945:Cisplatin