title: Radiation therapy oncology group protocol 02-29: a phase II trial of neoadjuvant therapy with concurrent chemotherapy and full-dose radiation therapy followed by surgical resection and consolidative therapy for locally advanced non-small cell carcinoma of the lung.
abstract: OBJECTIVE
  To evaluate mediastinal nodal clearance (MNC) rates after induction chemotherapy and concurrent, full-dose radiation therapy (RT) in a phase II trimodality trial (Radiation Therapy Oncology Group protocol 0229).
  
  
  METHODS
  Patients (n=57) with stage III non-small cell lung cancer (pathologically proven N2 or N3) were eligible. Induction chemotherapy consisted of weekly carboplatin (AUC = 2.0) and paclitaxel 50 mg/m(2). Concurrent RT was prescribed, with 50.4 Gy to the mediastinum and primary tumor and a boost of 10.8 Gy to all gross disease. The mediastinum was pathologically reassessed after completion of chemoradiation. The primary endpoint of the study was MNC, with secondary endpoints of 2-year overall survival and postoperative morbidity/mortality.
  
  
  RESULTS
  The grade 3/4 toxicities included hematologic 35%, gastrointestinal 14%, and pulmonary 23%. Forty-three patients (75%) were evaluable for the primary endpoint. Twenty-seven patients achieved the primary endpoint of MNC (63%). Thirty-seven patients underwent resection. There was a 14% incidence of grade 3 postoperative pulmonary complications and 1 30-day, postoperative grade 5 toxicity (3%). With a median follow-up of 24 months for all patients, the 2-year overall survival rate was 54%, and the 2-year progression-free survival rate was 33%. The 2-year overall survival rate was 75% for those who achieved nodal clearance, 52% for those with residual nodal disease, and 23% for those who were not evaluable for the primary endpoint (P=.0002).
  
  
  CONCLUSIONS
  This multi-institutional trial confirms the ability of neoadjuvant concurrent chemoradiation with full-dose RT to sterilize known mediastinal nodal disease.
authors.affiliation: Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. msuntha@umm.edu
authors.forename: Mohan
authors.initials: M
authors.lastname: Suntharalingam
authors.forename: Rebecca
authors.initials: R
authors.lastname: Paulus
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Edelman
authors.forename: Mark
authors.initials: M
authors.lastname: Krasna
authors.forename: Whitney
authors.initials: W
authors.lastname: Burrows
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Gore
authors.forename: Lynn D
authors.initials: LD
authors.lastname: Wilson
authors.forename: Hak
authors.initials: H
authors.lastname: Choy
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000556:secondary / Q000628:therapy*; D060830:Consolidation Chemotherapy / Q000379:methods; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis; D008297:Male; D008482:Mediastinum; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D009367:Neoplasm Staging / Q000379:methods; D017239:Paclitaxel / Q000008:administration & dosage; D011013:Pneumonectomy / Q000379:methods; D011300:Preoperative Care / Q000379:methods; D011446:Prospective Studies; D011879:Radiotherapy Dosage
chemical_list: D016190:Carboplatin; D017239:Paclitaxel