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. Int J Radiat Oncol Biol Phys 2012 Oct 01;84(2):456-63
Date
05/01/2012Pubmed ID
22543206DOI
10.1016/j.ijrobp.2011.11.069Scopus ID
2-s2.0-84865637205 (requires institutional sign-in at Scopus site) 90 CitationsAbstract
PURPOSE: 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).
PATIENTS AND 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.
Author List
Suntharalingam M, Paulus R, Edelman MJ, Krasna M, Burrows W, Gore E, Wilson LD, Choy HAuthor
Elizabeth M. Gore MD Professor in the Radiation Oncology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdultAged
Antineoplastic Combined Chemotherapy Protocols
Carboplatin
Carcinoma, Non-Small-Cell Lung
Consolidation Chemotherapy
Disease-Free Survival
Female
Humans
Lung Neoplasms
Lymph Nodes
Lymphatic Metastasis
Male
Mediastinum
Middle Aged
Neoadjuvant Therapy
Neoplasm Staging
Paclitaxel
Pneumonectomy
Preoperative Care
Prospective Studies
Radiotherapy Dosage