Combined treatment of nonsmall cell lung cancer NSCLC stage III with intensity-modulated RT radiotherapy and cetuximab: the NEAR trial.

Abstract

BACKGROUND:

The aim of this study was to evaluate efficacy and toxicity of radioimmunotherapy with intensity-modulated radiation (IMRT) and cetuximab in stage III nonsmall cell lung cancer (NSCLC).

METHODS:

NEAR was a prospective, monocentric phase II trial including patients unfit for chemoradiation regimen; treatment consisted of IMRT and weekly cetuximab followed by a 13-week maintenance period. Primary endpoints were toxicity and feasibility; secondary endpoints were remission rates at completion of the planned treatment according to Response Evaluation Criteria In Solid Tumor (RECIST), local/distant progression-free survival, and overall survival.

RESULTS:

Thirty patients (median age, 71 years) were treated within the protocol. Overall response rate was 63% (partial remission: 19 of 30) patients. Median locoregional, distant, overall progression-free survival was 20.5, 10.9, and 8.5 months. Median overall survival was 19.5 months, with an estimated 1- and 2-year survival of 66.7% and 34.9% respectively. Stage (IIIA vs IIIB) and histologic subtype did not have a significant impact on survival rates in our patients. Treatment was tolerated well with only mild toxicity (°3 pneumonitis: 3.3%, any °3 acute toxicity: 36.7%).

CONCLUSIONS:

Combined radioimmunotherapy with cetuximab was safe and feasible, especially in elderly patients with multiple comorbidities. A more intensified regimen warranted investigation.

• Authors: Alexandra D Jensen, Marc W Münter, Helge G Bischoff, Renate Haselmann, Uwe Haberkorn, Peter E Huber, Michael Thomas, Jürgen Debus, Klaus K Herfarth
• Journal: Cancer (Cancer) Vol. 117 Issue 13 Pg. 2986-94 (Jul 01 2011) ISSN: 1097-0142 [Electronic] United States
• PMID: 21264838 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 American Cancer Society.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Cetuximab

Topics

• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Carcinoma, Non-Small-Cell Lung (drug therapy, mortality, radiotherapy)
• Cetuximab
• Combined Modality Therapy
• Comorbidity
• Disease-Free Survival
• Female
• Humans
• Lung Neoplasms (drug therapy, mortality, radiotherapy)
• Male
• Middle Aged
• Neoplasm Staging
• Positron-Emission Tomography
• Radioimmunotherapy (adverse effects)
• Radiotherapy Dosage
• Radiotherapy, Intensity-Modulated (adverse effects, methods)
• Survival Rate