Combined treatment of nonsmall cell lung cancer NSCLC stage III with intensity-modulated RT radiotherapy and cetuximab: the NEAR trial.
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.
Department of Radiation Oncology, INF 400, Heidelberg, Germany. alexandra.jensen@med.uni-heidelberg.de
Alexandra D
AD
Jensen
Marc W
MW
Münter
Helge G
HG
Bischoff
Renate
R
Haselmann
Uwe
U
Haberkorn
Peter E
PE
Huber
Michael
M
Thomas
Jürgen
J
Debus
Klaus K
KK
Herfarth
D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D000068818:Cetuximab; D003131:Combined Modality Therapy; D015897:Comorbidity; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D049268:Positron-Emission Tomography; D016499:Radioimmunotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*; D015996:Survival Rate
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068818:Cetuximab