Jensen, A. D.;
Münter, M. W.;
Bischoff, H. G.;
Herpel, E.;
Haselmann, R.;
Timke, C.;
Haberkorn, U.;
Huber, P. E.;
Thomas, M.;
Debus, J.;
Herfarth, K. K.
IMRT and cetuximab in stage 3 non-small cell lung cancer: The NEAR trial (NCT00115518)
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Media type:
E-Article
Title:
IMRT and cetuximab in stage 3 non-small cell lung cancer: The NEAR trial (NCT00115518)
Contributor:
Jensen, A. D.;
Münter, M. W.;
Bischoff, H. G.;
Herpel, E.;
Haselmann, R.;
Timke, C.;
Haberkorn, U.;
Huber, P. E.;
Thomas, M.;
Debus, J.;
Herfarth, K. K.
Published:
American Society of Clinical Oncology (ASCO), 2007
Published in:
Journal of Clinical Oncology, 25 (2007) 18_suppl, Seite 18168-18168
Description:
18168 Background: For stage 3 non-small cell lung cancer (NSCLC), RCHT is the treatment of choice with sometimes marked side- effect. Hence, patients with co-morbidities may not be eligible for combined treatment. Based on the results at other tumor sites, a combined- modality treatment with the EGFR antibody cetuximab and IMRT should be evaluated in a prospective phase II trial. Methods: Pts with inoperable stage 3 NSCLC ineligible for RCHT are included in the trial. Treatment consists of cetuximab weekly and concurrent IMRT with 50 Gy to CTV and subsequent boost to GTV to 66 Gy. Staging and f/u include CT, FDG-PET, and lung function prior to/after completion of treatment (response assessment) plus CT scans in 3 mo intervals. Overall treatment time is 4 months. Side-effects and efficacy were assessed. Results: So far, 17 of 30 pts (median 70 yrs; 57–82 yrs) have been enrolled. The median f/u from treatment start was 6 months (1–17). 3 pts are still being treated, 13 pts have completed, and one pt died prior to completion of treatment. Where available, EGFR staining yielded a median receptor score of 2 (0–3) in 12 pts. 3/12 pts showed strong (3+), 2/12 showed no EGFR expression. The treatment was well tolerated with only 1 treatment-related °3 morbidity (esophagitis). All pts showed acneiforme skin rash (°I), but no significant reduction of lung function. 2 pts with underlying heart disease developed thrombembolic complications (arterial & pulmonary embolisms). We observed PR in 10/13 and SD in 3/13 pts (RECIST). All pts showed a marked reduction of SUV in PET even if CT did not show PR. Conclusion: Preliminary results of IMRT combined with cetuximab suggest a reasonably safe treatment with only mild side-effects and encouraging local response. Addition of cetuximab does not seem to increase toxicity of RT. [Table: see text]