Document Detail


Phase II study of cetuximab in combination with chemoradiation in patients with stage IIIA/B non-small-cell lung cancer: RTOG 0324.
MedLine Citation:
PMID:  21555682     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: Non-small-cell lung cancer (NSCLC) commonly expresses the epidermal growth factor receptor (EGFR), which is associated with poor clinical outcome. Cetuximab is a chimerized monoclonal antibody that targets the EGFR and, in preclinical models, it demonstrates radiosensitization properties. We report a phase II trial testing the combination of cetuximab with chemoradiotherapy (CRT) in unresectable stage III NSCLC.
PATIENTS AND METHODS: Eligibility criteria included unresectable stage III NSCLC, Zubrod performance status ≤ 1, weight loss ≤ 5%, forced expiratory volume in 1 second ≥ 1.2 L, and adequate organ function. Patients received an initial dose of cetuximab (400 mg/m(2)) on day 1 of week 1 and then weekly doses of cetuximab (250 mg/m(2)) until completion of therapy (weeks 2 through 17). During week 2, patients started CRT (63 Gy in 35 fractions) with weekly carboplatin at area under the [concentration-time] curve (AUC) 2 and six doses of paclitaxel at 45 mg/m(2) followed by carboplatin (AUC 6) and two cycles of paclitaxel (200 mg/m(2)) during weeks 12 through 17. Primary end points included safety and compliance of concurrent cetuximab and CRT.
RESULTS: In all, 93 patients were enrolled and 87 were evaluable. Median follow-up was 21.6 months. Response rate was 62% (n = 54), median survival was 22.7 months, and 24-month overall survival was 49.3%. Adverse events related to treatment included 20% grade 4 hematologic toxicities, 8% grade 3 esophagitis, and 7% grade 3 to 4 pneumonitis. There were five grade 5 events.
CONCLUSION: The combination of cetuximab with CRT is feasible and shows promising activity. The median and overall survival achieved with this regimen were longer than any previously reported by the Radiation Therapy Oncology Group.
Authors:
George R Blumenschein; Rebecca Paulus; Walter J Curran; Francisco Robert; Frank Fossella; Maria Werner-Wasik; Roy S Herbst; Philip O Doescher; Hak Choy; Ritsuko Komaki
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural     Date:  2011-05-09
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  29     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-06-09     Completed Date:  2011-08-12     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2312-8     Citation Subset:  IM    
Affiliation:
Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030-4009, USA. gblumens@mdanderson.org
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal / adverse effects,  therapeutic use*
Antineoplastic Agents / therapeutic use*
Carcinoma, Non-Small-Cell Lung / drug therapy*,  mortality,  radiotherapy
Combined Modality Therapy
Female
Humans
Lung Neoplasms / drug therapy*,  mortality,  radiotherapy
Male
Middle Aged
Neoplasm Staging
Patient Compliance
Grant Support
ID/Acronym/Agency:
U10 CA21661/CA/NCI NIH HHS; U10 CA32115/CA/NCI NIH HHS; U10 CA37422/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Antineoplastic Agents; PQX0D8J21J/cetuximab
Comments/Corrections
Comment In:
Strahlenther Onkol. 2012 Feb;188(2):194-5   [PMID:  22218504 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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