RTOG Study: Adding Cetuximab to Chemotherapy and Radiotherapy Leads to Improved Outcome for Lung Cancer Patients
-- Survival Results Better Than Any Previously Reported by RTOG --
Chicago, May 31, 2008 - Radiation Therapy Oncology Group (RTOG) investigators and ImClone Systems Incorporated (Nasdaq: IMCL) today announced that adding the biologic agent cetuximab (ERBITUX®) to chemotherapy and radiotherapy for patients with inoperable non-small cell lung cancer (NSCLC) resulted in higher median survival rates and two-year overall survival rates than previous RTOG studies in patients with Stage III A/B inoperable NSCLC. Investigators for RTOG, an NCI-funded national cooperative clinical trials group and clinical research enterprise component of the American College of Radiology (ACR), presented their results today at the American Society of Clinical Oncology's 44th Annual Meeting in Chicago.
Cetuximab is an IgG1 monoclonal antibody that targets the epidermal growth factor receptor (EGFR), thereby inhibiting cancer cell growth and proliferation. Cetuximab has been shown to enhance the activity of radiation therapy.
The phase II study of 87 evaluable patients with Stage IIIA/B inoperable NSCLC, RTOG 0324, showed a median survival of 22.7 months and a 2-year overall survival rate of 49.3% which are higher than those achieved in past RTOG studies. According to George Blumenschein, M.D., the study principal investigator from The University of Texas M.D. Anderson Cancer Center, "The combination of cetuximab and chemoradiotherapy is well tolerated and shows promise. Further phase III testing in the multicenter setting is warranted."
Patients entered on the multicenter trial received an initial dose of cetuximab followed by 7 weeks of cetuximab given concurrently with weekly doses of paclitaxel and carboplatin and 7 weeks of daily radiotherapy. Patients then received cetuximab once a week for 3 weeks followed by consolidation therapy of 6 weeks of cetuximab, paclitaxel, and carboplatin administered once a week. Adverse events related to the treatment were acceptable with 17 patients experiencing grade 4 hematologic toxicity and 7 patients with grade 3 esophagitis.
"We are very excited by these RTOG study results, which show that the addition of cetuximab to chemoradiation produced a considerable improvement in survival compared to previous RTOG studies of various therapeutic regimens in this setting. Additionally, the cetuximab chemoradiation regimen had a similar safety profile to that expected from chemoradiation alone," said Eric K. Rowinsky, M.D., Executive Vice President and Chief Medical Officer of ImClone. "These data also reinforce the positive data seen with cetuximab in non-small cell lung cancer and can serve as a foundation for further evaluation of cetuximab with chemoradiation in earlier stages."
"RTOG has long been at the forefront in testing novel agents with radiotherapy," relates Walter J. Curran, Jr., the RTOG Group Chair, and the Lawrence W. Davis Professor and Chair of the Department of Radiation Oncology in the Emory School of Medicine and Chief Medical Officer of the Emory Winship Cancer Institute. "This trial is another example of RTOG's commitment to advancing multi-modality cancer research."
Lung cancer is expected to account for 162,000 deaths in 2008, making it the leading cause of cancer mortality for both men and women.
# # #
ASCO Abstract #7516, A Phase II Study of Cetuximab (C225) In Combination with Chemoradiation (CRT) in Patients (PTS) with Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC): A Report of the 2 Year and Median Survival (MS) for the RTOG 0324 Trial, is available at www.abstract.asco.org/AbstView_55_36161.html.
Information about RTOG is available at www.rtog.org. A copy of the research protocol is available at www.rtog.org/members/protocols/0324/0324.pdf.
In addition to Dr. Blumenschein, authors include: R. Paulus, RTOG Headquarters, Philadelphia, PA; W. Curran, Emory University School of Medicine; F. Robert, University of Alabama at Birmingham, Birmingham, AL; F. Fossella and R. Komaki, The University of Texas M. D. Anderson Cancer Center, Houston, TX; M. Werner-Wasik, Thomas Jefferson University Hospital, Philadelphia, PA; P. Doescher, Medical College of Wisconsin, Milwaukee, WI; and H. Choy, The University of Texas Southwestern, Dallas, TX. The research was funded by National Cancer Institute grants CA21661, CA37422, and 32115.
The cetuximab used in this study was prepared by ImClone Systems Incorporated and supplied by the Bristol-Myers Squib (BMS) Company to patients free of charge. See www.erbitux.com and www.cancer.gov/cancertopics/druginfo/cetuximab for more information about cetuximab.
|
