TY - JOUR
T1 - Cetuximab as second-line therapy in patients with metastatic esophageal adenocarcinoma
T2 - A phase II southwest oncology group study (S0415)
AU - Gold, Philip J.
AU - Goldman, Bryan
AU - Iqbal, Syma
AU - Leichman, Lawrence P.
AU - Zhang, Wu
AU - Lenz, Heinz Josef
AU - Blanke, Charles D.
N1 - Funding Information:
Supported in part by the following Public Health Service Cooperative Agreement grant numbers awarded by the National Cancer Institute, Department of Health and Human Services: CA32102, CA38926, CA20319, CA45450, CA12644, CA58882, CA35090, CA35176, CA46113, CA76448, CA67575, CA11083, CA45807, CA58416, CA46368, CA35178, CA45377, CA68183, CA67663, CA74647, CA76429, CA27057, CA16385, CA35431, CA45808, CA37981, CA42777 and by Bristol Myers Squibb, ImClone Systems, Inc., and Response Genetics.
PY - 2010/9
Y1 - 2010/9
N2 - Introduction: Esophageal adenocarcinomas commonly express the epidermal growth factor receptor. This trial assessed the 6-month overall survival probability in metastatic esophageal cancer patients treated with cetuximab as second-line therapy. Methods: This was a multicenter, open-label phase II study of single-agent cetuximab for metastatic esophageal adenocarcinoma patients who failed one prior chemotherapy regimen. Adequate organ function and Zubrod performance status of 0 to 2 were required. Patients received cetuximab 400 mg/m2 intravenously (IV) on week 1 and 250 mg/m2 IV weekly thereafter. The primary objective was to determine 6-month overall survival. Secondary end points included progression-free survival, response rate, and toxicity. Tumor tissue was collected for correlative studies. Results: Sixty-three patients were registered, with eight ineligible or never treated. Fifty-five eligible patients (49 men, 6 women; median age = 61.2 years [range, 30.7-88.5]) were enrolled. Twenty patients survived more than 6 months for a 6-month overall survival rate of 36% (95% confidence interval [CI]: 24-50%). The median overall survival was 4.0 months (95% CI: 3.2-5.9). Median progression-free survival was 1.8 months (95% CI: 1.7-1.9). One partial response and two unconfirmed partial responses were observed. Two patients experienced grade 4 fatigue. There was one treatment-related death due to pneumonitis. Germline polymorphisms of epidermal growth factor receptor, epidermal growth factor, interleukin (IL)-8, cyclooxygenase (COX)-2, vascular epidermal growth factor receptor (VEGF), CCND1, neuropilin 1 (NRP1), and K-ras mutational status were not associated with response or survival. Conclusions: The 6-month overall survival rate of 36% observed on this study failed to meet the primary survival objective. Thus, cetuximab alone cannot be recommended in the second-line treatment of metastatic esophageal cancer.
AB - Introduction: Esophageal adenocarcinomas commonly express the epidermal growth factor receptor. This trial assessed the 6-month overall survival probability in metastatic esophageal cancer patients treated with cetuximab as second-line therapy. Methods: This was a multicenter, open-label phase II study of single-agent cetuximab for metastatic esophageal adenocarcinoma patients who failed one prior chemotherapy regimen. Adequate organ function and Zubrod performance status of 0 to 2 were required. Patients received cetuximab 400 mg/m2 intravenously (IV) on week 1 and 250 mg/m2 IV weekly thereafter. The primary objective was to determine 6-month overall survival. Secondary end points included progression-free survival, response rate, and toxicity. Tumor tissue was collected for correlative studies. Results: Sixty-three patients were registered, with eight ineligible or never treated. Fifty-five eligible patients (49 men, 6 women; median age = 61.2 years [range, 30.7-88.5]) were enrolled. Twenty patients survived more than 6 months for a 6-month overall survival rate of 36% (95% confidence interval [CI]: 24-50%). The median overall survival was 4.0 months (95% CI: 3.2-5.9). Median progression-free survival was 1.8 months (95% CI: 1.7-1.9). One partial response and two unconfirmed partial responses were observed. Two patients experienced grade 4 fatigue. There was one treatment-related death due to pneumonitis. Germline polymorphisms of epidermal growth factor receptor, epidermal growth factor, interleukin (IL)-8, cyclooxygenase (COX)-2, vascular epidermal growth factor receptor (VEGF), CCND1, neuropilin 1 (NRP1), and K-ras mutational status were not associated with response or survival. Conclusions: The 6-month overall survival rate of 36% observed on this study failed to meet the primary survival objective. Thus, cetuximab alone cannot be recommended in the second-line treatment of metastatic esophageal cancer.
KW - Cetuximab
KW - Esophageal cancer
KW - Second-line therapy
UR - http://www.scopus.com/inward/record.url?scp=77956267602&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77956267602&partnerID=8YFLogxK
U2 - 10.1097/JTO.0b013e3181e77a92
DO - 10.1097/JTO.0b013e3181e77a92
M3 - Article
C2 - 20631636
AN - SCOPUS:77956267602
SN - 1556-0864
VL - 5
SP - 1472
EP - 1476
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 9
ER -