Randomized Phase II Trial of Docetaxel Plus Cetuximab or Docetaxel Plus Bortezomib in Patients With Advanced Non–Small-Cell Lung Cancer and a Performance Status of 2: CALGB 30402
Year: 2009
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: PURPOSE: A randomized phase II trial of two novel treatment strategies in the first-line management of advanced non-small-cell lung cancer patients with performance status (PS) 2. PATIENTS AND METHODS: Patients were assigned to docetaxel 30 mg/m(2) on days 1, 8, and 15 every 28 days in combination with either cetuximab 400 mg/m(2) loading dose followed by 250 mg/m(2) weekly (D + C) or bortezomib 1.6 mg/m(2) on days 1, 8, and 15 every 28 days (D + B) for up to 4 cycles. Patients with responding or stable disease continued cetuximab or bortezomib until progression. The primary end point was progression-free survival (PFS) rate at 6 months. RESULTS: Sixty-four patients were enrolled and 59 were included in this analysis. Complete or partial response rates were 13.3% and 10.3% for D + C and D + B, respectively. Median PFS was 3.4 months in the D + C arm and 1.9 months in the D + B arm. Corresponding figures for 6-month PFS were 27.8% and 13.8% and 5.0 and 3.9 months for median survival, respectively. Grade 3/4 hematologic toxicity was 16% for D + C and 21% for D + B, whereas nonhematologic toxicities were observed in 63% and 44% of patients, respectively. There was one treatment-related death in each arm. CONCLUSION: These results confirm the poor prognosis associated with a PS of 2 and the difficulty in translating recent advances in targeted therapy to this subset of patients. While the results in the D + C arm are numerically superior, neither combination met the prespecified PFS end point to justify further research in this setting.
Source: Journal of Clinical Oncology
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G10814802, G199746015, G2647518335, Cancer and Leukemia Group B Statistical Center, Southeast Cancer Control Consortium, Inc, G3710026009, G4744150602, Cancer and Leukemia Group B, Cancer and Leukemia Group B, Hematology-Oncology Associates of Central New York CCOP, MOUNT SINAI COMMUNITY CLINICAL ONCOLOGY PROGRAM, Cancer and Leukemia Group B, G8665016104, G973482110
OpenAlex ID: W2127061733