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.

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Lilenbaum, R; Wang, X; Gu, L; Kirshner, J; Lerro, K; Vokes, E

Published Date

  • September 20, 2009

Published In

Volume / Issue

  • 27 / 27

Start / End Page

  • 4487 - 4491

PubMed ID

  • 19704058

Pubmed Central ID

  • PMC2754901

Electronic International Standard Serial Number (EISSN)

  • 1527-7755

Digital Object Identifier (DOI)

  • 10.1200/JCO.2009.22.7066


  • eng

Conference Location

  • United States