Originally published as JCO Early Release 10.1200/JCO.2009.22.7066 on August 24 2009

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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

From the Mount Sinai Cancer Center, Miami Beach, FL; Duke University, Durham; Southeast Cancer Control Consortium, Winston-Salem, NC; Hematology-Oncology Associates of Central New York, Syracuse, NY; University of Chicago, Chicago, IL.

Corresponding author: Rogerio Lilenbaum, MD, Mount Sinai Cancer Center, 4306 Alton Rd, Miami Beach, FL 33140; e-mail: rlilenba{at}msmc.com.

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/m² on days 1, 8, and 15 every 28 days in combination with either cetuximab 400 mg/m² loading dose followed by 250 mg/m² weekly (D + C) or bortezomib 1.6 mg/m² 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.

Written on behalf of the Cancer and Leukemia Group B (CALGB).

Supported in part by Grants No. CA31946 from the National Cancer Institute to the Cancer and Leukemia Group B (CALGB; R.L.S.) and CA33601 to the CALGB Statistical Center (S.G.); and by Grants No. CA45564, CA47577, CA45389, CA45808, and CA41287.

Presented in abstract form at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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