Biomarker-driven treatment of non–small cell lung cancer (NSCLC) with celecoxib failed to improve outcomes, according to a prospective study published in the Journal of Clinical Oncology.1
The purpose of this trial was to prospectively confirm findings from the CALGB 30203 trial (ClinicalTrials.gov Identifier: NCT00070486) in which celecoxib plus chemotherapy improved progression-free survival (PFS) and overall survival (OS) among patients with moderate to high COX-2 expression.
The double-blind, phase 3 CALGB 30801 trial (ClinicalTrials.gov Identifier: NCT01041781) planned to randomly assign 322 patients with a COX-2 index of at least 2 to receive standard chemotherapy plus 400 mg celecoxib twice daily or placebo.
At baseline, the median age was 64, 84.6% of patients were Caucasian, and 54% were male. Performance statuses were 0 (39.4%), 1 (52.2%), or 2 (8.3%) in the trial. COX-2 expression levels were among 28.2% and were at least 4 among the remaining patients.
Only 312 patients were enrolled due to study discontinuation for futility.
There was no difference in median PFS among patients with a COX-2 index of at least 2 but less than 4 (5.16 vs 5.26 months; hazard ratio [HR], 1.076; 95% CI, 0.853-1.367) or at least 4 (5.16 vs 5.45 months; HR, 1.046; 95% CI, 0.794-1.377) compared with placebo.
There was also no difference in median OS among patients with a COX-2 index of at least 2 and less than 4 (13.4 vs 13.8 months; P = .1816) or at least 4 (10.8 vs 6.1 months; P = .1909) compared with placebo.
Adding celecoxib to chemotherapy did not increase toxicity.
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According to the authors, this was the first biomarker-driven trial in NSCLC conducted in the United states. The results, however, “failed to confirm that COX-2 inhibition in addition to standard chemotherapy treatment for patients who were selected by COX-2 expression could improve outcomes,” wrote the authors.
- Edelman MJ, Wang X, Hodgson L, et al. Phase III randomized, placebo-controlled, double-blind trial of celecoxib in addition to standard chemotherapy for advanced non–small-cell lung cancer with cyclooxygenase-2 overexpression: CALGB 30801 (Alliance). J Clin Oncol. 2017 May 10. doi: 10.1200/JCO.2016.71.3743 [Epub ahead of print]