Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2014
A randomized, placebo-controlled, multicenter, biomarker-selected, phase 2 study of apricoxib in combination with erlotinib in patients with advanced non-small-cell lung cancer.
Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Cardiovascular/anti-inflammatory drugs repurposed for treating or preventing cancer: A systematic review and meta-analysis of randomized trials.Cancer medicine · 2024Pooled it
- The Efficacy and Safety of Celecoxib in Addition to Standard Cancer Therapy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Current oncology (Toronto, Ont.) · 2022Pooled it
- Eye, hepatobiliary, and renal disorders of erlotinib in patients with non-small-cell lung cancer: A meta-analysis.PloS one · 2020Pooled it
- Pooled it
- Trial
- Randomized, double-blind, placebo-controlled, multicenter phase II study of the efficacy and safety of apricoxib in combination with either docetaxel or pemetrexed in patients with biomarker-selected non-small-cell lung cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015Trial
- Ablation of prostaglandin ENature biomedical engineering · 2026Article
- Pierre-Marie Bamberger Syndrome Leading to the Diagnosis and Surgical Treatment of a Localized Lung Cancer.Cureus · 2023Article
- Review
- Prognostic implications of prostaglandin E-major urinary metabolite in resected non-small-cell lung cancer.Interdisciplinary cardiovascular and thoracic surgery · 2023Article
- Clinical benefit of COX-2 inhibitors in the adjuvant chemotherapy of advanced non-small cell lung cancer: A systematic review and meta-analysis.World journal of clinical cases · 2021Article
- Cyclooxygenase-2 Inhibitor: A Potential Combination Strategy With Immunotherapy in Cancer.Frontiers in oncology · 2021Review
- Pooled analysis of the clinical benefit of cyclooxygenase-2 inhibitors combined with chemotherapy in advanced non-small cell lung cancer.Translational cancer research · 2019Article
- Prostaglandin E-Major Urinary Metabolite (PGE-MUM) as a Tumor Marker for Lung Adenocarcinoma.Cancers · 2019Article
- The paradox role of caspase cascade in ionizing radiation therapy.Journal of biomedical science · 2016Review
- Phase 1 study of romidepsin plus erlotinib in advanced non-small cell lung cancer.Lung cancer (Amsterdam, Netherlands) · 2015Article
- Prostaglandin E2 and the EP receptors in malignancy: possible therapeutic targets?British journal of pharmacology · 2015Review
- Revisiting the role of COX-2 inhibitor for non-small cell lung cancer.Translational lung cancer research · 2015Article
- Therapeutic Effects of Repurposed Therapies in Non-Small Cell Lung Cancer: What Is Old Is New Again.The oncologist · 2015Review
- Cellular and molecular immunology of lung cancer: therapeutic implications.Expert review of clinical immunology · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 6 institutions in 1 country.
Funding
Abstract
Cyclooxygenase-2 (COX-2) overexpression is associated with a poor prognosis in non-small-cell lung cancer (NSCLC) and may promote resistance to epidermal growth factor receptor inhibitors. This randomized phase 2 trial evaluated apricoxib, a novel COX-2 inhibitor, in combination with erlotinib in biomarker-selected patients. Patients with stage IIIB/IV NSCLC previously treated with platinum-based chemotherapy were randomized (2:1) to 400 mg/day apricoxib plus 150 mg/day erlotinib (AP/E) or placebo plus erlotinib (P/E) in 21-day cycles until disease progression or unacceptable toxicity. The primary endpoint was time to progression (TTP). A decrease of 50% or more from baseline urinary prostaglandin E2 metabolite after a 5-day, open-label, run-in period was used to select eligible patients. One hundred twenty patients (median age 64 years) were randomized (78 to AP/E and 42 to P/E). Overall median TTP was 1.8 months in the AP/E group and 2.1 months in the P/E group, with a 12% objective response rate in both groups (intent-to-treat analysis). A subgroup analysis in patients aged 65 years or younger demonstrated a statistically significant TTP benefit for AP/E (hazard ratio 0.5 [95% confidence interval: not applicable-0.9]; p=0.018) and overall survival advantage at minimum 1-year follow-up (median 12.2 versus 4.0 months; hazard ratio=0.5; p=0.021). The most common adverse events were rash, diarrhea, fatigue, and nausea. Toxicity contributed to early discontinuations in patients aged more than 65 years treated with AP/E. This is the first randomized placebo-controlled study of a COX-2 inhibitor in NSCLC to use a prospective patient-selection strategy. Although AP/E seemed to improve TTP and overall survival in a subset of patients aged 65 years or younger, the primary endpoint of the trial was not met.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.