Studying apricoxib with erlotinib for lung cancer

Rachel E. Sanborn, M.D.
Co-medical director, Providence Thoracic Oncology Program
Medical oncologist, Providence Lung Cancer Clinic
Providence Oncology and Hematology Care Clinic-Eastside

Research presented at the American Society of Clinical Oncology annual meeting in June 2011 included a multi-institutional study of a combination therapy for patients with progressive metastatic non-small cell lung cancer.

Providence Oncology and Hematology Care Clinics participated in this trial, which involved 176 patients. The study evaluated apricoxib, a COX-2 inhibitor, in combination with erlotinib, a small-molecule tyrosine kinase inhibitor of the epidermal growth factor receptor pathway. The study screened patients after a single-agent run-in with apricoxib alone to receive erlotinib with apricoxib or placebo.

This study attempted to select patients with an optimized chance of benefit from COX-2 inhibition by evaluating levels of COX-2 inhibition through urinary PGE-M markers before and after patients received apricoxib. Patients demonstrating significant change in PGE-M excretion were eligible to participate.

Unfortunately, the trial did not meet its primary endpoint of improvement of the time to cancer progression compared with erlotinib alone – a standard drug for this population.

In a prespecified analysis, patients over the age of 65 tended to have higher rates of side effects, which caused them to withdraw from the study earlier than their younger counterparts.

The study was intriguing, however, given that for patients younger than 65, overall survival was 8.5 months with apricoxib, compared to 3.8 months with erlotinib alone.

Ongoing studies with apricoxib continue, including a trial at Providence Cancer Center that is evaluating apricoxib in combination with other chemotherapy agents (pemetrexed or docetaxel) for patients with progressive non-small cell lung cancer.

This study is actively recruiting patients. So far, Providence is a site of significant accrual for both of these studies.

Partnering with Hoosier

Providence Oncology and Hematology has partnered with Hoosier Oncology Group to conduct clinical research in multiple tumor types. In one recently completed phase I study presented at ASCO this year, patients with advanced solid cancers received the novel combination of amrubicin with cyclophosphamide. The combination was found to be safe and feasible, and a larger study is now in preparation for patients with metastatic small cell lung cancer.

Providence Oncology and Hematology continues to enroll patients in trials with Hoosier Oncology Group, including an ongoing study evaluating the multitargeted tyrosine kinase inhibitor, vandetanib, in combination with first-line chemotherapy for patients with metastatic small cell lung cancer.

The ASCO meeting provides an excellent opportunity to review and discuss the most cutting-edge clinical and translational research in a global format, and I look forward to attending the meetings each year. It is exhilarating to hear what advances are being made in all aspects of cancer care, but humbling to be reminded of how far we have to go.

The mechanisms of clinical research have changed dramatically since the War on Cancer was declared, and it will be fascinating to see how the future continues to unfold.

Clinical articles by Rachel E. Sanborn, M.D.