Boehringer Ingelheim announced it had completed the enrolment for GioTag, a real-world, retrospective study based on analysis of data from medical/electronic health records to assess the impact of sequential therapy in patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC). A total of 204 patients from 10 countries who sequentially received tyrosine kinase inhibitors (TKIs) – Giotrif® (afatinib) in first-line, followed by second-line osimertinib – were enrolled.
The study was initiated in December 2017 and the primary outcome was the time on treatment of first-line afatinib followed by osimertinib in patients who developed the T790M resistance mutation, in a real-world setting.
The study aims to provide insight into EGFR TKI sequencing strategy and its impact on delaying the onset of chemotherapy to help inform treatment approaches for EGFR mutation-positive NSCLC. Results are expected to be shared later this year.
“Further investigation is needed on the importance of EGFR TKI sequencing for patients with EGFR mutation-positive NSCLC. With more treatment options becoming available, doctors will have to plan beyond one line of targeted treatment keeping the bigger picture in mind right from the diagnosis,” said Dr Victoria Zazulina, Global Head of Solid Tumour Oncology, Medicine at Boehringer Ingelheim. “GioTag is one of the approaches to generate such evidence in the real-world setting and answer the “sequencing” question complementing the data collected in randomised clinical trials.”
Real-world evidence plays an increasingly important role in building the oncology community’s understanding of cancer medicines and their use in patients outside of a clinical trial environment.
Randomised Controlled Trials and Real-World Studies
Randomised controlled trials (RCTs) are designed to assess the efficacy and safety of study drugs under well-defined conditions and in selected patient populations. In contrast, real-world studies include everyday patients with characteristics that might preclude their participation in a RCT. Real-world studies are complementary to RCTs, and explore patient outcomes in populations more representative of clinical practice than prospective clinical trials. Real-world studies are essential for capturing clinically relevant data at the point of care, and providing clinically meaningful insights that can be applied to patient care.
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