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IPASS randomised 1,217 East Asian never-smokers and light former smokers between a tablet and chemotherapy. The tablet won, but only in the patients whose tumour carried an EGFR mutation; in the rest chemotherapy was better.
Mok, Wu, Thongprasert and colleagues randomised 1,217 previously untreated patients in East Asia with advanced pulmonary adenocarcinoma who were non-smokers or former light smokers to gefitinib 250 mg daily (609) or carboplatin with paclitaxel (608), with progression-free survival as the primary endpoint.
IPASS is the trial that made a predictive biomarker mandatory rather than interesting. Selection was clinical (ethnicity, histology, smoking history), and the overall result was positive, but the pre-planned biomarker analysis showed the effect was carried entirely by the mutation-positive subgroup and reversed in the mutation-negative one. After IPASS, treating advanced adenocarcinoma without knowing the EGFR status became indefensible.
The trial that turned EGFR testing into a standard of care rather than a research assay, and the clearest demonstration in oncology that a clinically selected population can hide two opposite treatment effects inside one positive result.
One of the most cited trial reports Europe PMC returns for EGFR in Non-small-cell lung cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
One of the most cited trial reports Europe PMC returns for EGFR in Non-small-cell lung cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
The template for every driver mutation since: find the responders, sequence them, and give the drug only to people whose tumour carries the lesion it was built for. Gefitinib had been close to abandonment on the strength of unselected trials.
Why a drug can look useless in one trial and transformative in another: the trials had different proportions of the patients the drug was for. It is the argument for genotyping before drawing conclusions from a response rate.
Shares FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer, Oncogene addiction, Driver mutation, Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch and the tag lung-evidence.
Shares Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib, Gefitinib, Driver mutation, Next-generation sequencing (NGS) and the tag lung-evidence.
Shares Histology, Adenocarcinoma of the lung, Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch, Biomarkers are not validated or standardised and the tag lung-evidence.
Shares Oncogene addiction, Adenocarcinoma of the lung, Driver mutation, Next-generation sequencing (NGS) and the tag lung-evidence.
Shares FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer, Driver mutation, Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch, Biomarkers are not validated or standardised and the tag lung-evidence.
Shares Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch, Biomarkers are not validated or standardised, Trial design, endpoints and cost, Paclitaxel / nab-paclitaxel and the tag lung-evidence.
Shares FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer, Driver mutation, Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch, EGFR-mutated non-small-cell lung cancer and the tag lung-evidence.
Shares Driver mutation, Next-generation sequencing (NGS), Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch, Biomarkers are not validated or standardised and the tag lung-evidence.