FDA Plans Guidance on OTC Cold Meds for Kids


B A R C E L O N A — Overexpression of BRCA1, one of the genes associated with aggressive breast cancer, also predicts cisplatin resistance, faster recurrence, and reduced survival in people with non–small cell lung cancers, Dr. Rafael Rosell reported at the 14th European Cancer Conference. Dr. Rosell and colleagues at the Catalan Institute of Oncology have been studying gene expression signatures that predict the behavior and treatment responsiveness of lung tumors. They’ve identified nine genes, all involved in the process of DNA repair, that may have potential predictive value. By far the biggest red flag is BRCA1. The investigators assessed expression of these nine genes in tumor tissue obtained from 126 people with stage IA-IIIA squamous cell carcinoma or adenocarcinoma. Overall, 42% of patients had stage IB tumors, and 26% had stage II lesions. BRCA1 was the only gene of the nine to show independent prognostic value as far as clinical outcomes. Patients in the uppermost quartile of BRCA1 expression showed much greater resistance to cisplatin-based treatment regimens, and were twice as likely to die within 3 years, compared with those in the lowest quartile. Median time to recurrence was 22 months among the high BRCA1 expressors, and median survival was 29 months. Among those in the lowest quartile, the majority was still alive and disease free after 3 years.

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@inproceedings{Rosell2007FDAPG, title={FDA Plans Guidance on OTC Cold Meds for Kids}, author={Rafael Rosell}, year={2007} }