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Foreword Michael K Gibson, MD, PhD, FACP, is Associate Professor of Medicine at the University Hospitals Case Medical Center, Seidman Cancer Center. After obtaining his MD from Johns Hopkins, he completed an Osler Medical Residency and Medical Oncology Fellowship at Johns Hopkins Hospital while concurrently earning a the Multi-disciplinary Head and Neck Malignancies Program and Medical Director of the Clinical Trials Unit at the University Hospitals Case Medical Center. Dr Gibson’s research interest is in bringing novel therapeutics to the treatment of aero-digestive cancers, based on rational pre-clinical investigation and in the setting of a patient focus. Along with his colleagues in radiation oncology and head and neck surgery, his goal is to integrate the multi-disciplinary pre-clinical research and clinical trials programs in head and neck cancer at the Seidman Cancer Center. In this role, he leads or co-leads all clinical trials within this domain, manages the clinical trials mechanism through the Cancer Center’s Clinical Research Offices, and treats patients at Seidman Cancer Center. Dr Gibson has extensive didactic training and applied experience in ethical issues associated with clinical research. In particular, he is strongly interested in supporting a culture of ethics and fairness in the CCC clinical research environment. He has published nearly four dozen papers in peer-reviewed journals on such topics as treatment of esophageal cancer with chemo-radiotherapy, and novel drug therapies for head and neck cancer. He is a reviewer for many medical publications, including the American Journal of Clinical Oncology, the International Journal of Radiation Oncology, Biology, Biophysics; and the Journal of Clinical Oncology. He is a frequent presenter at local, regional, national, and international medical meetings and conferences. He is a Chair of the Upper Gastrointestinal Subcommittee of the Eastern Cooperative Oncology Group, Member of the National Cancer Institute Esophago-gastric Task Force, and is a Fellow in the American College of Physicians. Michael K Gibson, MD, PhD, FACP would like to thank Lilit Karapetyan for assisting with this piece. A warm welcome to this edition of the Oncology & Hematology Review (US). Cancer care costs are placing an escalating burden on global healthcare systems, partly owing to the high price points for biological therapies. However, with patents on many of these biological treatments expiring, biosimilars offer the potential to reduce healthcare expenditure while improving patient access. Yet despite their promise, a regulatory pathway for biosimilars remains a significant challenge. The European experience of biosimilars, which includes a framework for approval established by the European Medicines Agency in 2006, is reviewed by Zelenetz. Crucially, Zelenetz highlights the need for healthcare professional education. The most aggressive subtype of breast cancer, triple negative breast cancer, represents an important clinical challenge with no targeted therapy available. In the first article on this topic, Saha and Nanda explore drugs targeting the programmed death 1/programmed death ligand 1 axis while other recent updates in triple negative breast cancer management are presented by Sanft and Moran. Cancer stem cells (CSC) are thought to play an important role in tumor pathogenesis and the gastrointestinal (GI) system provides a good example for CSC study. GI stem cells have a long life span and, coupled with rapid turnover, they may be predisposed to forming CSCs. As covered by Hubbard and Grothey, therapies that specifically target this subpopulation of cancer cells are opening exciting opportunities for future treatment. Esophageal cancer, a highly lethal malignancy with rising incidence worldwide, is typically associated with symptoms of dysphagia and odynophagia and, sometimes, with chest pain, hoarse voice and other subjective upper GI symptoms. We report in this edition a patient whose primary presentation was left hemiparesis due to metastatic esophageal cancer to his brain. This is an exceptional case due to the absence of esophageal disease symptoms and it is possible that this case represents a particular subtype of esophageal cancer or it may just be one of the rarest cases. The journal staff would like to thank all the contributors to this edition, from organizations to individuals and, in particular, the Editorial Board for their continued support and guidance. We hope you find the selection of articles in this edition stimulating and, as ever, we welcome feedback on any of the papers or suggestions for topics or controversies that you would like to see covered. n TO U CH MED ICA L MEDIA 13