Clinical advances in hematology & oncology : H&O
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The development of adjuvant therapy has made a significant positive impact on clinical outcomes for patients with breast cancer. Over the past 30 years the field of adjuvant therapy has evolved from its cyclophosphamide/methotrexate/5-fluorouracil beginnings by adding new agents and modifying treatment schedules and dosing. More recently, the application of targeted therapies based on hormone receptor status and HER2 expression is providing a new level of efficacy for these patients. ⋯ Currently there is some debate about how to best approach HER2 testing: with the protein-based immunohistochemistry or the genetic-based fluorescence in situ hybridization. Current research evaluating the different techniques may help to settle this question. Finally, new targeted agents are being investigated and ongoing research aims to identify additional potential therapeutic targets to further improve outcomes for these patients.
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Clin Adv Hematol Oncol · Dec 2005
Review Retracted PublicationSome ethical issues in phase II trials in acute leukemia.
This paper addresses several scientific and ethical issues that arise in the design and conduct of phase II clinical trials of experimental therapies. Although we discuss chemotherapy trials in acute leukemia, the issues pertain to a much larger class of early-phase clinical trials. ⋯ We show that statistical designs that target inappropriately low response rates or that apply early stopping rules too infrequently are at odds with good statistical and medical practice and that such designs often provide less benefit to the patients in the trial than would be obtained by simply treating all patients with standard therapy. The general conclusions are that statistical designs have both scientific and ethical implications, and that science, statistics, and ethics cannot be treated as separate issues.
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Clin Adv Hematol Oncol · Aug 2005
ReviewGastrointestinal stromal tumors and the evolution of targeted therapy.
Gastrointestinal stromal tumors (GISTs) historically have differed from other soft-tissue sarcomas in demonstrating a particularly grim prognosis. GISTs have an extraordinarily high rate of recurrence after surgical resection and are highly resistant to radiation and standard chemotherapy. The discovery that constitutive activation of the c-kit gene drives malignant behavior in GISTs exposed a weakness that was soon exploited through the application of the novel targeted therapy imatinib, a small-molecule tyrosine kinase inhibitor of Bcr-Abl, KIT, and the platelet-derived growth factor receptor-alpha and -beta. ⋯ Additionally, multiple new targeted agents are being tested in patients with imatinib-resistant GIST. The gains that have been made in the treatment of GIST through the use of imatinib have helped to open the door to a new era of development of targeted therapeutic agents in oncology. Whether this new era of targeted therapy will provide the same advances in more common malignancies will be determined only through the ongoing application and development of clinical trials.