Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
Medifocus: Vancouver company files a response to FDA's questions on its investigation device exemption application for a pivotal trial of its Microfocus APA 1000 system for the treatment of breast cancer. The application was submitted in Jun,e and FDA's letter was received July 13. The 238-patient pivotal clinical trial will assess the safety and efficacy of focused microwave heat energy delivered by the Microfocus APA 1000 in combination with neo-adjuvant chemotherapy on large breast cancer tumors as measured by tumor shrinkage. A Phase II multicenter randomized study of Microfocus APA 1000 showed that the median tumor shrinkage in the thermo-chemo arm was about 88% compared to about 59% for chemotherapy alone. Almost 80% of all breast tumors treated with Microfocus APA 1000 got substantially smaller versus 20% in the chemotherapy group
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Research In Brief
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Research In Brief
Stereotactic radiotherapy vs. surgery in lung cancer: Rates of regional recurrence, locoregional recurrence, distant metastasis and "freedom from any failure" in lobectomy-ineligible, non-small-cell lung cancer patients were similar for image-guided stereotactic radiotherapy (SBRT) and wedge resection (surgery) at 30 months, according to results of a nonrandomized study published online Jan. 11 by the Journal of Clinical Oncology. There was a trend toward reduced local recurrence with SBRT, the authors note. Overall survival was higher with wedge resection, but cause-specific survival was identical, Inga Grills, M.D., William Beaumont Hospital, Royal Oak, Mich., et al., note. The authors say their article appears to be the only available literature comparing SBRT and surgery head to head. A future randomized study might compare SBRT to limited resection in borderline operable patients initially; if that trial favored SBRT, a study of radiotherapy versus lobectomy in good surgical candidates might be appropriate, Grills states. Devices that deliver stereotactic radiation include Accuray's CyberKnife and GammaKnife systems
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