Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis decreased RV dilation, reduced pulmonary hypertension, decreased anatomic thrombus burden, and minimized intracranial hemorrhage in patients with acute massive and submassive PE. (A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE) [SEATTLE II]; NCT01513759).
Extra efficiency is possible, but it is difficult to predict when favorable conditions exist. If a factorial design is used, potential efficiency gains should be weighed against potential loss of power to arrive at the correct conclusion under possible scenarios of interest.
OBJECTIVE
To investigate whether patient-reported quality of life after high-dose external beam intensity-modulated radiotherapy for prostate cancer can be improved by decreasing planning target volume margins while using real-time tumor tracking.
METHODS
Study patients underwent radiotherapy with nominal 3-mm margins and electromagnetic real-time tracking. Morbidity was assessed before and at the end of radiotherapy using Expanded Prostate Cancer Index Composite (EPIC) questionnaires. Changes in scores were compared between the Assessing Impact of Margin Reduction (AIM) study cohort and the comparator Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment (PROST-QA) cohort, treated with conventional margins.
RESULTS
The 64 patients in the prospective AIM study had generally less favorable clinical characteristics than the 153 comparator patients. Study patients had similar or slightly poorer pretreatment EPIC scores than comparator patients in bowel, urinary, and sexual domains. AIM patients receiving radiotherapy had less bowel morbidity than the comparator group as measured by changes in mean bowel and/or rectal domain EPIC scores from pretreatment to 2 months after start of treatment (−1.5 vs −16.0, P = .001). Using a change in EPIC score >0.5 baseline standard deviation as the measure of clinical relevance, AIM study patients experienced meaningful decline in only 1 health-related quality of life domain (urinary) whereas decline in 3 health-related quality of life domains (urinary, sexual, and bowel/rectal) was observed in the PROST-QA comparator cohort.
CONCLUSIONS
Prostate cancer patients treated with reduced margins and tumor tracking had less radiotherapy-related morbidity than their counterparts treated with conventional margins. Highly contoured intensity-modulated radiotherapy shows promise as a successful strategy for reducing morbidity in prostate cancer treatment.
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