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Phase II study of hypofractionated image-guided radiotherapy for localized prostate cancer: Outcomes of 55 Gy in 16 fractions at 3.4 Gy per fraction
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摘要

Purpose

To estimate the late morbidity of a novel, hypofractionated external beam radiotherapy schedule of 55 Gy in 16 fractions (4 fractions/week, 3.4 Gy per fraction) for localized prostate cancer.

Methods and materials

A multi-center phase 2 study enrolled seventy-three patients between September 2004 and June 2006. After insertion of fiducial gold markers, they were treated with image-guidance (IGRT) using conformal techniques with intensity-modulation, if necessary, and then followed every 6 months for toxicity rating and PSA. Patient reported outcomes were collected yearly. Median follow up was 4.6 years.

Results

At 4 years post-radiotherapy, the cumulative incidence of combined urinary and bowel grade 3 toxicity was 7%(95%CI 3-16%) and grade 2+ was 33%(95%CI 24-46%). All except two patients recovered from their grade 3 events. Patient-reported reduction of function was most pronounced at year two for urinary function (mean 鈭?, SD 16), and at year one for bowel function (mean 鈭?, SD 21). The cumulative incidence of biochemical (PSA nadir + 2) or biopsy-proven relapse at 4 years was 9%(95%CI 4-18%).

Conclusions

Hypofractionated radiotherapy is clinically feasible and more convenient than conventional schedules for patients with localized prostate cancer. Phase 3 multicenter studies are on-going ().

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