Randomized Trial of Hypofractionated External-Beam Radiotherapy for Prostate Cancer

Abstract

Purpose To determine if escalated radiation dose using hypofractionation significantly reduces biochemical and/or clinical disease failure (BCDF) in men treated primarily for prostate cancer. Patients and Methods Between June 2002 and May 2006, men with favorable- to high-risk prostate cancer were randomly allocated to receive 76 Gy in 38 fractions at 2.0 Gy per fraction (conventional fractionation intensity-modulated radiation therapy [CIMRT]) versus 70.2 Gy in 26 fractions at 2.7 Gy per fraction (hypofractionated IMRT [HIMRT]); the latter was estimated to be equivalent to 84.4 Gy in 2.0 Gy fractions. High-risk patients received long-term androgen deprivation therapy (ADT), and some intermediate-risk patients received short-term ADT. The primary end point was the cumulative incidence of BCDF. Secondarily, toxicity was assessed. Results There were 303 assessable patients with a median follow-up of 68.4 months. No significant differences were seen between the treatment arms in terms of the distribution of patients by clinicopathologic or treatment-related (ADT use and length) factors. The 5-year rates of BCDF were 21.4% (95% CI, 14.8% to 28.7%) for CIMRT and 23.3% (95% CI, 16.4% to 31.0%) for HIMRT (P = .745). There were no statistically significant differences in late toxicity between the arms; however, in subgroup analysis, patients with compromised urinary function before enrollment had significantly worse urinary function after HIMRT. Conclusion The hypofractionation regimen did not result in a significant reduction in BCDF; however, it is delivered in 2.5 fewer weeks. Men with compromised urinary function before treatment may not be ideal candidates for this approach.

Clinical trials in low and middle-income countries — Successes and challenges

“…Randomized studies in breast cancer have shown that delivery can be given in a shorter period of time without effect on overall survival, local control or toxicities compared to standard fractionation (Haviland et al, 2013, Whelan et al, 2010, Owen et al, 2006). Similar findings are being reported in prostate cancer (Kupelian et al, 2007, Hoffman et al, 2014, Pollack et al, 2013). …”

Image-guided hypofractionated proton beam therapy for low-risk prostate cancer: Analysis of quality of life and toxicity, PCG GU 002

“…Therefore, in the present protocol, we proposed to combine a hypofractionated approach that benefits from the low ˛/ˇ ratio of prostate cancer and the conformality achieved with proton therapy to deliver an abbreviated course of therapy for low-risk prostate cancer. [1][2][3][4][5][6] All patients required image guidance with fiducial placement and magnetic resonance imaging registration. The rationale of this image guidance approach for proton therapy has been reviewed previously.…”

A korszerű sugárterápiás kezelések mellékhatásainak metaanalízise prosztatarákos betegeknél

“…Dearnaley [38] vizsgála-tában a normo-és hipofrakcionált kezelésben részesült betegek 7,8 és 5,9%-ában alakult ki mérsékelt vagy súlyos gastrointestinalis toxicitás. A Hoffman [42] által publikált RCT-ben ez az arány 5,1% és 10%, míg a Pollack [41] által 2013-ban publikált klinikai vizsgálati eredmé-nyek alapján 22,5% és 18,1%-ban fejlődött ki mérsékelt gastrointestinalis mellékhatás a hagyományos és hipofrakcionált módon sugárkezelt vizsgálati csoportokban.…”

“…Hoffman [42] elemzésében a normálfrakcioná-lású IMRT-kezelés esetében 16,5%-ban, míg a hipofrakcionálású IMRT-kezelés esetén 15,8%-ban alakult ki mérsékelt vagy súlyos urogenitalis toxicitás. Pollack [41] közleményében a hagyományos frakcionálású ágon 13,4%-ban, míg hipofrakcionálás esetén 21,5%-ban alakult ki késői urogenitalis toxicitás.…”