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ASCENDE-RT: An Analysis of Health-Related Quality of Life for a Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost With Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer

Published:February 20, 2017DOI:https://doi.org/10.1016/j.ijrobp.2017.02.027

      Purpose

      To report the patient-reported health-related quality of life (HR-QoL) outcomes for a multicenter randomized trial evaluating the safety and efficacy of 2 different techniques for dose escalation.

      Methods and Materials

      A total of 357 men with intermediate- and high-risk prostate cancer were stratified by risk group and randomized (1:1) to either a dose-escalated external beam (DE-EBRT) boost (n=177) or a low-dose-rate prostate brachytherapy (LDR-PB) boost (n=180) as part of combined modality therapy. The HR-QoL was assessed using the SF36v2 questionnaire, with additional scales for urinary, bowel, and sexual function. Date of starting androgen deprivation therapy was considered time zero, the median follow-up of 6 years. Scales were scored from 0 to 100; a decline in a mean score ≥10 compared with baseline was considered a clinically significant decline. This was an intent-to-treat analysis.

      Results

      Mean domain scores at baseline were well balanced between the 2 treatment arms. A clinically significant decline in mean scores in both the arms compared with baseline was noted for role physical (DE-EBRT [−11.4] and LDR-PB [−15.3]) and sexual function scale (DE-EBRT [−15.1] and LDR-PB [−19.2]). There was a significantly larger drop in mean scores in the LDR-PB group compared with the DE-EBRT group for physical function (−15.3 vs −6.9; P=.03), urinary function (−3.6 vs −0.5; P=.04).

      Conclusion

      At 6 years' follow up, there were no significant differences in mean scores in 9 of 11 scales compared with baseline in both arms. A clinically significant decline in mean scores was noted in both arms for role physical and sexual function scales. There was a statistically significant decline in physical function and urinary function scales in the LDR-PB arm compared with the DE-EBRT arm.
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      References

        • Kuban D.A.
        • Tucker S.L.
        • Dong L.
        • et al.
        Long-term results of the M. D. Anderson randomized dose escalation trial for prostate cancer.
        Int J Radiat Oncol Biol Phys. 2008; 70: 67-74
        • Dearnaley D.P.
        • Sydes M.R.
        • Graham J.D.
        • et al.
        Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: First results from the MRC RT01 randomized controlled trial.
        Lancet Oncol. 2007; 8: 475-487
        • Peeters S.
        • Heemsbergen W.
        • Koper P.
        • et al.
        Dose-response in radiotherapy for localized prostate cancer: Results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy.
        J Clin Oncol. 2006; 24: 1990-1996
        • Sathya J.
        • Davis I.
        • Julian J.
        • et al.
        Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate.
        J Clin Oncol. 2005; 23: 1192-1199
        • Zeitman A.
        • De Silvo M.
        • Slater J.
        • et al.
        Comparison of conventional-dose vs. high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: A randomized controlled trial.
        JAMA. 2005; 294: 1233-1239
        • Pollack A.
        • Hanlon A.
        • Horwitz E.
        • et al.
        Prostate cancer radiotherapy dose response: An update of Fox Chase experience.
        J Urol. 2004; 171: 1017-1387
        • Heemsbergen W.D.
        • Al-Mamgani A.
        • Slot A.
        • et al.
        Long-term results of the Dutch randomized prostate cancer trial: Impact of dose-escalation on local, biochemical, clinical failure, and survival.
        Radiother Oncol. 2014; 110: 104-109
        • Shipley W.U.
        • Verhey L.J.
        • Munzenrider J.E.
        • et al.
        Advanced prostate cancer: The results of a randomized comparative trial of high dose irradiation boosting with conformal protons compared with conventional dose irradiation using photons alone.
        Int J Radiat Oncol Biol Phys. 1995; 32: 3-12
        • Shen X.
        • Keith S.W.
        • Mishra M.V.
        • et al.
        The impact of brachytherapy on prostate cancer-specific mortality for definitive radiation therapy of high grade prostate cancer: A population based analysis.
        Int J Radiat Oncol Biol Phys. 2012; 83: 1154-1159
        • Amini A.
        • Jones B.L.
        • Jackson M.W.
        • et al.
        Survival outcomes of combined external beam radiotherapy and brachytherapy versus brachytherapy alone for intermediate-risk prostate cancer patients using National Cancer Data Base.
        Brachytherapy. 2016; 15: 135-146
        • Morris W.J.
        • Tyldesley S.
        • Rodda S.
        • et al.
        Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (the ASCENDE-RT Trial): An analysis of survival endpoints for a randomized trial comparing low-dose-rate brachytherapy boost to dose-escalated external beam boost for high- and intermediate-risk prostate cancer.
        Int J Radiat Oncol Biol Phys. 2017; 98: 275-285
        • Rodda S.
        • Tyldesley S.
        • Morris W.J.
        • et al.
        ASCENDE-RT: An analysis of treatment related morbidity for a randomized trial comparing low-dose-rate brachytherapy boost with a dose escalated external beam boost for high- and intermediate-risk prostate cancer.
        Int J Radiat Oncol Biol Phys. 2017; 98: 286-295
        • Ware Jr., J.E.
        SF-36 health survey update.
        Spine. 2000; 25: 3130-3139
        • Ware Jr., J.E.
        • Sherbourne C.D.
        The MOS 36-item short form health survey (SF-36). Conceptual framework and item selection.
        Med Care. 1992; 30: 473-483
        • Bosch J.L.
        • Halpern E.F.
        • Gazelle G.S.
        • et al.
        Comparison of preference-based utilities of the Short-Form 36 Health Survey and Health Utilities Index before and after treatment of patients with intermittent claudication.
        Med Decis Making. 2002; 22: 403-409
        • Osoba D.
        • Bezjak A.
        • Brundage M.
        • et al.
        Analysis and interpretation of health-related quality of life data from clinical trials: Basic approach of The National Cancer Institute of Canada Clinical Trials Group.
        Eur J Cancer. 2005; 41: 280-287
        • Guyatt G.
        • Osoba D.
        • Wu A.
        • et al.
        Methods to explain the clinical significance of health status measures.
        Mayo Clin Proc. 2002; 77: 371-383
        • Cella D.
        • Hanah E.A.
        • Dineen K.
        • et al.
        Meaningful change in cancer specific quality of life scores: Differences between improvement and worsening.
        Qual Life Res. 2002; 11: 207-221
        • King M.T.
        The interpretation of scores the EORTC quality of life questionnaire QLQ-30.
        Qual Life Res. 1996; 5: 555-567
        • Coste J.
        • Quinquis L.
        • Audureau E.
        • et al.
        Non response, incomplete and inconsistent responses to self-administered health-related quality of life measures in the general population: Patterns, determinants and impact on the validity of estimates—a population-based study in France using MOS SF-36.
        Health Qual Life Outcomes. 2013; 11: 44
        • Al-Mamgani A.
        • Van Putten W.L.
        • Van der Wielen G.J.
        • et al.
        Dose escalation and quality of life in patients with localized prostate cancer treated with radiotherapy: Long-term results of the Dutch randomized dose-escalation trial (CKTO 96-10 trial).
        Int J Radiat Oncol Biol Phys. 2011; 79: 1004-1012
        • Fransson P.
        • Lund J.A.
        • Damber J.E.
        • et al.
        Quality of life in patients with locally advanced prostate cancer given endocrine treatment with or without radiotherapy: 4-year follow-up of SPCG-7/SFUO-3, an open-label, randomised, phase III trial.
        Lancet Oncol. 2009; 10: 370-380
        • Hoskin P.J.
        • Rojas A.M.
        • Ostler P.J.
        • et al.
        Quality of life after radical radiotherapy for prostate cancer: Longitudinal study from a randomised trial of external beam radiotherapy alone or in combination with high dose rate brachytherapy.
        Clin Oncol. 2013; 25: 321-327
        • Brundage M.
        • Sydes M.
        • Parulekar W.
        • et al.
        Impact of radiotherapy when added to androgen-deprivation therapy for locally advanced prostate cancer: Long-term quality-of-life outcomes from the NCIC CTG PR3/MRC PR07 randomized trial.
        J Clin Oncol. 2015; 33: 2151-2157

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