Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials

Harvey C Quon, Hima Bindu Musunuru, Patrick Cheung, Geordi Pang, Alexandre Mamedov, Laura D'Alimonte, Andrea Deabreu, Liying Zhang, Andrew Loblaw, Harvey C Quon, Hima Bindu Musunuru, Patrick Cheung, Geordi Pang, Alexandre Mamedov, Laura D'Alimonte, Andrea Deabreu, Liying Zhang, Andrew Loblaw

Abstract

Introduction: The optimal prostate stereotactic body radiation therapy (SBRT) dose-fractionation scheme is controversial. This study compares long-term quality of life (QOL) from two prospective trials of prostate SBRT to investigate the effect of increasing dose (NCT01578902 and NCT01146340).

Material and methods: Patients with localized prostate cancer received SBRT 35 or 40 Gy delivered in five fractions, once per week. QOL was measured using the Expanded Prostate Cancer Index Composite at baseline and every 6 months. Fisher's exact test and generalized estimating equations were used to analyze proportions of patients with clinically significant change and longitudinal changes in QOL.

Results: One hundred fourteen patients were included, 84 treated with 35 Gy and 30 treated with 40 Gy. Median QOL follow-up was 56 months [interquartile range (IQR) 46-60] and 38 months (IQR 32-42), respectively. The proportion of patients reporting clinically significant declines in average urinary, bowel, and sexual scores were not significantly different between dose levels, and were 20.5 vs. 24.1% (p = 0.60), 26.8 vs. 41.4% (p = 0.16), and 42.9 vs. 38.5% (p = 0.82), respectively. Similarly, longitudinal analysis did not identify significant differences in QOL between treatment groups.

Conclusion: Dose-escalated prostate SBRT from 35 to 40 Gy in five fractions was not associated with significant decline in long-term QOL.

Keywords: clinical trial; prostatic neoplasms; quality of life; radiation effects; radiotherapy; stereotactic body radiotherapy.

Figures

Figure 1
Figure 1
Average change in EPIC (A) urinary (B) bowel and (C) sexual quality-of-life scores. Negative and positive changes reflect worse and better QOL after treatment, respectively. Horizontal dotted, dashed, and straight lines indicate 0.5, 1, and 2 SD of the baseline score.
Figure 2
Figure 2
Mean scores (and 95% confidence intervals) for (A) urinary (B) bowel (C) and sexual EPIC quality-of-life domains over time.

References

    1. Miralbell R, Roberts SA, Zubizarreta E, Hendry JH. Dose-fractionation sensitivity of prostate cancer deduced from radiotherapy outcomes of 5,969 patients in seven international institutional datasets: alpha/beta = 1.4 (0.9-2.2) Gy. Int J Radiat Oncol Biol Phys (2012) 82(1):e17–24.10.1016/j.ijrobp.2010.10.075
    1. Yu JB, Cramer LD, Herrin J, Soulos PR, Potosky AL, Gross CP. Stereotactic body radiation therapy versus intensity-modulated radiation therapy for prostate cancer: comparison of toxicity. J Clin Oncol (2014) 32(12):1195–201.10.1200/JCO.2013.53.8652
    1. Loblaw A, Cheung P, D’Alimonte L, Deabreu A, Mamedov A, Zhang L, et al. Prostate stereotactic ablative body radiotherapy using a standard linear accelerator: toxicity, biochemical, and pathological outcomes. Radiother Oncol (2013) 107(2):153–8.10.1016/j.radonc.2013.03.022
    1. Madsen BL, Hsi RA, Pham HT, Fowler JF, Esagui L, Corman J. Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: first clinical trial results. Int J Radiat Oncol Biol Phys (2007) 67(4):1099–105.10.1016/j.ijrobp.2006.10.050
    1. Boike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, et al. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol (2011) 29(15):2020–6.10.1200/JCO.2010.31.4377
    1. Gravis G, Marino P, Joly F, Oudard S, Priou F, Esterni B, et al. Patients’ self-assessment versus investigators’ evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15). Eur J Cancer (2014) 50(5):953–62.10.1016/j.ejca.2013.11.034
    1. Musunuru HB, Quon H, Davidson M, Cheung P, Zhang L, D’Alimonte L, et al. Dose-escalation of five-fraction SABR in prostate cancer: toxicity comparison of two prospective trials. Radiother Oncol (2016) 118(1):112–7.10.1016/j.radonc.2015.12.020
    1. Tang CI, Loblaw DA, Cheung P, Holden L, Morton G, Basran PS, et al. Phase I/II study of a five-fraction hypofractionated accelerated radiotherapy treatment for low-risk localised prostate cancer: early results of pHART3. Clin Oncol (R Coll Radiol) (2008) 20(10):729–37.10.1016/j.clon.2008.08.006
    1. Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology (2000) 56(6):899–905.10.1016/S0090-4295(00)00858-X
    1. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care (2003) 41(5):582–92.10.1097/00005650-200305000-00007
    1. Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika (1986) 73(1):13–22.10.1093/biomet/73.1.13
    1. Rodrigues G, Lukka H, Warde P, Brundage M, Souhami L, Crook J, et al. The prostate cancer risk stratification (ProCaRS) project: recursive partitioning risk stratification analysis. Radiother Oncol (2013) 109(2):204–10.10.1016/j.radonc.2013.07.020
    1. Talcott JA, Rossi C, Shipley WU, Clark JA, Slater JD, Niemierko A, et al. Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer. JAMA (2010) 303(11):1046–53.10.1001/jama.2010.287
    1. Beckendorf V, Guerif S, Le Prisé E, Cosset JM, Bougnoux A, Chauvet B, et al. 70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial. Int J Radiat Oncol Biol Phys (2011) 80(4):1056–63.10.1016/j.ijrobp.2010.03.049
    1. Little DJ, Kuban DA, Levy LB, Zagars GK, Pollack A. Quality-of-life questionnaire results 2 and 3 years after radiotherapy for prostate cancer in a randomized dose-escalation study. Urology (2003) 62(4):707–13.10.1016/S0090-4295(03)00504-1
    1. Syndikus I, Morgan RC, Sydes MR, Graham JD, Dearnaley DP, MRC RT01 collaborators . Late gastrointestinal toxicity after dose-escalated conformal radiotherapy for early prostate cancer: results from the UK Medical Research Council RT01 trial (ISRCTN47772397). Int J Radiat Oncol Biol Phys (2010) 77(3):773–83.10.1016/j.ijrobp.2009.05.052
    1. King CR, Collins S, Fuller D, Wang PC, Kupelian P, Steinberg M, et al. Health-related quality of life after stereotactic body radiation therapy for localized prostate cancer: results from a multi-institutional consortium of prospective trials. Int J Radiat Oncol Biol Phys (2013) 87(5):939–45.10.1016/j.ijrobp.2013.08.019
    1. Viani GA, Stefano EJ, Afonso SL. Higher-than-conventional radiation doses in localized prostate cancer treatment: a meta-analysis of randomized, controlled trials. Int J Radiat Oncol Biol Phys (2009) 74(5):1405–18.10.1016/j.ijrobp.2008.10.091
    1. Quon HC, Loblaw DA, Cheung P, Tang CI, Pang G, Morton G, et al. Dose escalation of 5-fraction radiation therapy for prostate cancer: quality of life comparison of 2 prospective trials. International Journal of Radiation Oncology Biology Physics (2012) 84(3):S148–9.10.1016/j.ijrobp.2012.07.383
    1. Tucker SL, Thames HD, Michalski JM, Bosch WR, Mohan R, Winter K, et al. Estimation of alpha/beta for late rectal toxicity based on RTOG 94-06. Int J Radiat Oncol Biol Phys (2011) 81(2):600–5.10.1016/j.ijrobp.2010.11.080
    1. Korfage IJ, Hak T, de Koning HJ, Essink-Bot ML. Patients’ perceptions of the side-effects of prostate cancer treatment – a qualitative interview study. Soc Sci Med (2006) 63(4):911–9.10.1016/j.socscimed.2006.01.027
    1. Chen RC, Clark JA, Talcott JA. Individualizing quality-of-life outcomes reporting: how localized prostate cancer treatments affect patients with different levels of baseline urinary, bowel, and sexual function. J Clin Oncol (2009) 27(24):3916–22.10.1200/JCO.2008.18.6486
    1. Quon HC, Ong A, Cheung P, Chu W, Chung HT, Vesprini D, et al. PATRIOT trial: randomized phase II study of prostate stereotactic body radiotherapy comparing 11 versus 29 days overall treatment time. J Clin Oncol (2015) 33(7_suppl):abstr6.
    1. Sander L, Langkilde NC, Holmberg M, Carl J. MRI target delineation may reduce long-term toxicity after prostate radiotherapy. Acta Oncol (2014) 53(6):809–14.10.3109/0284186X.2013.865077
    1. Rasch C, Barillot I, Remeijer P, Touw A, van Herk M, Lebesque JV. Definition of the prostate in CT and MRI: a multi-observer study. Int J Radiat Oncol Biol Phys (1999) 43(1):57–66.10.1016/S0360-3016(98)00351-4
    1. Ali AN, Rossi PJ, Godette KD, Martin D, Liauw S, Vijayakumar S, et al. Impact of magnetic resonance imaging on computed tomography-based treatment planning and acute toxicity for prostate cancer patients treated with intensity modulated radiation therapy. Pract Radiat Oncol (2013) 3(1):e1–9.10.1016/j.prro.2012.04.005

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere