scholarly journals Outcome and patient-reported toxicity in localised prostate cancer treated with dose-escalated hypofractionated intensity-modulated radiotherapy

2013 ◽  
Vol 12 (4) ◽  
pp. 326-333
Author(s):  
David Thomson ◽  
Sophie Merrick ◽  
Ric Swindell ◽  
James Wylie ◽  
Richard Cowan ◽  
...  

AbstractObjectiveTo report outcomes and late toxicity for a hypofractionated dose-escalated radiotherapy schedule in patients treated using intensity-modulated radiotherapy (IMRT) for localised prostate cancer.Materials and methodsEighty-eight men with localised prostate cancer were treated with 57 Gy in 19 daily fractions over 4 weeks. A total of 70 out of 88 had high-risk disease. Overall survival, cause-specific survival and biochemical progression-free survival (bPFS, Phoenix definition) were reported. Toxicity was measured retrospectively using Radiation Therapy Oncology Group (RTOG) criteria and assessed prospectively with a validated Late Effects in Normal Tissues Subjective, Objective, Management and Analytic (LENT/SOMA) patient questionnaire.ResultsAt 5 years, overall survival was 84%, cause-specific survival 88% and bPFS 65%. In patients with high-risk disease, 5-year bPFS was 62%. There was no RTOG toxicity above grade III. LENT/SOMA questionnaires were returned by 74% patients. Median scores for bowel and urinary function were <1. Maximum bowel and urinary toxicity scores ≥2 were reported by 64% and 59% of patients, respectively. The median score for sexual function was 1·5, but nearly all (96%) patients recorded a toxicity score ≥2 for at least one question.ConclusionsDose-escalated hypofractionated radiotherapy delivered using IMRT has promising outcomes and acceptable late toxicity. This fractionation schedule is being compared with conventional treatment within an on-going multicentre phase III clinical trial.

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
David Thomson ◽  
Sophie Merrick ◽  
Ric Swindell ◽  
Joanna Coote ◽  
Kay Kelly ◽  
...  

Background. The benefit of dose-escalated hypofractionated radiotherapy using intensity-modulated radiotherapy (IMRT) in prostate cancer is not established. We report 5-year outcome and long-term toxicity data within a phase II clinical trial.Materials and Methods. 60 men with predominantly high-risk prostate cancer were treated. All patients received neoadjuvant hormone therapy, completing up to 6 months in total. Thirty patients were treated with 57 Gy in 19 fractions and 30 patients with 60 Gy in 20 fractions. Acute and 2-year toxicities were reported and patients followed longitudinally to assess 5 year outcomes and long-term toxicity. Toxicity was measured using RTOG criteria and LENT/SOMA questionnaire.Results. Median followup was 84 months. Five-year overall survival (OS) was 83% and biochemical progression-free survival (bPFS) was 50% for 57 Gy. Five-year OS was 75% and bPFS 58% for 60 Gy. At 7 years, toxicity by RTOG criteria was acceptable with no grade 3 or above toxicity. Compared with baseline, there was no significant change in urinary symptoms at 2 or 7 years. Bowel symptoms were stable between 2 and 7 years. All patients continued to have significant sexual dysfunction.Conclusion. In high-risk prostate cancer, dose-escalated hypofractionated radiotherapy using IMRT results in encouraging outcomes and acceptable late toxicity.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
David P. Dearnaley ◽  
Isabel Syndikus ◽  
Helen Mossop ◽  
Alison J. Birtle ◽  
DJ Bloomfield ◽  
...  

2 Background: We aimed to explore the dose response relationship for two 3 Gray (Gy) hypofractionated radiotherapy (hRT) schedules for localised prostate cancer (PCa). Methods: hRT schedules of 60Gy/20 fractions (f) and 57Gy/19f were compared with conventional RT (cRT) 74Gy/37f; iso-effective for alpha-beta ratios of 2.5Gy and 1.5Gy respectively. The trial was powered to demonstrate non-inferiority between each hRT schedule and cRT, with 3,213 patients (pt) needed to rule out 5% inferiority (80% power, 1-sided alpha 5%) assuming 70% event-free rate in cRT, corresponding to a critical hazard ratio (HR) of 1.21. The trial was not formally powered to directly compare the two hRT schedules. Pt with N0 T1b-T3a localised PCa were randomized (1:1:1 ratio). The primary endpoint was PCa progression (freedom from biochemical failure by Phoenix consensus guidelines or PCa recurrence). Acute toxicity was assessed up to 18 weeks post treatment and late side effects to 5 years (yr) by RTOG, LENT-SOM and patient reported outcomes (PROs). Results: 3,216 pts were randomized between 2002 and 2011; 1,065 (74Gy), 1,074 (60Gy), 1,077 (57Gy). Baseline characteristics were well balanced across groups: median age 69 yr; NCCN risk group 15% low, 73% intermediate, 12% high. With median follow up 5.2yr, 5yr progression-free rate (95% CI) was 74Gy: 88.3% (86.0%, 90.2%); 60Gy: 90.6% (88.5%, 92.3%), 57Gy: 85.9 (83.4, 88.0); HR60/74: 0.83, 90% CI (0.68, 1.03), HR57/74: 1.20, 90% CI (0.99, 1.45). Significantly more events were observed with 57Gy compared to 60Gy; HR57/60: 1.44, 90% CI (1.18, 1.75), log-rank p=0.003. No significant difference in acute RTOG bladder or bowel toxicity was observed between hRT schedules. Late toxicity profile was favorable; with grade 2+ RTOG bladder (60Gy: 16/960 (1.7%); 57Gy: 11/962 (1.1%), p=0.34) and bowel (60Gy: 28/960 (2.9%); 57Gy: 17/962 (1.8%), p=0.10) toxicity at 2yr. Analysis of LENT-SOM and PROs supported these results. Conclusions: With 5 yr follow-up treatment with a 3Gy schedule of 60Gy/20f shows improved treatment efficacy compared to 57Gy/19f and is non-inferior to 74Gy/37f with a similar low level of acute and late normal tissue damage. Clinical trial information: ISRCTN97182923.


2005 ◽  
Vol 4 (1) ◽  
pp. 115-120 ◽  
Author(s):  
Ashesh B. Jani ◽  
John Gratzle ◽  
Emil Muresan ◽  
Mary K. Martel

An analysis of the effects of using the B-mode ultrasound Acquisition and Targeting (BAT) system for positioning of prostate cancer patients receiving external beam radiotherapy (EBRT) on late gastrointestinal (GI) and genitourinary (GU) toxicity is provided. The records of 49 consecutive patients treated using the BAT were reviewed; additionally, a comparison (No-BAT) group treated in a similar manner was identified, consisting of 49 patients treated immediately prior to this BAT group. There were no other fundamental differences between the two groups. The daily BAT movements were charted and late toxicity was scored for all patients using established toxicity scales. The results demonstrated similar GU toxicity rates between the two groups, but slightly lower rates of GI toxicity in the BAT group vs. the No-BAT group. However, regression analyses revealed that no factors, including BAT use, were significantly correlated with late GI or GU toxicity. Further efforts, perhaps better undertaken in a multi-institutional setting, are needed to determine whether BAT use can significantly reduce late GI toxicity.


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