CT 01 - Clinical Trials Session

2 - Impact of Prostate Cancer Hypofractionation on Patient Reported Outcomes: Baseline to 5 Years Change in the CHHIP Trial

Sunday, October 21
3:35 PM - 3:45 PM
Location: Stars at Night Ballroom

Impact of Prostate Cancer Hypofractionation on Patient Reported Outcomes: Baseline to 5 Years Change in the CHHIP Trial
J. Staffurth1,2, J. Haviland3, A. Wilkins3, I. Syndikus4, V. Khoo5, D. Bloomfield6, C. Parker5, J. Logue7, C. Scrase8, A. Birtle9, Z. Malik10, M. Panades11, C. Eswar12, J. Graham13, M. Russell14, P. Kirkbride15, J. O'Sullivan16, C. Cruickshank3, D. Dearnaley17, and E. Hall3; 1Velindre Cancer Centre, Cardiff, United Kingdom, 2Cardiff University, Cardiff, United Kingdom, 3The Institute of Cancer Research, London, United Kingdom, 4The Clatterbridge Cancer Centre, Wirral, United Kingdom, 5The Royal Marsden NHS Foundation Trust, London, United Kingdom, 6Royal Sussex County Hospital, Brighton, United Kingdom, 7The Christie NHS Foundation Trust, Manchester, United Kingdom, 8Ipswich Hospital, Ipswich, United Kingdom, 9Lancashire Teaching Hospitals NHS Foundation Trust, Preston, United Kingdom, 10Whiston Hospital, Prescot, United Kingdom, 11Lincoln County Hospital, Lincoln, United Kingdom, 12Southport General Infirmary, Southport, United Kingdom, 13Beacon Centre, Musgrove Park Hospital, Taunton, United Kingdom, 14Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, 15Sheffield Teaching Hospitals Foundation Trust, Sheffield, United Kingdom, 16Queen's University Belfast, Belfast, United Kingdom, 17The Institute of Cancer Research/The Royal Marsden NHS Foundation Trust, London, United Kingdom

Purpose/Objective(s): We have performed a quality of life (QoL) substudy investigating change in patient reported outcomes (PROs) up to 5 years in the Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy in Prostate Cancer (CHHiP) trial.

Materials/Methods: 3213 men with localised prostate cancer were randomly assigned (1:1:1) to receive 74Gy in 37 fractions, 60Gy in 20 fractions or 57Gy in 19 fractions. 2100 patients were recruited into the QoL substudy. UCLA Prostate Cancer Index (UCLA-PCI), Short Form (SF)-36 and Functional Assessment of Cancer Therapy-Prostate (FACT-P), or Expanded Prostate Cancer Index Composite (EPIC) and SF-12 quality-of-life questionnaires were completed at baseline and multiple time points up to 5 years post-radiotherapy. Analysis was on an intention-to-treat basis. Odds of change in symptoms (post-radiotherapy score at each time point minus baseline score) were compared between treatment arms using ordinal logistic regression; analysis of covariance was used to assess change over time for the domain scores, adjusting for baseline/pre-radiotherapy score.

Results: 1138 (73%) of the expected 1557 forms were available at 5 years: 352 for 74Gy, 386 for 60Gy and 400 for 57Gy. There was no significant difference in the prevalence or cumulative incidence of patients with overall ‘moderate or big’ bowel, urinary or sexual bother at 5-years between the three arms. There was no significant difference in the odds of "increase in score" from baseline to 5-years for overall bowel or urinary bother between the three arms (Table), and no evidence of an increase in bowel or urinary symptoms from 2 to 5-years. There was some evidence of a larger deterioration in overall sexual function in the 74Gy arm compared to both hypofractionated arms, which was most marked for sexual bother (Table). Sexual function appeared to deteriorate across all arms between 2 and 5-years. There were no significant differences in general QoL domain scores between arms at 2 and 5 years.

Conclusion: Change in bowel or urinary symptoms up to 5 years was similar between the treatment schedules in the CHHiP trial, but there was evidence of less decline in sexual function for the hypofractionated arms compared with the control arm. This supports the use of moderately hypofractionated radiotherapy for localized prostate cancer.
Ordinal logistic regression to show odds of "increase in score" from baseline to 5 years for each paired comparison of treatment groups
Item Comparison Odds ratio (99% CI) P-Value
Overall bowel bother 60 Gy vs 74 Gy 57 Gy vs 74 Gy 57 Gy vs 60 Gy 0.78 (0.52, 1.18) 0.75 (0.50, 1.12) 0.96 (0.64, 1.44) 0.12 0.06 0.80
Overall urinary bother 60 Gy vs 74 Gy 57 Gy vs 74 Gy 57 Gy vs 60 Gy 1.00 (0.67, 1.50) 1.08 (0.72, 1.61) 1.09 (0.73, 1.62) >0.99 0.62 0.58
Overall sexual bother 60 Gy vs 74 Gy 57 Gy vs 74 Gy 57 Gy vs 60 Gy 0.55 (0.30, 0.99) 0.52 (0.29, 0.94) 0.95 (0.53, 1.70) 0.009 0.004 0.82

Author Disclosure: J. Staffurth: Advisory Board; BAYER. Travel Expenses; BAYER. J. Haviland: None. A. Wilkins: None. V. Khoo: Speakers Bureau; Accuray, Astellas, Bayer, Ipsen, Janssen, Takeda and Tolmar. D. Bloomfield: None. C. Parker: Honoraria; Bayer, Takeda, Sanofi-Aventis, Janssen, Astellas. Consultant; BNIT, Bayer. Advisory Board; Bayer, BMS, Amgen. J. Logue: None. C. Scrase: None. A. Birtle: Honoraria; Roche, Janssen, Astellas, Bayer. Consultant/Advisory Role; Sanofi Aventis. P. Kirkbride: None. C. Cruickshank: None. D. Dearnaley: Honorary contract; Institute of Cancer Research. Research Grant; Cancer Research UK, na. Advisory Board; Takeda, Amgen, Janssen, Astellas, Sandoz. Royalty; Institute of Cancer Research. Patent/License Fees/Copyright; Institute of Cancer Research. Co lead; Cancer Research UK. E. Hall: Research Grant; AstraZeneca, Bayer HealthCare Pharmaceuticals Inc, Accuray Inc., Aventis Pharma Limited (Sanofi), Kyowa Hakko UK, Alliance Pharma (was Cambridge Laboratories).

John Staffurth, MD, MB, BS

Disclosure:
Employment
Cardiff University: Professor in Clinical Oncology: Employee; Velindre Cancer Centre: Consultant Clinical Oncologist: Employee

Compensation
BAYER: Advisory Board, Travel Expenses

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