ESTRO 2020 Abstract book

S178 ESTRO 2020

measure for a future randomised controlled trial (RCT) and refine the intervention. Material and Methods A prospective two-centre randomised (1:1 intervention or usual care (UC)) parallel group trial with repeated measures and mixed methods. Eligible patients were undergoing pelvic radiotherapy+/−chemotherapy/hormone therapy for prostate, lower gastrointestinal and gynaecological cancers. Participants randomised to eRAPID reported AE from home weekly for 12 weeks,18 &24 weeks. We measured and analysed descriptively: Patient-reported outcomes (validated questionnaires: FACT-G, EORTC-QLQ- C30), process of care (hospital records of patient contacts/admissions); economic measures (EQ5D-5L). Semi-structured interviews were conducted with staff and patients with thematic analysis. Ethics approval Yorkshire &The Humber Leeds East Research Ethics Committee (REC reference 16/YH/0371, 13.09.2016). ClinicalTrials.gov NCT02747264. Results Between Dec 2016-June 2018, 502 patients from Leeds Cancer Centre and Christie Hospital,Manchester were screened for eligibility, 228 were approached, 167 consented (73.2%) and were randomized (83-eRAPID,84- UC); 87-prostate,45-gynaecological, 34-lower gastrointestinal cancers. Withdrawals were 16/228=7% (10-eRAPID,6-UC). Patient compliance with online self- reports was 82% of expected at week 1, 63% at week 12. Return rates of outcome measures-99.8% at baseline,77.8% at 18 and 73.7% at 24 weeks. eRAPID patients reported less deterioration over time (biggest difference at 6 weeks): FACT-G mean change-score: eRAPID -2.9 (s.d.11.6); UC - 7.6 (s.d.10.5); QLQ-C30 summary-score change: eRAPID - 6.3 (s.d.11.8); -10.7 (s.d.13.8). The score changes were larger in chemo-radiotherapy patients. Similar trends were seen for EQ5D. The system was acceptable to patients and staff. Clinicians recommended longer online monitoring. Conclusion This pilot RCT confirmed the intervention is acceptable and recruitment is feasible (consent rate of >70%, withdrawal <10%; online completions 60-70%). Patient outcome measures suggest potential benefit in the chemo- radiotherapy groups, but this needs confirmation in a formally powered RCT. This is independent research was funded by the UK National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (reference number RP-PG-0611-20008). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. OC-0315 Quality of life after EBRT with or without focal boost for prostate cancer in the FLAME trial V. Groen 1 , E. Monninkhof 2 , H.M. Verkooijen 2 , M. Kunze- Busch 3 , H. De Boer 1 , J. Van der Voort van Zijp 1 , F. Pos 4 , R.J. Smeenk 3 , K. Haustermans 5 , S. Isebaert 5 , T. Depuydt 5 , U.A. Van der Heide 4 , L. Kerkmeijer 1 1 UMC Utrecht, Radiation Oncology, Utrecht, The Netherlands ; 2 UMC Utrecht, Epidemiology, Utrecht, The Netherlands ; 3 Radboud University Nijmegen Medical Center, Radiation Oncology, Nijmegen, The Netherlands ; 4 The Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands ; 5 University Hospitals, Radiation Oncology, Leuven, Belgium Purpose or Objective Survival rates of prostate cancer are improving with advanced treatment options. Therefore, quality of life

(QoL) is becoming increasingly important. In the present study, the aim was to compare patient reported health- related Quality of Life (HRQoL) between patients treated with 77Gy external beam radiotherapy in 35 fractions versus those treated with an additional focal boost to the macroscopic tumor nodule(s) up to 95Gy. Material and Methods For the present study, we included 571 patients with intermediate and high risk prostate cancer of the multicenter randomized controlled phase III FLAME trial (NCT01168479). In the FLAME trial, patients are asked to fill out the EORTC QLQ-PR25 (prostate specific) questionnaire at baseline and 1, 6, 12, 24 and 60 months after treatment. A linear mixed model for repeated measurements was used to assess the impact of the focal boost in comparison to standard treatment on HRQoL until 24 months after treatment. Covariates that are corrected for are age, baseline health related QoL and hormonal treatment. Analyses were performed for the separate domains of the prostate specific questionnaire, i.e. urinary symptoms, bowel symptoms, sexual activity and sexual functioning. The sexual activity and sexual functioning domains were analyzed exclusively for patients who did not receive hormonal therapy, resulting in a lower number at risk per follow-up moment. Results Of the 571 patients, 13 patients were excluded from further analysis because no HRQoL data was available. Of the 558 remaining patients, 184 patients (33%) did not receive hormonal therapy. There were no significant differences in QoL domains observed between both study arms. Figure 1 shows the observed median (interquartile range (IQR)) QoL per domain per time point. Urinary QoL decreased immediately after treatment and recovered within one year in both treatment arms. Median bowel- related QoL deteriorated little from baseline in the standard treatment arm and did not deteriorate from baseline in the FLAME treatment arm. Sexual activity did not change after radiotherapy. Sexual functioning was affected in both study arms and remained deteriorated over time in the standard treatment arm. In the FLAME treatment arm, sexual functioning recovered again between 12 and 24 months. Figure 1. Quality of life changes over time for different subdomains of the EORTC QLQ-PR25, stratified by FLAME treatment arm

* Higher score represents more symptoms or problems ** Lower score represents more problems Conclusion