ESTRO 38 Abstract book

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inoperable or whose metastases are unresectable due to their location. PV-0259 Cosmetic outcome in irradiated breast cancer patients and association with patient reported outcomes M. Batenburg 1 , M. Gregorowitsch 1 , D. Van den Bongard 1 , W. Maarse 2 , H. Verkooijen 3 1 UMC Utrecht, Radiation Oncology, Utrecht, The Netherlands ; 2 UMC Utrecht, Plastic Surgery, Utrecht, The Netherlands; 3 UMC Utrecht, Imaging Division, Utrecht, The Netherlands Purpose or Objective Locoregional treatment of breast cancer consists of surgery and, in the majority of cases, irradiation of the breast. These modalities affect cosmetic appearance of the breast. In this study, we evaluated the level of satisfaction with cosmetic outcome one to three years after the start of breast irradiation, determinants of low satisfaction, and its association with quality of life (QoL). Material and Methods This study was conducted within the UMBRELLA cohort, a prospective observational cohort including breast cancer patients referred for radiation treatment to the department of Radiation Oncology at the University Medical Centre Utrecht. In UMBRELLA, patients consent to collection of clinical and patient reported outcomes (PROs) for research purposes. All 821 patients treated with either lumpectomy or mastectomy followed by breast reconstruction between October 2013 and June 2018, with at least one year follow up were selected. Cosmetic satisfaction, QoL and depression were measured via self- reported questionnaires (resp. Sneeuw, EORTC QLQ-BR23 and C30, and HADS-NL). Patient reported cosmetic outcome was assessed in a 5 point scale: very satisfied, satisfied, neutral, dissatisfied and very dissatisfied with cosmetic outcome. For analysis, satisfied and very satisfied were considered “satisfied with cosmetic outcome” and dissatisfied and very dissatisfied were considered “dissatisfied with cosmetic outcome. Multivariate logistic regression analysis was used to assess the association between patient and tumor characteristics and poor cosmetic satisfaction. Results After respectively one, two and three years there were 64/821 (8%), 29/422 (7%), and 13/181 (7%) dissatisfied patients. BMI >25 and mastectomy followed by breast reconstruction were significantly associated with cosmetic dissatisfaction, (resp. adjusted OR 2.7 (95%CI 1.1-6.8) and 5.7 (95%CI 1.1-30.0)). High scores on the HADS depression subscale (>8) were significantly more common in dissatisfied patients than in satisfied/neutral patients after one and two years (Table 1). Patients who were dissatisfied with cosmetic outcome reported significantly lower scores for emotional functioning and body image than patients who were satisfied/neutral with their cosmetic outcome after one, two and three years (Figure 1). Conclusion Dissatisfaction with cosmetic outcome was present in 7-8% of the breast cancer patients one to three years after irradiation. BMI >25 and mastectomy followed by immediate reconstruction were associated with dissatisfaction with cosmetic outcome. Dissatisfied patients reported lower quality of life scores and higher depression scores. Late radiation complications like fibrosis, can occur years after radiation therapy. Therefore, to assess the impact of fibrosis on cosmetic outcome, long-term research has to be performed.

Joint Symposium: ESTRO-JASTRO: Clinical trials for particle therapy: which ones to run and how?

SP-0260 International collaborations in proton therapy: networks, trials and data collection C. Grau 1 1 Aarhus University Hospital, Danish Center for Particle Therapy, Aarhus N, Denmark Abstract text The key clinical research agenda for particle therapy (PT) is to establish the full range of indications for proton therapy. This will in most cases involve studies of PT applied to prevent radiation-induced side effects and/or induction of secondary tumours. In order to promote clinical research and integration of PT into radiation oncology, the European Particle Therapy Network (EPTN) will encourage and foster collaboration on trials and uniform prospective data registration. The vision and scope for clinical trials in the EPTN has been outlined in the special issue of Radiother Oncol July 2018: • Emphasis should be on performing high quality clinical trials with properly selected patients and using relevant, validated clinical endpoints. • A small number of pivotal RCTs are urgently needed. However, we need to develop, test and validate alternative evidence-based methodologies (e.g. ‘‘cohort multiple RCTs”). • Model-based selection (as predictive biomarker) is a useful concept for normal tissue complication probability (NTCP)-based clinical trials, and this concept should later be extended to incorporate Tumor Control Probability (TCP) as well. • Trials involving state-of-the-art photon RT are welcome, as particle therapy should be an integral component of radiation oncology. • European trials should be open to accredited centres with expertise and relative high numbers who wish to collaborate. • Prospective collection of high-quality data for patients treated with proton therapy outside of clinical trials (using common ontology and data collection forms). • Uniform guidelines for target and organ at risk delineation, as well as guidelines on dose constraints. • There is a need to develop an IT-infrastructure and European QA platform, not only for particle therapy trials, but also for prospective data registries. The platform for data collection and clinical trials QA have been secured through the collaboration of ESTRO-EPTN with EORTC. With a network of many recently opened and upcoming PT centres in Europe, all with a high academic interest and a capacity to perform clinical trials, the prospects for new clinical trials in PT are encouraging. SP-0261 Trial quality assurance and audits for proton therapy C. Clark 1 1 National Physical Laboratory, Medical Radiation Physics, Teddington, United Kingdom Abstract text One of the roles of quality assurance (QA) in clinical trials is to enable high quality practice-changing techniques to be tested rigorously for the benefit of patients. This is undertaken by monitoring adherence to trial protocol and thus minimising variations between recruiting centres. Currently extensive proton trial investigations are relatively new in Europe (and world-wide) and hence the QA programmes are in early development across most groups. Particle therapy (PT) raises some different requirements for QA, however there is also much we can learn from the established photon therapy approaches. In an environment where individual countries have few