S456
Clinical - Gynaecological
ESTRO 2026
irradiation patients mean doses to bone/muscle were similar for LN-negative and LN-positive patients at both centres. Keywords: Cervical cancer, Lumbopelvic dose, Back pain
differences between treatment arms and its correlation with global health/general quality of life (global-QOL). Material/Methods: The CTS integrates patient-reported symptoms(EORTC-C30/CX24) and physician- assessed CTCAE adverse events (AEs) for applications as an endpoint in clinical trials. Defined as a weighted mean of AEs/symptoms, it was developed using data from the EMBRACE-I study(2) on locally advanced cervical cancer. Two CTS were developed based on: 1) physician- assessed AEs (CTSCTCAE) and 2) patient- reported symptoms (CTSEORTC). Random forests ranked AEs/symptoms by association with: 1) Global-QO Land 2) radiation treatment intensity and CTS were calculated as weighted sums of those AEs/symptoms. Main AEs/symptoms contributing to the CTS are fatigue, pain, diarrhea, lack of appetite, and urinary frequency/incontinence. Validation was performed in the PARCER trial(3),evaluating intensity- modulated radiotherapy (IMRT) versus three- dimensional conformal radiotherapy (3DCRT) in reducing gastrointestinal AEsin post-operative cervical cancer. Previous analyses focused on gastrointestinal and urinary symptoms; no global- QOL differences were identified. CTCAE and EORTC-C30/C24 data were collected throughout follow-up. Assessments up to 3 years were considered. TheCTSCTCAE/CTSEORTCmeanpe r patientwerecomparedbetween treatment ar ms. Correlation with global-QOL was assessed by comparingCTS acrossglobal- QOL scoresaveragedper patient and categori zed into small (mean ≥ 80&< 90), medium (mean ≥ 70&< 80) and large deterioration (mean<70) with global-QOL = 90 as the reference(4).Wilcoxon rank test was used to determine statistically significant differences (p<0.05).
Proffered Paper 2646 Patient-informed and data-driven
cumulative toxicity score as an endpoint for clinical studies: Validation in a Phase III randomized trial (PARCER) Marta Pelizzola 1 , Sofia Spampinato 2 , Mayuri Charnalia 1 , Sudeep Gupta 3 , Sadhana Kannan 4 , Reena Engineer 5 , Tapas Dora 6 , Prachi Mittal 5 , Ankita Gupta 7 , Prachi Sawant 5 , Remi Nout 2 , Kari Tanderup 1 , Supriya Chopra 8 1 Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. 2 Department of Radiotherapy, Erasmus Medical Center, Rotterdam, Netherlands. 3 Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India. 4 Epidemiology and Clinical Trials Unit, Advanced Centre for Treatment and Education in Cancer,, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India. 5 Department of Radiation Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India. 6 Department of Radiation Oncology, Homi Bhabha Cancer Hospital, Sangrur, A Unit of Tata Memorial Center, Punjab, India. 7 Department of Radiation Oncology, Advanced Centre for Treatment and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi Mumbai, India. 8 Department of Radiation Oncology, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi Mumbai, India Purpose/Objective: To validate patient-informed, data- driven cumulative toxicity score (CTS)(1)in a randomized phase-III trial, demonstrating its ability to distinguish
Made with FlippingBook - Share PDF online