ESTRO 36 Abstract Book

S27 ESTRO 36 _______________________________________________________________________________________________

Purpose or Objective To provide a descriptive overview of the prospectively collected physician assessed bowel morbidity and patient reported outcome (PRO) within the multicenter EMBRACE study, and to jointly evaluate the development of The analysis was based on 1419 patients enrolled from 2008-2015. Treatment included image guided adaptive brachytherapy (IGABT) and EBRT delivered either by 3- D conformal technique or IMRT/VMAT and chemotherapy. Prescribed doses were 45-50Gy in 1.8-2.0Gy fractions. If pathological lymph nodes were present, a boost to 55- 65Gy was given. Morbidity was assessed according to the CTCAE v.3 and PRO according to EORTC QLQ C30/CX24 at baseline, every 3 months (1 st year), every 6 months (2 nd and 3 rd year) and yearly thereafter. Bowel endpoints evaluated were diarrhea, flatulence, incontinence, stenosis and fistula, all graded from 0 to 5 (flatulence G0- G2). The related PRO was included with following reportings; “a little”, “quite a bit” and “very much”. Relevant cut-off values were applied to report CTCAE and PRO: G≥2 and G≥1 versus “very much” and ≥”a little”. Crude incidences, prevalences and actuarial estimates were calculated. Results Baseline morbidity (BM) and follow up (FUP) information was available for 1176 patients (PRO 942). Median follow up was 27 months, 63% were treated with 3-D CRT and 37% with IMRT/VMAT. Figure 1 illustrates the bowel symptoms with prevalence rates at 5 years for diarrhea at 24% for G≥1, and 4% for G≥2 (CTCAE). According to PRO, any patient reported diarrhea was 35% and 3% for “very much”. Both reached a plateau at a certain level during FUP. Incontinence occurred in 9% as G≥1 and 2% as G≥2. For PRO any patient reported difficulty in controlling bowel was 29% and 3% for “very much”, both with increasing prevalence during FUP. Crude incidences of severe diarrhea and incontinence (G≥3, CTCAE) were 1.5% and 0.4%, respectively. Sigmoid, small bowel and colon stenosis G≥2 were present in 16 patients with 12 being G3/G4 with only one morbidity-related death because of necrotizing enteritis. Fistula G≥2 were present in 6 patients. Crude incidences and actuarial estimates are shown in table 1. individual symptoms. Material and Methods

Conclusion According to the data assessed within the EMBRACE study, bowel morbidity is overall frequently reported, however, severe morbidity is limited. The results indicate that patients report higher burden of bowel symptoms, however no direct correlation is possible between both assessment methods. The challenge is to find a practical way of interpreting the complementary information from PRO regarding morbidity. The data illustrate that different methodologies for quantification of morbidity provide different results, with actuarial analysis indicating higher magnitude than prevalence rates. In the future, better methods for quantifying relevance and burden of symptoms are warranted to further improve our morbidity profile in cervix cancer patients.