ESTRO 37 Abstract book

ESTRO 37

S455

To review how physician-assessed late morbidity after radiotherapy is reported in large clinical studies. Material and Methods By October 2017, a literature search was conducted in PubMed restricted to 'Radiotherapy and Oncology” (RO) and 'International Journal of Radiation Oncology, Biology and Physics” (IJROBP) published during the last 2 years with the search terms: 'morbidity” OR 'toxicity” AND 'neoplasms” AND 'radiotherapy”. The result was filtered to include studies with ≥300 patients and reporting on physician-assessed late morbidity after radiotherapy (fig.1). The studies were analyzed for: cancer type, number of patients, morbidity data collection, median follow-up, morbidity scoring system, reporting method and grading, and additional patient-reported outcome measures (PROM).

Additional PROM were included in 5 studies.

Conclusion Crude/actuarial incidence is the most common method of reporting late morbidity in RO and IJROBP in the last 2 years. Prevalence is rarely reported and duration of symptoms hardly ever. Incidence methods assume inherently that late morbidity is chronic after first occurrence. However, as many symptoms are fluctuating or may either heal spontaneously or after successful medical interventions, incidence may not reflect the burden of morbidity. Prevalence rates display the time- course of symptoms; but not in individual patients. Furthermore, only 33% of the studies presented data on mild G1 morbidity and PROM were rarely used to compensate for the lack of information. The current methods of morbidity reporting do not take the manifestation pattern and duration over time into account and therefore may fail to reflect the overall long-term symptom burden in individual patients. PO-0868 Nivolumab in association with Radiation Therapy in patients with lung and kidney cancer I. Desideri 1 , V. Scotti 1 , J. Topulli 1 , M. Baki 1 , C. Moroni 2 , M. Perna 1 , C. Muntoni 1 , F. Meacci 1 , B. Agresti 1 , G. Francolini 1 , V. Miele 2 , L. Livi 1 1 University of Florence, Radiotherapy, Firenze, Italy 2 University of Florence, Radiology Unit, Firenze, Italy Purpose or Objective Nivolumab, an anti-PD-1 human monoclonal antibody is currently approved in different settings in solid tumours. Radiation therapy (RT) plays an essential role in the management of metastatic disease. Here we present the results from a prospective analysis, with the purpose of evaluating safety and feasibility of Nivolumab and RT concomitant association in a cohort of patients. Material and Methods Patients who initiated therapy with Nivolumab and concurrently received RT along the course of their systemic treatment were prospectively analyzed. Treatment timing was defined as concomitant whenever the interval between Nivolumab infusion and RT did not exceed 2 months. Nivolumab interruption was allowed only during RT course. RT was performed either for a

Results The search resulted in 559 papers, which were filtered to 36 studies according to the criteria above. Study characteristics are shown in table 1. Morbidity data collection was almost equally distributed between retrospective (17 studies, 47%) and prospective (19 studies, 53%). Two thirds of studies recorded morbidity with the Common Toxicity Criteria for Adverse Events (CTCAE). Morbidity was reported in terms of crude incidences representing the worst grade over all follow-up observations (29 studies, 81%); actuarial estimates displaying the probability for the first occurrence of certain grades in accounting for patients at risk (22 studies, 61%) and prevalence rates representing the morbidity grades at one follow-up time point (3 studies, 16% of prospective studies). Reporting on duration of late morbidity was presented in one study through 'time to resolution”. Different grades of severity were presented in 32 studies, whereas four studies reported just the presence/absence of certain symptoms. Twelve studies presented data on all grading categories (G1,G2,G≥3), nine studies on moderate and severe morbidity only (G2,G≥3); and 6 studies on severe morbidity only (G≥3); five studies pooled data as either G2-5 (n=3) or all grades (n=2).