TY  - JOUR
A1  - Diefenhardt, Markus
A1  - Martin, Daniel
A1  - Ludmir, Ethan B.
A1  - Fleischmann, Maximilian
A1  - Hofheinz, Ralf-Dieter
A1  - Ghadimi, Michael
A1  - Kosmala, Rebekka
A1  - Polat, Bülent
A1  - Friede, Tim
A1  - Minsky, Bruce D.
A1  - Rödel, Claus
A1  - Fokas, Emmanouil
T1  - Development and validation of a predictive model for toxicity of neoadjuvant chemoradiotherapy in rectal cancer in the CAO/ARO/AIO-04 phase III trial
JF  - Cancers
N2  - Background: There is a lack of predictive models to identify patients at risk of high neoadjuvant chemoradiotherapy (CRT)-related acute toxicity in rectal cancer. Patient and Methods: The CAO/ARO/AIO-04 trial was divided into a development (n = 831) and a validation (n = 405) cohort. Using a best subset selection approach, predictive models for grade 3–4 acute toxicity were calculated including clinicopathologic characteristics, pretreatment blood parameters, and baseline results of quality-of-life questionnaires and evaluated using the area under the ROC curve. The final model was internally and externally validated. Results: In the development cohort, 155 patients developed grade 3–4 toxicities due to CRT. In the final evaluation, 15 parameters were included in the logistic regression models using best-subset selection. BMI, gender, and emotional functioning remained significant for predicting toxicity, with a discrimination ability adjusted for overfitting of AUC 0.687. The odds of experiencing high-grade toxicity were 3.8 times higher in the intermediate and 6.4 times higher in the high-risk group (p < 0.001). Rates of toxicity (p = 0.001) and low treatment adherence (p = 0.007) remained significantly different in the validation cohort, whereas discrimination ability was not significantly worse (DeLong test 0.09). Conclusion: We developed and validated a predictive model for toxicity using gender, BMI, and emotional functioning. Such a model could help identify patients at risk for treatment-related high-grade toxicity to assist in treatment guidance and patient participation in shared decision making.
KW  - rectal cancer
KW  - toxicity
KW  - neoadjuvant
KW  - chemoradiotherapy
KW  - risk score
Y1  - 2022
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-288081
SN  - 2072-6694
VL  - 14
IS  - 18
ER  -