Quality of life following TNT of rectal cancer in the CAO/ARO/AIO-12 phase 2 trial
OC-0273
Abstract
Quality of life following TNT of rectal cancer in the CAO/ARO/AIO-12 phase 2 trial
Authors: Rebekka Kosmala1, Emmanouil Fokas2, Adriana Salazar Hammann1, Patrick Paulus1, Michael Flentje1, Christoph-Thomas Germer3, Michael Ghadimi4, Ralf-Dieter Hofheinz5, Markus Diefenhardt2, Claus Rödel2, Bülent Polat1
1University Hospital Würzburg, Department of Radiation Oncology, Würzburg, Germany; 2University of Frankfurt, Department of Radiotherapy and Oncology, Frankfurt, Germany; 3University Hospital Würzburg, Department of General and Visceral Surgery, Würzburg, Germany; 4University Medical Center Göttingen, Department of General and Visceral Surgery, Göttingen, Germany; 5University Hospital Mannheim, Department of Medical Oncology, Mannheim, Germany
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Purpose or Objective
In a German phase 2, randomised multicentre trial the sequence of neoadjuvant chemoradiotherapy (CRT) followed by consolidation chemotherapy (CT) before total mesorectal excision showed a higher pathological complete response than induction CT before CRT. Here, we present detailed 3-year results on patient reported quality of life (QoL) of disease-free patients.
Material and Methods
Between June, 2015, and January, 2018, patients with rectal carcinoma (cT3-4 and/or node-positive) were randomly assigned to group A (induction CT with fluorouracil, leucovorin and oxaliplatin followed by CRT to 50.4 Gy with fluorouracil and oxaliplatin) and group B (CRT followed by CT). This is a secondary analysis on QoL of disease-free patients, which was measured before treatment, at the end of CT (group A) or CRT (group B), one week before surgery (123 days after start of treatment), after surgery and during follow-up (FU: 6 months, 1, 2 and 3 years) by using the EORTC QLQ-C30 and colorectal module CR29. ClinicalTrials.gov identifier: NCT02363374.
Results
Available questionnaires at baseline were 84.6% (n=132) in group A vs. 87.3% (n=131) in group B, 83.0% (n=93) vs. 77.5% (n=79) at 1 year, 76.5% (n=78) vs. 78.9% (n=71) at 2 years, and 67.4% (n=60) vs. 71.8% (n=56) at 3 years. The EORTC summary score was stable in both groups (range 0 to 100): baseline: group A mean 82.2 (SEM +/- 1.2) and group B 82.1 (SEM +/- 1.4); at 3 years: group A 78.6 (SEM +/- 1.9) and group B 76.9 (SEM +/- 2.1). Nausea/vomiting was more pronounced at the end of induction CT in comparison to baseline (group A: 19.1 vs. 2.4 at baseline). Urinary frequency showed poorer patient reported outcome right after CRT (group B: 47.8 vs. 33.6 at baseline). One week before surgery and at all following time-points, no clinically relevant differences (more than 10 points) between groups were found in QoL domains. In both arms role and body function declined and did not fully recover during FU (difference from baseline to 3 years of 10-15 points).
Conclusion
Overall QoL showed no clinically relevant difference between the two sequences of total neoadjuvant treatment at any time-point. As expected reported nausea/vomiting was worse at the end of induction CT as measured in group A and urinary urge was more pronounced right after radiotherapy as measured in group B. In both arms certain dimensions of QoL showed permanent, moderate deterioration during FU.