Patient-reported outcomes from the BESPOKE CRC study.
Authors: Kasi Pashtoon Murtaza , Rivero Samuel , Aushev Vasily N. , Langer Nathan , Wang Christopher Gene , Cannon Timothy Lewis , Berim Lyudmyla Derby , Feinstein Trevor , Grothey Axel , McCollom Joseph William , Kalmadi Sujith R. , Zakari Ahmed , Dayyani Farshid , Gravenor Donald , Meyer Janelle Marie , Sharif Saima , Jurdi Adham A , Liu Minetta C. , Aleshin Alexey , Kopetz Scott 
Published: January 2024

54 Background: BESPOKE CRC is a multicenter, prospective, observational study that investigates the clinical utility of ctDNA for optimal use of adjuvant chemotherapy and early detection of recurrence in patients (pts) with surgically resected CRC. The perceived utility and impact ctDNA testing results have on pts’ anxiety about cancer recurrence is not entirely known. Herein, we formally report perceived utility and dimensions of well being that pts getting ctDNA testing reported. Methods: A total of 1792 pts with stages I–IV CRC were enrolled and followed for a median of 16.6 months with serial ctDNA analysis using a personalized, tumor-informed assay (SignateraTM, Natera, Inc.). An optional survey was collected at the time of enrollment and at 4 and 12 weeks (w), and 6, 12, 18 and 24 months (m) post-resection. The survey included: (1) Hospital Anxiety and Depression Scale (HADS), (2) Fear of Cancer Recurrence (FCR-4), (3) National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index-19 items (NCCN-FACT FCSI-19 version 2), and (4) ctDNA utility questionnaire (perceived utility and impact of ctDNA test results on pts’ anxiety about recurrence). The score ranges were: HADS: 0 (no) to 21 (valid) anxiety/depression; FCR-4: 0 (minimal) to 20 (maximum) fear of cancer recurrence; FCSI-19: 0 (severely symptomatic) to 76 (asymptomatic); ctDNA utility: 5=strongly agree, 4=agree, 3=neutral, 2=disagree, 1=strongly disagree. Results: A total of 1129/1123/1125/1136 responses from 414/413/413/418 pts were received for HADS/FCR-4/FCSI-19/ctDNA questionnaires, respectively. When compared between ctDNA-negative and -positive pts, FCR-4 and FCSI-19 surveys revealed marginal numerical differences in pts’ mean FCR-4/FCSI-19 scores, although statistically significant (FCR-4: 9.1 vs 10.4, p<0.01; FCSI-19: 58.6 vs. 53.8, p<0.001). No significant differences in the anxiety and depression scores (HADS) were found between ctDNA-negative and -positive pts. Irrespective of the ctDNA result, 89% of the responders said they valued the additional information received from ctDNA results, and 86% said they would continue using the ctDNA test to monitor cancer. Regardless of the ctDNA results, 74% of pts reported feeling they were receiving the right treatment after receiving their results. ctDNA results reduced anxiety about cancer recurrence in 62% of pts. Notably, ctDNA-negative pts felt less anxious of recurrence compared to ctDNA-positive pts (average score 4.01 vs 3.57, p<0.0001). Conclusions: Most responders valued the information they received through the personalized, tumor-informed ctDNA tests and would continue ctDNA testing. Pts with ctDNA positive results felt slightly more anxious about CRC recurrence, while ctDNA-negative pts reported reduced anxiety levels. Our results for the first time show the important dimensions of pt well being and perceived utility of ctDNA testing in pts with CRC. Clinical trial information: NCT04264702 .