Follow-up after surgery for liver metastases: the FUTURE-mets study

To date no evidence-based surveillance protocol after surgical treatment of colorectal liver metastasis (CRLM) has been developed, mostly due to the lack of prospectively gathered data. The current standard of care follow-up approach in most hospitals consists of regular clinical evaluation, carcinoembryonic antigen (CEA) monitoring and medical imaging (thoracoabdominal CT-scans and/or MRI). However, current literature indicates that follow-up could mainly be based on CEA monitoring and that other diagnostic modalities have little additional value, with regards to survival outcomes.
As frequent multimodality surveillance does not seem to result in better survival outcomes, improvement of follow-up should focus on optimizing patients’ quality of life, rather than survival. A patient-controlled follow-up scheme, mainly consisting of CEA level monitoring at home, might be feasible and beneficial from both a patient and societal perspective, especially in light of the worldwide COVID-19 pandemic. In view of the increasing importance of value based healthcare, patient reported outcomes, and mandatory national social distancing measures, evaluation of such a surveillance programme is needed.
The current prospective study aims to evaluate a patient-controlled surveillance strategy. We hypothesize that a patient-controlled follow-up after surgical treatment of CRLM is non-inferior in quality of life outcomes compared to reference values for recurrent/metastatic CRC patients.

Study design: A multicentre prospective study.

A patient-controlled follow-up after surgery for colorectal liver metastasis mainly consisting of CEA assessments at home improves quality of life outcomes and reduces anxiety and fear of cancer recurrence when compared to the current standard of care follow-up, while maintaining an equal or greater cost-effectiveness and with no expected differences in overall or cancer-specific survival outcomes.

All of the retrospective questionnaires, with the exception of the ASC-CW, will be completed at baseline and every 6 months thereafter until the end of the study (3 years after inclusion) or when patients leave the study due to disease recurrence. The ASC-CW scale will be completed once at 12 months following inclusion and in case of no disease recurrence.
In case of disease recurrence patients are requested to complete the QLQ-C30, STAI-6 and EQ-5D-5L at time of disease recurrence and once six-months thereafter. If disease recurrence is found before 12 months after inclusion, subjects are no longer requested to complete the ASC-CW. The ecological momentary assessment of momentary quality of life will be performed for the entire duration of the study, regardless of disease recurrence.

In order to determine non-inferiority in quality of life 138 patients need to be included in the study.
Follow-up will be performed for up to 3 years after enrolment. Patients will enroll in a patient-controlled surveillance strategy. In this study blood sampling will be performed at home by the patients themselves using a self-administered blood-sampling kit. Serum CEA monitoring will be performed every 3 months during the first 2 years of follow-up after enrolment and every 6 months thereafter. Further clinical and diagnostic evaluation will be performed in case of symptoms, CEA levels above 5 μg/L or a greater than 25% increase of CEA levels compared to the prior measurement. Patients will have one planned in hospital evaluation with medical imaging (CT and/or MRI) 1 year after enrolment. In case of normal CEA values, patients decide whether clinical evaluation will be performed.