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Bevacizumab (Bev) plus chemotherapy is a standard first-line treatment in metastatic colorectal cancer (mCRC), however to date no predictive factors of response have been identified. Results of our previous analysis on patients enrolled in a randomized prospective phase III multicenter study (ITACa study) showed a predictive value of Vascular Endothelial Growth Factor (VEGF) polymorphism (VEGF + 936), a 27-nucleotide variable number tandem repeat (VNTR) of the endothelial nitric oxide synthase (eNOS) gene and eNOS + 894 polymorphism. mCRC patients, treated with Bev plus chemotherapy, were included in this prospective validation trial. eNOS + 894G > T was analyzed by Real time PCR, while the eNOS VNTR and VEGF + 936C > T were determined by standard PCR and direct sequencing analysis. These polymorphisms were assessed in relation to progression-free survival (PFS), overall survival (OS) and objective response rate (ORR). These three polymorphisms were not predictive of PFS (p 0.91, 0.59 and 0.09, respectively), and OS (p 0.95, 0.32 and 0.46, respectively). Moreover, the haplotype analyses did not confirm what was found in our previous study; patients bearing a specific haplotype of eNOS had not significantly improved outcomes. This prospective study failed to validate the predictive impact of eNOS and VEGF polymorphisms for response to Bev plus first-line chemotherapy in mCRC patients.

IntroductionONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours.Methods and analysisThis is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher’s exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs.Ethics and disseminationEthical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations.Protocol versionVersion 2, 6 April 2021.Trial registration numberNCT04826458.

BACKGROUND The use of oral treatments is constantly growing in the area of onco-hematology, raising adherence and safety issues. There is an increasing body of literature highlighting the importance of patient empowerment in the self-management of cancer therapies. Within this scenario, the ONCO-TreC platform was customized and fine-tuned through a prospective multicenter training-validation study in cancer patients treated with oral anticancer drugs. OBJECTIVE This prospective randomized trial was designed to compare the effectiveness of two different strategies, ie, an electronic diary (ONCO-TreC) and a paper diary, for the management of oral cancer treatments in patients with solid and hematological tumors. METHODS Ad hoc strategies are planned to measure and monitor adherence to treatment and to assess usability and acceptability of the electronic diary. Informed consent will be obtained from all study participants. RESULTS This innovative eHealth system is expected to contribute to increasing the adherence to and safety of cancer care, promoting patient empowerment and improving patient-doctor communication. Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol no. 2982/2020; reference no. 2108). CONCLUSIONS Findings will be disseminated through peer-reviewed journals, conferences and event presentations. CLINICALTRIAL ClinicalTrials.gov NCT04826458; Institutional ID no. IRST100.28