The treatment of cancer may be improved by testing the chemo sensitivity of cancer cells obtained from the patient’s tumor. 3D culture represents a promising method for modeling of patient tumors in vitro. The purpose of this study was to test the feasibility of a clinical trial offering patients with metastatic colorectal cancer treatment based on in-vitro testing anti-cancer therapy sensitivity.
Main inclusion criteria were stage IV colorectal cancer, PS 0-1, previous exposure to 5FU, oxaliplatin, irinotecan, bevacizumab and, if RAS/RAF wild-type, an EGFR inhibitor. Fresh cancer tissues from metastases were cultivated as tumoroids. The culturing protocol which was originally developed for resected tissue was optimized for the smaller tissue amounts received from needle biopsies. Ten patients were to be included and at least five of them to have clinically applicable results in order for the procedure to be feasible.
Ten patients were included from September to December 2017 in one institution. Biopsies were from liver (6), peritoneum (2), retroperitoneum (1) and lung (1). Rebiopsies were allowed and a total of 19 biopsy sessions were performed with ultrasound (14), CT (3) or sigmoidoscopy (2). In seven cases, the biopsy, tumorsphere formation and sensitivity testing was successful. Median time from biopsy to result was 34 days (range 19-50). A notable challenge was obtaining sufficient viable tumor tissue resulting in increased culture times or the need for re-biopsies.
This is the first clinical study of its kind. The method of selecting last-line treatment of colorectal cancer based on fresh biopsies was feasible as results were obtained in seven out of ten cases. The trial is now extended to a phase II trial with PFS as the primary endpoint.
Clinical trial identification
Legal entity responsible for the study
Lars Henrik Jensen.
L.H. Jensen: Travel grants: Roche, Amgen, Bayer. G. Hagel, H. Harling, O. Thastrup: 2cureX. All other authors have declared no conflicts of interest.