Feasibility of implementation of the early tumor shrinkage as a potential predictive marker to daily clinical practice in patients with RAS wild type metastatic colorectal cancer, treated with cetuximab – a non-interventional observational study

Czech version

Authors: J. Fínek ¹; M. Vočka ²; J. Bauer ²; E. Kubala ³; K. Zycháčková ⁴; M. Šedivá ⁵; M. Gharibyar ⁴; I. Kocáková ⁶; E. Čmuchařová ⁷; M. Vaňková ⁸
Authors‘ workplace: Department of Oncology and Radiotherapy, Faculty of Medicine in Pilsen, University Hospital in Pilsen, Charles University, Czech Republic ¹; Department of Oncology, First Faculty of Medicine, Charles University, and General University Hospital in Prague, Czech Republic ²; Department of Oncology and Radiotherapy, Faculty of Medicine in Hradec Králové and University Hospital Hradec Králové, Czech Republic ³; Department of Oncology, Baťa Hospital Zlín, Czech Republic ⁴; Institute of Radiation Oncology, Bulovka University Hospital, Czech Republic ⁵; Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, and Faculty of Medicine, Masaryk University, Czech Republic ⁶; Oncology Department, Masaryk Hospital, Ústí nad Labem, Czech Republic ⁷; Oncology Clinic, Hospital AGEL Karviná, Czech Republic ⁸
Published in: Klin Onkol 2024; 38(2): 110-117
Category: Original Articles
doi: https://doi.org/10.48095/ccko2024110

Overview

Background: With the aim to show the feasibility of early tumor shrinkage (ETS) concept implementation into daily clinical practice in the Czech Republic, a non-interventional, multicentric, single arm, prospective study in real world set-up was performed. Material and methods: The study objectives were to explore the time interval from the treatment starting date to the date of the first radiographic control (TFRC) and evaluate the proportion of patients who achieved ≥ 20% tumor regression within the first 8 weeks of first-line therapy, in the real-world settings. Results: The medians of TFRC in all individual participating centers were > 12 weeks (range 14.0–36.4 weeks). TFRC ≤ 8 weeks was reported for only 3% of patients in the cohort with first-line therapy, and there were only 3 patients (1%) who achieved tumor regression of ≥ 20% by day 60 (8.6 weeks). Conclusion: These findings indicate that the basic time parameter of ETS could not realistically be employed in routine oncology care of patients with metastatic colorectal cancer (mCRC) in the Czech Republic, unless there would be a strict request to perform TRFC by week 8 since the initiation of the therapy. In addition, the frequency of objective tumor response to first-line therapy with cetuximab + chemotherapy was evaluated. Based on the relative regression in the sum of diameters of measurable metastatic lesions, unconfirmed partial responses were achieved in 42.4 % and unconfirmed complete response in 8.6% of patients, altogether corresponding to the overall response rate of 51% with first-line therapy. The frequency of responses was higher among patients with left than right sided primary tumors. It seems that the regimen of cetuximab/FOLFOX might be more active in frontline therapy of right sided RAS wild type mCRC than cetuximab/FOLFIRI.

Keywords:

colorectal cancer – Chemotherapy

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