| Abstract | Cilj istraživanja: Primarni ciljevi ovog istraživanja bili su procjena učinkovitosti liječenja TT dobivanjem rezultata preživljenja bez progresije (PFS), ukupnog preživljenja (OS) te objektivne stope odgovora (ORR).
Ispitanici i postupci: U ovo ispitivanje uključeno je 80 bolesnika (> 18 godina) s mCRC koji su liječeni s više linija kemoterapije, uključujući TT. Analizirali su se bolesnici koji su liječeni TT od 2017.-2021. U ispitivanje su bili uključeni ispitanici s mCRC i neuspjelim liječenjem prethodnom terapijom temeljenom na fluoropirimidinima, irinotekanu i oksaliplatini sa ili bez imunoterapije (bevacizumab, cetuksimab, panitumumab), a koji su progredirali nakon navedene terapije. Kriteriji uključivanja sudionika u istraživanje bili su kao i u studiji RECOURSE.
Rezultati: Tijekom razdoblja 2017.-2021. u Klinici za onkologiju i radioterapiju KBC-a Split liječilo se 58 muškaraca (72,5%) i 22 žene (27,5%), a medijan dobi iznosio je 66 godina (raspon; 48-85). Pema anatomskoj raspodjeli, ovisno o desnostranoj ili ljevostranoj zahvaćenosti kolona, lijevi kolon bio je zahvaćen u 67 bolesnika (83,75%) dok je desni kolon bio zahvaćen u 13 bolesnika (16,25%). S obzirom na molekularne značajke tumora, svima je određen profil tumora, bilo da se radilo o RAS mutiranom (41; 51,25%) ili RAS divljem tipu (39; 48,75%) tumora, koji ujedno određuju i vrstu primanja terapije. Najbolji odgovor na TT, prema RECIST kriterijima bio je stabilna bolest (SD) i zabilježena je kod 12 bolesnika (15%). Progesija bolesti (PD) zabilježena je kod 65 bolesnika (81,25%) liječenih TT. ORR iznosila je 0%, dok je stopa kontrole bolesti (CR+PR+SD) iznosila 15%. Od ukupnog broja ispitanika u vrijeme analize, 6 bolesnika je bilo živo (7,5%), a medijan ukupnog preživljenja (OS) iznosio je 6,8 mjeseci (raspon 1,17-11), dok PFS za TT iznosio 2,4 mjeseca.
Zaključci: Rezultati ovog istraživanja pokazuju da TT kao treća linija liječenja mCRC značajno utječe na produljenje PFS, što se podudara sa studijom RECOURSE. Nemjerljivost ORR stope u našoj studiji ukazuje da rezultati RCT ipak odudaraju od stvarne kliničke prakse. |
| Abstract (english) | Objectives: The main aim of this study was to evaluate the efficacy of TT treatment by obtaining the results of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR).
Patients and Methods: This retrospective study included 80 patients (> 18 years) with mCRC who were treated with multiple lines of chemotherapy, including TT. Patients who were treated with TT from 2017-2021 were analyzed. Subjects with mCRC and failed treatment with previous therapy based on fluoropyrimidines, irinotecan, and oxaliplatin with or without immunotherapy (bevacizumab, cetuximab, panitumumab) and who progressed after mentioned therapy were included in the trial. The criteria for the inclusion of participants in the research were the same as those in the RECOURSE study.
Results: During the period 2017-2021. 58 men (72.5%) and 22 women (27.5%) were treated at the Oncology and Radiotherapy Clinic of Split, and the median age was 66 years (range: 48-85). According to the anatomical distribution, depending on the right- or left-sided involvement of the colon, the left colon was affected in 67 patients (83.75%), while the right colon was affected in 13 patients (16.25%). Considering the molecular features of the tumor, a tumor profile was determined for all, whether it was a RAS mutated (41; 51.25%) or RAS wild type (39; 48.75%) tumor, which also determines the type of received therapy. The best response to TT, according to RECIST criteria, was stable disease (SD) and was recorded in 12 patients (15%). Disease progression (PD) was recorded in 65 patients (81.25%) treated with TT. The ORR was 0%, while the disease control rate (CR+PR+SD) was 15%. Of the total number of subjects at the time of analysis, 6 patients were alive (7.5%), and the median overall survival (OS) was 6.8 months (range 1.17-11), while PFS for TT was 2.4 months.
Conclusion: The results of this study show that TT as a third-line treatment for mCRC significantly affects the prolongation of PFS, which coincides with the RECOURSE study. The immeasurable ORR rate in our study indicates that the results of the RCT still deviate from the actual clinical practice. |
