ASCO Meeting Abstracts
Final analysis of the Greek cohort of the AGENT phase III study arfolitixorin in metastatic colorectal cancer
A. Koumarianou1, E. Bournakis2, A. Kotsakis3, A. Ntavatzikos1, K. Kamboli1, N. Kentepozidis4, L. Skintemo5, R. Tell6, C. Papadimitriou7
1Hematology Oncology Unit, 4th Internal Medicine Department, Attikon University Hospital, Haidari, Greece; 2Oncologic Clinical Trials and Research Clinic, Metropolitan General Hospital, Cholargos, Greece; 3Medical Oncology Department, University of Thessaly, Larissa, Greece; 4Medical Oncology, 251 Hellenic Airforce General Hospital, Athens, Greece; 5Clinical Trial, Isofol Medical AB, Gothenburg, Sweden; 6R&D Department, Isofol Medical AB, Göteborg, Sweden; 7Oncology Unit, University of Athens – Aretaieio Hospital, Athens, Greece
Background: The AGENT trial, a pivotal international randomized phase III study (NCT03750786; Tabernero et al., 2024), investigated arfolitixorin in metastatic colo- rectal cancer (mCRC). This study presents the final analysis focusing on the Greek patient subpopulation.
Methods: Patients with mCRC were randomized to receive arfolitixorin (Arm A: 120 mg/m2 given as two intravenous bolus doses) or leucovorin (Arm B: 400 mg/m2 as a single intravenous infusion), both in combination with 5-FU, oxaliplatin, and bev- acizumab. Response assessments were conducted every 8 weeks by blinded inde- pendent central review (BICR), and toxicity was reported according to MedDRA Version 22.1. The primary endpoint was ORR per RECIST v1.1 by BICR. Key secondary endpoints included PFS, DoR, OS, and safety.
Results: A total of 59 patients were included, with 24 in Arm A and 35 in Arm B. The mean age was 63.8 years, all Caucasians, and 84.5% had ECOG PS 0. Molecular profiling for BRAF, KRAS, and NRAS revealed frequencies of 6.1%, 55.6%, and 7.8%, respectively. Compared to Arm B, patients in Arm A exhibited higher ORR [41.7% (95% CI:22.1%, 63.4%) vs. 37.1% (95% CI:21.5%, 55.1%)], superior DoR [18.6 (5.3, NR$) vs.9.9 (5.1, 14.8)], longer median PFS [13.1 vs. 7.6 months; HR (95% CI):0.554(0.261, 1.176)], and a trend toward improved OS [not reached vs. 28.6 months; HR (95% CI):0.732(0.325, 1.649)]. Grade !3 drug-related AE rates were similar between arms, with fatigue (53.4%), hematologic toxicity (53.4%), nausea (50%), and sensory neuropathy (27.6%) being the most frequently reported. However, only one patient discontinued treatment in Arm A compared to three in Arm B. Notably, efficacy and survival outcomes in this Greek analysis were inversely pro- portional to those of the overall study population, highlighting potential regional variations.
Conclusions: The AGENT trial did not demonstrate clinical superiority of arfolitixorin over leucovorin in first-line therapy for mCRC. Nonetheless, this analysis suggests potential benefits associated with arfolitixorin in the Greek population, possibly influenced by regional and genetic factors. Limitations, including the small sample size, warrant cautious interpretation of these findings.
Clinical trial identification: NCT03750786.
Legal entity responsible for the study: The authors. Funding: Isofol Medical AB, Gothenburg, Sweden.
Disclosure: A. Koumarianou: Financial Interests, Institutional, Research Grant: Merck. E. Bournakis: Financial Interests, Personal, Invited Speaker: Janssen. L. Skintemo, R. Tell: Other, Personal, Full or part-time Employment: Isofol Medical. All other authors have declared no conflicts of interest.
https://doi.org/10.1016/j.annonc.2024.05.044
Authors:
Nikolaos Tsoukalas, Athina Christopoulou, Christos N. Papandreou, Anna Koumarianou, Ilias Athanasiadis, Stavros Peroukidis, Georgios Samelis, Amanda Psyrri, Nikolaos Kapodistrias, Achilleas Nikolakopoulos, Charalampos Andreadis, Alexandros Ardavanis, Epaminondas Samantas, Alexandros Bokas, Barbounis Vassilios, Nikolaos K. Kentepozidis, Dimitrios Mavroudis, Athanasios Athanasiadis, Pavlos Papakotoulas, Ioannis Boukovinas
ACT for prevention and prophylaxis of cancer-associated thrombosis (CAT). 2020
Authors:
Nikolaos Tsoukalas, Athina Christopoulou, Christos N Papandreou, Nikolaos Kapodistrias, Anna Koumarianou, Stavros Peroukidis, Haralabos Kalofonos, Georgios Samelis, Charalampos Andreadis, Alexandros Ardavanis, Epaminontas Samantas, Alexandros Bokas, Athanasios Ligdas, Ilias Athanasiadis, Vasileios Barbounis, Nikolaos K. Kentepozidis, Dimitrios Mavroudis, Athanasios Athanasiadis, Pavlos Papakotoulas, Ioannis Boukovinas;
Authors:
Ioannis Sougklakos, Ioannis Boukovinas, Spyros Xynogalos, Stylianos Kakolyris, Nikolaos Ziras, Michael Vaslamatzis, Athanasios Athanasiadis, Alexandros Ardavanis, Nikolaos E. M. Androulakis, Athina Christopoulou, Paris Makrantonakis, Iliada Bompolaki, Charalampos Christofyllakis, Nikolaos K. Kentepozidis, Christos E. Emmanouilides, Charalambos Kouroussis, Efthimios Prinarakis, Ageliki Kalisperi, Dimitrios Mavroudis, Vassilis Georgoulias;
Authors:
Michail Nikolaou, Nikolaos Ziras, Ilias Athanasiadis, Alexandros Ardavanis, Michael Vaslamatzis, Nikolaos K. Kentepozidis, Paris Makrantonakis, Athina Christopoulou, Vasiliki Michalaki, Aristidis Polyzos, Christos E. Emmanouilides, Nikolaos Vardakis, Athanasios Kotsakis, Vassilis Georgoulias;
Implications of KRAS status in first-line chemotherapy with bevacizumab in advanced colorectal cancer: A phase IV study of Hellenic Oncology Research Group (HORG). Authors: Anna Koumarianou, Nikolaos Ziras, Stylianos Kakolyris, Michael Vaslamatzis, Aristidis Polyzos, Nikolaos K. Kentepozidis, Athina Christopoulou, Spyros Xynogalos, Athanasios Athanasiadis, Ilias Athanasiadis, Athanasios Anagnostopoulos, Athanasios Karampeazis, Christos E. Emmanouilides, Ioannis Boukovinas, Paris Makrantonakis, Charalambos Kouroussis, Efthimios Prinarakis, Dora Hatzidaki, Vassilis Georgoulias; Hellenic Oncology Research Group (HORG), Athens, Greece; Hellenic Oncology Research Group (HORG), Athens, AZ, Greece.J Clin Oncol 36, 2018 (suppl; abstr e15521). http://abstracts.asco.org/214/AbstView_214_220989.html
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A phase II trial of cabazitaxel in patients with metastatic NSCLC progressing after docetaxel-based treatment. , , , , , , , , , , , and
A multicenter phase I-II trial of weekly paclitaxel and carboplatin plus bevacizumab in women with triple-negative metastatic breast cancer. , , , , , , , , and
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