Primary results of the AGO-Zervix-1 Study: A prospective, randomized phase III study to compare the effects of paclitaxel and topotecan with those of cisplatin and topotecan in the treatment of patients with recurrent and persistent cervical cancer.

Autor: Gass P; Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany. Electronic address: paul.gass@uk-erlangen.de., Thiel FC; Department of Gynecology and Obstetrics, Alb Fils Clinics, Klinik am Eichert, Göppingen, Germany., Häberle L; Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany; Biostatistics Unit, Department of Gynecology and Obstetrics, Erlangen University Hospital, Erlangen, Germany., Ackermann S; Department of Gynecology and Obstetrics, Klinikum Darmstadt, Darmstadt, Germany., Theuser AK; Institut für Frauengesundheit GmbH, Erlangen, Germany., Hummel N; Institut für Frauengesundheit GmbH, Erlangen, Germany., Boehm S; Institut für Frauengesundheit GmbH, Erlangen, Germany., Kimmig R; Department of Gynecology and Obstetrics, Essen University Hospital, Essen, Germany., Reinthaller A; Department of Gynecology and Gynecologic Oncology, AKH Vienna University Hospital, Vienna, Austria., Becker S; Department of Gynecology and Obstetrics, Frankfurt University Hospital, Frankfurt am Main, Germany., Hilpert F; Onkologisches Therapiezentrum, Krankenhaus Jerusalem, Hamburg, Germany., Janni W; Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany., Vergote I; Department of Gynaecology and Obstetrics, Division of Gynaecological Oncology, Leuven University Hospitals, Leuven, Belgium., Harter P; Department of Gynecology & Gynecologic Oncology, Ev. Kliniken Essen-Mitte, Essen, Germany., Emons J; Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany., Hein A; Department of Gynaecology and Obstetrics, Klinikum Esslingen, Esslingen, Germany., Beckmann MW; Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany., Fasching PA; Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany., Pöschke P; Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany.
Jazyk: angličtina
Zdroj: Gynecologic oncology [Gynecol Oncol] 2024 Apr; Vol. 183, pp. 25-32. Date of Electronic Publication: 2024 Mar 14.
DOI: 10.1016/j.ygyno.2024.03.002
Abstrakt: Background: Before the era of immunotherapies and antibody-drug conjugates, there were limited chemotherapeutic options for patients with recurrent and metastatic cervical cancer. Combination therapies with cisplatin have shown some superiority over monotherapy. This study examined platinum-free treatment regimens, comparing a combination of topotecan and paclitaxel (TP) with topotecan and cisplatin (TC) in patients with recurrent or metastatic cervical cancer, with or without prior platinum-based treatment.
Methods: The AGO-Zervix-1 Study (NCT01405235) is a prospective, randomized phase III study in which patients were randomly assigned at a 1:1 ratio to treatment within the control arm with topotecan (0.75 mg/m 2 ) on days 1-3 and cisplatin (50 mg/m 2 ) on day 1 every 3 weeks and in the study arm topotecan (1.75 mg/m 2 ) and paclitaxel (70 mg/m 2 ) on days 1, 8, and 15 every 4 weeks or treatment. The primary study aim was overall survival; progression-free survival, toxicity, and quality of life were secondary aims. The interim and final analysis is here reported after recruitment of 173 of 312 planned patients.
Results: Median overall survival in the TP arm was 9.6 months, compared with 12.0 months in the TC arm (log-rank test, P = 0.33). Median progression-free survival rates were 4.4 months with TP and 4.2 months with TC (log-rank test, P = 0.47). Leukopenia and nausea/vomiting were more frequent in the cisplatin-containing arm. Otherwise, toxicity profiles were comparable. There were no differences in FACT-G-assessed quality of life.
Conclusion: Platinum-based combination chemotherapy remains the standard of care chemotherapy regimen for patients with recurrent or metastatic cervical cancer.
Competing Interests: Declaration of competing interest P.G. has received honoraria from Novartis, MSD, and AstraZeneca. I.V. reports Consulting fees from Agenus, AstraZeneca, Bristol Myers Squibb, Eisai, Genmab, GSK, Immunogen, Karyopharm, Mersana, MSD, Molecular Partners, Novocure, Novartis, Oncoinvent, Regeneron, Seagen, Verastem Oncology, Zai Lab, Zentalis. P.H. declares honoraria from Amgen, Astra Zeneca, GSK, Roche, Sotio, Stryker, Zai Lab, MSD, Clovis, Eisai, Mersana, Exscientia, Advisory Board participations from Astra Zeneca, Roche, GSK, Clovis, Immunogen, MSD, Miltenyi, Novartis, Eisai and Research Funding (Inst) from Astra Zeneca, Roche, GSK, Genmab, DFG, European Union, DKH, Immunogen, Seagen, Clovis, Novartis. The other authors have no conflicts of interest to declare.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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