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

Gynecol Oncol. 2024 Apr:183:25-32. doi: 10.1016/j.ygyno.2024.03.002. Epub 2024 Mar 14.

Abstract

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/m2) on days 1-3 and cisplatin (50 mg/m2) on day 1 every 3 weeks and in the study arm topotecan (1.75 mg/m2) and paclitaxel (70 mg/m2) 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.

Keywords: Cervical cancer; Cisplatin; Metastatic; Paclitaxel; Recurrent; Topotecan.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols* / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Cisplatin* / administration & dosage
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local* / drug therapy
  • Paclitaxel* / administration & dosage
  • Paclitaxel* / adverse effects
  • Progression-Free Survival
  • Prospective Studies
  • Quality of Life
  • Topotecan* / administration & dosage
  • Uterine Cervical Neoplasms* / drug therapy
  • Uterine Cervical Neoplasms* / pathology

Substances

  • Paclitaxel
  • Topotecan
  • Cisplatin

Associated data

  • ClinicalTrials.gov/NCT01405235