Real-life data on treatment and outcomes in advanced ovarian cancer: An observational, multinational cohort study (RESPONSE trial)

Christian Marth*, Miguel Henriques Abreu, Klaus Kaae Andersen, Karoliina M Aro, Maria de Lurdes Batarda, Dorry Boll, Anne Weng Ekmann-Gade, Ulla-Maija Haltia, Jesper Hansen, Ala Jabri Haug, Claus Høgdall, Jacob Korach, Heini Lassus, Kristina Lindemann, Els Van Nieuwenhuysen, Petronella B Ottevanger, Stephan Polterauer, Tine Henrichsen Schnack

*Corresponding author for this work

Abstract

BACKGROUND: This study aimed to describe the treatment strategies and outcomes for women with newly diagnosed advanced high-grade serous or endometrioid ovarian cancer (OC).

METHODS: This observational study collected real-world medical record data from eight Western countries on the diagnostic workup, clinical outcomes, and treatment of adult women with newly diagnosed advanced (Stage III-IV) high-grade serous or endometrioid OC. Patients were selected backward in time from April 1, 2018 (the index date), with a target of 120 patients set per country, followed for ≥20 months.

RESULTS: Of the 1119 women included, 66.9% had Stage III disease, 11.7% had a deleterious BRCA mutation, and 26.6% received bevacizumab; 40.8% and 39.3% underwent primary debulking surgery (PDS) and interval debulking surgery (IDS), respectively. Of the patients who underwent PDS, 55.5% had no visible residual disease (VRD); 63.9% of the IDS patients had no VRD. According to physician-assessed responses (at the first assessment after diagnosis and treatment), 53.2% of the total population had a complete response and 25.7% had a partial response to first-line chemotherapy after surgery. After ≥20 months of follow-up, 32.9% of the patients were disease-free, 46.4% had progressive disease, and 20.6% had died. Bevacizumab use had a significant positive effect on overall survival (hazard ratio [HR], 0.62; 95% CI, 0.42-0.91; p = .01). A deleterious BRCA status had a significant positive effect on progression-free survival (HR, 0.60; 95% CI, 0.41-0.84; p < .01).

CONCLUSIONS: Women with advanced high-grade serous or endometrioid OC have a poor prognosis. Bevacizumab use and a deleterious BRCA status were found to improve survival in this real-world population.

LAY SUMMARY: Patients with advanced (Stage III or IV) ovarian cancer (OC) have a poor prognosis. The standard treatment options of surgery and chemotherapy extend life beyond diagnosis for 5 years or more in only approximately 45% of patients. This study was aimed at describing the standard of care in eight Western countries and estimating how many patients who are diagnosed with high-grade serous or endometrioid OC could potentially be eligible for first-line poly(adenosine diphosphate ribose) polymerase inhibitor (PARPi) maintenance therapy. The results highlight the poor prognosis for these patients and suggest that a significant proportion (79%) would potentially be eligible for first-line PARPi maintenance treatment.

Original languageEnglish
JournalCancer
Volume128
Issue number16
Pages (from-to)3080-3089
Number of pages10
ISSN0008-543X
DOIs
Publication statusPublished - 15 Aug 2022

Keywords

  • Adult
  • Bevacizumab
  • Carcinoma, Endometrioid/drug therapy
  • Carcinoma, Ovarian Epithelial/drug therapy
  • Cohort Studies
  • Female
  • Humans
  • Neoplasm, Residual
  • Ovarian Neoplasms/drug therapy
  • Progression-Free Survival
  • ovarian cancer
  • real-world data
  • bevacizumab
  • poly(adenosine diphosphate ribose) polymerase (PARP) inhibitor
  • first-line treatment

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