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Review
Outcomes and endpoints of relevance in gynecologic cancer clinical trials
  1. Ainhoa Madariaga1,
  2. Rodrigo Sanchez-Bayona1,
  3. Fernanda G Herrera2,
  4. Pedro T Ramirez3 and
  5. Antonio González Martín4
  1. 1 Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain
  2. 2 Department of Oncology, Radiation Oncology Service, Centre Hospitalier Universitaire Vaudois CHUV-UNIL, Ludwig Institute for Cancer Research and AGORA Cancer Research Center, Lausanne, Switzerland
  3. 3 Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, Texas, USA
  4. 4 Department of Medical Oncology, Cancer Center Clinica Universidad de Navarra, Madrid, Spain
  1. Correspondence to Dr Ainhoa Madariaga, Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, 28041, Spain; ainhoa.madariaga{at}salud.madrid.org

Abstract

Drug development is paramount to improve outcomes in patients with gynecologic cancers. A randomized clinical trial should measure whether a clinically relevant improvement is detected with the new intervention compared with the standard of care, using reproductible and appropriate endpoints. Clinically meaningful improvements in overall survival and/or quality of life (QoL) are the gold standards to measure benefit of new therapeutic strategies. Alternative endpoints, such as progression-free survival, provide an earlier measure of the effect of the new therapeutic drug, and are not confounded by the effect of subsequent lines of therapy. Yet, its surrogacy with improved overall survival or QoL is unclear in gynecologic malignancies. Of relevance to studies assessing maintenance strategies are other time-to-event endpoints, such as progression-free survival two and time to second subsequent treatment, which provide valuable information on the disease control in the longer term. Translational and biomarker studies are increasingly being incorporated into gynecologic oncology clinical trials, as they may allow understanding of the biology of the disease, resistance mechanisms, and enable a better selection of patients who might benefit from the new therapeutic strategy. Globally, the endpoint selection of a clinical trial will differ according to the type of study, population, disease setting, and type of therapeutic strategy. This review provides an overview of primary and secondary endpoint selection of relevance for gynecologic oncology clinical trials.

  • Ovarian Cancer
  • Endometrial Neoplasms
  • Cervical Cancer
  • Quality of Life (PRO)/Palliative Care

https://doi.org/10.1136/ijgc-2022-003727

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    Footnotes

    • Twitter @AinhoaMada, @pedroramirezMD

    • Contributors Conceptualization: AM. Writing – original draft: AM, RS-B. Writing – review and editing: all authors.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests AM: AstraZeneca (Advisory Board, speaker), GSK (Advisory Board, speaker, travel and accommodation), Clovis (speaker) and PharmaMar (Advisory Board). RS-B: Novartis (Advisory Board, speaker), AstraZeneca (speaker, travel and accommodation), MSD (speaker), Lilly (Advisory Board, speaker), GSK (Advisory Board, speaker, travel and accommodation), Clovis (speaker), Seagen (speaker), Pfizer (travel and accommodation). FH: research support from BMS and the Prostate Cancer Foundation, travel and accommodation support from Johnson & Johnson, leadership or fiduciary roles in Roche-ImFlame/ImCore, chairman of EORTC Gynecology Cancer Group. AGM: ALKERMES (Advisory Board, personal), AMGEN (Advisory Board, personal), ASTRA ZENECA (Advisory Board, personal, invited speaker), CLOVIS (invited speaker, personal, Advisory Board), Eisai (Advisory Board, personal), GENMAB (Advisory Board, personal), GSK (invited speaker, personal, Advisory Board), HederaDx (Advisory Board, personal), Illumina (Advisory Board, personal), Inmunogen (Advisory Board, personal), Macrogenics (Advisory Board, personal), MERSANA (Advisory Board, personal), MSD (invited speaker, personal), MSD (Advisory Board, personal), NOVARTIS (Advisory Board, personal), NOVOCURE (invited speaker, personal), ONCOINVENT (Advisory Board, personal), PHARMAMAR (Advisory Board, personal), Regeneron (Advisory Board, personal), ROCHE (Advisory Board, personal), ROCHE (invited speaker, personal), SOTIO (Advisory Board, personal), SUTRO (Advisory Board, personal), Takeda (invited speaker, personal), Zaylab (invited speaker, personal). AGM other with non-financial interest: ARAVIVE, coordinating PI, Institutional, ENGOT PI of AVB-500 phase III trial; GSK, coordinating PI, Institutional, PI of ANITA trial; MSD, Steering Committee Member, personal, member of ENGOT ov43-SC; Novartis, coordinating PI, Institutional, ENGOT PI of EPIK-O trial; Roche, coordinating PI, Institutional, PI of ANITA trial. PTR has no conflicts of interest.

    • Provenance and peer review Commissioned; internally peer reviewed.