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Advances and Concepts in Cervical Cancer Trials: A Road Map for the Future
  1. Satoru Sagae, MD*,
  2. Bradley J. Monk, MD†,
  3. Eric Pujade-Lauraine, MD‡,
  4. David K. Gaffney, MD§,
  5. Kailash Narayan, MD∥,
  6. Sang Young Ryu, MD,
  7. Mary McCormack, PhD, FRCR#,
  8. Marie Plante, MD**,
  9. Antonio Casado, MD††,
  10. Alexander Reuss, MSc‡‡,
  11. Adriana Chávez-Blanco, DVM§§,
  12. Henry Kitchener, MD∥∥,
  13. Byung-Ho Nam, PhD¶¶,
  14. Anuja Jhingran, MD##,
  15. Sarah Temkin, MD***,
  16. Linda Mileshkin, MD∥,
  17. Els Berns, MD†††,
  18. Suzy Scholl, MD‡‡‡,
  19. Corinne Doll, MD§§§,
  20. Nadeem R. Abu-Rustum, MD∥∥∥,
  21. Fabrice Lecuru, MD¶¶¶ and
  22. William Small, MD###
  1. *Department of Gynecologic Oncology, Sapporo West Kojinkai Clinic, Sapporo, Japan;
  2. †University of Arizona Cancer Center-Phoenix, Creighton University School of Medicine at St Joseph’s Hospital and Medical Center, Phoenix, AZ;
  3. ‡Hôtel-Dieu, AP-HP, Université Paris Descartes, Paris, France;
  4. §Department of Radiation Oncology, Huntsman Cancer Hospital, University of Utah Health Care, Salt Lake City, UT;
  5. ∥Division of Radiation Oncology, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia;
  6. Department of Surgery, Chonnam National University Medical School, Gwangju, South Korea;
  7. #Department of Oncology, University College Hospital London, London, United Kingdom;
  8. **Division of Gynecologic Oncology, Centre Hospitalier Universitaire de Québec, Quebec, Quebec, Canada;
  9. ††Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Spain;
  10. ‡‡Coordinating Center for Clinical Trials of the Phipps-University of Marburg, Marburg, Germany;
  11. §§GICOM Grupo Mexicano de Investigación en Cáncer de Ovario y Tumores Ginecológicos, A.C. México City, México;
  12. ∥∥Institute of Cancer Sciences, University of Manchester, St Mary’s Hospital, Manchester, United Kingdom;
  13. ¶¶Biotechnology Research Division, National Fisheries Research and Development Institute, Busan, South Korea;
  14. ##Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX;
  15. ***Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD;
  16. †††Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands;
  17. ‡‡‡Médecin - Spécialiste en Oncologie, Institut Curie, Paris, France;
  18. §§§Division of Radiation Oncology, Department Oncology, University of Calgary, Calgary, Alberta, Canada;
  19. ∥∥∥Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY;
  20. ¶¶¶Chirurgie Cancérologique Gynécologique et du Sein, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; and
  21. ###Department of Radiation Oncology, Stritch School of Medicine Loyola University, Chicago, IL.
  1. Address correspondence and reprint requests to: Satoru Sagae, MD, PhD, Department of Gynecologic Oncology, Sapporo West Kojinkai Clinic, Miyanosawa 1-1-1-30 Nishi-ku, Sapporo 063-0051, Japan. Email; s_sagae@kojinkai.or.jp.

Abstract

Objective Cervical cancer is responsible for more than a quarter of a million deaths globally each year, mostly in developing countries, making therapeutic advances in all health care settings a top priority. The Gynecologic Cancer InterGroup (GCIG) is a worldwide collaboration of leading national research groups that develops and promotes multinational trials in gynecologic cancer. In recognition of the pressing need for action, the GCIG convened an international meeting with expert representation from the GCIG groups and selected large sites in low- and middle-income countries.

Methods The focus was to develop a consensus on several concepts for future clinical trials, which would be developed and promoted by the GCIG and launched with major international participation. The first half of the meeting was devoted to a resume of the current state of the knowledge and identifying the gaps in need of new evidence, validating control arms for present and future clinical trials and identifying national and international barriers for studies of cervix cancers. The second half of the meeting was concerned with achieving consensus on a path forward.

Results and Conclusions There were 5 principal outcomes as follows: first, a proposal to expand fertility-preserving options with neoadjuvant chemotherapy; second, validation of the assessment of sentinel lymph nodes using minimally invasive surgery with an emphasis on identification and management of low-volume metastasis, such as isolated tumor cells and micrometastasis; third, evaluation of hypofractionation for palliative and curative radiation under the umbrella of the GCIG Cervix Cancer Research Network; fourth, adding to the advances in antiangiogenesis therapy in the setting of metastatic disease; and fifth, developing a maintenance study among women at high risk of relapse. The latter 2 systemic interventions could study PI3K (phosphatidylinositol-3-kinase) inhibitors, immunotherapy, anti–human papillomavirus approaches, or novel antiangiogenic agents/combinations.

  • Cervical cancer
  • Clinical trials
  • Gynecologic Cancer InterGroup
  • GCIG

https://doi.org/10.1097/IGC.0000000000000587

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    Footnotes

    • The authors declare no conflicts of interest.

    • Presented at the Gynecologic Cancer InterGroup Cervix Cancer brainstorming day, Melbourne, Australia, November 6, 2014.