This transcript has been edited for clarity.
Hello. I'm Dr Maurie Markman from Cancer Treatment Centers of America in Philadelphia. I want to briefly discuss a very important randomized trial that was recently published in the New England Journal of Medicine, "A Randomized Trial of Lymphadenectomy in Patients With Advanced Ovarian Neoplasms."[1]
This is an important study for several reasons. First, it demonstrates quite clearly how it is possible to perform randomized phase 3 trials in the ovarian cancer arena on a question in the setting of surgery rather than a question of chemotherapy.
Therefore, [regarding previous] statements saying that it is very hard to perform these studies, the current study demonstrates that that is not the case. If new ideas come up—new surgical procedures, new strategies, hypotheses—I think it should be considered whether, before it becomes standard of care, perhaps we should do a well-designed, randomized phase 3 trial.
The second point I want to emphasize is that this phase 3 randomized trial, which included 647 patients, demonstrates that more aggressive surgery in ovarian cancer with additional morbidity does not improve outcomes. We now have data from several phase 3 randomized trials that have looked at neoadjuvant chemotherapy versus an initial, more aggressive surgery in ovarian cancer.
The randomized phase 3 trials in the neoadjuvant setting have demonstrated equivalent outcomes, specifically survival, with less morbidity and even mortality. In the setting of advanced disease, giving chemotherapy first may be a reasonable option. This is increasingly accepted as a very reasonable approach in ovarian cancer management.
In this particular trial published in the New England Journal of Medicine, the hypothesis was that, in patients who have had all gross residual disease resected, perhaps doing a lymph node dissection might further improve outcomes by removing undetectable macroscopic disease. However, the study very clearly demonstrated no improvement in outcomes.
This study is a landmark trial. Hopefully, these results will stop the performance of this unnecessary and potentially dangerous additional procedure with surgical cytoreduction. Again, this study demonstrates the ability to perform excellent, evidence-based, phase 3 randomized trials in the surgical arena in ovarian cancer management.
I encourage you to read this paper in the New England Journal of Medicine, whether you are interested in ovarian cancer management or looking at an incredibly well-designed, phase 3 randomized trial and the outcomes.
Thank you for your attention.
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Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Landmark Trial Suggests Stopping 'Unnecessary and Potentially Dangerous' Surgery in Advanced Ovarian Cancer - Medscape - Mar 28, 2019.
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