This transcript has been edited for clarity.
I'm Dr Maurie Markman from Cancer Treatment Centers of America. I want to briefly discuss two abstracts on gynecologic cancer that were presented at the recent 2021 American Society of Clinical Oncology (ASCO) meeting. As always, many interesting abstracts on new drugs, new combinations, and new strategies were presented at ASCO. But this year was unique, in my opinion, because two incredibly important phase 3 randomized trials did not set a new standard for the management of three different conditions, but rather clearly established the existing standard.
The OUTBACK study looked at the question of the use of adjuvant chemotherapy following chemoradiation therapy in the management of locally advanced cervix cancer. Chemoradiation therapy has now been used for several decades, is well established, and improves survival in women with cervical cancer. But we have not known whether additional chemotherapy following chemoradiation would improve outcomes. This study clearly demonstrated that it does not.
This was an international study; 919 patients were randomly assigned to receive chemoradiation followed by no chemotherapy vs chemoradiation plus four cycles of carboplatin/paclitaxel. The addition of the four cycles of carboplatin/paclitaxel did not improve progression-free survival (PFS) or overall survival. Therefore, the standard of care clearly is and should be chemoradiation without adjuvant chemotherapy. Clinical trials are always of interest, but outside the clinical trial setting, this should be the standard.
The second study looked at another interesting question, this time in ovarian cancer. We have known for almost a decade that the use of bevacizumab maintenance therapy in the first-line setting significantly improves PFS in women with advanced ovarian cancer. However, the initial trials had an endpoint of approximately 15 months of maintenance chemotherapy with bevacizumab. So, the open question was, would giving additional bevacizumab beyond the 15-months maintenance period improve outcomes? This was an international phase 3 randomized trial known as BOOST.
Patients (N = 927) were randomly assigned to the standard of care with 15 months of maintenance bevacizumab vs 30 months of bevacizumab. The study clearly demonstrated no additional benefit from the additional 15 months of bevacizumab. Therapy was well tolerated, but there was no improvement in PFS or overall survival. Therefore, if one is using bevacizumab as a maintenance strategy in the first-line setting, following a response to platinum-based chemotherapy, the standard of care would be 15 months of bevacizumab, not longer.
These are two important studies that do not change the standard of care but clearly confirm the existing standard of care. Again, clinical trials are always of interest to try to change the paradigm because of an improved outcome. But today, these are the standards of care demonstrated in these excellent randomized phase 3 trials.
I thank you for your attention.
Maurie Markman, MD, is president of medicine and science at Cancer Treatment Centers of America in Philadelphia. He has more than 20 years of experience in cancer treatment and gynecologic oncology research.
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Cite this: Maurie Markman. ASCO Data Confirm Standard-of-Care Treatments for Cervical, Ovarian Cancer - Medscape - Jul 09, 2021.