VIDEO: 'Highly anticipated' trial addresses adjuvant chemotherapy in cervical cancer
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In this video, Robert Coleman, MD, FACOG, FACS, chief scientific officer of US Oncology Research, spoke with Healio about the OUTBACK trial presented at the ASCO Annual Meeting.
Chemoradiation has largely proven successful in locally advanced and high-risk cervical cancer, but women often experience recurrences, according to Coleman. The researchers therefore set up the “highly anticipated” OUTBACK trial to assess whether the use of four cycles of adjuvant chemotherapy after chemoradiation would be beneficial.
For the large, international, randomized phase 3 study, investigators randomly assigned women to concurrent chemoradiation, which is the current standard of care, or standard of care plus adjunct chemotherapy with carboplatin and paclitaxel.
Unfortunately, overall survival was no better in the experimental arm when compared with the standard-of-care arm, Coleman noted, adding that only 62% of women actually received four cycles of chemotherapy.
“The added toxicity was essentially not allowing us to give this treatment in a feasible way,” he said.
The researchers also found reductions in quality-of-life scores during adjunct chemotherapy.
Despite the negative results, OUTBACK answered important questions, according to Coleman.
“This is a super important trial that addressed off-the-shelf opportunities for a disease that has a global footprint,” he said. “The lack of benefit was disappointing, but it offers a new opportunity to evaluate other potential agents, including immunotherapy, after chemoradiation in this patient population.”
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Mileshkin LR, et al. Late-Breaking Abstract 3. Presented at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.
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