Bradley Monk, MD, FACCOG, FACS, discusses the creation and findings of the OUTBACK trial.
Bradley Monk, MD, FACCOG, FACS, a gynecologic oncologist at Arizona Oncology and the medical director of gynecologic oncology research at the US Oncology Network, discusses the creation and findings of the OUTBACK trial (NCT01414608).
The OUTBACK trial was focused on looking to see if additional cycles of chemotherapy would further improve survival in patients with cervical cancer. End points of the study included overall survival (OS), progression-free survival (PFS), acute and long-term toxicities, patterns of disease recurrence, and quality of life.
Findings showed that despite the additional cycles of chemotherapy, the 5-year OS was similar between the 2 groups. The 5-year OS for the chemotherapy alone was 71% and 72% for the chemotherapy plus adjuvant chemotherapy group and PFS for the control group was 61% and 63% for the experimental group. Similar disease recurrence patterns between the 2 groups were also reported.
0:08 \ This trial reported at ASCO 2021, showed that there was no difference when 4 additional cycles of carboplatin and paclitaxel was added to chemotherapy. There was no difference in the 5-year OS, which in the chemotherapy radiation alone group was 71%. When there were 4 additional cycles of carboplatin and paclitaxel after chemotherapy and radiation, the 5-year survival was 1% greater with a hazard ratio of .90 and confidence interval of .70 overlapping 1 with an upper boundary of 1.17. Interestingly, there was also no improvement in PFS. The 5-year PFS was 61% versus 63% comparing chemotherapy radiation alone versus chemotherapy radiation in adjuvant chemotherapy respectively.