Bradley Monk, MD

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.

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.

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Bradley Monk, MD, FACCOG, FACS, discusses the creation and findings of the OUTBACK trial.

OUTBACK Trial Reveals No Benefit for Adjuvant Chemotherapy in Cervical Cancer

Bradley Monk, MD, a professor on the Clinical Scholar Track at the University of Arizona College of Medicine, Phoenix and a gynecologic oncologist at Arizona Oncology (US Oncology Network), discusses the phase 1b/2 innovaTV 205 (ENGOT-cx8/GOG-3024; NCT03786081) trial in patients with recurrent or metastatic cervical cancer.

This study is looking at the combination of tisotumab vedotin plus bevacizumab (Avastin), pembrolizumab (Keytruda), or carboplatin (Paraplatin). Testing these combinations makes sense biologically and mechanistically, according to Monk. The patients on this trial, who progressed on their second-line of therapy or later, will be in 1 of the 3 dose-escalation arms. The investigators identified the appropriate doses of tisotumab plus each of the 3 other therapies.

Monk explains that in the same space where these agents are used in earlier lines of therapy, the investigators will see how they will affect patients by way of dose expansion. To find the recommended phase 2 dose, patients will receive therapy with 1 of the combinations every 3 weeks. Because the half-life is only 1.7 days, there will be a fourth arm in the phase 2 looking at weekly dosing.

There will be an interim analysis after 15 patients are enrolled in each arm. The primary end point is overall survival. Monk says the investigators are also interested in the adverse events associated with these combinations. One adverse event associated with tisotumab is epistaxis, an eye toxicity, which they have a mitigation strategy for of eye drops. Patients on this drug also can also experience fatigue and neuropathy.

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Bradley Monk, MD, discusses the phase 1b/2 innovaTV 205 trial in patients with recurrent or metastatic cervical cancer.

Investigating Combinations in Recurrent or Metastatic Cervical Cancer

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, discusses trabectedin as a potential agent to treat ovarian cancer.

Read about research into ovarian cancer > >

Articles

Trabectedin as a Treatment Option for Patients with Ovarian Cancer

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, discusses the utility of bevacizumab for the treatment of cervical cancer.

Bevacizumab has been looked at in many solid tumors, including ovarian cancer.

Treatment options for patients with cervical cancer are limited.

Bevacizumab plus chemotherapy elicits a survival advantage in this population.

MORE: Bevacizumab Receives Priority Review for Advanced Cervical Cancer > >

Bevacizumab for Cervical Cancer

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, discusses clinical trial endpoints and individualizing treatment in patients with ovarian cancer.

The last approved agent in advanced epithelial ovarian cancer was the carboplatin + gemcitabine doublet used in platinum-sensitive recurrence

This doublet was approved based on a PFS endpoint

Since then, it has been difficult to get ovarian cancer drugs approved based on a PFS endpoint

The challenge remains to see the value of PFS

Maintaining long term tumor control, though of value to the patient, may not be of value to regulators

Though certain agents may be equally efficacious, they may have different toxicity profiles

Ideally, clinicians need agents approved on a PFS endpoint in order to individualize treatments

Individualized Treatments and Clinical Trial Endpoints in Ovarian Cancer

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, discusses the role of bevacizumab in the treatment of metastatic cervical cancer.

The recently completed phase III GOG 240 study looked at the addition of bevacizumab to standard chemotherapy for the treatment of metastatic cervical cancer

Adding bevacizumab improved overall survival by nearly 4 months and improved response rate to about 50%

Metastatic cervical cancer was previously though to be resistant to chemotherapy

The FDA will be interested in these data, though it remains to be seen if approval will follow