Patient-Reported Outcome Study is “Critically Important” in Cervical Cancer

Patient-reported outcomes (PROs) should be a mandated component of clinical trials seeking approval for novel therapeutic agents in cervical cancer or other gynecologic malignancies, as they pertain to relevant questions surrounding how patients feel during treatment, according to Maurie Markman, MD.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, CancerNetwork® spoke with Markman, president of Medicine & Science at City of Hope Cancer Centers Atlanta, Chicago and Phoenix, about key presentations at the meeting featuring critical developments in the gynecologic cancer space. Of note, he highlighted a session exploring PROs from the phase 3 OUTBACK trial (ACTRN12610000732088), which evaluated the use of chemoradiotherapy with or without adjuvant chemotherapy for those with locally advanced cervical cancer.

According to Markman, this “critically important” study exhibits “fascinating information” related to parameters such as the impacts of therapy on quality of life, sexual issues, and body image for this cervical cancer population.

Transcript:

What I would like to comment on for a moment is what I consider to be the most important study, not only in [gynecologic] area but one I would argue should start becoming part of the mandated paradigm for new drugs, new strategies, and, quite frankly, for any FDA approvals in the future, and that is patient-reported outcomes. I think we are long past the time—I can’t be clearer on this—where we assess what patients feel based on a checklist obtained in a research study by a doctor or research nurse where they ask a patient a question and they check a box [regarding] what they felt, what toxicity [they had], [or] what fatigue meant. That’s how we have done this for decades. Patient-reported outcomes actually get to the questions that are relevant to the patients; the patients complete the information, and they address the impact [of therapy] on their lives.

What we have seen is a well-designed, critically important study looking at patient-reported outcomes in the OUTBACK study, which is in [cervical] cancer. [There is] fascinating information looking at baseline, 1-year, 2-year, and 3-year impacts on patients; their quality of life; and issues of sexuality, body image, and critically important issues which are now being addressed. Remarkably, I would say, chemoradiation—which has been the standard of care in locally advanced cervical cancer for multiple decades—for the first time—we should have had this information a long time ago—[has data showing] what the impact is on patients. Yes, they are living longer, which is phenomenal, but what is the impact? What do you tell patients who are considering this treatment strategy vs, perhaps in the future, alternative strategies that other patients have said they feel [certain ways] 1 year, 2 years, or 3 years later?

That is the importance of this particular study. Again, I want to emphasize that I believe this should be mandated; when a new drug is being approved by the FDA, the study or randomized trial needs to include patient-reported outcomes, even, phase 2 studies that need accelerated approval. It’s not hard to do, but it gets at the questions that are much more relevant: what do patients feel? It’s an important study. I cannot emphasize it enough.

Reference

Mercieca-Bebber R, Barnes E, Moore K, et al. Patient-reported outcomes (PROs) in locally advanced cervical cancer (LACC): insights from the OUTBACK trial. J Clin Oncol. 2025;43(suppl 16):5503. doi:10.1200/JCO.2025.43.16_suppl.5503