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PROs Comparable Between Niraparib, Placebo in Advanced Ovarian Cancer

November 29, 2020

Dana Chase, MD, FACOG, Arizona Oncology, Tempe, discusses patient-reported outcomes in patients receiving niraparib on the PRIMA trial.

These results were presented at the 2020 Virtual ESMO Congress.



My name is Dr. Dana Chase. I'm a gynecologic oncologist at Arizona Oncology in Phoenix, Arizona. I want to talk to you today about an abstract that was presented at ESMO 2020. The title of the abstract was "Patient‑Reported Outcomes in Patients Receiving Niraparib on the PRIMA Trial."

This was an interesting abstract because it explored quality of life for patient‑reported outcomes on a large clinical trial, which looked at maintenance therapy after first‑line treatment of ovarian cancer.

Essentially, the PRIMA trial looked at niraparib versus placebo in an all‑comer patient population who demonstrated at least a partial response to platinum‑based chemotherapy in the first‑line setting for metastatic ovarian cancer.

On this trial, women were randomized 2 to 1 to receive niraparib at a dose of 300 milligrams daily versus placebo. The primary endpoint was progression‑free survival, but there were some key secondary endpoints, which included patient‑reported outcomes.

As you're aware, patient‑reported outcomes are typically measured by patient‑reported tools. These are surveys that the patients themselves fill out regarding their quality of life. There were multiple tools used in this study that included the FACI, the EORTC scales, both for cancer and for ovarian cancer.

What's interesting about this study is the instruments were measured at baseline, so at trial onset and then every 8 weeks for the first 50 or so weeks. The patient filled out the survey data at baseline and then the first time that she filled the survey out next was at 8 weeks.

Eventually, it was transitioned to every 12 weeks until discontinuation. In addition, they measured quality of life at some time after discontinuation as well. What's always concerning about these quality of life tools is that sometimes patients don't fill them out.

Whenever you're reporting about a patient‑reported outcome, you want to document the compliance rate. What was amazing about this trial was that really patient compliance rates were consistently high. Over 80% across all PRO instruments compliance rates were demonstrated throughout the trial.

Really, you only saw this break off a little bit towards the end of the measurement time. In general, patient‑reported outcome compliance rates were very high. First, looking at the FACI, which is an ovarian cancer symptom index, this assessed symptoms such as lack of energy, nausea, cramps in the stomach area, or vomiting.

There's an overall score as well. In general, women on niraparib versus women on placebo demonstrated pretty equivalent symptoms, meaning there wasn't really a decrement in quality of life whether or not you were on placebo or niraparib.

When they explored quality of life regarding these specific symptoms, like energy, nausea, vomiting, stomach cramping, the rates were pretty similar at least in the initial part of the study. There was, for example, a little bit of an uptake in nausea in the niraparib arm just within the first 3 to 5 months on study drug.

Overall, that did not translate into more vomiting or more cramps in the stomach area. Fatigue, interestingly enough, fatigue scores were very similar amongst the 2 arms. When they looked at some of the European quality of life study tools, again, no significant difference in terms of quality of life on niraparib versus placebo.

This includes global health, physical function, fatigue, and pain. You might think when you're starting a patient on this medication that you're going to see some differences in terms of quality of life because of certain mild to moderate symptoms that patients experience on PARP inhibitor therapy in general.

This thankfully did not translate into differences on these quality of life surveys or scales. That was pretty consistent, even in the ovarian‑specific EORTC quality of life tools. No significant changes in abdominal or GI symptoms or pain scales. Pretty consistent in terms of equivalence and quality of life amongst the 2 arms.

In conclusion, important to understand that, number 1, we can measure quality of life on these large clinical trials and get a good compliance. That's some drawbacks of measuring quality of life that you can't consistently demonstrate compliance rates with patients. On this study, we saw very good compliance rates across the board.

In terms of an ovarian cancer‑specific measurement tool, percentages of patients reporting lethargy, nausea, vomiting, and abdominal cramps were similar in niraparib versus placebo. That was pretty consistent across the European scales as well.

Overall, consistent with other patient‑reported outcome data presented from other studies involving niraparib. Quality of life does not seem to change whether or not you're on placebo versus niraparib, meaning these women that went on niraparib didn't experience changes in their quality of life despite the trial reporting mild to moderate symptoms at least when you initiate therapy.

How does this apply to us in clinical practice, and what we might do for our patients when we're putting them on these now‑approved drugs? I think what we can tell them is in these large studies, although side effects can happen, it really didn't seem to translate into quality of life differences.

I think that is extremely helpful when you're starting a patient on a new medication, and there's some concern that there might be quality of life changes. That was the conclusion of the study and again was pretty useful information for those of us that are prescribing this medication pretty regularly now. 

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