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Impassion031 Outcomes Show Importance of Looking Beyond Initial Trial Data

At this year’s virtual ESMO conference, researchers involved in the Impassion031 reported findings showing that the combination of atezolizumab and nab-paclitaxel followed by doxorubicin and cyclophosphamide resulted in a 16.5% increase in pCR vs. placebo and chemotherapy.  

After further reviewing the data, the authors presented the first analysis of patient-reported outcomes at the virtual San Antonio Breast Cancer Symposium. 

Elizabeth Mittendorf, MD, PhD, the Rob and Karen Hale Distinguished Chair in Surgical Oncology at Brigham & Women’s Hospital, and a professor at Harvard Medical School, told MD/alert, that the patient-reported outcomes were a key finding from the study overall. 

"For a study like Impassion031, I think the patient-reported outcomes are critical, and the reason I say that is because we’re talking about a regimen that’s offered for earlier stage, triple-negative breast cancer. Stage two or three disease in the pre-operative setting, and so it’s a largely curable patient population. So, we of course, we want to increase that path like complete response, but we have to be quite cognizant of the fact that since they are curable, the toxicities and the impact of the treatment on their functioning really matters."

Dr Mittendorf noted that for patients treated with therapeutic agents, one of the most common side effects is thyroid disorders, which can require patients to be on thyroid replacement therapy for the rest of their lives, regardless of the course of their cancer treatment. 

In their findings, Dr Mittendorf said they looked at a few specific symptoms of health-related quality of life, including fatigue, nausea, and vomiting. She said in both arms there was a decline in "basically every domain that we measured," but that there was also improvement in both arms later in the course of treatment.  

One notable exception she pointed to was role function:

"What we found was in the adjuvant setting—meaning after the patient had gotten their preoperative regimen and underwent surgery—in that adjuvant setting that patients who were receiving atezolizumab did not completely recover in that role function domain and we attribute it to the fact that the trial continued the treatment of the immunotherapeutic agent atezolizumab in the adjuvant setting. And so, the patients that were randomized to that arm of the trial were still required to come into the hospital, the clinic, or wherever they were being treated, in order to receive a therapy. And so, we hypothesize that was what was impacting the role function. But in all the other domains, the curves look very comparable between the two arms of the study, suggesting that with the addition of immunotherapy, we increase that path to complete response rate. But we didn't do it at the detriment of these patient-reported outcomes."

Dr Mittendorf said that while the role function data did not line up with the rest of the findings at this stage in the research, she believed that those findings would change as they continue through their treatment progression.  

Despite the issues associated with immunotherapy, she said the treatment has been a "game-changer" for patients and providers, with some calling it the fourth pillar of cancer care along with chemotherapy, surgery, and radiation.  

"When we first started using immunotherapeutic agents in oncology, it was a real challenge because patients would have side effects that we might have seen with chemotherapy. One that comes to mind is abdominal pain that with chemotherapy. We would simply suggest, you know, ‘take it easy, mild, bland diet. You're going to be OK.’ But with immunotherapy, it could have been a sign of a very aggressive colitis or something that required treatment, and so it required a tremendous amount of education of providers as well as of patients. And so, with that in mind, I think the community of the providers, oncologists that are administering immunotherapeutic agents have in fact become much more comfortable with the side effects."

"I think that we anticipated that patients would do well with their PRO assessment, in part because we thought that they were doing well with the treatment," Dr Mittendorf continued. "But it was good to get the rigorous data from these validated surveys to confirm that and be able to say very importantly that we were achieving an improvement in the pathological response rate, again, without a detriment in their quality of life."
 

By Adam Hochron 
 

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