David Cella, PhD, Department of Medical Social Sciences, Northwestern University, Chicago, Illinois, discusses results from a phase 3 study examining health-related quality of life (HRQoL) in patients with newly diagnosed ovarian cancer treated with veliparib plus chemotherapy followed by veliparib maintenance. These results were presented at the virtual 2020 ESMO Annual Meeting.
Transcript
Hi. I'm Dave Cella. I am a Professor of Medical Social Sciences at Northwestern University in Chicago, Illinois.
I'm going to talk with you briefly about PARP inhibitors in ovarian cancer treatment, in particular about quality of life in patients with newly diagnosed stage 3 or 4 ovarian cancer that have been treated with veliparib plus chemotherapy and some of whom were followed by veliparib maintenance.
The question we ask here in this presentation is whether quality of life is better or not with the addition of veliparib to chemotherapy.
The background of this work is that we looked at veliparib, which is an oral poly (ADP-ribose) polymerase, or PARP, inhibitor on quality of life in this phase 3 trial in women with advanced ovarian cancer. All of these patients received the carboplatin-paclitaxel backbone for 6 cycles. That's standard therapy for ovarian cancer.
What was different here was that we randomly assigned women to either get veliparib throughout, that is to get veliparib with the chemotherapy and then followed by veliparib maintenance, or to get veliparib with chemotherapy but then followed by placebo as maintenance or a control group, which was the chemotherapy-only followed by placebo, so receiving no veliparib.
We measured quality of life with simple and straightforward questionnaires looking at ovarian cancer symptoms and treatment side effects and the EuroQol-5D-5L. We looked at analysis of on-treatment comparisons of the average change from baseline in these quality of life scores and the median time to symptom worsening.
The demographics of the patients were similar across treatment arms. Study compliance was better than 90% of the on-treatment patients.
Looking at the results, in terms of the mean change from baseline on the EQ-5D, we find that the scores generally go up, that is get better, in all 3 groups. The veliparib plus chemotherapy followed by veliparib maintenance, in purple, did not go up as dramatically as the veliparib plus chemotherapy followed by placebo or the placebo plus chemotherapy followed by placebo.
Although all groups improved, there were similar but non-significant improvements in the veliparib plus chemo followed by veliparib arm.
In terms of time to symptom worsening, on the 18-item symptom questionnaire, there were no differences across these different groups, veliparib plus the chemotherapy followed by veliparib all the way down to the placebo plus chemotherapy followed by placebo, that the average time to symptom worsening in the overall scale was around 10 months.
It was also around 10 months on the emotional symptoms and around 6 or 7 months on treatment side effects and about 7 or 8 months on functional well-being. No differences across the different treatment arms.
In conclusion, we found that compared to placebo plus chemotherapy followed by placebo maintenance, the addition of veliparib followed by veliparib maintenance showed smaller improvements in quality of life scores from baseline. That's naturally to be expected given the added adverse events or toxicity of the treatment.
For both primary study arms, while early declines in treatment side effect scores were noted, improvements were observed in later cycles. The time to symptom worsening of quality of life domains was similar across the study arms.
We note that there were no clinically meaningful differences observed between the veliparib followed by veliparib arm and the placebo followed by placebo arm for any of the health-related quality of life domains.
We concluded in this study that adding veliparib to the carboplatinum backbone followed by veliparib maintenance does not substantially increase treatment burden, as measured by quality of life, compared to chemotherapy alone in women with newly diagnosed, advanced stage, high-grade serous epithelial ovarian cancer.
Given that there is a significant advantage of about 6 months to progression-free survival by adding veliparib to chemotherapy during the chemo period as well as maintenance, we conclude that this is an efficacious treatment from both the clinical endpoint of progression-free survival as well as the quality of life benefit. Thank you.
