Veliparib plus chemotherapy, chemo alone improve QOL in advanced-stage ovarian cancer
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Veliparib plus carboplatin/paclitaxel followed by veliparib maintenance showed smaller improvements in health-related quality of life measures from baseline compared with carboplatin/paclitaxel alone among patients with newly diagnosed stage III or IV ovarian cancer.
David Cella, PhD, of Northwestern University, presented data from a phase 3 study of the effect of the PARP inhibitor veliparib (ABT-888, AbbVie) on health-related quality of life in women with advanced-stage ovarian cancer at ESMO Virtual Congress 2020.
“The primary endpoint of the trial involved progression free survival comparing the veliparib throughout arm, which is with chemotherapy and maintenance, to the control arm, which was placebo throughout along with chemotherapy, for six cycles.” Cella said during his presentation.
Cella and colleauges assessed efficacy of veliparib (150 mg oral twice daily) plus carboplatin/paclitaxel for 6 cycles followed by maintenance with veliparib 300/400 mg (vel-throughout) or placebo (vel-comb only) or placebo with carboplatin/paclitaxel followed by placebo maintenance (CP alone). They measured health-related quality of life at screening, day 1 of cycle 1 and at every other cycle until discontinuation.
Of 1,069 patients included in the study, 351 received vel-throughout, 363 received vel-comb only and 355 received CP alone.
Researchers observed health-related quality of life score improvements from baseline in the vel-throughout and CP alone arms as well as smaller improvements in the vel-throughout compared with the CP alone arms in most domains.
“For both of the primary study arms, while the early declines in treatment scores were noted, improvements were observed in all arms in later cycles,” Cella said.
Exploratory analysis indicated no significant differences in time to symptom worsening between the arms for any health-related quality of life domain. Median time to symptom worsening was 10.5 months for the vel-throughout arm compared with 10.1 months for the CP arm regarding ‘disease-related symptom’ and 8.1 months compared with 8.1 months regarding ‘functional well-being’ domains, according to the results.
“The addition of veliparib to chemotherapy followed by veliparib maintenance does not substantially increase treatment burden as measured by health-related quality of life compared to chemotherapy alone in women with newly-diagnosed, advanced stage, high-grade, serous epithelial ovarian cancer,” Cella concluded.
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Cella D, et al. Abstract 809MO. Presented at: European Society for Medical Oncology Virtual Congress 2020; Sept. 19-21, 2020.
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