Abstract P5-19-05: Health-related quality of life during a phase 2 study of talazoparib in patients with advanced breast cancer and germline BRCA1/2 mutations (ABRAZO)
Authors: Hurvitz SA , Turner NC , Telli ML , Rugo HS , Mailliez A , Ettl J , Grischke E-M , Mina LA , Balmaña J , Fasching PA , Tudor C , Quek RGW , Hannah AL , Robson ME , Wardley AM 
Published: February 2018

Abstract
Background: Talazoparib (TALA; 1 mg/d) was well tolerated and exhibited promising antitumor activity in ABRAZO, a 2-cohort, 2-stage, open-label phase 2 study (NCT02034916) in patients (pts) with locally advanced or metastatic breast cancer and gBRCA1/2 mutations following platinum-based therapy (cohort 1 [C1]) or ≥3 platinum-free cytotoxic-based regimens (cohort 2 [C2]). This analysis evaluates health-related quality of life (QoL) for both cohorts.
Methods: QoL was assessed on day 1 (baseline) and every 6 weeks for the initial 24 weeks and every 12 weeks thereafter, or sooner if progression was clinically suspected, using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. For all scales, results were summarized using descriptive statistics for each cohort and at each time point, based on Characters (max 3400 including title, body and table [including spaces]): 3363 No abbreviations in title; title sentence case; define acronyms; no figures Category: Psychosocial, QOL, and Educational Aspects – Other 2 observed values and changes from baseline (clinically meaningful defined as ≥10-point change from baseline). Time to deterioration (TTD; defined as ≥10-point decrease in global health status [GHS]/functional scales or increase in symptom scales) analyses using survival analysis methods were carried out on the GHS/functional scales of QLQ-C30 and symptom scales of QLQ-BR23.
Results:GHS was maintained from baseline across all time points for both C1 and C2 except at week 24 in C2, when a statistically significant but not clinically meaningful improvement in GHS was observed. In C1, statistically significant and clinically meaningful improvement was observed at specific time points in 4 functional scales (body image, week 6; sexual functioning, week 24; sexual enjoyment, week 36; and future perspective, weeks 6, 18, and 24) and in 3 symptom scales (dyspnea, week 24; insomnia, week 24; and breast symptoms, weeks 6 and 36). Statistically significant and clinically meaningful deterioration in C1 was observed in 2 functional scales (emotional functioning, week 12 and end of treatment, and role functioning, end of treatment) and in 1 symptom scale (fatigue, week 6). In C2, statistically significant and clinically meaningful improvement was observed at specific time points in 4 functional scales (role functioning, week 24; social functioning, week 24; sexual enjoyment, week 18; and future perspective, weeks 6, 12, and 18) and in 5 symptom scales (nausea/vomiting, week 18; pain, weeks 12, 18, and 24; insomnia, week 24; breast symptoms, weeks 12 and 18; and arm symptoms, week 48). For C2, no statistically significant and clinically meaningful deterioration was observed for any functional or symptoms scales across all time points, except in the dyspnea symptom scale at week 18. For C1 and C2, the median (95% confidence interval) TTD of GHS was 2.8 (2.1-3.0) and 5.5 (4.2-5.7) months, respectively. The median TTD for all QLQ-C30 functional scales for C1 and C2 ranged 2.1-3.1 and 4.2-5.6 months, respectively; the median TTD for all QLQ-BR23 symptoms scales ranged 2.6-4.0 and 4.2-5.6 months, respectively.
Conclusions: The QoL of TALA-treated patients during ABRAZO was maintained. QoL is being evaluated among atients with germline BRCA1/2 mutated advanced BC treated with TALA vs physician's choice chemotherapy in the phase 3 EMBRACA trial (NCT01945775).
Citation Format: Hurvitz SA, Turner NC, Telli ML, Rugo HS, Mailliez A, Ettl J, Grischke E-M, Mina LA, Balmaña J, Fasching PA, Tudor C, Quek RGW, Hannah AL, Robson ME, Wardley AM. Health-related quality of life during a phase 2 study of talazoparib in patients with advanced breast cancer and germline BRCA1/2 mutations (ABRAZO) [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-19-05.