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- W2806055242 abstract "1049 Background: Compared to placebo (P) + fulvestrant (F), the MONARCH 2 HR+, HER2- ABC trial showed abemaciclib + F significantly improved PFS and ORR with a generally tolerable safety profile. Here, patient-reported HRQoL, functioning, and symptoms are reported. Methods: Study details were previously reported (Sledge et al. 2017). Data from the modified Brief Pain Inventory short form (mBPI-sf), EORTC QLQ-C30 and EORTC BR23 were collected at baseline, cycle 2 (C2), every 2 cycles from C3 - C13, and then every 3 cycles until short term follow up. Time to worsening (TTW) of pain (≥2 point increase of “worst pain” or ≥ 1 level increase of WHO analgesic class) were analyzed by Cox model. Change from baseline for EORTC QLQ-C30 and BR23 subscales and mBPI-sf were analyzed by mixed model. Differences of change from baseline (for each and across all visits) between arms were analyzed. Results: PRO completion rates were > 85% for baseline and on-treatment visits; duration of treatment was longer for abemaciclib + F patients (median 15 vs 9 cycles). The TTW for pain was similar between abemaciclib + F and P + F arms (HR = 0.900; p = .4005). No clinical and statistical significance was observed in the EORTC QLQ-C30 and BR23 function and symptom scales or the mBPI-sf; exceptions were higher diarrhea, appetite loss (AL) and nausea/vomiting (N/V) in the abemaciclib + F arm, which were consistent with reported adverse events (AE). The by-cycle analysis showed these higher mean symptom scores were transient for AL and NV, which increased in the first few cycles then gradually returned to near-baseline after cycle 7. Mean diarrhea scores returned to near-baseline levels post-therapy. Conclusions: In addition to significantly improved PFS and ORR, abemaciclib + F did not show statistically significant and clinically meaningful differences in patient-reported global health, functioning, or most symptoms compared to P + F. Increased GI-related symptoms were transient and consistent with the manageable, reversible AE profile; the highest symptom burden was reported during early visits. Clinical trial information: NCT02107703." @default.
- W2806055242 created "2018-06-13" @default.
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- W2806055242 date "2018-05-20" @default.
- W2806055242 modified "2023-09-27" @default.
- W2806055242 title "Health-related quality of life (HRQoL) in MONARCH 2: Abemaciclib plus fulvestrant in women with HR+, HER2- advanced breast cancer (ABC) who progressed on endocrine therapy." @default.
- W2806055242 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.1049" @default.
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