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Impact of tucatinib on health-related quality of life (HRQoL) in patients with HER2+metastatic breast cancer (MBC) with and without brain metastases (BM)
Mueller, V. Paplomata, E. Hamilton, E. P. Zelnak, A. Fehrenbacher, L. Jakobsen, E. H. Curtit, E. Boyle, F. Brix, E. H. Brenner, A. J.
Mueller, V.
Paplomata, E.
Hamilton, E. P.
Zelnak, A.
Fehrenbacher, L.
Jakobsen, E. H.
Curtit, E.
Boyle, F.
Brix, E. H.
Brenner, A. J.
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Abstract
Background: Patients (pts) with human epidermal growth factor receptor 2 positive
(HER2+) MBC, particularly pts with BM, have limited treatment (tx) options and
increased likelihood to report deterioration in HRQoL. Maintaining QoL in pts with
MBC who progress through different lines of therapy is an important outcome incapecitabine (C) demonstrated statistically significant improvement in progression
free survival (PFS) and overall survival (OS) over T + C alone. In HER2+ MBC pts with
and without BM, TUC + T + C had a manageable safety profile similar to T + C alone.
Here we report the impact of TUC on HRQoL, a secondary objective in H2C.
Methods: Assessment of HRQoL was initiated with protocol version 7, using the EQ-
5D-5L which includes a EQ visual analog scale (EQ-VAS) and descriptive system (EQ-
5D) of 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and
anxiety/depression. Each dimension has 5 levels: no, slight, moderate, severe, or
extreme problems. Data were available from 330 of 612 pts and were collected at
Cycles (C) 1, 3-9 (every 2 C; 21 day C), C 12 and beyond (every 3 C), and at 30 day
follow-up. TUC and placebo group EQ-5D-5L scores were calculated for each dimension
and summarized. HRQoL pt reported outcomes were evaluated using longitudinal
and descriptive data analyses.
Results: In H2C, data from 217 pts on the TUC arm and 113 pts on the placebo arm
were available for HRQoL analyses. In all 5 EQ-5D-5L domains, most pts in both arms
reported only slight or no problems. Reported moderate, severe, or extreme problems
were low and similar between tx arms. No clinically meaningful differences in
HRQoL were observed between tx arms. Mean EQ-5D-5L VAS scores were similar
between tx arms and stable throughout duration of therapy. Decline on EQ-5D-5L
domains and VAS scores were not seen while pts were on therapy. All available QoL
data will be presented.
Conclusions: In H2C, addition of TUC resulted in statistically significant and clinically
meaningful improvement in PFS and OS. Moreover, QoL in pts treated with TUC + T +
C was maintained throughout the tx period which was longer compared to pts
receiving only T + C.
clinical trials. In the HER2CLIMB (H2C) study, tucatinib (TUC) + trastuzumab (T) +
Description
Date
2020
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Keywords
Type
Meetings and Proceedings
Citation
Mueller V, Paplomata E, Hamilton EP, Zelnak A, Fehrenbacher L, Jakobsen EH, et al. 275O Impact of tucatinib on health-related quality of life (HRQoL) in patients with HER2+ metastatic breast cancer (MBC) with and without brain metastases (BM). Annals of Oncology. 2020;31:S349-S50.