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abstract
Background To evaluate
the influence of treatment on health-related quality of life (HRQoL) in
919 women with recurrent ovarian cancer
enrolled in the TRINOVA-1 study, a randomized,
placebo-controlled phase 3 study that demonstrated that trebananib 15
mg/kg
QW plus weekly paclitaxel significantly improved
PFS compared with placebo plus weekly paclitaxel (7.2 versus 5.4
months;
hazard ratio, 0.66; 95% CI, 0.57–0.77; P<0.001).
Patients and Methods
HRQoL was assessed with the Functional Assessment of Cancer
Therapy–Ovary (FACT-O; comprising FACT-G and the ovarian cancer–specific
subscale [OCS]) and EuroQOL EQ-5D instruments
before treatment on day 1 of weeks 1, 5, 9, 13, 17, and every 8 weeks
thereafter
and at the safety follow-up visit. A
pattern-mixture model was used to evaluate influence of patient dropout
on FACT-O and
OCS scores over time.
Results 834 of 919
randomized patients (91%) had a baseline and ≥1 post-baseline HRQoL
assessment. At baseline, scores for all instruments
were similar for both arms. At 25 weeks mean±SD
changes from baseline were negligible, with mean±SD changes typically
<1 unit
from baseline: −2.4±16.6 in the trebananib arm
and −1.6±15.2 in the placebo arm for FACT-O, −0.71±5.5 in the trebananib
arm
and −0.86±4.9 in the placebo arm for OCS, and
−0.02±0.22 in the trebananib arm and 0.02±0.19 in the placebo arm for
EQ-5D.
Distribution of scores was similar between
treatment arms at baseline and over the course of the study. In
pattern-mixture
models, there was no evidence that patient
dropout affected differences in mean FACT-O or OCS scores. Edema had
limited effect
on either FACT-O or OCS scores in patients with
grade ≥2 edema or those with grade 1 or no edema.
Conclusions Our results demonstrate that the improvement in PFS among patients in the trebananib arm in the TRINOVA-1 study was achieved
without compromising HRQoL.
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