Highlights
- •This Q-TWiST analysis assessed quality-adjusted survival in patients with mTNBC.
- •Pembrolizumab showed a significant Q-TWiST benefit in PD-L1–positive mTNBC.
- •The benefits continued to accrue with longer follow-up time.
- •Pembrolizumab demonstrated a favourable benefit-risk profile in this population.
Abstract
Objective
In the KEYNOTE-355 (KN355) trial, pembrolizumab in combination with chemotherapy demonstrated
superior efficacy and manageable safety compared with chemotherapy alone in patients
with previously untreated locally recurrent inoperable and metastatic triple-negative
breast cancer (mTNBC) with PD-L1 positive (Combined Positive Score [CPS]≥ 10) tumours.
This study aimed to evaluate the clinical benefits and risks of pembrolizumab measured
by quality-adjusted survival in the trial population.
Methods
The study used data from the final analysis of KN355. The Quality-adjusted Time Without
Symptoms of disease progression or Toxicity of treatment (Q-TWiST) analysis was used
to compare treatments of pembrolizumab plus chemotherapy versus chemotherapy alone.
Patients’ survival time was partitioned into three health states — toxicity before
disease progression (TOX), time without symptoms or toxicity before disease progression
(TWiST), and relapse (REL). Utilities for these health states were estimated using
EuroQol-5 Dimensions, 3 Levels (EQ-5D-3L) data collected in KN355. Q-TWiST was derived
as the utility-weighted sum of the mean health state durations.
Results
Patients randomised to pembrolizumab plus chemotherapy had 3.7 months greater Q-TWiST
(relative gain of 18%; P = 0.003) compared to those randomised to chemotherapy at the median follow-up of
44 months, and 4.3 months greater Q-TWiST (relative gain of 20%; P = 0.004) at the maximum follow-up of 52 months. The Q-TWiST gain increased with longer
follow-up time.
Conclusions
Pembrolizumab plus chemotherapy was associated with statistically significant and
clinically important improvement in Q-TWiST compared to chemotherapy in previously
untreated PD-L1–positive mTNBC.
Keywords
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Article info
Publication history
Published online: October 29, 2022
Accepted:
September 26,
2022
Received in revised form:
September 25,
2022
Received:
August 3,
2022
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
