Patient-reported outcomes from the randomized ALICE trial evaluating the addition of atezolizumab to anthracycline-based chemotherapy in metastatic triple-negative breast cancer

TL;DR

Adding atezolizumab to chemotherapy improved quality of life and symptom control in metastatic triple-negative breast cancer patients.

Contribution

This study shows that atezolizumab improves patient-reported outcomes in metastatic triple-negative breast cancer when added to chemotherapy.

Findings

Atezolizumab improved quality of life, emotional functioning, and pain control compared to chemotherapy alone.

Pain was consistently reduced in the atezolizumab group across all time points.

Higher baseline quality of life predicted better outcomes with atezolizumab treatment.

Abstract

The ALICE trial demonstrated that adding atezolizumab to anthracycline-based immunomodulatory chemotherapy improved progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC), including those with PD-L1–negative tumors. Here, we report the patient-reported outcome measures (PROMs).

Patients were randomized to receive chemotherapy plus atezolizumab (atezo-chemo) or chemotherapy plus placebo (placebo-chemo). PROMs were collected at baseline and weeks 9, 17, 25, and 49 using the EORTC QLQ-C15-PAL, Chalder Fatigue Questionnaire (CFQ), and Numeric Rating Scale (NRS) for pain.

PROMs were available from 64 of 68 patients. At week 9, mean changes from baseline favored the atezo-chemo arm across all QLQ-C15-PAL domains, CFQ scores, and NRS pain intensity. Time-to-deterioration analyses also favored atezo-chemo, with statistically significant hazard ratios for global quality of life (QoL; HR 0.24), emotional functioning (HR 0.30), and pain (HR 0.20). Pain—a pre-specified cardinal symptom—improved in the atezo-chemo group at all time points. At 12 months, PROMs indicated sustained tolerability. Better baseline PROM scores were associated with improved PFS and overall survival, especially among patients treated with atezolizumab. Patients with >median QoL score at baseline recorded improved PFS when treated with atezolizumab (HR 0.25), while patients with ≤median QoL score did not (HR 1.02).

Adding atezolizumab to the study-chemotherapy in mTNBC improves both PFS and patient-reported quality of life, emotional well-being and symptom control. These findings support continued development of this combination regimen and suggest that baseline quality of life may serve as a useful predictor of immunotherapy benefit.

NCT03164993, May 24th 2017; https://clinicaltrials.gov/ct2/show/record/NCT03164993.

•Atezolizumab added to chemotherapy improved all patient-reported outcomes in metastatic TNBC compared to chemotherapy alone.•Time-to-deterioration data showed significant benefit of atezolizumab for quality of life, emotional functioning and pain.•Pain, a cardinal symptom, was consistently reduced in the atezolizumab arm across all time points.•The atezolizumab–chemotherapy combination was well tolerated over 12 months.•Higher baseline quality of life predicted greater benefit from atezolizumab, suggesting its potential as a selection marker.

Atezolizumab added to chemotherapy improved all patient-reported outcomes in metastatic TNBC compared to chemotherapy alone.

Time-to-deterioration data showed significant benefit of atezolizumab for quality of life, emotional functioning and pain.

Pain, a cardinal symptom, was consistently reduced in the atezolizumab arm across all time points.

The atezolizumab–chemotherapy combination was well tolerated over 12 months.

Higher baseline quality of life predicted greater benefit from atezolizumab, suggesting its potential as a selection marker.

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