Atezolizumab plus chemotherapy improved progression-free survival and patient-reported quality of life in metastatic triple-negative breast cancer
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Key Takeaway
Consider atezolizumab plus chemotherapy for metastatic triple-negative breast cancer, particularly in patients with better baseline quality of life.
This randomized trial investigated the addition of atezolizumab to anthracycline-based chemotherapy compared with chemotherapy plus placebo in patients with metastatic triple-negative breast cancer. The study included 68 patients and followed them for 12 months. Safety and tolerability data were not reported, but the study noted sustained tolerability at 12 months.
Regarding patient-reported outcomes, the combination of atezolizumab and chemotherapy demonstrated statistically significant hazard ratios favoring the treatment group for global quality of life (HR 0.24), emotional functioning (HR 0.30), and pain (HR 0.20). Absolute numbers for these outcomes were not reported.
For progression-free survival, patients with a quality of life score above the median at baseline experienced improved progression-free survival with atezolizumab (HR 0.25). Conversely, patients with a quality of life score at or below the median baseline did not show an improvement in progression-free survival with atezolizumab (HR 1.02).
Overall survival was listed as a secondary outcome but was not reported in the results. The study did not report adverse events, serious adverse events, discontinuations, or specific limitations. Funding or conflicts of interest were not reported. The practice relevance and certainty notes were not provided in the source data.
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View Original Abstract ↓
BACKGROUND: 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).
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
TRIAL REGISTRATION: NCT03164993, May 24 2017; https://clinicaltrials.gov/ct2/show/record/NCT03164993.
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