Adding Atezolizumab to Chemo Doesn't Worsen QOL in Early TNBC
Adding the immune checkpoint inhibitor atezolizumab to first-line therapy for early triple-negative breast cancer (TNBC) did not significantly worsen patients' quality of life, according to new data from the IMpassion031 trial.
In the randomized phase 3 trial, patients received neoadjuvant atezolizumab or placebo plus chemotherapy, followed by surgery and adjuvant atezolizumab or observation.
An analysis of patient-reported outcomes showed that, after a brief decline in health-related quality of life (HRQOL) in both the atezolizumab and control arms, the burden of treatment eased and then remained similar throughout follow-up.
"Treatment-related symptoms in both arms were similar, and the addition of atezolizumab to chemotherapy was tolerable, with no additional treatment side-effect bother reported," said Elizabeth Mittendorf, MD, PhD, of the Dana-Farber Cancer Institute in Boston.
She presented these results in an oral abstract presentation during the 2020 San Antonio Breast Cancer Symposium.
Initial Results
Primary results of the IMpassion031 trial were reported at ESMO 2020 and published in The Lancet.
The trial enrolled patients with treatment-naive early TNBC, and they were randomized to receive chemotherapy plus atezolizumab or placebo. Atezolizumab was given at 840 mg intravenously every 2 weeks.
Chemotherapy consisted of nab-paclitaxel at 125 mg/m2 every week for 12 weeks followed by doxorubicin at 60 mg/m2 and cyclophosphamide at 600 mg/m2 every 2 weeks for 8 weeks. Patients then underwent surgery, which was followed by either atezolizumab maintenance or observation.
The addition of atezolizumab was associated with a 17% improvement in the rate of pathological complete response (pCR) in the intention-to-treat population.
Among patients positive for PD-L1, atezolizumab was associated with a 20% improvement in pCR rate.
Patients Have Their Say
At SABCS 2020, Mittendorf presented patient-reported outcomes (PRO) for 161 patients randomized to atezolizumab plus chemotherapy and 167 assigned to placebo plus chemotherapy.
The outcome measures – including role function (the ability to work or pursue common everyday activities), physical function, emotional and social function, and HRQOL – came from scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
The exploratory PRO endpoints were mean function and disease- or treatment-related symptoms as well as mean change from baseline in these symptoms.