First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis
| Autor: | L.A. Emens, S. Adams, C.H. Barrios, V. Diéras, H. Iwata, S. Loi, H.S. Rugo, A. Schneeweiss, E.P. Winer, S. Patel, V. Henschel, A. Swat, M. Kaul, L. Molinero, S.Y. Chui, P. Schmid |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Paclitaxel Population Triple Negative Breast Neoplasms Antibodies Monoclonal Humanized Placebo Gastroenterology 03 medical and health sciences 0302 clinical medicine Breast cancer Atezolizumab Interquartile range Albumins Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans education Triple-negative breast cancer education.field_of_study business.industry Hazard ratio Hematology medicine.disease Survival Analysis Confidence interval 030104 developmental biology Oncology 030220 oncology & carcinogenesis business |
| Zdroj: | Annals of Oncology. 32:983-993 |
| ISSN: | 0923-7534 |
| Popis: | Background Guidelines recommend atezolizumab plus nab-paclitaxel (A + nP) for first-line treatment of unresectable, locally advanced, or metastatic triple-negative breast cancer expressing programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (IC), based on IMpassion130. We report the final overall survival (OS) and safety of that study as per the prespecified analysis plan. Patients and methods Patients were randomized to nP 100 mg/m2 (days 1, 8, and 15 of a 28-day cycle) with atezolizumab 840 mg (A + nP) or placebo (P + nP; days 1 and 15), until progression or unacceptable toxicity. Coprimary endpoints were progression-free survival [intention-to-treat (ITT) and PD-L1 IC-positive populations] and OS (tested hierarchically in the ITT population and, if significant, in the PD-L1 IC-positive population). Results Each arm comprised 451 patients; 666 (73.8%) had died by the final OS analysis cut-off (median follow-up, 18.8 months; interquartile range, 8.9-34.7 months). Median OS in the ITT population was 21.0 months [95% confidence interval (CI), 19.0-23.4 months] with A + nP, and 18.7 months (95% CI, 16.9-20.8 months) with P + nP [stratified hazard ratio (HR), 0.87; 95% CI, 0.75-1.02; P = 0.077]. Exploratory analysis in the PD-L1 IC-positive population showed a median OS of 25.4 months (95% CI, 19.6-30.7 months) with A + nP (n = 185) and 17.9 months (95% CI, 13.6-20.3 months) with P + nP (n = 184; stratified HR, 0.67; 95% CI, 0.53-0.86). Safety outcomes were consistent with previous analyses and the known toxicity profiles of each agent. Immune-mediated adverse events of special interest were reported in 58.7% and 41.6% of patients treated with A + nP and P + nP, respectively. Conclusion Although the OS benefit in the ITT population was not statistically significant, precluding formal testing, clinically meaningful OS benefit was observed with A + nP in PD-L1 IC-positive patients, consistent with prior interim analyses. This combination remained safe and tolerable with longer follow-up. |
| Databáze: | OpenAIRE |
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