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Clinical Trial
. 2020 May;31(5):582-589.
doi: 10.1016/j.annonc.2020.02.003. Epub 2020 Feb 20.

Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer

S Adams  1 , V Diéras  2 , C H Barrios  3 , E P Winer  4 , A Schneeweiss  5 , H Iwata  6 , S Loi  7 , S Patel  8 , V Henschel  9 , S Y Chui  8 , H S Rugo  10 , L A Emens  11 , P Schmid  12
Affiliations
Free article
Clinical Trial

Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer

S Adams et al. Ann Oncol. 2020 May.
Free article

Abstract

Background: Metastatic triple-negative breast cancer (mTNBC) is incurable. A key treatment goal is providing palliation while maintaining patients' health-related quality of life (HRQoL). IMpassion130 demonstrated progression-free survival benefit with atezolizumab + nab-paclitaxel (A + nP) versus placebo + nab-paclitaxel (Pl + nP) in first-line treatment of mTNBC patients with programmed death-ligand 1 positive (PD-L1+) tumors. We report data on patient-reported outcomes (PROs), which capture patient perspectives of treatment.

Patients and methods: Patients with untreated advanced or mTNBC received atezolizumab (840 mg) or placebo every 2 weeks in combination with nab-paclitaxel (100 mg/m2) on days 1, 8, and 15 of each 28-day cycle until progression or intolerance. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and its Breast Cancer Module (QLQ-BR23) on day 1 of each cycle, at end of treatment, and every 4 weeks during 1 year of follow-up. Time-to-deterioration (TTD) in HRQoL (first ≥10-point decrease from baseline lasting two cycles) was a secondary end point. Exploratory end points included TTD in functioning and mean and mean change from baseline scores in HRQoL, functioning, and disease- and treatment-related symptoms.

Results: Baseline completion of PROs was 92% (QLQ-C30) and 89% (QLQ-BR23) and remained >80% through cycle 20 in intent-to-treat (ITT) and PD-L1+ patients. No differences between arms in median TTD in PD-L1+ patients were observed for HRQoL {hazard ratio (HR) 0.94 [95% confidence interval (CI) 0.69-1.28]} or physical [HR 1.02 (95% CI 0.76-1.37)] or role [HR 0.77 (95% CI 0.57-1.04)] functioning. Mean baseline scores for A + nP versus Pl + nP for HRQoL (67.5 versus 65.0) and physical (82.8 versus 79.4) and role (73.7 versus 71.7) functioning were comparable between arms and throughout the course of treatment, with no clinically meaningful (≥10 point) changes from baseline until patients discontinued treatment. No differences in clinically meaningful worsening in treatment symptoms (fatigue, diarrhea, or nausea/vomiting) were observed between arms. Results in ITT patients were similar.

Conclusions: A + nP as first-line treatment for mTNBC delayed progression without compromising patients' day-to-day functioning or HRQoL or worsening treatment symptoms. CLINICALTRIAL.

Gov identifier: NCT02425891.

Keywords: atezolizumab; health-related quality of life; nab-paclitaxel; patient function; patient-reported outcomes; triple-negative breast cancer.

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Conflict of interest statement

Disclosure SA has received institutional support from Genentech, Merck, Amgen, Bristol-Meyers Squibb (BMS), Novartis, and Celgene and medical writing support from Genentech, and is an uncompensated member of the Steering Committee for IMpassion130. VD has received honoraria for serving on advisory boards for Roche/Genentech, Pfizer, Eli Lilly, Novartis, Daiichi Sankyo, AstraZeneca, AbbVie, and Odonate. CHB has received research grants from Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GSK, Roche/Genentech, Eli Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, BioMarin, BMS, Daiichi Sankyo, Abraxis BioScience, AB Science, Asana BioSciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, and Millennium and consulting fees from Roche/Genentech, Boehringer Ingelheim, GSK, Novartis, Pfizer, Eisai, Bayer, Merck Sharp & Dohme (MSD), and AstraZeneca. EPW has received research grants for support of the parent study and medical writing support from F. Hoffman-La Roche and honoraria from Eli Lilly, Leap, Genentech, Infinite MD, Carrick Therapeutics, GSK, Jounce, Genomic Health, Merck, and Seattle Genetics and is a scientific advisory board member for Leap. AS has received research grants from Celgene, Roche, AbbVie, and Molecular Partners; consulting fees and travel expenses from Roche and AstraZeneca; honoraria from Roche, Celgene, AstraZeneca, Novartis, MSD, Tesaro, and Eli Lilly; and honoraria and travel expenses from Pfizer. HI has received honoraria, consulting fees, and research support for the parent study and editorial support from F. Hoffman-La Roche and Chugai; serves as an uncompensated member of the steering committee for the parent trial; and has received honoraria and consulting fees from Novartis, AstraZeneca, Pfizer, Eli Lilly, and Daiichi Sankyo. SL has received institutional support and is an uncompensated consultant for Novartis, BMS, Roche/Genentech, and Merck; has received institutional support from Puma Biotechnology and Eli Lilly; is an uncompensated consultant for Seattle Genetics and Pfizer; and had fees paid to institution for consulting for Aduro Biotechnology. SP and SYC are employees of Genentech and own Roche stock. VH is an employee of and owns stock options from Roche. HSR has received research support for the parent study and editorial support from F. Hoffman-La Roche; institutional support from Pfizer, Novartis, Eli Lilly, Merck, OBI, Eisai, and Plexxikon; institutional and travel support from Genentech/Roche and MacroGenics; travel support from PUMA, Mylan, Novartis, and Pfizer; research support from Immunomedics; research and travel support from Daiichi Sankyo; and honoraria from Celltrion. LAE is co-chair of the steering committee for the parent study and chair of the KATE2 steering committee and has received honoraria from AbbVie, Amgen, Celgene, Gritstone, MedImmune, Peregrine, and Syndax; honoraria and travel support from AstraZeneca, Bayer, MacroGenics, Replimune, and Vaccinex; travel support from BMS, Genentech, Novartis, and Roche; potential future stock from MolecuVax; institutional support from Aduro Biotech, AstraZeneca, the Breast Cancer Research Foundation, BMS, Corvus, the Department of Defense, EMD Serono, Genentech, MaxCyte, Merck, the National Cancer Institute, the NSABP Foundation, Roche, the Translational Breast Cancer Research Consortium, and HeritX, Inc, and royalties from Aduro. PS has received research funding and editorial support for the present study from F. Hoffmann-La Roche; research grants and institutional support from AstraZeneca, Genentech, Roche, OncoGenex, and Novartis; and honoraria or consulting fees from Pfizer, AstraZeneca, Novartis, Roche, Merck, Boehringer Ingelheim, Bayer, Eisai, Celgene, and Puma; and is an uncompensated steering committee member for the IMpassion130 trial. PS's spouse is an employee of Roche.

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