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. 2022 Sep 19;8(1):108.
doi: 10.1038/s41523-022-00457-3.

Patient-reported outcomes from a randomized trial of neoadjuvant atezolizumab-chemotherapy in early triple-negative breast cancer

Carlos H Barrios  1 , Shigehira Saji  2 , Nadia Harbeck  3 , Hong Zhang  4 , Kyung H Jung  5 , Sheetal Patel  6 , Shilpen Patel  6 , Anh Nguyen Duc  7 , Mario Liste-Hermoso  7 , Stephen Y Chui  6 , Elizabeth A Mittendorf  8
Affiliations

Patient-reported outcomes from a randomized trial of neoadjuvant atezolizumab-chemotherapy in early triple-negative breast cancer

Carlos H Barrios et al. NPJ Breast Cancer. .

Abstract

Patient-reported outcomes data assessing patients' experience of immunotherapy treatment burden in potentially curable early-stage triple-negative breast cancer (TNBC) are lacking. These patient-reported data inform clinical benefit and decision-making for adding atezolizumab to neoadjuvant chemotherapy in early-stage TNBC. IMpassion031 (NCT03197935) randomly assigned patients with stage II/III TNBC (T2-T4d primary tumors) to 5 cycles (4 weeks/cycle) of every 2-week neoadjuvant atezolizumab 840 mg or placebo with weekly nab-paclitaxel (3 cycles) followed by every 2-week dose-dense doxorubicin+cyclophosphamide (2 cycles). After surgery, the atezolizumab-chemotherapy arm received atezolizumab 1200 mg every 3 weeks (11 cycles). The placebo-chemotherapy arm was observed under standard of care. To assess treatment burden from the patients' perspective, which comprised measures of the treatment-related impact on patients' functioning and health-related quality of life (HRQoL), as well as patients' experience of treatment-related symptoms plus their associated bother, patients completed the EORTC QLQ-C30 and FACT-G single-item GP5. Predefined secondary endpoints included mean and mean change from baseline values in the QLQ-C30 function (role and physical) and global health status/quality of life scales. Exploratory endpoints included mean and mean change from baseline in treatment-related symptoms, and treatment side effect bother. Mean physical, role function, and HRQoL were similar between arms at baseline and throughout treatment. In the neoadjuvant period, both arms exhibited clinically meaningful declines of similar magnitude from baseline in physical, role function, and HRQoL, and reported similar treatment side effect to bother at each visit. Improved pathologic complete response from adding atezolizumab to neoadjuvant chemotherapy for early-stage TNBC occurred without imposing additional treatment burden on patients.

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Conflict of interest statement

All authors received support from Genentech, Inc., during the conduct of the study. Editorial support provided by an independent medical writer, under the guidance of the authors, was funded by the sponsor. The authors declare no competing non-financial interests except as noted below. C.H.B. reports institutional grants and research support from Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GSK, Roche/Genentech, Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, BioMarin, Bristol Myers Squibb, Daiichi Sankyo, Abraxis Biosciences, AB Science, Asana Biosciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, and Millennium; and fees for serving on advisory boards and consulting from Boehringer Ingelheim, GSK, Novartis, Pfizer, Roche/Genentech, Eisai, Bayer, MSD, and AstraZeneca. S.S. has received speaking and consulting fees from Chugai, Kyowa Kirin, and Novartis; and speaking fees and/or grants from Lilly, AstraZeneca, Pfizer, MSD, Eisai, Takeda, and Taiho. N.H. has received personal fees from AstraZeneca, Bristol Myers Squibb, MSD, and Roche. H.Z. has received consulting fees from Roche/Genentech. K.H.J. has received personal fees from Roche, Novartis, AstraZeneca, Takeda, and Celgene. She.P. and Shi.P. are employees and stockholders of Roche/Genentech. A.N.D is an employee of Roche and has a patent pending relevant to this work. M.L.-H. is an employee and stockholder of Roche. S.Y.C. is an employee of and stockholder in Roche/Genentech and has a patent pending relevant to this work. E.A.M. reports research support from GSK; honoraria from Physicians’ Education Resource; compensation for serving on advisory boards from AstraZeneca, Exact Sciences, Merck, Peregrine Pharmaceuticals, Roche/Genentech, SELLAS Life Sciences, and TapImmune; institutional support from AstraZeneca, EMD Serono, Galena Biopharma, and Roche/Genentech; and serving as an uncompensated steering committee member for Bristol Myers Squibb, Lilly, and Roche/Genentech.

Figures

Fig. 1
Fig. 1. Mean values at each time point for physical function, role function, and HRQoL.
Error bars indicate 95% confidence intervals. Mean values at each time point for a physical function, b role function, and c HRQoL was measured using the EORTC QLQ-C30. A atezolizumab, C cycle, M month, P placebo, Tx DC treatment discontinuation.
Fig. 2
Fig. 2. Mean change from baseline values at each time point in physical function, role function, and HRQoL.
Error bars indicate 95% confidence intervals. Mean change from baseline values at each time point in a physical function, b role function, and c HRQoL was measured using the EORTC QLQ-C30. A atezolizumab, C cycle, GHS global health status, M month, P placebo, Tx DC treatment discontinuation.
Fig. 3
Fig. 3. Mean change from baseline values at each time point in fatigue, nausea and vomiting, and diarrhea.
Error bars indicate 95% confidence intervals. Mean change from baseline values at each time point in a fatigue, b nausea and vomiting, and c diarrhea was measured using the EORTC QLQ-C30. A atezolizumab, BL baseline, C cycle, P placebo.
Fig. 4
Fig. 4. Proportion of patients selecting each response option by visit in the FACT-G GP5 item in the atezolizumab-chemotherapy and placebo-chemotherapy arms.
Proportion of patients selecting each response option by a visit in the FACT-G GP5 item (“I am bothered by side effects of treatment”) in a the atezolizumab-chemotherapy arm and b the placebo-chemotherapy arm. BL baseline, C cycle, M month, Tx DC treatment discontinuation.
See this image and copyright information in PMC

References

    1. Howlader N, et al. SEER cancer statistics review, 1975-2014. Bethesda, MD: National Cancer Institute; 2017.
    1. Dent R, et al. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin. Cancer Res. 2007;13:4429–4434. doi: 10.1158/1078-0432.CCR-06-3045. - DOI - PubMed
    1. Foulkes WD, Smith IE, Reis-Filho JS. Triple-negative breast cancer. N. Engl. J. Med. 2010;363:1938–1948. doi: 10.1056/NEJMra1001389. - DOI - PubMed
    1. Budd GT, et al. SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer. J. Clin. Oncol. 2015;33:58–64. doi: 10.1200/JCO.2014.56.3296. - DOI - PMC - PubMed
    1. Masuda N, et al. Adjuvant capecitabine for breast cancer after preoperative chemotherapy. N. Engl. J. Med. 2017;376:2147–2159. doi: 10.1056/NEJMoa1612645. - DOI - PubMed