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Comment & Response
April 18, 2019

Concerns Regarding Phase 1b Clinical Trial of Atezolizumab Plus nab-Paclitaxel for Metastatic Breast Cancer

Author Affiliations
  • 1Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China
JAMA Oncol. 2019;5(6):908. doi:10.1001/jamaoncol.2019.0314

To the Editor In the study by Adams et al,1 the results of a phase 1b clinical trial with a 2-year-follow-up revealed that atezolizumab plus nab-paclitaxel was clinically safe and tolerable in patients with metastatic triple-negative breast cancer. However, we have some concerns.

All the enrolled patients experienced 1 or more treatment-related adverse events, however, the incidence of immune-related hypothyroidism was not described.1 In another recently published article, Schmid et al2 reported the results of a phase 3 clinical trial that explored the safety and clinical activity of the combination of atezolizumab and nab-paclitaxel. Immune-related hypothyroidism occurred more frequently in patients who received the combination therapy than in those who received placebo plus nab-paclitaxel therapy (17.3% vs 4.3%). Therefore, routine examinations of thyroid function, including TSH (thyrotropin), free T3 (triiodothyronine), and free T4 (thyroxine), during immunotherapy (even during thyroid hormone replacement therapy for patients with a diagnosis of hypothyroidism) may be recommended for patients receiving immune checkpoint inhibitor therapy.

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