Objective@#To assess the
incidence and characteristics of
thyroid dysfunction during anti-
Programmed cell death 1 receptor (PD-1) antibody SHR-1210
therapy in
patients with advanced solid
tumor.@*
Methods@#The
medical records of 98
patients who initiated SHR-1210
treatment between April 27, 2016 and June 8, 2017 in the phase 1 trial to evaluate the
safety,
efficacy, and
pharmacokinetics of SHR-1210 in
patients with advanced solid
tumors were retrospectively reviewed.
Serological tests of
thyroid stimulating hormone (TSH) and free
thyroxine (fT4) were measured at baseline and prior to each SHR-1210
administration.@*Results@#A total of 86
patients had normal
thyroid function before the first
dose of SHR-1210
treatment. Nine out of 86 (10.5%)
patients developed new onset
hypothyroidism from euthyroid
state. 12
patients presented
thyroid dysfunction at baseline, 10 of whom were subclinical hypothyroid and 2 were
hypothyroidism. Four out of 10
patients developed
hypothyroidism from subclinical hypothyroid. Most
patients with
hypothyroidism were asymptomatic.
Thyroid dysfunction occurred early (median, 55days) after the initiation of SHR-1210. The severity of
hypothyroidism were all grade 1-2. No grade 3-4
hypothyroidism occurred. No
patients discontinue the
treatment of SHR-1210 due to clinical impact of the
thyroid dysfunctions.@*Conclusions@#
Thyroid-related adverse events were common during anti-PD-1 antibody SHR-1210
treatment . The
incidence of
hypothyroidism is lower in
patients with euthyroid
state than in
patients with
thyroid dysfunction at baseline during SHR-1210
treatment .
Thyroid function can be improved after
thyroid hormone replacement. During SHR-1210
treatment, it is necessary to pay
attention to monitor the
thyroid function, especially in the
patients with
thyroid dysfunction at baseline.@*Trial registration@#
Chinese Clinical Trial Registry, 2016L01455