Status
Conditions
About
This is an observational, retrospective and monocentric study, conducted at the university Hospital of Brest The primary objective is to assess the association between the occurrence of thyroid dysfunction in patients treated with Nivolumab® for a non-small cell lung cancer and prognosis and therapeutic response The second objective is to assess prognosis and therapeutic response according to severity and subtype of thyroid dysfunction
Full description
Cohort characteristics
The patients' characteristics were collected from medicals records: age, gender, smoking status (absent, current or weaned), WHO performance index, neoplastic characteristics (tumor histology, history of brain metastasis, prior radiotherapy treatment, prior therapy lines (defined by the number of chemotherapy or immunotherapy regimens used before Nivolumab® treatment) We also recorded data about expression of tumor PD-L1, LDH levels and the lymphocyte to neutrophil ratio (dNLR) summarized in the LIPI score (Lung immune prognostic index), which distinguishes three categories: good prognosis (normal LDH, dNLR <3), intermediate prognosis (abnormal LDH or dNLR> 3), poor prognosis (abnormal LDH and dNLR> 3),
Treatment schedule and morphological monitoring
Nivolumab® (3mg/kg mg) was administered as an IV infusion for 30 minutes every 2 weeks until disease progression, unacceptable toxicity, or death. Tumor assessment was performed every 2 months until disease progression. Tumor assessment was based on the results of the computerized tomodensitometry (CT) + injection of a radioiodine contrast agent and/or 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET/CT) (18FDG-PET/CT), according to the RECIST 1.1 or iRECIST 1.1 ((immune) Response Evaluation Criteria in Solid Tumors) criterion. In case of a dissociated response (response of a lesion associated with a progression of another lesion) or in case of suspicion of pseudo-progression (increase in size or appearance of new lesions linked to the influx of immune cells within the tumor), a new morphological evaluation after two additional cycles was taken into account.
Thyroid function screening and classification of thyroid dysfunction
Thyroid function screening was performed before (<3 months) and during treatment with Nivolumab® (TSH, free T4 (fT4), free T3 (fT3) ± Anti-thyroid peroxidase antibodies (TPOAb) and/or TSH receptor antibodies (TRAbs) were measured by electrochemiluminescence (Reference laboratory values were: TSH, 0.27-4.20 mIU/L; fT4, 11.6-22.0 pmol/L; fT3, 4.0-6.8 pmol/L; TPOAb, <34 kIU/L; and TRAb, <1.75 U/L
For classification of thyroid dysfunction, the CTCAE classification was not taken into account because it is not adapted to thyroid dysfunction that is often asymptomatic. Only abnormalities of the thyroid function tests were considered as follow:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal