Feasibility and Safety of Intrathoracic Biopsy and Repeat Biopsy for Evaluation of Programmed Cell Death Ligand–1 Expression for Immunotherapy in Non–Small Cell Lung Cancer

Abstract

Purpose To determine feasibility and safety of biopsy and repeat biopsy for assessment of programmed cell death ligand-1 (PD-L1) status. Materials and Methods This retrospective analysis reviewed 101 patients who underwent transthoracic core needle biopsy for the KEYNOTE-001 (MK-3475) clinical trial of pembrolizumab, an antiprogrammed cell death-1 therapy for non-small cell lung cancer, from May 2012 to September 2014. Sixty-one male patients (mean age, 66.1 years; range 36-83 years) and 40 female patients (mean age, 66.8 years; age range, 36-90 years) were included. Data collected included population characteristics, treatment history, target location, size, and depth from pleura. Adequacy of the tissue sample for diagnostic testing and rates of biopsy-related complications were assessed. Statistical analysis was performed by using univariate and multivariate generalized linear models to determine significant risk factors for biopsy complications. Results A total of 110 intrathoracic biopsies were performed, and 101 (91.8%) were performed as repeat biopsies subsequent to a previous percutaneous or bronchoscopic biopsy or previous surgical biopsy or resection. More than 84.5% (93 of 110) of biopsies were performed in patients who had undergone previous local or systemic therapy. Specimens were adequate for evaluation of PD-L1 expression in 96.4% of biopsies. Procedure-related complications occurred in 28 biopsies (25.4%); pneumothorax was most common (22.7%). Overall mean number of core needle biopsy samples obtained was 7.9 samples. Conclusion Image-guided transthoracic core needle biopsy is an effective method for obtaining tissue for PD-L1 expression analysis. RSNA, 2017.

Programmed death ligand 1 expression in EBUS aspirates of non–small cell lung cancer: Is interpretation affected by type of fixation?

“…Although most published studies mention a failure rate, it is not always defined with this very precise criterion. Generally, however, although the failure rate is often higher for cytology specimens than the larger types of histology specimens, such as core biopsies, this is not the case between cytology specimens and smaller biopsy specimens, such as endoscopic bronchial biopsies . With these latter specimens, the failure rate is usually approximately 10%, a figure borne out by the current study, in which 10 of 60 pairs of specimens originally included could not be assessed because one or both specimens of a pair were inadequate.…”

CT‐guided transthoracic needle biopsy for evaluation of PD‐L1 expression: Comparison of 22C3 and SP263 assays

“…The 20.0% pneumothorax rate of our study are also lower than 23% from the study by Tsai et al . that assessed the feasibility and safety of CT‐guided biopsy for evaluation of PD‐L1 . In their study, in which an average of eight cores was obtained for evaluation of PD‐L1, 5 out of 25 patients who developed pneumothorax required intervention, whereas in our study with an average acquisition of five cores, none required intervention.…”

“…The same study mentioned above has shown that at least four cores are needed to reach an optimal correlation with the whole tumor for PD‐L1 status . Another study evaluating the feasibility of CT‐guided biopsy for evaluation of PD‐L1 status has acquired average of eight cores exclusively for the analysis of PD‐L1 status . Greater number of cores and lower gauge needles do result in greater amount of tumor tissue, and intuitively, having a larger amount of tissue is advantageous for undergoing various molecular studies.…”

“…Phase 2 of Blueprint study did include biopsy specimens for the comparability analysis of four different assays, but the absolute number is very small (20 samples), core needle samples and mixed with bronchial biopsy samples, and lacks detailed information on how those biopsy samples were acquired. There is another study exploring the feasibility of PD‐L1 testing from samples obtained with CT‐guided TNB, but biopsies in that study were carried out exclusively for enrollment into the clinical trial (KEYNOTE‐001), which we believe to inadequately represent the biopsy setting in routine clinical practice. Therefore, the purpose of this study is to evaluate the concordance of two different PD‐L1 IHC assays specifically using CT‐guided biopsy samples and assess the CT‐guided‐biopsy‐related characteristics concerning PD‐L1 testing in a routine clinical setting.…”

The growth of non-solid neoplastic lung nodules is associated with low PD L1 expression, irrespective of sampling technique

“…At the same time, many other data underlined reliability of core needle biopsy (CNB) for lung cancer molecular profiling, even if some reports documented a slightly higher rate of complications [11][12][13]. More recently, both FNA cytology and CNB have been reported to be accurate, feasible and safe procedures for PD-L1 testing both retrospectively and in prospective studies [14][15][16]. It should be underlined that few data are known on the molecular features which characterize neoplastic lesions presenting as NSN, and poor information are available regarding the specific pattern of tumour presentation and growth as well as the diagnostic accuracy of different bioptic approaches in these settings.…”