Objectives

Lung cancer diagnosis nowadays greatly relies on molecular analysis and assessment of PD-L1 expression. Adequacy of tissue samples obtained with EBUS-TBNA plays a crucial role in this process.

The 22G (Acquire) needle with Franseen tip was developed to perform transbronchial needle biopsy (TBNB) with improved quality. The objective of the present study was to verify whether the PD-L1 assessment rate is related to the type of needle used: 22G (Acquire) TBNB needle vs regular 22G (Expect) TBNA needle.

Methods

International randomized clinical trial, patients with suspected (N)SCLC and an indication for staging via EBUS were recruited in 5 institutions. Patients were randomized equally between the two needles. Samples were analyzed by two blinded pathologists. The primary outcome was PD-L1 suitability rate.

Results

154 patients randomized (n=76 (Acquire) TBNB; n=78 (Expect) TBNA). 92.9% of them had a final diagnosis of malignancy. (Acquire) needle yielded a suitability for PD-L1 analysis of 80.0% (95%CI 0.68-0.94) while it was 76.7% (95%CI 0.65-0.85) with the (Expect) needle (p=0.633). As regards specimens quality, (Acquire) TBNB needle returned better results (65.3% (95%CI 0.57-0.73) vs 49.4% (95%CI 0.41-0.57, p=0.005) and yielded more tissue cores (72.0% (95%CI 0.60-.81) vs 41.0% (95%CI 0.31-0.54, p<0.01). Tissue adequacy, sensitivity for malignancy and N2/N3 disease and adequacy for molecular analysis did not statistically differ.

Conclusion

The 22G (Acquire) TBNB needle provided tissue specimens of higher quality compared to the (Expect) TBNA needle. However, suitability rate for PD-L1 analysis was not influenced by the needle type.