Repeat needle biopsies combined with clinical observation are safe and accurate in the management of a solitary pulmonary nodule.

Background: Sixty percent of removed solitary pulmonary nodules (SPNs) are benign. An approach that reduces the unnecessary excision of benign nodules is consistent with the oncologic objective of organ preservation.

Methods: A prospective observational study was performed at a lung cancer referral center in which consecutive patients were evaluated who presented with SPNs measuring < 4 cm on computed tomography (CT) scans. Patients underwent transbronchial biopsy (TBB), percutaneous needle aspiration (PCNA), clinical observation, repeat CT scans, and repeat biopsies. Patients were observed clinically and underwent repeat biopsies in an effort to reduce unnecessary surgical intervention.

Results: One hundred eighteen patients underwent 194 biopsy sessions, including 137 TBB sessions and 57 PCNA sessions. The mean follow-up was 4 years. The shortest follow-up of a benign lesion was 3 years. The incidence of malignancy was 61%. The positive predictive value, negative predictive value, sensitivity, specificity, and accuracy all were 100%. Five patients had a delayed change in diagnosis from benign to malignant. This delay in diagnosis neither resulted in a change in tumor stage nor had an impact on patient management or survival.

Conclusions: Repeat needle biopsies combined with clinical observation and repeat CT scans can classify an SPN as benign versus malignant with 100% accuracy (95% confidence interval, 96.1-100.0%). An SPN diagnostic approach that includes a TBB, then PCNA, clinical observation, repeat CT scans, and repeat biopsies for continued suspicion of malignancy appears to reduce the unnecessary surgical excision of benign nodules from the current rate of 60% to 5% of SPN resections without affecting the survival of patients who have malignant SPNs.