PS68. Surgical Results from the NORTHSTAR Trial: Feasibility of Pulmonary Resection after Osimertinib in Stage IV disease
MD Anderson Cancer Center
Bellaire, TX
United States - Contact Me
Dr. Antonoff completed her undergraduate studies at the University of Pennsylvania and earned her medical degree at the University of Minnesota, where she also completed internship and residency in General Surgery. Dr. Antonoff completed a fellowship in Cardiothoracic Surgery at Washington University in St Louis. She joined MD Anderson in 2014, where she’s currently an Associate Professor and Program Director for Education. Dr. Antonoff’s research interests include pulmonary metastatic disease, early detection of lung cancer, and localized therapy for metastatic lung cancer. She leads a multi-institutional trial for lung-limited metastatic colorectal cancer, and she’s the surgical PI for multiple trials evaluating the role of local consolidative therapy for metastatic non-small cell lung cancer. She holds leadership roles in the WTS, the STS, the AATS, and the TSDA, as well as Editorial Board positions for Annals of Thoracic Surgery, Journal of Thoracic and Cardiovascular Surgery, Innovations, CTSNet, and Journal of Thoracic Disease.
Description
We have previously demonstrated that patients with oligometastatic non-small cell lung cancer (NSCLC) treated with local consolidative therapy (LCT) have improved survival outcomes compared to patients treated with systemic therapy alone, and that oligometastatic patients with EGFR mutations derive a more substantial benefit from LCT. A phase 2 randomized, multicenter study to evaluate the efficacy of osimertinib with or without LCT for patients with EGFR-mutant stage IV NSCLC (NORTHSTAR) was undertaken, including patients with oligo- as well as polymetastatic disease. We sought to assess feasibility and safety of lung resection in this patient population.
Methods:
Previously untreated patients with EGFR-mutant NSCLC (L858R, Ex19 deletion) or acquired EGFR T790M were enrolled in the NORTHSTAR trial. Patients with non-progressive disease after 6-12 weeks of osimertinib were randomized 1:1 to continue osimertinib alone or to undergo LCT + osimertinib. LCT patients underwent either surgery or radiation, and surgical patients were reviewed for details of intraoperative and 30-day postoperative courses. All procedures occurred between 06/2018-09/2022.
Results:
20 NORTHSTAR patients underwent lung resection, including 11 (55%) women, with median age of 65.1 years. 18 (90%) and 2 (10%) patients presented with poly- and oligometastatic disease, respectively. Procedures were performed by thoracotomy in 19 (95%) patients, and included 17 (85%) lobectomies, 1 (5%) wedge, and 2 (10%) segmentectomies. 3 (15%) had evidence of pretreatment malignant effusions. Surgeons reported operations as severely difficult in 17 (85%, Figure), with severe adhesions in 7 (35%) and severe hilar fibrosis in 13 (65%). Median operative duration and blood loss were 234 min (interquartile range [IQR] 154-271) and 175 mL (IQR 100-219), respectively, with 2 (10%) receiving intraoperative transfusion. There were no perioperative mortalities or ICU admissions. Median postoperative chest tube duration was 2.2 days (IQR: 1.4-2.7). Typical postoperative events occurred with prolonged airleak in 1 (5%) and atrial arrhythmias in 2 (10%).
Conclusions:
Patients with metastatic EGFR-mutated NSCLC who were randomized to LCT and underwent lung resection successfully achieved outcomes similar to historical standards for early-stage disease. These operations are feasible and safe, emphasizing the importance of including surgical resection in ongoing clinical trials for stage IV NSCLC.