Neoadjuvant nivolumab plus chemotherapy versus chemotherapy for resectable NSCLC: subpopulation analysis of Chinese patients in CheckMate 816.

BACKGROUND: Neoadjuvant nivolumab plus chemotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) versus chemotherapy alone in patients with resectable non-small-cell lung cancer (NSCLC) in the global phase III CheckMate 816 study. Here, we report post hoc exploratory efficacy, safety, and surgical outcomes in the Chinese subpopulation of this study. METHODS: Adults with stage IB-IIIA resectable NSCLC were randomized to receive nivolumab 360 mg plus chemotherapy or chemotherapy alone every 3 weeks for three cycles followed by surgery. Primary endpoints included EFS and pCR (both per blinded independent review). EFS and pCR results were from 14 October 2022, and 16 September 2020, database locks, respectively. RESULTS: The Chinese subpopulation comprised 97 patients (nivolumab plus chemotherapy, 44; chemotherapy, 53). At 38.2 months of minimum follow-up, median EFS was not reached [95% confidence interval (CI) 23.4 months-not reached] in the nivolumab plus chemotherapy arm and 13.9 months (95% CI 8.3-34.3 months) in the chemotherapy arm (hazard ratio 0.47, 95% CI 0.25-0.88). pCR rates were 25.0% (95% CI 13.2% to 40.3%) and 1.9% (95% CI 0.0% to 10.1%), respectively (odds ratio 11.05; 95% CI 1.41-86.49). Of 97 Chinese patients, 36 (82%) in the nivolumab plus chemotherapy arm and 41 (77%) in the chemotherapy arm underwent definitive surgery. Grade 3-4 treatment-related adverse events occurred in 18/43 patients (42%) treated with nivolumab plus chemotherapy and 22/53 patients (42%) treated with chemotherapy. CONCLUSIONS: Consistent with findings in the global study population of CheckMate 816, neoadjuvant nivolumab plus chemotherapy improved EFS and pCR versus chemotherapy in the Chinese subpopulation without impacting treatment tolerability or the feasibility of surgery. These findings support the use of nivolumab plus chemotherapy as a standard neoadjuvant treatment option for Chinese patients with resectable NSCLC.

Systemic-pulmonary polytetrafluoroethylene shunts in palliative operations for congenital heart disease. Revival of the central shunt.

The concept of central shunting in smaller children with the Waterston shunt was initially well accepted. It has been abandoned because of the difficult estimation of lumen size, preferential flow to the right side, and difficulty in the take-down of the shunt. We have replaced the Waterston shunt with a short segment of polytetrafluoroethylene between the ascending aorta and the main pulmonary artery. From January 1979 to December 1986, 190 shunt operations were performed in 157 patients, with the use of 26 classic Blalock-Taussig shunts (13.7%), six Waterston shunts (3.1%), nine Glenn shunts (4.7%), 80 central aortopulmonary polytetrafluoroethylene shunts (42.2%), and 69 modified Blalock-Taussig shunts (36.3%). Polytetrafluoroethylene grafts were used for 149 of the 190 (78.4%) shunts. Overall mortality was 15.2%, with nine early deaths (4.7%) and 20 late deaths (10.5%). Deaths were due to the complex nature of the congenital anomaly or definitive surgical repair. The patients weighed from 1.6 to 48 kg and ages ranged from 1 day to 22 years. We have modified our technique so that (1) graft length is less than 0.5 cm and both ends are beveled, (2) the aortotomy is fashioned with a punch, (3) the center of the polytetrafluoroethylene graft is never clamped, (4) heparin is given during the construction of the shunt, and (5) aspirin (10 mg/kg/day) is administered daily. Patency ranges from 1 to 4 years. We conclude that the polytetrafluoroethylene shunt provides excellent palliation and that the central shunt, in the smaller child and infant, offers the benefits of shunting without distortion of the peripheral pulmonary arteries.