"Lung ART provides robust evidence that 3D conformal PORT cannot generally be recommended as part of the standard of care in patients with resected stage IIIA N2 NSCLC. Because mediastinal relapse was substantially reduced by radiotherapy, other analyses are warranted to identify the patients for whom PORT could be used," researchers write in The Lancet Oncology.
For more than two decades, the role of PORT has been "controversial in patients with completely resected N2 NSCLC, because no contemporary clinical trials with adequate staging and treatment were available," say the authors of a linked comment.
Therefore, results of Lung ART trial have been "eagerly awaited" and the study team should be "congratulated for completing this challenging trial," write Dr. Lizza Hendriks and Dr. Dirk De Ruysscher of Maastricht University Medical Center, in the Netherlands.
The open-label, randomized, phase-3 Lung ART compared PORT to no PORT in 501 patients with pathology-proven, completely resected N2 NSCLC.
Almost all (91%) patients were staged with 18F-fluorodeoxyglucose (18F-FDG)-PET, all patients had baseline brain imaging, and 96% received neoadjuvant or adjuvant chemotherapy. PORT was administered with 3D conformal radiotherapy (89%) or intensity-modulated radiotherapy (11%).
At a median follow-up of 4.8 years, despite about a 50% risk reduction in mediastinal relapses with PORT compared with no PORT, three-year disease-free survival was 47% with PORT and 44% without PORT, report Dr. Cecile Le Pechoux of Gustave Roussy, in Villejuif, France, and colleagues.
Median disease-free survival was 30.5 months and 22.8 months, respectively (hazard ratio, 0.86; 95% confidence interval, 0.68 to 1.08; P=0.18).
Although the three-year disease-free survival was higher than expected in both groups, the trial did not meet its primary objective of significantly improving disease-free survival with PORT, the authors say.
Late grade-3 or worse cardiopulmonary toxicity was higher with PORT (11%) than without (5%).
"Two patients died from pneumonitis, partly related to radiotherapy and infection, and one patient died due to chemotherapy toxicity (sepsis) that was deemed to be treatment-related, all of whom were in the PORT group," the researchers report.
The comment authors say, "Lung ART shows that PORT should not be offered to patients with completely resected N2 NSCLC, although its role in the current treatment landscape should be investigated, but in a personalized way and with utmost care to minimize toxicity."
"In the meantime, incomplete resections should be avoided, and pathology reports should thoroughly report the completeness of resections according to the International Association for the Study of Lung Cancer standards so that each centre can improve their standard of care," they add.
This study had no commercial funding.
SOURCE: https://bit.ly/3sswqIx and https://bit.ly/3Eez86s The Lancet Oncology, online December 14, 2021.
By Reuters Staff
Posted on
site created by:
© 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy
HEAD OFFICE
Laarderhoogtweg 25
1101 EB Amsterdam
The Netherlands
T: +31 85 4012 560
E: publishers@medicom-publishers.com