ESMO 2020 | LungART clinical trial update
Martin Reck, MD, PhD, German Center of Lung Research, Grosshansdorf, Germany, discusses Lung ART (NCT00410683), a clinical trial investigating radiation therapy in patients with non-small cell lung cancer (NSCLC) that has been completely removed by surgery. The trial failed to reach its primary endpoint of an improvement in disease-free survival (DFS) with mediastinal post-operative radiotherapy (PORT) in NSCLC. Furthermore, it was not observed a difference in the overall survival between the two arms of the trial. And radiotherapy-associated toxicity was substantially increased in the group of patients who received post-operative radiotherapy. Prof. Reck highlights the need to re-word treatment recommendations, and re-think the recommendation to post-operative radiotherapy in patients with resected NSCLC. This interview was recorded via an online conference call with The Video Journal of Oncology (VJOncology).
Transcript (edited for clarity)
The Lung ART try was a very important try, and we have waited a long time for these results. So in management of patients with resected non-small-cell lung cancer, we still are struggling with the optimum management with the OptiMA at UN treatment. Currently, patients with resected non-small-cell lung cancer are receiving an Ativan chemotherapy. But there is still the question, whether these patients also should receive an adjuvant radiotherapy, especially when they did have mediastinal lymph node metastasis...
The Lung ART try was a very important try, and we have waited a long time for these results. So in management of patients with resected non-small-cell lung cancer, we still are struggling with the optimum management with the OptiMA at UN treatment. Currently, patients with resected non-small-cell lung cancer are receiving an Ativan chemotherapy. But there is still the question, whether these patients also should receive an adjuvant radiotherapy, especially when they did have mediastinal lymph node metastasis.
Well, we only have very old data availably coming from a Cochrane analysis. But this data only showed that there is no risk of increased mortality receiving an adjuvant radiotherapy in an end to stage of disease. And these are not very satisfying data. So the Lung ART try was a prospective try randomizing patients with a confirmed, in to status and a resection to an postoperative mediastinal irradiation are a control arm.
The primary endpoint was disease-free survivors. Secondary endpoints were tolerability and overall survival and a couple of additional secondary endpoints. And in principle, we did observe a trend in disease-free survival favoring the patients who have received the postoperative mediastinal irradiation. However, this improvement was not significant, and formally this was a negative trial. Further or more, we also did observe that there was no difference in overall survival between the two arms of the trial, and there was a substantial increase in radiotherapy associated toxicity in the group of patients who had received the postoperative radiotherapy. So, in summary, we really have to reword our treatment recommendations. We have to rethink about our recommendation to post aperitif radiotherapy in patients with resected non-small-cell lung cancer and into disease. I think we need further information for a real individualized approach of postoperative radiotherapy.
Read more...
