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An international randomized trial, comparing post-operative conformal radiotherapy (PORT) to no PORT, in patients with completely resected non-small cell lung cancer (NSCLC) and mediastinal N2 involvement: Primary end-point analysis of LungART (IFCT-0503, UK NCRI, SAKK) NCT00410683
Le Pechoux, C. Pourel, N. Barlesi, F. Faivre-Finn, Corinne Lerouge, D. Zalcman, G. Antoni, D. Lamezec, B. Nestle, U. Boisselier, P.
Le Pechoux, C.
Pourel, N.
Barlesi, F.
Faivre-Finn, Corinne
Lerouge, D.
Zalcman, G.
Antoni, D.
Lamezec, B.
Nestle, U.
Boisselier, P.
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Abstract
Background: Adjuvant PORT has been controversial since publication of a metaanalysis
showing PORT could be deleterious especially in pN0 pN1 pts. However,
changes have taken place in the management of stage IIIAN2 NSCLC pts including use
of adjuvant chemotherapy (CT), patients’ workup, quality of surgery and radiotherapy.
Therefore the role of PORT warranted further investigations in high risk pts.
Methods: LungART is a multi-institutional randomized phase III trial comparing mediastinal
PORT (54 Gy/27-30 fractions) to no PORT. Ptswere eligible if theywere PS 0-2, had
a complete resection with nodal exploration, proven N2 disease; prior (neo)-adjuvant CT
was allowed. The main end-point was disease-free survival (DFS). 500 pts and 292 events
were required to showan improvement in DFS from30%to 42%withPORT (bilateral test).
Secondary endpoints included toxicity, local control, patterns of recurrence, overall survival
(OS), second cancers, prognostic and predictive factors of treatment effect.
Results: Between August 2007 and July 2018, 501 patients were randomized after
surgery or after CT: 252 pts allocated to PORT, and 249 to CA. Median age was 61
(range¼36-85), 66% male, histology: mostly adenocarcinoma (73%) and work-up
included PET scan in 91% pts. Most patients received CT (post op 77%, pre-op 18%).
Analysis for DFS was performed with a median FU of 4.8 yrs; toxicity evaluated on 487
pts (246 in CA). Early and late Gr 3-5 cardio-pulmonary toxicity was respectively 7 and
20% in PORT vs 3,2 and 7,7 % in CA. DFS hazard ratio was 0.85 (95% CI 0.67; 1.07);
p¼0.16; median DFS was 30.5 months in PORT arm [24;48] and 22.8 in CA [17;37]; 3-
year DFS was 47.1% with PORT vs 43.8% with no PORT. 3-year OS was 66.5% with
PORT vs 68.5% with no PORT.
Conclusions: LungART is the first European randomized study evaluating modern
PORT after complete resection, in pts selected predominantly with PET scan and
having received (neo)adjuvant CT. 3-year DFS was higher than expected in both arms
and PORT was associated with a non-statistically significant 15% increase in DFS
among stage IIIAN2 pts.
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Date
2020
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Article
Citation
Le Pechoux C, Pourel N, Barlesi F, Faivre-Finn C, Lerouge D, Zalcman G, et al. LBA3_PR An international randomized trial, comparing post-operative conformal radiotherapy (PORT) to no PORT, in patients with completely resected non-small cell lung cancer (NSCLC) and mediastinal N2 involvement: Primary end-point analysis of LungART (IFCT-0503, UK NCRI, SAKK) NCT00410683. Annals of Oncology. 2020;31:S1178-S.