Post-Operative Radiotherapy (PORT) Versus No PORT in Patients With Completely Resected Non-Small Cell Lung Cancer and Proven Mediastinal N2 Involvement: An Open Label Randomised Phase 3 Superiority Trial (Lung ART (IFCT-0503, UK NCRI, SAKK))

Péchoux, C. Le; Pourel, N.; Lerouge, D.; Antoni, D.; Lamezec, B.; Nestle, Ursula; Boisselier, P.; Dansin, Éric; Paumier, A.; Peignaux, Karine; Thillays, F.; Zalcman, Gérard; Madelaine, J.; Pichon, Éric; Larrouy, Anne; Lavolé, A.; Argo-Leignel, D.; Derollez, Marc; Faivre-Finn, Corinne; Hatton, Matthew; Riesterer, Oliver; Bouvier-Morel, Emilie; Dunant, Ariane; Edwards, John; Thomas, Pascal; Mercier, Olaf; Bardet, A.

doi:10.2139/ssrn.3875389

Cited by 1 publication

(9 citation statements)

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“…Both trials evaluating modern PORT in patients with stage IIIAN2 NSCLC were then negative for the primary end point (DFS). 16,17 The DFS was high in both trials (Table 2 and Fig 1). PORT was associated with a nonstatistically significant 8%-15% increase in DFS among patients with mediastinal involvement.…”

Section: Port Evidence In Patients With Pn2 R0mentioning

confidence: 84%

“…Two prospective randomized phase III studies (Table 2 and Fig 1) evaluating modern PORT in patients with completely resected stage IIIA-N2 NSCLC, who received (neo)adjuvant chemotherapy, were reported: a European trial (Lung ART, NCT00410683, presented at the European Society of Medical Oncology 2020 congress) and the single-center recently published Chinese PORT-C trial. 16,17…”

Section: Port Evidence In Patients With Pn2 R0mentioning

confidence: 99%

“…Lung ART compared conformal (three-dimensional [3D]: 89%, intensity-modulated radiotherapy [IMRT]: 11%) PORT given at the dose of 54 Gy/27-30 fractions with observation. 17 The main objective of this randomized trial was disease-free survival (DFS), and 500 patients (292 events) were required to show an improvement in DFS from 30% to 42% with PORT (bilateral test, power = 80%, alpha = 5%). Between August 2007 and July 2018, 501 patients were randomly assigned after surgery or after chemotherapy: 252 patients allocated to PORT and 249 to the control arm.…”

Section: Port Evidence In Patients With Pn2 R0mentioning

confidence: 99%

“…OS was not different between the two arms (the 3-year OS was 66.5% with PORT v 68.5% with no PORT). 17…”

Section: Port Evidence In Patients With Pn2 R0mentioning

confidence: 99%

“…12-15 But two phase III randomized trials have recently been presented or published: the Lung Adjuvant Radiotherapy Trial (Lung ART) evaluating PORT in patients with R0 with N2-proven mediastinal involvement, having received neoadjuvant or adjuvant chemotherapy, and the PORT-C evaluating the effect of PORT in patients with postoperative stage IIIA-N2 after complete resection and adjuvant chemotherapy; both provide more insight in the debate of PORT. 16,17 In this review, we describe the existing literature on PORT, emphasizing on the recent randomized evidence, and discuss possible future directions in operable NSCLC patients.…”

Section: Introductionmentioning

confidence: 99%

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Indications and Parameters Around Postoperative Radiation Therapy for Lung Cancer

Lévy

Mercier

Péchoux

2022

JCO

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Patients with locally advanced resected non–small-cell lung cancer present a high risk of relapse. Although adjuvant platinum–based chemotherapy has become the standard of care, the role of postoperative radiation therapy (PORT) has been controversial for years. In patients with incomplete resection, PORT should be proposed, on the basis of a strong consensus, despite the absence of randomized evidence. In patients with completely resected (R0) non–small-cell lung cancer, a meta-analysis showed poorer outcomes after PORT in the absence of mediastinal involvement (pN0 and pN1). In patients with pN2, the role of PORT was less clear and required further research. The meta-analysis included trials using older radiation techniques and poorer quality of surgery according to today's standards, and selection of patients was not positron emission tomography–based. Newer retrospective and nonrandomized studies and subgroup analyses of randomized trials evaluating adjuvant chemotherapy suggested a survival benefit of PORT in patients with pN2 R0. Two recent randomized trials (Lung ART and PORT-C) evaluating conformal PORT versus no PORT retrieved no disease-free survival advantage for stage IIIA-N2 patients, even if mediastinal relapse was significantly decreased with PORT. PORT had no effect on survival, possibly given the high rate of distant relapse and risk of additional cardiopulmonary toxicity. Ongoing and future analyses are planned in Lung ART to identify patients for whom PORT could be recommended. Incorporation of newer systemic treatments (immune checkpoint inhibitors or targeted therapy in oncogene-addicted patients) is underway in the neoadjuvant and/or adjuvant setting. Better identification of patients at a high risk of disease recurrence, with analysis of circulating tumor DNA, on the basis of the detection of postsurgical minimal (or molecular) residual disease is warranted in future studies.

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Section: Port Evidence In Patients With Pn2 R0mentioning

confidence: 84%

Section: Port Evidence In Patients With Pn2 R0mentioning

confidence: 99%

Section: Port Evidence In Patients With Pn2 R0mentioning

confidence: 99%

“…OS was not different between the two arms (the 3-year OS was 66.5% with PORT v 68.5% with no PORT). 17…”

Section: Port Evidence In Patients With Pn2 R0mentioning

confidence: 99%