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P2.08 .26 Randomized Phase II Trial of Adjuvant Ra ...
P2.08 .26 Randomized Phase II Trial of Adjuvant Radiochemotherapy, Concurrent Versus Sequential, in Resected pN2 NSCLC. ARCCS Trial
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The ARCCS trial was a Phase II randomized study comparing concurrent versus sequential adjuvant chemoradiotherapy (CHT-RT) using modern radiotherapy techniques (IMRT/VMAT-IGRT) in patients with resected pN2 non-small cell lung cancer (NSCLC). The trial aimed to assess treatment-related acute esophageal toxicity (grade 3) and locoregional recurrence-free survival (LRFS) as co-primary endpoints. Eligible patients underwent lobectomy and received cisplatin-based chemotherapy (up to 4 cycles) combined with postoperative radiotherapy (PORT) of 50 Gy, plus a boost in cases of positive surgical margins (PSM) or extracapsular nodal extension (ECE).<br /><br />Due to low enrollment—attributed mainly to the COVID-19 pandemic and discouraging results from the LungART and PORT-C trials indicating no disease-free survival benefit and increased toxicity from PORT—the study closed after enrolling only 24 patients (11 in concurrent arm A, 13 in sequential arm B). All patients had adenocarcinoma histology. Nearly 30% presented with PSM or ECE. Treatment completion rates differed slightly between groups.<br /><br />After a median follow-up of 44 months, locoregional control was good, with 3-year LRFS rates of 82% (arm A) and 91% (arm B). No grade 3 acute esophageal toxicities occurred, and low-grade esophageal toxicity was mild across both arms. A minority of patients experienced pneumonitis in the sequential arm. Despite these positive signals, the small sample size precludes definitive conclusions on the superiority or safety of concurrent radiochemotherapy postoperatively.<br /><br />The trial highlights that PORT, historically utilized in pN2 NSCLC management, now holds a very limited role due to advances in immunotherapy and targeted treatment. PORT may still be appropriate in highly selected cases with significant locoregional risk, but only when delivered with state-of-the-art radiotherapy methods to reduce toxicity and optimize outcomes.<br /><br />In summary, ARCCS provides limited but important data supporting the tolerability of modern PORT combined with chemotherapy, though evolving systemic therapies are reshaping the standard of care for resected pN2 NSCLC.
Asset Subtitle
Paolo Borghetti
Meta Tag
Speaker
Paolo Borghetti
Topic
Local-Regional Non-small Cell Lung Cancer
Keywords
ARCCS trial
Phase II study
concurrent chemoradiotherapy
sequential chemoradiotherapy
pN2 non-small cell lung cancer
postoperative radiotherapy
IMRT
VMAT-IGRT
locoregional recurrence-free survival
esophageal toxicity
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