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1. Department of radiotherapy, Centre L. Bérard, Lyon, France

Acute radiation pneumonitis in non-small cell lung cancer: is respiratory-gated control useful? Results of a French prospective phase III randomized study. L. Claude 1 , D. Arpin 1-2 , V Servois 3 , M. Ayadi 4 , S. Dussart 5 , C. Ferlay 5 , and MA. Mahé 6.

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1. Department of radiotherapy, Centre L. Bérard, Lyon, France

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  1. Acute radiation pneumonitis in non-small cell lung cancer: is respiratory-gated control useful? Results of a French prospective phase III randomized study L. Claude1, D. Arpin1-2, V Servois3, M. Ayadi4, S. Dussart5,C. Ferlay5, and MA. Mahé6 1. Department of radiotherapy, Centre L. Bérard, Lyon, France 2. Department of pneumology, Hôpital de Mâcon, France 3. Department of radiology, Institut Curie, Paris, France 4. Department of physics, Centre L. Bérard, Lyon, France 5. Department of biostatistic and epidemiology, Centre Léon Bérard, Lyon, France 6. Department of radiotherapy, Institut d’oncologie de l’Ouest, Nantes

  2. Background • Respiratory-gated conformal radiotherapy (RGRT) is used to limit the impact of respiratory movements during RT and allows in theory a decrease of dosimetric parameters predictive of ARP. • This prospective randomized trial was conducted to evaluate the real impact of RGRT on ARP incidence. • ARP prospective evaluation included clinical, functional, CT and management evaluations 6-8 and then 10-12 weeks after the end of RT. • ARP was scored according to both Lent-Soma and RTOG (acute) classifications.

  3. Inclusion criteria • Patients (pts) > 18 y. with proven non-metastatic NSCLC • Curative RT intent (adjuvant or exclusive) • Conformal RT (median dose 66Gy, 2Gy/fr) was delivered • Either during free breathing (FB) • Or using respiratory-gated conformal radiotherapy (RGRT) • Between July 2006 and July 2011 : 242 pts were randomized • 120 pts in FB arm • 122 pts in RGRT arm

  4. No difference in term of acute moderate/severe lung toxicity • The rate of all ARP (ARP ≥1 Lent Soma) between 6 and 12 weeks was • 19.3% in FB arm • 29.0% in RGRT arm NS • The rate of severe ARP (symptomatic requiring treatment) between 6 and 12 weeks • 7.7% (FB) • 5.7% (RGRT) NS RGRT failed to demonstrate any impact in term of prevention of ARP in our phase III prospective randomized study

  5. No difference in term of local control or DFS • No difference in term of loco-regional responses rates • 78% (CI95%[66-86]) RL • 73% (CI95%[60-82]) AR (NS) • With a median follow-up of 25.2 months, the 1y-DFS was 38% (CI95%[31 – 45]) for the whole cohort. • 41% (CI95%[31 – 50]) RL • 35% (CI95%[27 – 45]) AR (NS)

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