TY - JOUR
T1 - The acute and late toxicity results of a randomized phase II dose-escalation trial in non-small cell lung cancer (PET-boost trial)
AU - van Diessen, Judi
AU - de Ruysscher, Dirk
AU - Sonke, Jan-Jakob
AU - Damen, Eugène
AU - Sikorska, Karolina
AU - Reymen, Bart
AU - van Elmpt, Wouter
AU - Westman, Gunnar
AU - Fredberg Persson, Gitte
AU - Dieleman, Edith
AU - Bjorkestrand, Hedvig
AU - Faivre-Finn, Corinne
AU - Belderbos, José
PY - 2019/2/1
Y1 - 2019/2/1
N2 - Background and purpose: The PET-boost randomized phase II trial (NCT01024829) investigated dose-escalation to the entire primary tumour or redistributed to regions of high pre-treatment FDG-uptake in inoperable non-small cell lung cancer (NSCLC) patients. We present a toxicity analysis of the 107 patients randomized in the study. Materials and methods: Patients with stage II–III NSCLC were treated with an isotoxic integrated boost of ≥72 Gy in 24 fractions, with/without chemotherapy and strict dose limits. Toxicity was scored until death according to the CTCAEv3.0. Results: 77 (72%) patients were treated with concurrent chemoradiotherapy. Acute and late ≥G3 occurred in 41% and 25%. For concurrent (C) and sequential or radiotherapy alone (S), the most common acute ≥G3 toxicities were: dysphagia in 14.3% (C) and 3.3% (S), dyspnoea in 2.6% (C) and 6.7% (S), pneumonitis in 0% (C) and 6.7% (S), cardiac toxicity in 6.5% (C) and 3.3% (S). Seventeen patients died of which in 13 patients a possible relation to treatment could not be excluded. In 10 of these 13 patients progressive disease was scored. Fatal pulmonary haemorrhages and oesophageal fistulae were observed in 9 patients. Conclusion: Personalized dose-escalation in inoperable NSCLC patients results in higher acute and late toxicity compared to conventional chemoradiotherapy. The toxicity, however, was within the boundaries of the pre-defined stopping rules.
AB - Background and purpose: The PET-boost randomized phase II trial (NCT01024829) investigated dose-escalation to the entire primary tumour or redistributed to regions of high pre-treatment FDG-uptake in inoperable non-small cell lung cancer (NSCLC) patients. We present a toxicity analysis of the 107 patients randomized in the study. Materials and methods: Patients with stage II–III NSCLC were treated with an isotoxic integrated boost of ≥72 Gy in 24 fractions, with/without chemotherapy and strict dose limits. Toxicity was scored until death according to the CTCAEv3.0. Results: 77 (72%) patients were treated with concurrent chemoradiotherapy. Acute and late ≥G3 occurred in 41% and 25%. For concurrent (C) and sequential or radiotherapy alone (S), the most common acute ≥G3 toxicities were: dysphagia in 14.3% (C) and 3.3% (S), dyspnoea in 2.6% (C) and 6.7% (S), pneumonitis in 0% (C) and 6.7% (S), cardiac toxicity in 6.5% (C) and 3.3% (S). Seventeen patients died of which in 13 patients a possible relation to treatment could not be excluded. In 10 of these 13 patients progressive disease was scored. Fatal pulmonary haemorrhages and oesophageal fistulae were observed in 9 patients. Conclusion: Personalized dose-escalation in inoperable NSCLC patients results in higher acute and late toxicity compared to conventional chemoradiotherapy. The toxicity, however, was within the boundaries of the pre-defined stopping rules.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85054736180&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30327236
U2 - https://doi.org/10.1016/j.radonc.2018.09.019
DO - https://doi.org/10.1016/j.radonc.2018.09.019
M3 - Article
C2 - 30327236
SN - 0167-8140
VL - 131
SP - 166
EP - 173
JO - Radiotherapy and oncology
JF - Radiotherapy and oncology
ER -