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

N1 - Publisher Copyright: © 2018 Elsevier B.V.

PY - 2019

Y1 - 2019

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.

KW - Dose painting

KW - Dose-escalation

KW - Non-small cell lung cancer

KW - PET-boost

KW - Toxicity

U2 - 10.1016/j.radonc.2018.09.019

DO - 10.1016/j.radonc.2018.09.019

M3 - Journal article

C2 - 30327236

AN - SCOPUS:85054736180

VL - 131

SP - 166

EP - 173

JO - Radiotherapy & Oncology

JF - Radiotherapy & Oncology

SN - 0167-8140

ER -