The acute and late toxicity results of a randomized phase II dose-escalation trial in non-small cell lung cancer (PET-boost trial)

Judi van Diessen, Dirk De Ruysscher, Jan-Jakob Sonke, Eugene Damen, Karolina Sikorska, Bart Reymen, Wouter van Elmpt, Gunnar Westman, Gitte Fredberg Persson, Edith Dieleman, Hedvig Bjorkestrand, Corinne Faivre-Finn, José Belderbos

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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.
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), dyspnea 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 hemorrhages and oesophageal fistulae were observed in 9 patients.


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

Original languageEnglish
JournalRadiotherapy & Oncology
Early online date25 Sept 2018
Publication statusPublished - 2018

Research Beacons, Institutes and Platforms

  • Manchester Cancer Research Centre


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