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05.07.2018 | Original Article

Radiation-induced acute toxicities after image-guided intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for patients with spinal metastases (IRON-1 trial)

First results of a randomized controlled trial

verfasst von: Tanja Sprave, MD, Vivek Verma, MD, Robert Förster, MD, Ingmar Schlampp, MD, Thomas Bruckner, PhD, Tilman Bostel, MD, Stefan Ezechiel Welte, MD, Eric Tonndorf-Martini, Rami El Shafie, MD, Nils Henrik Nicolay, MD PhD, Jürgen Debus, MD PhD, Harald Rief, MD PhD

Erschienen in: Strahlentherapie und Onkologie | Ausgabe 10/2018

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Abstract

Purpose

Radiation therapy (RT) provides an important treatment approach in the palliative care of vertebral metastases, but radiation-induced toxicities in patients with advanced disease and low performance status can have substantial implications for quality of life. Herein, we prospectively compared toxicity profiles of intensity-modulated radiotherapy (IMRT) vs. conventional three-dimensional conformal radiotherapy (3DCRT).

Methods

This was a prospective randomized monocentric explorative pilot trial to compare radiation-induced toxicity between IMRT and 3DCRT for patients with spinal metastases. A total of 60 patients were randomized between November 2016 and May 2017. In both cohorts, RT was delivered in 10 fractions of 3 Gy each. The primary endpoint was radiation-induced toxicity at 3 months.

Results

Median follow-up was 4.3 months. Two patients suffered from grade 3 acute toxicities in the IMRT arm, along with 1 patient in the 3DCRT group. At 12 weeks after treatment (t2), 1 patient reported grade 3 toxicity in the IMRT arm vs. 4 patients in the 3DCRT group. No grade 4 or 5 adverse events occurred in either group. In the IMRT arm, the most common side effects by the end of irradiation (t1) were grade 1–2 xerostomia and nausea in 8 patients each (29.6%), and dyspnea in 7 patients (25.9%). In the 3DCRT group, the most frequent adverse events (t1) were similar: grade 1–2 xerostomia (n = 10, 35.7%), esophagitis (n = 10, 35.8%), nausea (n = 10, 35.8%), and dyspnea (n = 5, 17.9%).

Conclusion

This is the first randomized trial to evaluate radiation-induced toxicities after IMRT versus 3DCRT in patients with vertebral metastases. This trial demonstrated an additional improvement for IMRT in terms of acute side effects, although longer follow-up is required to further ascertain other endpoints.

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Titel: Radiation-induced acute toxicities after image-guided intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for patients with spinal metastases (IRON-1 trial)
First results of a randomized controlled trial
verfasst von: Tanja Sprave, MD
Vivek Verma, MD
Robert Förster, MD
Ingmar Schlampp, MD
Thomas Bruckner, PhD
Tilman Bostel, MD
Stefan Ezechiel Welte, MD
Eric Tonndorf-Martini
Rami El Shafie, MD
Nils Henrik Nicolay, MD PhD
Jürgen Debus, MD PhD
Harald Rief, MD PhD
Publikationsdatum: 05.07.2018
Verlag: Springer Berlin Heidelberg
Erschienen in: Strahlentherapie und Onkologie / Ausgabe 10/2018
Print ISSN: 0179-7158
Elektronische ISSN: 1439-099X
DOI: https://doi.org/10.1007/s00066-018-1333-z

Springer Medizin

Radiation-induced acute toxicities after image-guided intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for patients with spinal metastases (IRON-1 trial)

First results of a randomized controlled trial