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 = Radiogene Akuttoxizität nach bildgeführter intensitätsmodulierter Strahlentherapie versus dreidimensionaler konformaler Strahlentherapie bei Patienten mit Wirbelkörpermetastasen (IRON-1 trial) / Tanja Sprave, Vivek Verma, Robert Förster, Ingmar Schlampp, Thomas Bruckner, Tilman Bostel, Stefan Ezechiel Welte, Eric Tonndorf-Martini, Rami El Shafie, Nils Henrik Nicolay, Jürgen Debus, Harald Rief
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 3Gy 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..
Medienart: |
E-Artikel |
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Erscheinungsjahr: |
05 July 2018 2018 |
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Erschienen: |
05 July 2018 |
Enthalten in: |
Zur Gesamtaufnahme - volume:194 |
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Enthalten in: |
Strahlentherapie und Onkologie - 194(2018), 10, Seite 911-920 |
Sprache: |
Englisch |
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Weiterer Titel: |
Radiogene Akuttoxizität nach bildgeführter intensitätsmodulierter Strahlentherapie versus dreidimensionaler konformaler Strahlentherapie bei Patienten mit Wirbelkörpermetastasen (IRON-1 trial) |
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Beteiligte Personen: |
Sprave, Tetyana, 1978- [VerfasserIn] |
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Links: |
Volltext [lizenzpflichtig] |
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Anmerkungen: |
Gesehen am 02.04.2020 |
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Umfang: |
10 |
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doi: |
10.1007/s00066-018-1333-z |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
1693839288 |
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245 | 1 | 0 | |a Radiation-induced acute toxicities after image-guided intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for patients with spinal metastases (IRON-1 trial) |b first results of a randomized controlled trial = Radiogene Akuttoxizität nach bildgeführter intensitätsmodulierter Strahlentherapie versus dreidimensionaler konformaler Strahlentherapie bei Patienten mit Wirbelkörpermetastasen (IRON-1 trial) |c Tanja Sprave, Vivek Verma, Robert Förster, Ingmar Schlampp, Thomas Bruckner, Tilman Bostel, Stefan Ezechiel Welte, Eric Tonndorf-Martini, Rami El Shafie, Nils Henrik Nicolay, Jürgen Debus, Harald Rief |
246 | 3 | 1 | |a Radiogene Akuttoxizität nach bildgeführter intensitätsmodulierter Strahlentherapie versus dreidimensionaler konformaler Strahlentherapie bei Patienten mit Wirbelkörpermetastasen (IRON-1 trial) |
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520 | |a 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 3Gy 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. | ||
650 | 4 | |a Aged | |
650 | 4 | |a Cohort Studies | |
650 | 4 | |a Dose Fractionation, Radiation | |
650 | 4 | |a Female | |
650 | 4 | |a Follow-Up Studies | |
650 | 4 | |a Humans | |
650 | 4 | |a Intensity-modulated radiotherapy | |
650 | 4 | |a Male | |
650 | 4 | |a Middle Aged | |
650 | 4 | |a Palliative Care | |
650 | 4 | |a Palliative radiotherapy | |
650 | 4 | |a Pilot Projects | |
650 | 4 | |a Prospective Studies | |
650 | 4 | |a Radiation Injuries | |
650 | 4 | |a Radiotherapy, Conformal | |
650 | 4 | |a Radiotherapy, Image-Guided | |
650 | 4 | |a Radiotherapy, Intensity-Modulated | |
650 | 4 | |a Side effects | |
650 | 4 | |a Spinal bone metastases | |
650 | 4 | |a Spinal Neoplasms | |
650 | 4 | |a Toxicity | |
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