HYPORT adjuvant acute toxicity and patient dosimetry quality assurance results - Interim analysis
Copyright © 2022 Elsevier B.V. All rights reserved..
BACKGROUND: HYPORT adjuvant trial is a randomised phase III open-label noninferiority trial comparing standard moderately hypofractionated 3 week adjuvant radiation therapy in breast cancer with a novel 1-week schedule. The trial was initiated in March 2019 and is open to recruitment with a total sample size of 2100. We report the results of dosimetric quality assurance, acute toxicity and pre planned first interim safety analysis in the first 271 patients.
METHODS: Stage I-III breast cancer planned for adjuvant radiation therapy to the breast/chest-wall (along with regional nodes as indicated) were randomised to receive 40 Gy/15 fractions/3 weeks or 26 Gy/5 fractions/1 week. For simultaneous integrated boost, the patients in the control arm received 8 Gy/15 fractions/3 weeks, while those in the experimental arm received 6 Gy/5 fractions/1 week (to the tumour bed). For sequential boost, the prescribed dose was 12 Gy/4 fractions/4 days in both arms. Compliance to pre specified dosimetric parameters and acute toxicities were evaluated.
RESULT: Data of the first 271 patients was analysed of whom 104 patients received tumour bed boost using SIB. All mandatory dosimetric criteria were met apart from one patient with a higher contralateral breast dose due to optimal internal mammary nodal coverage. Overall three patients (1.1%) experienced grade 3 radiation dermatitis (none received SIB), no other Grade 3 or higher toxicities reported.
CONCLUSION: This acute toxicity interim analysis demonstrates that hypofractionated adjuvant radiotherapy with SIB for patients with breast cancer is feasible, and associated with minimal severe acute toxicities.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:174 |
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| Enthalten in: |
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology - 174(2022) vom: 15. Sept., Seite 59-68 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Chakraborty, Santam [VerfasserIn] |
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| Links: |
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| Themen: |
Acute toxicity |
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| Anmerkungen: |
Date Completed 03.10.2022 Date Revised 11.10.2022 published: Print-Electronic CTRI: CTRI/2018/12/016816 ClinicalTrials.gov: NCT03788213 Citation Status MEDLINE |
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| doi: |
10.1016/j.radonc.2022.07.003 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM343377594 |
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| 245 | 1 | 0 | |a HYPORT adjuvant acute toxicity and patient dosimetry quality assurance results - Interim analysis |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 03.10.2022 | ||
| 500 | |a Date Revised 11.10.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CTRI: CTRI/2018/12/016816 | ||
| 500 | |a ClinicalTrials.gov: NCT03788213 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 Elsevier B.V. All rights reserved. | ||
| 520 | |a BACKGROUND: HYPORT adjuvant trial is a randomised phase III open-label noninferiority trial comparing standard moderately hypofractionated 3 week adjuvant radiation therapy in breast cancer with a novel 1-week schedule. The trial was initiated in March 2019 and is open to recruitment with a total sample size of 2100. We report the results of dosimetric quality assurance, acute toxicity and pre planned first interim safety analysis in the first 271 patients | ||
| 520 | |a METHODS: Stage I-III breast cancer planned for adjuvant radiation therapy to the breast/chest-wall (along with regional nodes as indicated) were randomised to receive 40 Gy/15 fractions/3 weeks or 26 Gy/5 fractions/1 week. For simultaneous integrated boost, the patients in the control arm received 8 Gy/15 fractions/3 weeks, while those in the experimental arm received 6 Gy/5 fractions/1 week (to the tumour bed). For sequential boost, the prescribed dose was 12 Gy/4 fractions/4 days in both arms. Compliance to pre specified dosimetric parameters and acute toxicities were evaluated | ||
| 520 | |a RESULT: Data of the first 271 patients was analysed of whom 104 patients received tumour bed boost using SIB. All mandatory dosimetric criteria were met apart from one patient with a higher contralateral breast dose due to optimal internal mammary nodal coverage. Overall three patients (1.1%) experienced grade 3 radiation dermatitis (none received SIB), no other Grade 3 or higher toxicities reported | ||
| 520 | |a CONCLUSION: This acute toxicity interim analysis demonstrates that hypofractionated adjuvant radiotherapy with SIB for patients with breast cancer is feasible, and associated with minimal severe acute toxicities | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Equivalence Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Acute toxicity | |
| 650 | 4 | |a Breast cancer | |
| 650 | 4 | |a Dosimetry | |
| 650 | 4 | |a Hypofractionation | |
| 650 | 4 | |a Randomised controlled trial | |
| 700 | 1 | |a Chatterjee, Sanjoy |e verfasserin |4 aut | |
| 700 | 0 | |a Hyport Adjuvant Author Group |e verfasserin |4 aut | |
| 700 | 1 | |a Backianathan, Selvamani |e investigator |4 oth | |
| 700 | 1 | |a Lal, Punita |e investigator |4 oth | |
| 700 | 1 | |a Gupta, Subhash |e investigator |4 oth | |
| 700 | 1 | |a Ahmed, Rosina |e investigator |4 oth | |
| 700 | 1 | |a Misra, Shagun |e investigator |4 oth | |
| 700 | 1 | |a Solomon, Patricia |e investigator |4 oth | |
| 700 | 1 | |a Balakrishan, Rajesh |e investigator |4 oth | |
| 700 | 1 | |a Bhushal, Subecha |e investigator |4 oth | |
| 700 | 1 | |a Guha, Debashree |e investigator |4 oth | |
| 700 | 1 | |a Maria Das, K J |e investigator |4 oth | |
| 700 | 1 | |a Mahata, Anurupa |e investigator |4 oth | |
| 700 | 1 | |a Mandal, Samar |e investigator |4 oth | |
| 700 | 1 | |a Kumari, Abha |e investigator |4 oth | |
| 700 | 1 | |a Finlay Godson, Henry |e investigator |4 oth | |
| 700 | 1 | |a Ganguly, Sandip |e investigator |4 oth | |
| 700 | 1 | |a Kumari, Abha |e investigator |4 oth | |
| 700 | 1 | |a Shamsudden, C |e investigator |4 oth | |
| 700 | 1 | |a Dinesh, M |e investigator |4 oth | |
| 700 | 1 | |a Dey, Debdeep |e investigator |4 oth | |
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