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Brunt, A. Murray; Wheatley, Duncan; Yarnold, John; Somaiah, Navita; Kelly, Stephen; Harnett, Adrian; Coles, Charlotte; Goodman, Andrew; Bahl, Amit; Churn, Mark; Zotova, Rada; Sydenham, Mark; Griffin, Clare L; Morden, James P; Bliss, Judith M; The FAST-Forward Trial Management Group (2016)
Publisher: Elsevier
Languages: English
Types: Article
Subjects: /dk/atira/pure/researchoutput/pubmedpublicationtype/D017428, /dk/atira/pure/researchoutput/pubmedpublicationtype/D016449, Comparative Study, /dk/atira/pure/researchoutput/pubmedpublicationtype/D016428, /dk/atira/pure/researchoutput/pubmedpublicationtype/D013485, /dk/atira/pure/researchoutput/pubmedpublicationtype/D003160, Phase III randomised trial, Breast cancer, Hypofractionation, Radiology Nuclear Medicine and imaging, Clinical Trial, Phase III, Oncology, Research Support, Non-U.S. Gov't, Randomized Controlled Trial, Hematology, Radiotherapy, Journal Article, R1
Background and purpose

FAST-Forward is a phase 3 clinical trial testing a 1-week course of whole breast radiotherapy against the UK standard 3-week regimen after primary surgery for early breast cancer. Two acute skin toxicity substudies were undertaken to test the safety of the test schedules with respect to early skin reactions.

Material and methods

Patients were randomly allocated to 40 Gy/15 fractions (F)/3-weeks, 27 Gy/5F/1-week or 26 Gy/5F/1-week. Acute breast skin reactions were graded using RTOG (first substudy) and CTCAE criteria v4.03 (second substudy) weekly during treatment and for 4 weeks after treatment ended. Primary endpoint was the proportion of patients within each treatment group with grade ⩾3 toxicity (RTOG and CTCAE, respectively) at any time from the start of radiotherapy to 4 weeks after completion.

Results

190 and 162 patients were recruited. In the first substudy, evaluable patients with grade 3 RTOG toxicity were: 40 Gy/15F 6/44 (13.6%); 27 Gy/5F 5/51 (9.8%); 26 Gy/5F 3/52 (5.8%). In the second substudy, evaluable patients with grade 3 CTCAE toxicity were: 40 Gy/15F 0/43; 27 Gy/5F 1/41 (2.4%); 26 Gy/5F 0/53.

Conclusions

Acute breast skin reactions with two 1-week schedules of whole breast radiotherapy under test in FAST-Forward were mild.

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