Hypofractionated Breast Radiotherapy for 1 Week versus 3 Weeks (FAST-Forward)
2020 · paper · Clinical trials
Reports 5-year results of a UK randomized trial of 4096 breast cancer patients comparing one-week five-fraction radiotherapy with the standard three-week schedule. The 26 Gy five-fraction schedule was non-inferior for local tumour relapse and had similar normal tissue effects; 27 Gy caused more.
Checked: PDF from europepmc.org, fetched 4 Oct 2026. Page numbers are those of that PDF.
9 findings
Substance Table 1, implant-based reconstruction, 27 Gy: "4/11 (27·3%)"; 4/11 is 36·4% (27·3% is 3/11).
- p. 5 Table 1, Primary surgery, Implant-based reconstruction, 27 Gy column
4/11 (27·3%)
Judge's note: Viewed the Table 1 crop: 27 Gy column reads 7/11 (63·6%), 4/11 (27·3%), 0. 7+4+0 = 11 matches the 11 mastectomies with immediate reconstruction, and 7/11 = 63·6% is right, so the count 4 is consistent and the percentage is wrong (63·6% + 27·3% leaves 9·1% unaccounted for with 0 unspecified). No footnote or text gives another denominator. Affects a small baseline subgroup only.
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Substance Table 3, Death, Other cause, 40 Gy (n=1361): "17 (1·7%)"; 17/1361 is 1·2%.
- p. 9 Table 3, Death > Other cause, 40 Gy column
17 (1·7%)
- p. 9 Table 3, Death, Unknown, 40 Gy
6 (1·2%)
Judge's note: Viewed the Table 3 crop: the cell reads 17 (1·7%). The count is right: the 40 Gy death sub-rows 47+12+10+17+6 = 92 match the Death row. Other cells in the column use n=1361 (47 = 3·5%, 12 = 0·9%, 10 = 0·7%), and the same row's other columns are right (27/1367 = 2·0%, 16/1368 = 1·2%). The footnote about patients counted in more than one row does not change the denominator. The percentage is wrong; the cell below (C013) is also wrong, and the two look mis-set together.
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Substance Table 3, Death, Unknown, 40 Gy (n=1361): "6 (1·2%)"; 6/1361 is 0·4%.
- p. 9 Table 3, Death > Unknown, 40 Gy column
6 (1·2%)
Judge's note: Viewed the Table 3 crop: the cell reads 6 (1·2%). The count 6 is confirmed by the column sum (47+12+10+17+6 = 92) and by the text total of 11 deaths of unknown cause (6+2+3). The other columns of the row are right (2/1367 = 0·1%, 3/1368 = 0·2%). No other denominator is stated. A different cell from C012, so not a duplicate; 1·2% is the correct percentage for the row above (17/1361), which suggests the percentages were mis-set.
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Substance Table 5, skin problems in breast, 27 Gy, baseline: "24/290 (4·1%)"; the denominator 290 does not fit the printed percentage (24/290 = 8.3%) and should be about 590 (24/590 = 4.1%).
- p. 11 Table 5, Skin problems in breast, 27 Gy, baseline column
24/290 (4·1%)
Judge's note: The page image reads 24/290 (4·1%). The other 27 Gy baseline denominators in the QLQ-BR23 block are 584 to 591 (590, 589, 584, 591), and 40 Gy and 26 Gy in the same row are 582 and 590. The footnote says the total is those who completed the question, but nothing explains a halving for this one item, and the printed percentage only fits a denominator near 590. The exact value (584 to 591 all give 4·1%) is for the authors to confirm; 590 is the likeliest single-digit slip.
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Reference or label "median follow-up of 71·5 months (IQR 71·3 to 71·7)" (Summary and Results): an interquartile range of 0·4 months is incompatible with Figure 2, where 36–38% of patients are still at risk at 6 years (72 months); the interval is probably a 95% CI for the median labelled as IQR.
- p. 8 Results, paragraph 2
median follow-up of 71·5 months (IQR 71·3 to
- p. 2 Summary, Findings
71·5 months (IQR 71·3 to 71·7)
- p. 8 Figure 2, number at risk at 5 and 6 years
486
Only the authors can say what is right here.
Judge's note: Viewed Figure 2 on the page 8 image and the Summary crop. Numbers at risk at 6 years are 486/1361, 508/1367 and 524/1368, so more than 25% of patients had follow-up beyond 72 months and the upper quartile of follow-up must exceed 72 months, above the printed 71·7. This holds for either a simple or a reverse Kaplan-Meier calculation of follow-up, since being at risk at 72 months means being followed at least that long. Recruitment ran from Nov 2011 to June 2014 with a snapshot in Nov 2019, which also implies a spread of years, not weeks. No definition in the text explains the interval. What the interval really is (95% CI or otherwise) only the authors can say.
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Reference or label "Test dose levels were informed by START8 and FAST15 trials generating α/β values for late normal tissue effects": reference 15 is the FAST-Forward acute skin toxicity paper (Brunt et al, Radiother Oncol 2016), not the FAST trial, which is references 13 and 14.
- p. 4 Randomisation and masking, last paragraph
informed by START8 and FAST15
- p. 14 Reference 15
Acute skin toxicity
- p. 14 Reference 15
Acute skin toxicity associated with a 1-week schedule of whole breast radiotherapy
- p. 4 Methods, Randomisation and masking
START8 and FAST15
Judge's note: The page 4 crop shows superscript 15 after FAST, so it is not an extraction artefact. The reference list crop shows ref 15 = "Acute skin toxicity associated with a 1-week schedule of whole breast radiotherapy ... in the UK FAST-Forward Trial", ref 13 = FAST 10-year results, ref 14 = first results of the UK FAST trial. Elsewhere FAST is cited as 13,14 (page 3, page 13) and ref 15 is used correctly for the acute toxicity substudy (pages 3 and 5). Verified entirely from the reference list in the file; the intended citation is most likely 14 (or 13,14).
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Reference or label Table 1: footnote ‡ ("Patients could have more than one type of adjuvant systemic therapy") is attached to the heading "Neoadjuvant chemotherapy received‡" and is absent from "Adjuvant therapy received: all patients", while the other two adjuvant headings carry it.
- p. 6 Table 1, row heading
Neoadjuvant chemotherapy received‡
- p. 6 Table 1 footnote
‡Patients could have more than one type of adjuvant systemic therapy.
- p. 6 Table 1, row heading
Adjuvant therapy received: all patients
Judge's note: Viewed the page 6 crops of the row headings and of the footnotes. The neoadjuvant row is a mutually exclusive Yes/No/Unknown split summing to the column n (48+1312+1 = 1361), so a footnote about more than one type of adjuvant therapy does not apply to it. The two headings "Adjuvant therapy received:‡ HER2-positive patients" and "...:‡ ER-positive patients" carry the symbol; the first adjuvant heading does not. The symbol looks misplaced by one heading; the data are unaffected.
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Wording Summary says "we recruited and obtained consent from 4096 patients", but 4110 patients were enrolled and randomised (Figure 1, Results); 4096 is the intention-to-treat population after 14 withdrew consent for use of their data.
- p. 2 Summary, Findings
we recruited and obtained consent from 4096 patients
- p. 8 Results, paragraph 1
4110 patients
- p. 4 Figure 1, top box
4110 patients enrolled and
Judge's note: Checked the Summary crop, Figure 1 in the layout text and the Results paragraph on the page 8 image. Figure 1: "4110 patients enrolled and randomly assigned" (1368+1370+1372), then 7+3+4 withdrew consent, leaving 1361+1367+1368 = 4096. The Summary gives the analysed number as the number recruited and says 1361/1367/1368 "were assigned", where 1368/1370/1372 were assigned. No statement in the paper redefines 'recruited'. Wording issue; the analysed population is correctly 4096.
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Wording Discussion, page 13: "dose intensities well within the limits of tolerance for these structures.26,27"; no anatomical structures are named in the preceding text, so "these structures" has no antecedent.
- p. 13 Discussion, right column, paragraph 1
well within the limits of tolerance for these structures.26,27
- p. 13 Discussion, right column, paragraph on partial-breast and regional radiotherapy
dose intensities well within the limits of tolerance for these structures.
Only the authors can say what is right here.
Judge's note: Read the paragraph on the page image. The preceding sentences mention only "patients requiring regional radiotherapy" and the nodal substudy; no structure (such as the brachial plexus, the subject of reference 27) is named in the paragraph. The only "brachial plexus" in the body text is in the Figure 1 legend, in an unrelated context. The EQD2 figures are correct. The sentence is ambiguous as printed, and the authors should name the structures.
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15 minor (typos and the like; most checked by the judge only)
Wording Distant relapse, 26 Gy (n=1368): Table 3 prints "76 (5·5%)" and Table 2 prints "76 (5·6%)"; 76/1368 is 5·56%, so 5·6% is right.
- p. 9 Table 3, Distant relapse, 26 Gy column
76 (5·5%)
- p. 7 Table 2, Distant relapse, 26 Gy (n=1368)
76 (5·6%)
Judge's note: Viewed Table 2 in the crop (76 (5·6%)) and Table 3 on the page 9 image (76 (5·5%)). Same count, same intention-to-treat denominator, same event; no population or time-point difference is stated. 5·556 is not a rounding tie. A 0·1-point inconsistency that changes nothing of substance, hence minor.
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Wording Table 4, Breast distortion, 40 Gy: "232/5724 (4·0%)"; 232/5724 is 4·05%, which rounds to 4·1%.
- p. 10 Table 4, Breast distortion, 40 Gy
232/5724 (4·0%)
Judge's note: Viewed the Table 4 crop: the cell reads 232/5724 (4·0%). 4·053 is not a tie. Other cells in the table are rounded normally, not truncated (330/5728 = 5·76 printed 5·8; 236/5937 = 3·975 printed 4·0), so truncation is not the convention. Either the percentage or one of the counts is off by a small amount; the meaning is unchanged.
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Typo Results, paragraph 1: "4096 patients were included in the intention-to-treat anlaysis"; "anlaysis" should be "analysis".
- p. 8 Results, paragraph 1
to-treat anlaysis
- p. 8 Results, first paragraph
intention-to-treat anlaysis
- p. 8
were included in the intention-to-treat anlaysis
Judge's note: Viewed the page 8 image: the word is printed "anlaysis" at the start of a line, with no hyphenation involved. Plain misspelling.
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Typo Table 4, breast or chest wall oedema, 27 Gy: "217/6287 (3·4%)"; 217/6287 is 3.45%, which rounds to 3·5%.
- p. 10 Table 4, Breast or chest wall oedema, 27 Gy
217/6287 (3·4%)
Judge's note: Read the cell on the page image. 217/6287 = 3.452%. Other cells in the table are rounded conventionally, not truncated (330/5728 = 5.76 printed 5·8%; 503/5944 = 8.46 printed 8·5%). Every misrounded cell found in Tables 4 and 5 has a second decimal of 5 (x.x5), which suggests a two-step rounding artefact. The difference is 0.1 percentage point and changes no conclusion.
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Typo Table 4, breast or chest wall oedema, 26 Gy: "155/6318 (2·4%)"; 155/6318 is 2.45%, which rounds to 2·5%.
- p. 10 Table 4, Breast or chest wall oedema, 26 Gy
155/6318 (2·4%)
Judge's note: Read the cell on the page image. 155/6318 = 2.453%. The table rounds conventionally elsewhere, so this is the same x.x5 rounding slip as C016. Different cell from C016, so not a duplicate. Cosmetic.
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Typo Table 5: three percentages are 0.1 below the correctly rounded value: "67/580 (11·5%)" (11.55%, rounds to 11·6%), "81/589 (13·7%)" (13.75%, rounds to 13·8%), "171/2533 (6·7%)" (6.75%, rounds to 6·8%).
- p. 11 Table 5, Skin appearance changed, 26 Gy, baseline
67/580 (11·5%)
- p. 11 Table 5, Arm or shoulder pain, 26 Gy, baseline
81/589 (13·7%)
- p. 12 Table 5 (continued), Difficulty raising arm, 40 Gy, follow-up
171/2533 (6·7%)
Judge's note: All three cells read as quoted on the page images (pages 11 and 12). The table rounds conventionally elsewhere (170/573 = 29.67 printed 29·7%; 62/586 = 10.58 printed 10·6%), so truncation is not the convention. All three have a second decimal of 5, the same pattern as C016, C017, C022 and C023. Cosmetic.
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Typo Table 5, breast harder or firmer, 26 Gy, p value for comparison between 27 Gy and 26 Gy: "0·1007" is printed to four significant figures where every other p value in the table has at most two.
- p. 11 Table 5, Breast harder or firmer, 26 Gy, p between 27 Gy and 26 Gy
0·1007
Only the authors can say what is right here.
Judge's note: The page image reads 0·1007. Other four-decimal p values in the table (0·0003, 0·0018, 0·0080, 0·0097) are small values at two significant figures; 0·1007 is not. It is probably 0·10 or 0·107 with a stray digit, but which one cannot be determined from the paper, so this is a query to the authors. The value is non-significant either way.
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Typo Table 5, arm or shoulder pain, 26 Gy, p value for comparison with 40 Gy: "0·2006" is printed to four significant figures, unlike the other p values in the table.
- p. 11 Table 5, Arm or shoulder pain, 26 Gy, p vs 40 Gy
0·2006
Only the authors can say what is right here.
Judge's note: The page image reads 0·2006 beside OR 1·14 (0·93–1·40). A Wald p value from that interval is about 0.21, so the magnitude is right and only the formatting is odd (probably 0·20 or 0·21). Same kind of slip as C020 in a different cell. Cosmetic; the authors should confirm the intended value.
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Typo Table 5, skin problems in breast, 27 Gy, follow-up: "209/2596 (8·0%)"; 209/2596 is 8.05%, which rounds to 8·1%.
- p. 11
209/2596 (8·0%)
Judge's note: Read the cell on the page image. 209/2596 = 8.051%. Same x.x5 rounding slip as the other Table 4 and 5 cells. Cosmetic.
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Typo Table 5, skin problems in breast, 26 Gy, baseline: "18/590 (3·0%)"; 18/590 is 3.05%, which rounds to 3·1%.
- p. 11
18/590 (3·0%)
Judge's note: Read the cell on the page image. 18/590 = 3.051%. Same x.x5 rounding slip as the other cells. Cosmetic.
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Typo Table 5 column header reads "over 3–60 months of follow-up" on page 11 but "over 3–60 months follow-up" on the continuation on page 12.
- p. 12 Table 5 continued, column header
over 3–60 months follow-up
- p. 11 Table 5, column header
over 3–60 months of
Judge's note: Both headers read as quoted on the page images. Trivial inconsistency between the two parts of the same table; the meaning is unaffected.
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Typo Results, page 12: "(OR 1·42, 1·17, 1·72, p=0·0003)" gives the estimate and its interval as a comma list with no "95% CI" or "to"; it should read OR 1·42 [95% CI 1·17 to 1·72].
- p. 12 Results, text below Table 5, left column
(OR 1·42, 1·17, 1·72,
Judge's note: The page image shows the comma-separated form, so it is not an extraction artefact. The values match Table 5 (1·42 (1·17–1·72), p=0·0003). Elsewhere on the same page the paper writes "OR 2·29 [95% CI 1·60 to 3·27]". Formatting slip; the numbers are right.
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Typo Results, page 12: "51·6 Gy for 27 Gy in 5 fractions, and 48·3 Gy for 26 Gy in 5 fractions" uses the numeral where the rest of the paper writes "five fractions".
- p. 12 Results, α/β estimate paragraph
51·6 Gy for 27 Gy in 5 fractions
Judge's note: Confirmed on the page image. A text search finds "five fractions" everywhere else in the article and "5 fractions" only in this sentence (twice). House-style inconsistency only.
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Typo Declaration of interests (PDF p.14) prints the company name as "Merck Sharpe and Dohme"; the company's name is Merck Sharp & Dohme (no 'e').
- p. 14 Declaration of interests
Merck Sharpe and Dohme
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the company's correct name is Merck Sharp & Dohme ("Sharp" without a final 'e'). Viewed the crop of the Declaration of interests on PDF page 14: the text reads "Janssen-Cilag, Merck Sharpe and Dohme, Puma Biotechnology", as quoted. The name appears only once in the article, so there is no internal spelling to compare with. Cosmetic misspelling of a proper name.
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Typo Declaration of interests (PDF p.14) names the company two ways in consecutive sentences: "DAW reports travel grants from Roche Pharmaceuticals outside the submitted work. CCK reports personal fees from Roche Pharmaceutical outside the submitted work." (and plain "Roche" in the sentence before).
- p. 14 Declaration of interests
Roche Pharmaceuticals outside
- p. 14 Declaration of interests
Roche Pharmaceutical outside
Judge's note: Viewed both crops of the Declaration of interests on PDF page 14. The text prints "Roche Pharmaceuticals" for DAW and "Roche Pharmaceutical" (no 's') for CCK in the next sentence, and "Pfizer, and Roche" for JMB just before. The inconsistency is on the page as described. It is cosmetic, and the declarations are per-author statements that may each have been worded by the author concerned, so either form could have been intended; the page does not show which is right.
Second check: none (judge only)