Trastuzumab after Adjuvant Chemotherapy in HER2-Positive Breast Cancer
Breast Diseases: A Year Book Quarterly, 2006 · paper · Clinical trials
A randomized trial of one year of trastuzumab versus observation after chemotherapy in women with HER2-positive early breast cancer. At the first interim analysis, trastuzumab improved disease-free survival (hazard ratio 0.54); severe cardiotoxicity occurred in 0.5%.
0 findings
None that passed a second check.
12 minor (typos and the like; most checked by the judge only)
Substance Table 1, pathological tumor size 0–2 cm, observation group (N=1693): printed "683 (40.4)"; 683/1693 is 40.3%.
- p. 5 Table 1, Pathological tumor size, 0–2 cm, Observation column
683 (40.4)
Judge's note: The page image shows 683 (40.4) in the observation column (N=1693). The column counts 172+683+723+97+18 sum to 1693, and the other cells in this block round correctly. Only this percentage disagrees with its count, and with 40.3 the column sums to 100.0.
Second check: another model agreed
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Substance Table 1, previous radiotherapy, Missing, 1-yr trastuzumab (N=1694): printed "3 (0.1)"; 3/1694 is 0.2%.
- p. 6 Table 1 (continued), Previous radiotherapy, Missing, 1 Yr of Trastuzumab
3 (0.1)
Judge's note: The image shows 3 (0.1). The Yes and No rows use N=1694 (1308 gives 77.2, 383 gives 22.6). Elsewhere in Table 1, 3 missing patients in this group are printed as 0.2 (e.g., nodal status). The counts are consistent: 1308+383+3=1694.
Second check: another model agreed
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Substance Table 1, type of chemotherapy, Missing, 1-yr trastuzumab (N=1694): printed "1 (0.2)"; 1/1694 is 0.06%, i.e. 0.1.
- p. 6 Table 1 (continued), Type of adjuvant or neoadjuvant chemotherapy, Missing, 1 Yr of Trastuzumab
1 (0.2)
Judge's note: The image shows 1 (0.2). The counts 102+1151+440+1 sum to 1694. Elsewhere in Table 1, one patient in this group is printed as 0.1 (menopausal status missing, p5).
Second check: another model agreed
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Substance Table 3, distant recurrence, soft tissue, 1-yr trastuzumab (N=1694): printed "6 (0.3)"; 6/1694 is 0.35%, i.e. 0.4.
- p. 8 Table 3, Distant recurrence, Soft tissue, 1 Yr of Trastuzumab
6 (0.3)
Judge's note: The image shows 6 (0.3). In the same column, 6 contralateral breast cancers and 6 deaths without prior recurrence are printed as 6 (0.4). The column denominator is N=1694. 0.354 is not a rounding tie.
Second check: another model agreed
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Wording Fig. 2 legend says the P values "were obtained from the unadjusted Cox model", but the Methods say log-rank tests gave the P values for time-to-event end points, and the Results give the same DFS P value as "P<0.0001 by the log-rank test".
- p. 9 Figure 2 legend
The hazard ratios (with 95 percent confidence intervals and P values) are for the patients assigned to receive trastuzumab for one year, as compared with those assigned to observation, and were obtained from the unadjusted Cox model.
- p. 10 Results, Efficacy
P<0.0001 by the log-rank test
Only the authors can say what is right here.
Judge's note: Checked the Fig. 2 legend (p9 image), the Methods text (p8: log-rank tests for P values, Cox models for HRs and CIs) and the Results (p10). For the same DFS comparison the paper names two different procedures for the P value. The numbers need not differ; this is a question to the authors about which test produced the P values in Fig. 2.
Second check: another model agreed
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Wording Discussion: "trastuzumab improved the disease-free survival in all subgroups (Fig. 3)", yet several Fig. 3 subgroup 95% CIs include 1 (e.g., Central and South America 0.90 (0.33–2.48); ≥60 yr 0.70 (0.40–1.23); anthracyclines and taxanes 0.77 (0.53–1.13)).
- p. 12 Discussion, first paragraph
trastuzumab im-proved the disease-free survival in all subgroups (Fig. 3)
- p. 11 Figure 3
0.90 (0.33–2.48)
- p. 11 Figure 3, Anthracyclines and taxanes row
0.77 (0.53–1.13)
- p. 11 Figure 3, ≥60 yr row
0.70 (0.40–1.23)
Only the authors can say what is right here.
Judge's note: Fig. 3 (p11 image): every point estimate is below 1, but many intervals cross 1, including >5 cm 0.85 (0.36–2.03), ER-neg/PgR-pos 0.67 (0.24–1.84), ER-pos/PgR-neg 0.63 (0.34–1.17) and no anthracyclines 0.63 (0.27–1.47). The Results say only 'no evidence of substantial heterogeneity'. As worded, the Discussion claims more than the figure shows.
Second check: another model agreed
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Typo Acknowledgments: "Adjuvant Study Group, Westdeutsche Studiengruppe and (ASG&WSG), and Biomed-2" — a stray 'and' comes before the abbreviation.
- p. 12 Acknowledgments, 9 groups not affiliated with BIG
Westdeutsche Studiengruppe and (ASG&WSG)
Judge's note: The p12 image shows the text exactly as quoted, so this is not an extraction artefact. The list punctuation is garbled.
Second check: none (judge only)
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Typo Reference 20 reads "Hudziak RM, Schlessinger J, Ulrich A.", while refs 2 and 23 spell the author "Ullrich A".
- p. 13 Reference 20
Hudziak RM, Schlessinger J, Ulrich A.
- p. 13 Reference 23
Shepard HM, Ullrich A. p185HER2
- p. 13 Reference 23
Shepard HM, Ullrich A.
- p. 13 Reference 23
Fend- ly BM, Shepard HM, Ullrich A
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that refs 20, 23 and 2 name the same author (Axel Ullrich) and that 'Ullrich' is the correct spelling. The p13 image confirms 'Ulrich A.' in ref 20 and 'Ullrich A.' in ref 23; the text layer has 'Ullrich A' in ref 2.
Second check: none (judge only)
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Typo Appendix: "Istituto Nazionale per lo Studie e la Cura dei Tumori" — 'Studie' for 'Studio'.
- p. 13 Appendix, affiliation of L.G.
Istituto Nazionale per lo Studie e la Cura dei Tumori
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the institute's official Italian name uses 'Studio'. The p13 image shows 'Studie'.
Second check: none (judge only)
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Typo Appendix: "Pontificia Universidad Catòlica do Rio Grande do Sul" — mixed Spanish/Portuguese and a grave accent on 'Catòlica'.
- p. 13 Appendix, affiliation of C.H.B.
Pontifìcia Universidad Catòlica do Rio Grande do Sul
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the official name is 'Pontifícia Universidade Católica do Rio Grande do Sul'. The p13 image shows 'Universidad' and 'Catòlica' with a grave accent.
Second check: none (judge only)
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Typo Reference 29 reads "Baselga J, Tripaty D, Mendelsohn J, et al.", while refs 5 and 33 read "Tripathy D".
- p. 14 Reference 29
Baselga J, Tripaty D, Mendelsohn J, et al.
- p. 13 Reference 5
Vogel CL, Cobleigh MA, Tripathy D, et
- p. 13 Reference 5
Vogel CL, Cobleigh MA, Tripathy D, et al.
- p. 14 Reference 29
Baselga J, Tripaty D, Mendelsohn J
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that this is the same author, Debu Tripathy. The p14 image shows 'Tripaty D' in ref 29; the p13 image shows 'Tripathy D' in ref 5, and the text layer has 'Tripathy D' in ref 33. Ref 7 does not list Tripathy, contrary to one reviewer note.
Second check: none (judge only)
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Typo Reference 35 reads "Paik S, Bryant J, Tan-Chi E, et al.", while ref 36 reads "Tan-Chiu E".
- p. 14 Reference 35
Paik S, Bryant J, Tan-Chi E, et al.
- p. 14 Reference 36
Tan-Chiu E, Piccart M.
- p. 14 Reference 35
Paik S, Bryant J, Tan-Chi E
- p. 14 Reference 36
Tan-Chiu E, Piccart M
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that both refer to the same NSABP author, Eleftherios Tan-Chiu. The p14 image confirms 'Tan-Chi E' in ref 35 and 'Tan-Chiu E' in ref 36.
Second check: none (judge only)