This article was retracted on May 17, 2021
TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathological Complete Response to Pertuzumab and Trastuzumab in Breast Cancer (J Clin Oncol 37:714-722, 2019)
In late May 2020, as we prepared data for a presentation on secondary end points related to this study, we noted discrepancies in the pathologic complete response (pCR) entries onto the database. pCR was a key end point that is required for analysis of the primary objective. This error related predominantly to misclassification of ypT1a/microinvasive disease as pCR. Once we discovered the error, we asked a second independent pathologist to independently review all pathology reports and ultimately 10 cases required reclassification from pCR to no pCR.
Since uncovering these errors, our study team has taken a number of important actions to immediately rectify and address these issues, which we now outline in the Supplementary Methods of a corrected version of the manuscript. We reanalyzed the data using the corrected pCR designations and are now unable to reject the null hypothesis as outlined in the predefined analysis plan for the primary objective.
We believe that the revised primary results of this study remain critical for investigators initiating clinical trials with similar treatment or end points. However, considering the number of numerical corrections, the authors wish to retract the original manuscript and resubmit a corrected version to Journal of Clinical Oncology (JCO). A corrected version of the manuscript is now published (J Clin Oncol 39:2247-2256, 2021) and includes the following updates:
The primary objective did not meet the predefined statistical boundaries. The receiver operating characteristic analysis, with percent reduction in SULmax as the predictor, yielded an area under the curve of 0.72 (80% CI, 0.64 to 0.80, P = .12) in the evaluable patients, thus not rejecting the null hypothesis for the primary end point.
Although the primary objective did not meet the predefined statistical boundaries, the data continue to show that an absence of early change in SULmax is associated with a lower likelihood of achieving pCR after four cycles of pertuzumab or trastuzumab in early-stage human epidermal growth factor receptor 2–positive breast cancer, and the observed negative predictive value (91%) assessed as part of the primary objective remains essentially unchanged.
The association between lack of early SULmax change and lower probability of pCR is further strengthened in an exploratory subset analysis performed with reanalysis that excludes seven patients who had a low SUL at baseline (< 2).
Numerical corrections are also presented for the receiver operating characteristic analysis of baseline SULmax and D15 SULmax, and the multivariable logistic regression that adjusted for baseline SULmax and percent reduction in SULmax.
We accept full responsibility for our errors and express our apology to JCO, JCO reviewers, and JCO readers. Our research team is committed to high standards in clinical trial conduct and is revising our internal data entry procedures to eliminate the risk of such errors in the future. The authors apologize once again for the retraction and encourage readers to review the corrected manuscript for additional details (J Clin Oncol 39:2247-2256, 2021).