This article was retracted on August 21, 2020
Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor–Positive Metastatic Breast Cancer: ALTERNATIVE (J Clin Oncol 36:741-748, 2018)
On July 30, 2018, during review of the primary analysis study report submitted to Health Authorities, a programming error in the calculation of the hazard ratio (HR) and P-value estimates of the secondary end points of progression free survival (PFS) and overall survival (OS) for the comparison lapatinib (LAP) + aromatase inhibitor (AI) versus trastuzumab (TRAS) + AI was detected. Over the following months, the efficacy and safety datasets were thoroughly checked, and additional errors in statistical programming were found that impacted some efficacy and quality of life (QoL) analyses. Most important, these errors did not impact the primary PFS end point (comparison LAP + TRAS + AI v TRAS + AI) and only resulted in multiple minor numerical changes on some secondary efficacy and QoL analyses, without affecting the major conclusions of the study.
However, considering the number of minor numerical corrections, the authors wish to retract the original manuscript and re-submit a corrected version to Journal of Clinical Oncology. A corrected version of the manuscript is now published (J Clin Oncol 39:79-89, 2021) and includes the following updates to the primary and secondary efficacy end points:
Primary end point of progression-free survival (PFS) comparing LAP + TRAS + AI versus TRAS + AI was not affected (P value changed from 0.0064 to 0.0063) and no change in hazard ratio (HR 0.62). Thus, the observation that dual blockade with LAP + TRAS + Al showed superior PFS versus TRAS + Al in patients with HER2-positive/HR-positive metastatic breast cancer (MBC) remains unchanged.
Secondary end point of PFS comparing LAP + AI versus TRAS + AI: HR changed from 0.71 (95% Cl: 0.51, 0.98) to 0.85 (95% Cl: 0.62, 1.17) and P value changed from 0.03 to 0.3159. Thus, in contrast to the original report, there is no statistically significant difference observed in this secondary end point.
Secondary end point of overall survival (OS) comparing LAP + TRAS + Al versus TRAS + AI: there was no change in the HR and P-value calculations.
Secondary end point of OS comparing LAP + AI and TRAS + AI: HR changed from 0.82 (95% Cl: 0.49, 1.36) to 0.91 (95% Cl: 0.55, 1.50) and a change in P value from 0.699 to 0.718.
There were minor numerical changes to the QoL table in supplementary file.
The authors apologize for the retraction and encourage readers to review the corrected manuscript for additional details (https://ascopubs.org/doi/abs/10.1200/JCO.20.01894).