{"entity":{"id":"paper-luca-gianni-j-clin-oncol-2022","kind":"paper","name":"Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study","aka":[],"tldr":"Paper by Luca Gianni indexed on Europe PMC as PubMed record 34890214, in Journal of Clinical Oncology (2022), one of the most cited records naming an author with this name at Fondazione Michelangelo.","summary":"Purpose: We aimed to improve efficacy and reduce toxicity of high-risk human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) treatment by replacing taxanes and trastuzumab with trastuzumab emtansine (T-DM1).\n\nMethods: The phase III KAITLIN study (NCT01966471) included adults with excised HER2-positive EBC (node-positive or node-negative, hormone receptor-negative, and tumor > 2.0 cm). Postsurgery, patients were randomly assigned 1:1 to anthracycline-based chemotherapy (three-four cycles) and then 18 cycles of T-DM1 plus pertuzumab (AC-KP) or taxane (three-four cycles) plus trastuzumab plus pertuzumab (AC-THP). Adjuvant radiotherapy/endocrine therapy was permitted. Coprimary end points were invasive disease-free survival (IDFS) in the intention-to-treat node-positive and overall populations with hierarchical testing.\n\nResults: The median follow-up was 57.1 months (interquartile range, 52.1-60.1 months) for AC-THP (n = 918) and 57.0 months (interquartile range, 52.1-59.8 months) for AC-KP (n = 928). There was no significant IDFS difference between arms in the node-positive (n = 1,658; stratified hazard ratio [HR], 0.97; 95% CI, 0.71 to 1.32) or overall population (n = 1846; stratified HR, 0.98; 95% CI, 0.72 to 1.32). In the overall population, the three-year IDFS was 94.2% (95% CI, 92.7 to 95.8) for AC-THP and 93.1% (95% CI, 91.4 to 94.7) for AC-KP. Treatment completion rates (ie, 18 cycles) were 88.4% for AC-THP and 65.0% for AC-KP (difference driven by T-DM1 discontinuation because of laboratory abnormalities [12.5%]). Similar rates of grade ≥ 3 (55.4% v 51.8%) and serious adverse events (23.3% v 21.4%) occurred with AC-THP and AC-KP, respectively. KP decreased clinically meaningful deterioration in global health status versus THP (stratified HR, 0.71; 95% CI, 0.62 to 0.80).\n\nConclusion: The primary end point was not met. Both arms achieved favorable IDFS. Trastuzumab plus pertuzumab plus chemotherapy remains the standard of care for high-risk HER2-positive EBC.\n\nIndexed on Europe PMC as PubMed record 34890214 (DOI 10.1200/jco.21.00896). Its author list gives \"Gianni L\" with the affiliation \"Michelangelo Foundation, Milan, Italy\", which names Fondazione Michelangelo; that is how the record was matched to Luca Gianni, and no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"J Clin Oncol 2022","url":"https://doi.org/10.1200/jco.21.00896"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34890214/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/34890214"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["luca-gianni"],"bottlenecks":[],"keyPapers":[],"journals":["jco"],"dependsOn":[],"notes":[],"journal":"Journal of Clinical Oncology","year":2022,"doi":"10.1200/jco.21.00896","pmid":"34890214","authors":"Krop IE, Im SA, Barrios C, et al.","paperType":"rct","findings":[],"whatItMeans":"One of the most cited papers Europe PMC returns for Luca Gianni at Fondazione Michelangelo, so it is a natural starting point for reading their work. The record was linked automatically from the author list and affiliation; read the abstract above and the paper itself before relying on any figure.","caveats":["Matched to the person by surname, initials and an affiliation string naming the institution on the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.","Two authors sharing a surname, initials and institution cannot be told apart by this method; the person's profile links are the place to confirm authorship."]},"route":"/key-papers/paper-luca-gianni-j-clin-oncol-2022/","neighbours":{"person":[{"id":"luca-gianni","kind":"person","name":"Luca Gianni","route":"/people/luca-gianni/"}],"journal":[{"id":"jco","kind":"journal","name":"Journal of Clinical Oncology","route":"/journals/jco/"}]}}