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.

MedStar author(s):
Citation: Journal of Clinical Oncology. 40(5):438-448, 2022 02 10.PMID: 34890214Department: Associate Dean for Research DevelopmentForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Ado-Trastuzumab Emtansine/tu [Therapeutic Use] | *Anthracyclines/tu [Therapeutic Use] | *Antibiotics, Antineoplastic/tu [Therapeutic Use] | *Antibodies, Monoclonal, Humanized/tu [Therapeutic Use] | *Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use] | *Breast Neoplasms/dt [Drug Therapy] | *Receptor, ErbB-2/ai [Antagonists & Inhibitors] | *Trastuzumab/tu [Therapeutic Use] | Ado-Trastuzumab Emtansine/ae [Adverse Effects] | Adult | Aged | Anthracyclines/ae [Adverse Effects] | Antibiotics, Antineoplastic/ae [Adverse Effects] | Antibodies, Monoclonal, Humanized/ae [Adverse Effects] | Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects] | Breast Neoplasms/en [Enzymology] | Breast Neoplasms/pa [Pathology] | Chemotherapy, Adjuvant | Disease-Free Survival | Female | Humans | Middle Aged | Receptor, ErbB-2/me [Metabolism] | Time Factors | Trastuzumab/ae [Adverse Effects]Year: 2022Local holdings: Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2008ISSN:
  • 0732-183X
Name of journal: Journal of clinical oncology : official journal of the American Society of Clinical OncologyAbstract: CONCLUSION: 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.METHODS: 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.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).RESULTS: 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).All authors: Barrios C, Bonnefoi H, Boulet T, De Laurentiis M, Ellis PA, Fehrenbacher L, Gianni L, Gralow J, Harbeck N, Huang CS, Im SA, Im YH, Ito Y, Krop IE, Liu H, Macharia H, Nowecki Z, Shah J, Song C, Swain SM, Toi M, Trask P, Winer EPOriginally published: Journal of Clinical Oncology. :JCO2100896, 2021 Dec 10Fiscal year: FY2022Digital Object Identifier: ORCID: Date added to catalog: 2022-01-25
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 34890214 Available 34890214

Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2008

CONCLUSION: 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.

METHODS: 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.

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).

RESULTS: 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).

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