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Old 05-31-2020, 06:38 PM   #1
Lani
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Join Date: Mar 2006
Posts: 4,778
Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2+ Brea

Breast Cancer With Brain Metastases in the HER2CLIMB Trial


J Clin Oncol
. 2020 May 29;JCO2000775. doi: 10.1200/JCO.20.00775. Online ahead of print.
Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial

Nancy U Lin 1 , Virginia Borges 2 , Carey Anders 3 , Rashmi K Murthy 4 , Elisavet Paplomata 5 , Erika Hamilton 6 , Sara Hurvitz 7 , Sherene Loi 8 , Alicia Okines 9 , Vandana Abramson 10 , Philippe L Bedard 11 , Mafalda Oliveira 12 , Volkmar Mueller 13 , Amelia Zelnak 14 , Michael P DiGiovanna 15 , Thomas Bachelot 16 , A Jo Chien 17 , Ruth O'Regan 5 , Andrew Wardley 18 , Alison Conlin 19 , David Cameron 20 , Lisa Carey 21 , Giuseppe Curigliano 22 , Karen Gelmon 23 , Sibylle Loibl 24 , JoAl Mayor 25 , Suzanne McGoldrick 25 , Xuebei An 25 , Eric P Winer 1
Affiliations expand
PMID: 32468955 DOI: 10.1200/JCO.20.00775
Abstract

Purpose: In the HER2CLIMB study, patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs) showed statistically significant improvement in progression-free survival (PFS) with tucatinib. We describe exploratory analyses of intracranial efficacy and survival in participants with BMs.

Patients and methods: Patients were randomly assigned 2:1 to tucatinib or placebo, in combination with trastuzumab and capecitabine. All patients underwent baseline brain magnetic resonance imaging; those with BMs were classified as active or stable. Efficacy analyses were performed by applying RECIST 1.1 criteria to CNS target lesions by investigator assessment. CNS-PFS (intracranial progression or death) and overall survival (OS) were evaluated in all patients with BMs. Confirmed intracranial objective response rate (ORR-IC) was evaluated in patients with measurable intracranial disease.

Results: There were 291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm. The risk of intracranial progression or death was reduced by 68% in the tucatinib arm (hazard ratio [HR], 0.32; 95% CI, 0.22 to 0.48; P < .0001). Median CNS-PFS was 9.9 months in the tucatinib arm versus 4.2 months in the control arm. Risk of death was reduced by 42% in the tucatinib arm (OS HR, 0.58; 95% CI, 0.40 to 0.85; P = .005). Median OS was 18.1 versus 12.0 months. ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%; P = .03).

Conclusion: In patients with HER2-positive breast cancer with BMs, the addition of tucatinib to trastuzumab and capecitabine doubled ORR-IC, reduced risk of intracranial progression or death by two thirds, and reduced risk of death by nearly half. To our knowledge, this is the first regimen to demonstrate improved antitumor activity against BMs in patients with HER2-positive breast cancer in a randomized, controlled trial.
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Old 06-01-2020, 01:23 PM   #2
donocco
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Join Date: Oct 2013
Posts: 474
Re: Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2+ Brea

Very informative. Thank you.

However it is important to know Tucatanib has significant side effects. Severe diarrhea serious liver toxicity fatigue, rash, hand foot syndrome anemia anorexia stomatitis increased liver enzymes and nausea and vomiting.
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