Preservation of quality of life in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial)
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Preservation of quality of life in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial). / Mueller, Volkmar; Wardley, Andrew; Paplomata, Elisavet; Hamilton, Erika; Zelnak, Amelia; Fehrenbacher, Louis; Jakobsen, Erik; Curtit, Elsa; Boyle, Frances; Harder Brix, Eva; Brenner, Andrew; Crouzet, Laurence; Ferrario, Cristiano; Muñoz-Mateu, Montserrat; Arkenau, Hendrik-Tobias; Iqbal, Nayyer; Aithal, Sramila; Block, Margaret; Cold, Soeren; Cancel, Mathilde; Hahn, Olwen; Poosarla, Teja; Stringer-Reasor, Erica; Colleoni, Marco; Cameron, David; Curigliano, Giuseppe; Siadak, Muriel; DeBusk, Kendra; Ramos, Jorge; Feng, Wentao; Gelmon, Karen.
in: EUR J CANCER, Jahrgang 153, 08.2021, S. 223-233.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Preservation of quality of life in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial)
AU - Mueller, Volkmar
AU - Wardley, Andrew
AU - Paplomata, Elisavet
AU - Hamilton, Erika
AU - Zelnak, Amelia
AU - Fehrenbacher, Louis
AU - Jakobsen, Erik
AU - Curtit, Elsa
AU - Boyle, Frances
AU - Harder Brix, Eva
AU - Brenner, Andrew
AU - Crouzet, Laurence
AU - Ferrario, Cristiano
AU - Muñoz-Mateu, Montserrat
AU - Arkenau, Hendrik-Tobias
AU - Iqbal, Nayyer
AU - Aithal, Sramila
AU - Block, Margaret
AU - Cold, Soeren
AU - Cancel, Mathilde
AU - Hahn, Olwen
AU - Poosarla, Teja
AU - Stringer-Reasor, Erica
AU - Colleoni, Marco
AU - Cameron, David
AU - Curigliano, Giuseppe
AU - Siadak, Muriel
AU - DeBusk, Kendra
AU - Ramos, Jorge
AU - Feng, Wentao
AU - Gelmon, Karen
N1 - Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
PY - 2021/8
Y1 - 2021/8
N2 - AIMS: In HER2CLIMB, tucatinib significantly improved progression-free and overall survival in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer. We evaluated the impact of tucatinib on health-related quality of life (HR-QoL) in HER2CLIMB.METHODS: Patients were randomised 2:1 to tucatinib or placebo combined with trastuzumab and capecitabine. Starting with protocol version 7, the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS) were administered at day 1 of cycle 1, every two cycles during cycles 3-9, every three cycles during cycle 12 and thereafter and at each patient's 30-day follow-up visit.RESULTS: Among 364 patients eligible for HR-QoL assessment, 331 (91%) completed ≥1 assessment. EQ-VAS scores were similar for both arms at baseline and maintained throughout treatment. EQ-5D-5L scores were similar between the treatment arms, stable throughout therapy and worsened after discontinuing treatment. Risk of meaningful deterioration (≥7 points) on EQ-VAS was reduced 19% in the tucatinib vs. placebo arm (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.55, 1.18); the median (95% CI) time to deterioration was not reached in the tucatinib arm and was 5.8 months (4.3, -) in the placebo arm. Among patients with brain metastases (n = 164), risk of meaningful deterioration on EQ-VAS was reduced 49% in the tucatinib arm (HR: 0.51; 95% CI: 0.28, 0.93); the median (95% CI) time to deterioration was not reached in the tucatinib arm and was 5.5 months (4.2, -) in the placebo arm.CONCLUSIONS: HR-QoL was preserved for patients with HER2+ metastatic breast cancer who were treated with tucatinib added to trastuzumab and capecitabine and maintained longer with tucatinib therapy than without it among those with brain metastases.CLINICAL TRIAL REGISTRATION: NCT02614794.
AB - AIMS: In HER2CLIMB, tucatinib significantly improved progression-free and overall survival in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer. We evaluated the impact of tucatinib on health-related quality of life (HR-QoL) in HER2CLIMB.METHODS: Patients were randomised 2:1 to tucatinib or placebo combined with trastuzumab and capecitabine. Starting with protocol version 7, the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS) were administered at day 1 of cycle 1, every two cycles during cycles 3-9, every three cycles during cycle 12 and thereafter and at each patient's 30-day follow-up visit.RESULTS: Among 364 patients eligible for HR-QoL assessment, 331 (91%) completed ≥1 assessment. EQ-VAS scores were similar for both arms at baseline and maintained throughout treatment. EQ-5D-5L scores were similar between the treatment arms, stable throughout therapy and worsened after discontinuing treatment. Risk of meaningful deterioration (≥7 points) on EQ-VAS was reduced 19% in the tucatinib vs. placebo arm (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.55, 1.18); the median (95% CI) time to deterioration was not reached in the tucatinib arm and was 5.8 months (4.3, -) in the placebo arm. Among patients with brain metastases (n = 164), risk of meaningful deterioration on EQ-VAS was reduced 49% in the tucatinib arm (HR: 0.51; 95% CI: 0.28, 0.93); the median (95% CI) time to deterioration was not reached in the tucatinib arm and was 5.5 months (4.2, -) in the placebo arm.CONCLUSIONS: HR-QoL was preserved for patients with HER2+ metastatic breast cancer who were treated with tucatinib added to trastuzumab and capecitabine and maintained longer with tucatinib therapy than without it among those with brain metastases.CLINICAL TRIAL REGISTRATION: NCT02614794.
U2 - 10.1016/j.ejca.2021.05.025
DO - 10.1016/j.ejca.2021.05.025
M3 - SCORING: Journal article
C2 - 34214937
VL - 153
SP - 223
EP - 233
JO - EUR J CANCER
JF - EUR J CANCER
SN - 0959-8049
ER -
