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, V., Wardley, A., Paplomata, E., Hamilton, E., Zelnak, A., Fehrenbacher, L., Jakobsen, E., Curtit, E., Boyle, F., Harder Brix, E., Brenner, A., Crouzet, L., Ferrario, C., Muñoz-Mateu, M., Arkenau, H., Iqbal, N., Aithal, S., Block, M., Cold, S., Cancel, M., Hahn, O., Poosarla, T., Stringer-Reasor, E., Colleoni, M., Cameron, D., Curigliano, G., Siadak, M., DeBusk, K., Ramos, J., Feng, W., & Gelmon, K. European Journal of Cancer, 153:223–233, August, 2021.
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) [link]Paper  doi  abstract   bibtex   
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 3e9, 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 Z 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 HER2þ 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.
@article{mueller_preservation_2021-1,
	title = {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)},
	volume = {153},
	issn = {09598049},
	url = {https://linkinghub.elsevier.com/retrieve/pii/S0959804921003348},
	doi = {10.1016/j.ejca.2021.05.025},
	abstract = {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 3e9, 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 Z 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 HER2þ 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.},
	language = {en},
	urldate = {2022-01-06},
	journal = {European Journal of Cancer},
	author = {Mueller, Volkmar and Wardley, Andrew and Paplomata, Elisavet and Hamilton, Erika and Zelnak, Amelia and Fehrenbacher, Louis and Jakobsen, Erik and Curtit, Elsa and Boyle, Frances and Harder Brix, Eva and Brenner, Andrew and Crouzet, Laurence and Ferrario, Cristiano and Muñoz-Mateu, Montserrat and Arkenau, Hendrik-Tobias and Iqbal, Nayyer and Aithal, Sramila and Block, Margaret and Cold, Soeren and Cancel, Mathilde and Hahn, Olwen and Poosarla, Teja and Stringer-Reasor, Erica and Colleoni, Marco and Cameron, David and Curigliano, Giuseppe and Siadak, Muriel and DeBusk, Kendra and Ramos, Jorge and Feng, Wentao and Gelmon, Karen},
	month = aug,
	year = {2021},
	pages = {223--233},
	file = {Mueller et al. - 2021 - Preservation of quality of life in patients with h.pdf:/Users/neil.hawkins/Zotero/storage/PNU2RKBT/Mueller et al. - 2021 - Preservation of quality of life in patients with h.pdf:application/pdf},
}
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