Volkmar Mueller1, Andrew Wardley2, Elisavet Paplomata3, Erika Hamilton4, Amelia Zelnak5, Louis Fehrenbacher6, Erik Jakobsen7, Elsa Curtit8, Frances Boyle9, Eva Harder Brix10, Andrew Brenner11, Laurence Crouzet12, Cristiano Ferrario13, Montserrat Muñoz-Mateu14, Hendrik-Tobias Arkenau15, Nayyer Iqbal16, Sramila Aithal17, Margaret Block18, Soeren Cold19, Mathilde Cancel20, Olwen Hahn21, Teja Poosarla22, Erica Stringer-Reasor23, Marco Colleoni24, David Cameron25, Giuseppe Curigliano26, Muriel Siadak27, Kendra DeBusk28, Jorge Ramos29, Wentao Feng30, Karen Gelmon31. 1. Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: v.mueller@uke.de. 2. Manchester Breast Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine & Health, University of Manchester, Manchester, UK. 3. Carbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, WI, USA. 4. Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA. 5. Northside Hospital, Sandy Springs, GA, USA. 6. Kaiser Foundation Research Institute, Oakland, CA, USA. 7. Sygehus Lillebaelt - Vejle Sygehus, Denmark. 8. University Hospital of Besançon, Besançon, France. 9. Mater Hospital North Sydney, NSW, Australia. 10. Herlev Hospital, Herlev, Denmark. 11. Mays Cancer Center at the UT Health San Antonio, San Antonio, TX, USA. 12. Center Eugene Marquis, Rennes, France. 13. Jewish General Hospital, Montreal, Quebec, Canada. 14. Hospital Clinic de Barcelona, Translational Genomics and Targeted Therapeutics, Institut d'Investigacions Biomèdiques Pi i Sunyer-IDIBAPS, Barcelona, Spain. 15. Sarah Cannon Research Institute UK and Cancer Institute, University College London, London, UK. 16. Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada. 17. Cancer Treatment Centers of America / Eastern Regional Medical Center, Philadelphia, PA, USA. 18. Nebraska Cancer Specialists, Omaha, NE, USA. 19. Odense University Hospital, Odense, Denmark. 20. CHU Tours - Hopital Bretonneau, Tours, France. 21. University of Chicago Medical Center, Chicago, IL, USA. 22. Mitchell Cancer Institute, University of South Alabama, Mobile, AL, USA. 23. Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, AL, USA. 24. IEO, European Institute of Oncology, IRCCS, Milan, Italy. 25. Edinburgh Cancer Research Centre, IGMM, University of Edinburgh, Edinburgh, Scotland. 26. European Institute of Oncology, IRCCS, and University of Milano, Milan, Italy. 27. Medical Affairs, Seagen, Inc, Bothell, WA, USA. 28. Health Economics Outcome Research, Seagen Inc., Bothell, WA, USA. 29. Clinical Development, Seagen Inc., Bothell, WA, USA. 30. Biometrics, Seagen Inc., Bothell, WA, USA. 31. British Columbia Cancer Agency - Vancouver Centre, Vancouver, BC, Canada.
Abstract
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.
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.
Authors: Gabriel Rinnerthaler; Christian Singer; Edgar Petru; Daniel Egle; Andreas Petzer; Ursula Pluschnig; Simon Peter Gampenrieder; Georg Pfeiler; Michael Gnant; Birgit Grünberger; Peter Krippl; Kathrin Strasser-Weippl; Christoph Suppan; Christine Brunner; Renate Pusch; Margit Sandholzer; Marija Balic; Rupert Bartsch Journal: Wien Klin Wochenschr Date: 2022-09-23 Impact factor: 2.275