Volkmar Müller1, Naiba Nabieva2, Lothar Häberle3, Florin-Andrei Taran4, Andreas D Hartkopf5, Bernhard Volz6, Friedrich Overkamp7, Anna Lisa Brandl8, Hans-Christian Kolberg9, Peyman Hadji10, Hans Tesch11, Johannes Ettl12, Michael P Lux13, Diana Lüftner14, Erik Belleville15, Peter A Fasching16, Wolfgang Janni17, Matthias W Beckmann18, Pauline Wimberger19, Carsten Hielscher20, Tanja N Fehm21, Sara Y Brucker22, Diethelm Wallwiener23, Andreas Schneeweiss24, Markus Wallwiener25. 1. Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany. Electronic address: vmueller@uke.uni-hamburg.de. 2. Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany. Electronic address: Naiba.Nabieva@uk-erlangen.de. 3. Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany; Biostatistics Unit, Department of Gynecology, University Hospital Erlangen, Erlangen, Germany. Electronic address: Lothar.Haeberle@uk-erlangen.de. 4. Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany. Electronic address: florin.andrei.taran@gmail.com. 5. Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany. Electronic address: andy.hartkopf@icloud.com. 6. Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany. Electronic address: Bernhard.Volz@uk-erlangen.de. 7. Oncologianova GmbH, Recklinghausen, Germany. Electronic address: overkamp@oncoconsult.onmicrosoft.com. 8. Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany. Electronic address: Anna.Brandl@uk-erlangen.de. 9. Marienhospital Bottrop, Bottrop, Germany. Electronic address: hans-christian.kolberg@mhb-bottrop.de. 10. Nordwest Hospital, Frankfurt, Germany. Electronic address: Hadji.Peyman@KHNW.DE. 11. Oncology Practice at Bethanien Hospital, Frankfurt, Germany. Electronic address: Hans.Tesch@chop-studien.de. 12. Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. Electronic address: johannes.ettl@lrz.tu-muenchen.de. 13. Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany. Electronic address: Michael.Lux@uk-erlangen.de. 14. Department of Hematology, Oncology and Tumor Immunology, Charité University Hospital Berlin, Campus Benjamin Franklin, Berlin, Germany. Electronic address: diana.lueftner@charite.de. 15. ClinSol GmbH Wuerzburg, Wuerzburg, Germany. Electronic address: belleville@clin-sol.com. 16. Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany. Electronic address: Peter.Fasching@uk-erlangen.de. 17. Department of Gynecology, University Hospital Ulm, Ulm, Germany. Electronic address: wolfgang.janni@uniklinik-ulm.de. 18. Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany. Electronic address: Matthias.Beckmann@uk-erlangen.de. 19. Department of Gynecology and Obstetrics, University Hospital Dresden, Dresden, Germany. Electronic address: Pauline.Wimberger@uniklinikum-dresden.de. 20. gSUND Gynäkologie Kompetenzzentrum Stralsund, Stralsund, Germany. Electronic address: hielscher@gyn-stralsund.de. 21. Department of Gynecology, Heinrich Heine University of Dusseldorf, Dusseldorf, Germany. Electronic address: tanja.fehm@med.uni-duesseldorf.de. 22. Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany. Electronic address: Sara.Brucker@med.uni-tuebingen.de. 23. Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany. Electronic address: Diethelm.Wallwiener@med.uni-tuebingen.de. 24. Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany; National Center for Tumor Diseases and Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany. Electronic address: Andreas.Schneeweiss@med.uni-heidelberg.de. 25. Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany. Electronic address: markus.wallwiener@gmail.com.
Abstract
OBJECTIVES: Improved progression-free survival is considered as treatment goal for patients with metastatic breast cancer (MBC) since it is assumed to delay or prevent deterioration of quality of life. Aim of our analysis was to examine the influence of disease progression on health-related quality of life (HRQoL). MATERIALS AND METHODS: The PRAEGNANT study comprises a real-life registry for patients with MBC. HRQoL was assessed with the EORTC-QLQ-C30 Version 3.0 questionnaire at study entry and every 3 months thereafter. The primary endpoint was minimally important deterioration (MID) in global HRQoL score by ≥ five points between baseline and any follow-up assessment. A logistic regression model was built with MID (yes/no) at a follow-up timepoint as outcome variable and several covariates as predictors. RESULTS: In total, 329 patients were included in this analysis, with disease progression in 63 patients. Concerning the primary study aim, progression status predicted MID of global HRQoL status in addition to the other covariates. The adjusted odds ratio for the effect of progression status on MID was 2.22 (95% CI: 1.04 - 4.73). Comparisons of mean differences of QoL domains/scales yielded no differences. CONCLUSIONS: We provide evidence that disease progression in patients with metastatic breast cancer in a real-world registry has a significant negative impact on HRQoL as measured by MID of HRQoL. This study emphasizes the relevance of avoiding progression and prolonging PFS to maintain QoL.
OBJECTIVES: Improved progression-free survival is considered as treatment goal for patients with metastatic breast cancer (MBC) since it is assumed to delay or prevent deterioration of quality of life. Aim of our analysis was to examine the influence of disease progression on health-related quality of life (HRQoL). MATERIALS AND METHODS: The PRAEGNANT study comprises a real-life registry for patients with MBC. HRQoL was assessed with the EORTC-QLQ-C30 Version 3.0 questionnaire at study entry and every 3 months thereafter. The primary endpoint was minimally important deterioration (MID) in global HRQoL score by ≥ five points between baseline and any follow-up assessment. A logistic regression model was built with MID (yes/no) at a follow-up timepoint as outcome variable and several covariates as predictors. RESULTS: In total, 329 patients were included in this analysis, with disease progression in 63 patients. Concerning the primary study aim, progression status predicted MID of global HRQoL status in addition to the other covariates. The adjusted odds ratio for the effect of progression status on MID was 2.22 (95% CI: 1.04 - 4.73). Comparisons of mean differences of QoL domains/scales yielded no differences. CONCLUSIONS: We provide evidence that disease progression in patients with metastatic breast cancer in a real-world registry has a significant negative impact on HRQoL as measured by MID of HRQoL. This study emphasizes the relevance of avoiding progression and prolonging PFS to maintain QoL.
Authors: Andreas Schneeweiss; Michael P Lux; Wolfgang Janni; Andreas D Hartkopf; Naiba Nabieva; Florin-Andrei Taran; Friedrich Overkamp; Hans-Christian Kolberg; Peyman Hadji; Hans Tesch; Achim Wöckel; Johannes Ettl; Diana Lüftner; Markus Wallwiener; Volkmar Müller; Matthias W Beckmann; Erik Belleville; Diethelm Wallwiener; Sara Y Brucker; Florian Schütz; Peter A Fasching; Tanja N Fehm Journal: Geburtshilfe Frauenheilkd Date: 2018-03-21 Impact factor: 2.915
Authors: Mireia Margelí Vila; Sonia Del Barco Berron; Miguel Gil-Gil; Cristian Ochoa-Arnedo; Rafael Villanueva Vázquez Journal: Breast Date: 2020-06-26 Impact factor: 4.380
Authors: Volkmar Müller; Achim Wöckel; Michael P Lux; Wolfgang Janni; Andreas D Hartkopf; Naiba Nabieva; Florin-Andrei Taran; Peyman Hadji; Hans Tesch; Johannes Ettl; Diana Lüftner; Manfred Welslau; Erik Belleville; Sara Y Brucker; Florian Schütz; Peter A Fasching; Tanja N Fehm; Hans-Christian Kolberg; Andreas Schneeweiss; Friedrich Overkamp Journal: Geburtshilfe Frauenheilkd Date: 2018-11-26 Impact factor: 2.915
Authors: Michael Patrick Lux; Sarah Böhme; Stephanie Hücherig; Ulli Jeratsch; Niclas Kürschner; Diana Lüftner Journal: Breast Cancer Res Treat Date: 2019-05-07 Impact factor: 4.624
Authors: Elena Laakmann; Julius Emons; Florin-Andrei Taran; Wolfgang Janni; Sabrina Uhrig; Friedrich Overkamp; Hans-Christian Kolberg; Peyman Hadji; Hans Tesch; Lothar Häberle; Johannes Ettl; Diana Lüftner; Markus Wallwiener; Carla Schulmeyer; Volkmar Müller; Matthias W Beckmann; Erik Belleville; Pauline Wimberger; Carsten Hielscher; Christian Kurbacher; Rachel Wuerstlein; Christoph Thomssen; Michael Untch; Bernhard Volz; Peter A Fasching; Tanja N Fehm; Diethelm Wallwiener; Sara Y Brucker; Andreas Schneeweiss; Andreas D Hartkopf Journal: Geburtshilfe Frauenheilkd Date: 2020-11-06 Impact factor: 2.915
Authors: Peter A Fasching; J Thaddeus Beck; Arlene Chan; Michele De Laurentiis; Francisco J Esteva; Guy Jerusalem; Patrick Neven; Xavier Pivot; Giulia V Bianchi; Miguel Martin; David Chandiwana; Brad Lanoue; Antonia Ridolfi; Yingbo Wang; Karen Rodriguez Lorenc; Arnd Nusch Journal: Breast Date: 2020-09-23 Impact factor: 4.380
Authors: Marloes E Clarijs; Jacob Thurell; Friedrich Kühn; Carin A Uyl-de Groot; Elham Hedayati; Maria M Karsten; Agnes Jager; Linetta B Koppert Journal: Cancers (Basel) Date: 2021-05-12 Impact factor: 6.639
Authors: Anouk K M Claessens; Bram L T Ramaekers; Dorien J A Lobbezoo; Roel J W van Kampen; Maaike de Boer; Agnes J van de Wouw; M Wouter Dercksen; Sandra M E Geurts; Manuela A Joore; Vivianne C G Tjan-Heijnen Journal: Qual Life Res Date: 2020-08-20 Impact factor: 4.147
Authors: Hanna Huebner; Christian M Kurbacher; Geoffrey Kuesters; Andreas D Hartkopf; Michael P Lux; Jens Huober; Bernhard Volz; Florin-Andrei Taran; Friedrich Overkamp; Hans Tesch; Lothar Häberle; Diana Lüftner; Markus Wallwiener; Volkmar Müller; Matthias W Beckmann; Erik Belleville; Matthias Ruebner; Michael Untch; Peter A Fasching; Wolfgang Janni; Tanja N Fehm; Hans-Christian Kolberg; Diethelm Wallwiener; Sara Y Brucker; Andreas Schneeweiss; Johannes Ettl Journal: BMC Cancer Date: 2020-11-11 Impact factor: 4.430