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Final results from IMPROVE: a randomized, controlled, open-label, two-arm, cross-over phase IV study to determine patients' preference for everolimus in combination with exemestane or capecitabine in combination with bevacizumab in advanced HR-positive, HER2-negative breast cancer.
- Source :
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BMC Cancer . 4/6/2020, Vol. 20 Issue 1, p1-12. 12p. 2 Diagrams, 6 Charts, 3 Graphs. - Publication Year :
- 2020
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Abstract
- <bold>Background: </bold>The objective of the IMPROVE study was patients' preference for either endocrine-based therapy or combined chemo- and anti-angiogenic therapy in advanced HR-positive/HER2-negative breast cancer.<bold>Methods: </bold>In this randomized, cross-over phase IV study, 77 patients were recruited in 26 sites in Germany. Patients were randomized 1:1 to receive either capecitabine plus bevacizumab (Cap+Bev) as first-line therapy followed by cross-over to everolimus plus exemestane (Eve+Exe) as second-line therapy (Arm A) or the reverse sequence (Arm B). The primary endpoint was patients' preference for either regimen, assessed by the Patient Preference Questionnaire 12 weeks after cross-over. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life (QoL).<bold>Results: </bold>61.5% of patients preferred Cap+Bev (p = 0.1653), whereas 15.4% preferred Eve+Exe and 23.1% were indecisive. Physicians showed a similar tendency towards Cap+Bev (58.1%) as the preferred regimen versus Eve+Exe (32.3%). Median first-line PFS was longer for Cap+Bev than for Eve+Exe (11.1 months versus 3.5 months). Median second-line PFS was similar between Cap+Bev and Eve+Exe (3.6 months versus 3.7 months). Median OS was comparable between Arm A (28.8 months) and Arm B (24.7 months). 73.0% and 52.6% (first-/second-line, Cap+Bev) and 54.1% and 52.9% (first-/second-line, Eve+Exe) of patients experienced grade 3/4 TEAEs. No treatment-related deaths occurred. QoL and treatment satisfaction were not significantly different between arms or treatment lines.<bold>Conclusions: </bold>Patients tended to favor Cap+Bev over Eve+Exe, which was in line with physicians' preference. Cap+Bev showed superior first-line PFS, while QoL was similar in both arms. No new safety signals were reported.<bold>Trial Registration: </bold>EudraCT No: 2013-005329-22. Registered on 19 August 20. [ABSTRACT FROM AUTHOR]
- Subjects :
- *BREAST cancer
*PROGRESSION-free survival
*PROTEIN metabolism
*THERAPEUTIC use of antineoplastic agents
*RESEARCH
*FERRANS & Powers Quality of Life Index
*CLINICAL trials
*STEROIDS
*RESEARCH methodology
*CELL receptors
*PATIENT satisfaction
*PROGNOSIS
*EVALUATION research
*MEDICAL cooperation
*TREATMENT effectiveness
*COMPARATIVE studies
*RANDOMIZED controlled trials
*QUALITY of life
*RESEARCH funding
*QUESTIONNAIRES
*CROSSOVER trials
*BREAST tumors
Subjects
Details
- Language :
- English
- ISSN :
- 14712407
- Volume :
- 20
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- BMC Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 142593731
- Full Text :
- https://doi.org/10.1186/s12885-020-06747-y