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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 :
- BMC Cancer; 4/6/2020, Vol. 20 Issue 1, p1-12, 12p, 2 Diagrams, 6 Charts, 3 Graphs
- Publication Year :
- 2020
-
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 :
- Complementary Index
- Journal :
- BMC Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 142593731
- Full Text :
- https://doi.org/10.1186/s12885-020-06747-y