Abstract
BackgroundThe 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.MethodsIn 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).Results61.5% 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.ConclusionsPatients 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.Trial registrationEudraCT No: 2013–005329-22. Registered on 19 August 20
Highlights
The objective of the IMPROVE study was patients’ preference for either endocrine-based therapy or combined chemo- and anti-angiogenic therapy in advanced Hormone receptor (HR)-positive/Human epidermal growth factor receptor 2 (HER2)-negative breast cancer
capecitabine plus bevacizumab (Cap+Bev) showed superior first-line progression-free survival (PFS), while quality of life (QoL) was similar in both arms
20–30% of all patients treated with curative intent develop metastatic Breast cancer (BC) (MBC) [1]
Summary
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. Systemic treatment of advanced BC (locally recurrent and inoperable or MBC) offers a wide range of options including endocrine therapy, immunochemotherapy, kinase inhibitors, radiation therapy, and supportive measures. For postmenopausal patients with advanced hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive/HER2negative) BC various treatment options exist. Chemotherapy may be considered as a reasonable alternative in patients for whom endocrine treatment is inappropriate including individuals presenting with acute visceral crisis and/or hormone-resistant tumors [2,3,4]. There are limited data from clinical trials having directly compared chemotherapy and endocrinebased treatment in patients with MBC. A previous metaanalysis reported similar efficacy of both treatment strategies, the drugs utilized were outdated as per today’s standard of care [5]
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