Combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor-positive, HER2 negative, advanced breast cancer: to prescribe for the patient or the physician? A meta-analysis of phase II and III randomized clinical trials
Abstract Background Elderly patients are underrepresented in clinical study where combined endocrine strategies were compared to endocrine therapy (ET) in hormone receptors positive, HER2 negative, metastatic breast cancer. The role of the new endocrine approaches in elderly women is still unclear....
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-05-01
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| Series: | BMC Cancer |
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| Online Access: | http://link.springer.com/article/10.1186/s12885-020-06933-y |
| _version_ | 1818836171093966848 |
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| author | Claudia Omarini Federico Piacentini Isabella Sperduti Monica Barbolini Chrystel Isca Angela Toss Laura Cortesi Elena Barbieri Massimo Dominici Luca Moscetti |
| author_facet | Claudia Omarini Federico Piacentini Isabella Sperduti Monica Barbolini Chrystel Isca Angela Toss Laura Cortesi Elena Barbieri Massimo Dominici Luca Moscetti |
| author_sort | Claudia Omarini |
| collection | DOAJ |
| description | Abstract Background Elderly patients are underrepresented in clinical study where combined endocrine strategies were compared to endocrine therapy (ET) in hormone receptors positive, HER2 negative, metastatic breast cancer. The role of the new endocrine approaches in elderly women is still unclear. Methods We performed a meta-analysis of first line phase II/III randomized trials on ET versus combined strategies considering clinical benefit and safety profile. Trials with hazard ratio (HR) for PFS in elderly patients were included. Results Overall, the meta-analysis showed a PFS advantage for the experimental arms [HR 0.77, p 0.016] with a significant high/moderate heterogeneity [I2 65.46%, p 0.005]. For patients on CDK 4/6 inhibitors and ET, HR was 0.57 (p < 0.0001), with low heterogeneity [I2 0.0001%, p 0.96]. Hematological adverse events, as well as diarrhea with Abemaciclib, were significantly higher in elderly population. Conclusions The magnitude of PFS benefit due to the combined strategies in elderly patients is similar to those reported in the overall clinical trial population. Adding CDK4/6 inhibitors to ET significantly prolongs PFS, even if toxicity profile have to be carefully considered. Future trials should be designed taking into account patients’ age, geriatric assessment and comorbidity. |
| first_indexed | 2024-12-19T03:02:22Z |
| format | Article |
| id | doaj.art-30245269f8334eaebbed057edb937585 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-19T03:02:22Z |
| publishDate | 2020-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-30245269f8334eaebbed057edb9375852022-12-21T20:38:09ZengBMCBMC Cancer1471-24072020-05-0120111010.1186/s12885-020-06933-yCombined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor-positive, HER2 negative, advanced breast cancer: to prescribe for the patient or the physician? A meta-analysis of phase II and III randomized clinical trialsClaudia Omarini0Federico Piacentini1Isabella Sperduti2Monica Barbolini3Chrystel Isca4Angela Toss5Laura Cortesi6Elena Barbieri7Massimo Dominici8Luca Moscetti9Division of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of ModenaDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of ModenaDepartment of Bio-Statistics, RCCS Regina Elena National Cancer InstituteDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of ModenaDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of ModenaDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of ModenaDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of ModenaDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of ModenaDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of ModenaDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of ModenaAbstract Background Elderly patients are underrepresented in clinical study where combined endocrine strategies were compared to endocrine therapy (ET) in hormone receptors positive, HER2 negative, metastatic breast cancer. The role of the new endocrine approaches in elderly women is still unclear. Methods We performed a meta-analysis of first line phase II/III randomized trials on ET versus combined strategies considering clinical benefit and safety profile. Trials with hazard ratio (HR) for PFS in elderly patients were included. Results Overall, the meta-analysis showed a PFS advantage for the experimental arms [HR 0.77, p 0.016] with a significant high/moderate heterogeneity [I2 65.46%, p 0.005]. For patients on CDK 4/6 inhibitors and ET, HR was 0.57 (p < 0.0001), with low heterogeneity [I2 0.0001%, p 0.96]. Hematological adverse events, as well as diarrhea with Abemaciclib, were significantly higher in elderly population. Conclusions The magnitude of PFS benefit due to the combined strategies in elderly patients is similar to those reported in the overall clinical trial population. Adding CDK4/6 inhibitors to ET significantly prolongs PFS, even if toxicity profile have to be carefully considered. Future trials should be designed taking into account patients’ age, geriatric assessment and comorbidity.http://link.springer.com/article/10.1186/s12885-020-06933-yMetastatic breast cancerEndocrine therapyCD4/6 inhibitorsPalbociclibRibociclibAbemaciclib |
| spellingShingle | Claudia Omarini Federico Piacentini Isabella Sperduti Monica Barbolini Chrystel Isca Angela Toss Laura Cortesi Elena Barbieri Massimo Dominici Luca Moscetti Combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor-positive, HER2 negative, advanced breast cancer: to prescribe for the patient or the physician? A meta-analysis of phase II and III randomized clinical trials BMC Cancer Metastatic breast cancer Endocrine therapy CD4/6 inhibitors Palbociclib Ribociclib Abemaciclib |
| title | Combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor-positive, HER2 negative, advanced breast cancer: to prescribe for the patient or the physician? A meta-analysis of phase II and III randomized clinical trials |
| title_full | Combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor-positive, HER2 negative, advanced breast cancer: to prescribe for the patient or the physician? A meta-analysis of phase II and III randomized clinical trials |
| title_fullStr | Combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor-positive, HER2 negative, advanced breast cancer: to prescribe for the patient or the physician? A meta-analysis of phase II and III randomized clinical trials |
| title_full_unstemmed | Combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor-positive, HER2 negative, advanced breast cancer: to prescribe for the patient or the physician? A meta-analysis of phase II and III randomized clinical trials |
| title_short | Combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor-positive, HER2 negative, advanced breast cancer: to prescribe for the patient or the physician? A meta-analysis of phase II and III randomized clinical trials |
| title_sort | combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor positive her2 negative advanced breast cancer to prescribe for the patient or the physician a meta analysis of phase ii and iii randomized clinical trials |
| topic | Metastatic breast cancer Endocrine therapy CD4/6 inhibitors Palbociclib Ribociclib Abemaciclib |
| url | http://link.springer.com/article/10.1186/s12885-020-06933-y |
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