Prolonged clinical benefit from the maintenance hormone therapy in patients with metastatic breast cancer

Lim, Seung Taek; Lee, Soo Hyun; Han, Jungwoo; Park, Byeong Woo; Kim, Kyung Sik; Park, Seho; Kim, Joo Hang; Choi, Hye Jin; Sohn, Joohyuk

doi:10.1016/j.breast.2013.08.013

Cited by 6 publications

(3 citation statements)

References 17 publications

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“…A small number of previous studies supported this treatment pattern, but none of them mainly used Fulvestrant as a maintenance drug 33 . A retrospective study investigating the efficacy of maintenance hormone therapy showed that median PFS of maintenance hormone therapy was 14.4 months (95% CI: 11.6-17.3 months), but 98.5% of the enrolled patients received AI or SERMs as maintenance therapy instead of Fulvestrant 34 . A prospective phase 2 study evaluating efficacy of Fulvestrant as maintenance therapy in Chinese patients with disease control after first-line chemotherapy illustrated that median PFS since Fulvestrant treatment was 16.1 months (95% CI: 10.3 - not reached), and median PFS since first-line chemotherapy was 19.5 months (95% CI: 15.6 - not reached) 35 .…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Fulvestrant 500mg in Hormone-receptor Positive Human Epidermal Receptor 2 Negative Advanced Breast Cancer: A Real-world Study in China

Lei

Song

et al. 2020

J. Cancer

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Background: Fulvestrant 500mg has proved its clinical effectiveness in previous trials as primary or second line treatment of hormone receptor positive, human epidermal receptor 2 negative (HR+/HER2˗) post-menopausal advanced breast cancer. This real-world study aimed to investigate the efficacy and safety of Fulvestrant in HR+/HER2˗ Chinese advanced breast cancer patients. Method: HR+/HER2˗ advanced breast cancer patients who received Fulvestrant 500mg from January 2015 to December 2018 in Beijing Cancer Hospital were enrolled in this retrospective study. Progression free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR), overall survival (OS) and adverse events (AEs) of Fulvestrant were investigated. Result: In total 303 enrolled patients [median age was 51 years (range: 21-82)], 255 (84.2%) patients were at postmenopausal status at the start of Fulvestrant treatment and 264 patients (87.1%) had advanced breast cancer. The median PFS (95% confidence interval) was 14.1 months (10.1-18.0) for the first-line, 11.2 months (2.2-20.3) for the second-line and 6.7 months (4.8-8.5) for ≥third-line of Fulvestrant. The ORR and CBR were 3.8% and 86.8% for the first-line, 5.5% and 75.4% for the second-line, 1.1% and 61.1% for ≥third-line of Fulvestrant. The multivariate subgroup analyses showed, PFS was significantly longer for the patients with light tumor burden, less palliative chemotherapy before Fulvestrant and long disease-free interval. For patients receiving Fulvestrant after palliative chemotherapy, the median PFS was numerically greater in maintenance treatment group than those who progressed after chemotherapy. Only 5.0% of patients (15/303) experienced adverse events and majority were grade 1-2. The most common adverse event was headache and palpitation, with merely one patient had severe adverse event (pulmonary embolism). Conclusion: Fulvestrant is an effective, safe and well-tolerated treatment regimen in endocrine therapy for HR+/HER2˗ metastatic breast cancer. Light tumor burden, less palliative chemotherapy before Fulvestrant and long disease-free survival (DFS) might be the ideal condition of Fulvestrant treatment. Fulvestrant can be effective for premenopausal patients with drug-induced menopause. Patients of different luminal subtypes can benefit from Fulvestrant. For patients with visceral metastases, presence of liver metastases rather than lung metastases was poor prognostic factor. Fulvestrant may also be considered as a maintenance treatment after first-line palliative chemotherapy.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Fulvestrant 500mg in Hormone-receptor Positive Human Epidermal Receptor 2 Negative Advanced Breast Cancer: A Real-world Study in China

Lei

Song

et al. 2020

J. Cancer

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“…Therefore, measures to reduce toxicity during chemotherapy, prolong PFS and OS have become the key to treatment options. Thanks to the new generation of drugs with less toxicity and better targeting, they have gradually entered the clinical stage, and advanced tumor maintenance treatment has gradually demonstrated its clinical application advantages and have been successfully used in solid tumors, such as blood tumors, lung cancer and breast cancer (4)(5)(6)(7). In the past two decades, with the progress of tumor molecular biology and new drug research, molecularly targeted drugs that specifically interfere with the biological behavior of tumors have gradually demonstrated clinical application advantages in tumor therapy due to their high selectivity and high therapeutic index.…”

Section: Introductionmentioning

confidence: 99%

Chemotherapeutic Effectiveness of Combining Cetuximab for Metastatic Colorectal Cancer Treatment: A System Review and Meta-Analysis

Liang

Xiao

et al. 2020

Front. Oncol.

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This meta-analysis used the database including PubMed, Medline, Cochrane Library, CNKI, Chinese-Cqvip, and Wanfang for randomized controlled trials (RCTs) to investigate the clinical effectiveness for combining cetuximab treatment with chemotherapy for treating metastatic colorectal cancer (mCRC). A total of 12 RCTs involved 7,108 patients with mCRC were included. The patients received chemotherapy with (3,521 cases) or without cetuximab (3,587 cases). Outcomes were overall survival (OS), progression-free survival (PFS), disease control rate (DCR), overall response rate (ORR), odd ratio (OR), and risk ratio (HR). Our results showed that the chemotherapy alone group has shorter OS, PFS, and ORR than the chemotherapy plus cetuximab group, with significant differences (PFS:HR = 0.77, 95% CI = 0.72-0.82, P < 0.00001; OS:HR = 0.88, 95% CI = 0.79-0.99, P = 0.03; ORR:OR = 1.79, 95% CI = 1.30-2.47; P = 0.0003). Results of subgroup analysis showed that cetuximab treatment prolonged PFS and OS in KRAS wild-type patients, with statistically significant differences (PFS:HR = 0.79, 95% CI = 0.65-0.95, P = 0.01; OS:HR = 0.85, 95% CI = 0.74-0.98, P = 0.02). Combining cetuximab with chemotherapy, the PFS and OS of wild-type KRAS patients and the ORR of all patients were significantly improved.

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“…For patients with HR-positive and HER2-negative MBC, HT is also an attractive alternative, at least in patients with potentially endocrine-responsive diseases that have entered non-progression status after first-line chemotherapy. In several reported studies of HT with powerful endocrine agents [aromatase inhibitors (AIs) or tamoxifen], the median TTP of patients was 14.4–18.5 months after previous chemotherapy (first- or second-line) [ 18 , 19 ]. There seemed to be a TTP disparity between the maintenance capecitabine monotherapy (MCT) and HT groups, but we must be cautious that the patient populations of the various studies might be completely different.…”

Section: Introductionmentioning

confidence: 99%

Hormonal therapy might be a better choice as maintenance treatment than capecitabine after response to first-line capecitabine-based combination chemotherapy for patients with hormone receptor-positive and HER2-negative, metastatic breast cancer

Chen

Hong

et al. 2016

Chin J Cancer

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BackgroundBoth hormonal therapy (HT) and maintenance capecitabine monotherapy (MCT) have been shown to extend time to progression (TTP) in patients with metastatic breast cancer (MBC) after failure of taxanes and anthracycline-containing regimens. However, no clinical trials have directly compared the efficacy of MCT and HT after response to first-line capecitabine-based combination chemotherapy (FCCT) in patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer.MethodsWe retrospectively analyzed the charts of 138 HR-positive and HER2-negative MBC patients who were in non-progression status after FCCT and who were treated between 2003 and 2012 at the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, in Beijing, China. The median number of first-line chemotherapy cycles was 6 (range, 4–8); combined agents included taxanes, vinorelbine, or gemcitabine. Of these 138 patients, 79 received MCT, and 59 received HT. Single-agent capecitabine was administered at a dose of 1250 mg/m2 twice daily for 14 days, followed by a 7-day rest period, repeated every 3 weeks. Of the 59 patients who received HT, 37 received aromatase inhibitors (AIs), 8 received selective estrogen receptor modulators (SERMs), and 14 received goserelin plus either AIs or SERMs. We then compared the MCT group and HT group in terms of treatment efficacy.ResultsWith a median follow-up of 43 months, patients in the HT group had a much longer TTP than patients in the MCT group (13 vs. 8 months, P = 0.011). When TTP was adjusted for age, menopausal status, Karnofsky performance status score, disease-free survival, site of metastasis, number of metastatic sites, and response status after FCCT, extended TTP was still observed for patients in the HT group (hazard ratio: 0.63; 95% confidence interval: 0.44–0.93; P = 0.020). We also observed a trend of overall survival advantage for patients in the HT group vs. patients in the MCT group, but the difference was not significant (43 vs. 37 months, P = 0.400). In addition, patients in the HT group generally tolerated the treatment well, whereas patients in the MCT group experienced grades 3–4 adverse events, the most frequent of which were hand-foot syndrome (15.8%) and hematologic abnormalities (7.6%).ConclusionFor HR-positive and HER2-negative MBC patients, HT might be considered a treatment after response to FCCT but prior to MCT as a long-term administration.

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Prolonged clinical benefit from the maintenance hormone therapy in patients with metastatic breast cancer

Abstract: MHT showed considerable efficacy and tolerability in this study. Further randomized prospective study is warranted.

Cited by 6 publications

References 17 publications

Efficacy and Safety of Fulvestrant 500mg in Hormone-receptor Positive Human Epidermal Receptor 2 Negative Advanced Breast Cancer: A Real-world Study in China

Efficacy and Safety of Fulvestrant 500mg in Hormone-receptor Positive Human Epidermal Receptor 2 Negative Advanced Breast Cancer: A Real-world Study in China

Chemotherapeutic Effectiveness of Combining Cetuximab for Metastatic Colorectal Cancer Treatment: A System Review and Meta-Analysis

Hormonal therapy might be a better choice as maintenance treatment than capecitabine after response to first-line capecitabine-based combination chemotherapy for patients with hormone receptor-positive and HER2-negative, metastatic breast cancer

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