Efficacy and safety of metronomic chemotherapy with all-oral combination of low-dose etoposide/capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and/or taxanes.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 115-115
Author(s):  
Yan Wei

115 Background: The purpose of this study is to determine the efficacy and safety of metronomic chemotherapy with all-oral combination of low-dose etoposide/capecitabine in patients with metastatic breast cancer (MBC) previously treated with anthracyclines and/or taxanes. Methods: From June 2008 to April 2012, 22 women with MBC were enrolled and 16 patients were evaluable for toxicity and response. Treatment consisted of capecitabine (1,400 mg/m2 daily, taken in 2 oral doses) on days 1-14 and oral etoposide ( 30 mg/m2 daily ) on days 1-7 . Cycles were repeated every 3 weeks unless disease progression or unacceptable toxicity occurred or patient consent was withdrawn. The primary endpoint was clinical benefit rate (CR + PR + SD≥24 weeks); secondary endpoint was toxicity and time to progression (TTP). Tumor response was evaluated by RECIST criteria, and adverse events were evaluated by NCI-CTC AE v3.0. Results: Sixteen patients were included and received 145 cycles of chemotherapy, with a median of 7 cycles (range, 2-26 cycles). One of the 16 patients had partial response (PR 6.25%), 10 showed stable disease (SD 62.5%) and 5 had progression of disease (PD 31.25%), with a clinical benefit rate of 50% (CR + PR + SD≥24 weeks). Median TTP was 5.0 months (range, 1.5-20 months), and mean TTP was 6.06 months. Adverse effects were mild, and the main adverse effects were leucopenia (13%) and fatigue (13%). All patients are survival till now. Conclusions: An all-oral combination of low-dose etoposide plus capecitabine is a new regimen and has showed effective in treating MBC patients and can be well tolerated. It’s very economic compared with most other schedules today. It is worthy of further study on a large scale, especially in the developing countries.

Author(s):  
Pavani Chalasani ◽  
Kiah Farr ◽  
Vicky Wu ◽  
Isaac Jenkins ◽  
Alex Liu ◽  
...  

Abstract Background Treatment options for metastatic breast cancer (MBC) refractory to anthracyclines and taxanes are limited. In a phase III trial, eribulin demonstrated a significant improvement in overall survival compared to treatment of physician’s choice, but had limited tolerability because of neutropenia and peripheral neuropathy. Based on prior studies of alternative treatment schedules with other therapies, we hypothesized that a low-dose metronomic schedule of eribulin would permit patients to remain on treatment more consistently without treatment delays, resulting in longer time to progression, and improved toxicity profile. Methods We conducted a multi-site single arm, phase II trial patients with MBC. All patients were treated with metronomic eribulin (0.9 mg/m2 administered intravenously on days 1, 8, and 15 of a 28-day cycle.) Treatment was continued until the patient developed disease progression, unacceptable toxicity, or chose to stop the study. Patients must have had prior taxane exposure. The primary endpoint was progression-free survival. Secondary end points were overall survival, response rate, and clinical benefit rate. Exploratory biomarkers were performed to analyze change in levels of circulating endothelial cells (CECs), circulating endothelial precursors, and carbonic anhydrase IX (CAIX) with response to therapy. Findings We consented 86 patients and 59 were evaluable for final analysis. Median age was 59 years; 78% had HER2 negative tumors. The median progression-free survival (PFS) was 3.5 months with overall survival (OS) of 14.3 months. Objective response rate was 15% with clinical benefit rate of 48%. Reported grade 3 neutropenia and peripheral neuropathy were 18% and 5%, respectively. Treatment discontinuation due to toxicity was seen in 3% of patients. Interpretation Metronomic weekly low-dose eribulin is an active and tolerable regimen with significantly less myelosuppression, alopecia, and peripheral neuropathy than is seen with the approved dose and schedule, allowing longer duration of use and disease control, with similar outcomes compared to the standard dose regimen.


2006 ◽  
Vol 17 (8) ◽  
pp. 961-967 ◽  
Author(s):  
Laura Orlando ◽  
Anna Cardillo ◽  
Andrea Rocca ◽  
Alessandra Balduzzi ◽  
Raffaella Ghisini ◽  
...  

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e11567-e11567 ◽  
Author(s):  
Mirela Souto ◽  
Andrea Shimada ◽  
Caroline Chaul Barbosa ◽  
Manuel Cruz Abrahao ◽  
Artur Katz

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12500-e12500
Author(s):  
Shinichiro Kubo

e12500 Background: Currently, there are no data related to re-administering trastuzumab (T) + pertuzumab (P) beyond the second-line therapy to patients with human epidermal growth factor receptor 2-positive advanced/metastatic breast cancer (HER2-MBC) who had previously received P. The present study targeted patients with HER2-MBC who were previously treated with P and aimed to evaluate the efficacy and safety of additional administration (top-up intervention) of P post-disease progression (PD) after standard treatment with T plus chemotherapy vinorerbine(VNR) or eribulin (ERI). Methods: SBP-08 was a multicenter, collaborative, single-arm phase II study of HER2-MBC patients who had previously received P. After standard treatment with T and chemotherapy, P was additionally administered (top-up intervention) post-PD. Results: Eleven HER2-MBC patients, recruited between June 2016 and June 2018, who had previously received P participated in this study. Their mean age was 63.5 years, and 45% were estrogen receptor (ER)-negative, while 55% were ER-positive. The mean chemotherapy history was 3.6 regimens, with a median of four regimens. Previous treatment regimens with P had been effective in all patients. All patients had organ metastasis and treatment histories with TDM-1. Initially, during the two-year case collection period, registration of 30 patients was planned. However, the study was terminated because the interim analysis did not demonstrative effectiveness, and it was decided that there were no potential benefits to the patients. The overall response rate (ORR) of the standard treatment was 0%, stable disease (SD) was 36%, PD was 55%, and the clinical benefit rate (CBR) was 0%. The following combination anticancer agents were used: VNR (10 patients) and ERI (one patient). The intervention treatment (top-up with P) achieved the following: ORR 0%, SD 22%, PD 78%, and CBR 0%. PFS for the standard treatment was 1.6 months, whereas PFS for the intervention treatment was 1.3 months. In the standard treatment, febrile neutropenia was observed in two patients. No increases in adverse events were observed with the intervention treatment. Conclusions: No clinical benefit was demonstrated with the intervention treatment in the present study. Top-up with P after standard treatment with T and chemotherapy post-PD was deemed ineffective. Clinical trial information: UMIN000020837.


2015 ◽  
Vol 77 (2) ◽  
pp. 365-374 ◽  
Author(s):  
Herman Andres Perroud ◽  
Carlos Maria Alasino ◽  
Maria Jose Rico ◽  
Leandro Ernesto Mainetti ◽  
Francisco Queralt ◽  
...  

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