Evaluation of response rate and disease control rate as potential predictors of overall survival in anthracycline-pretreated women receiving first-line chemotherapy for metastatic breast cancer (MBC).

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 2552-2552 ◽  
Author(s):  
J. Liu ◽  
K. S. Albain ◽  
S. Chan ◽  
A. D. Seidman ◽  
D. Tai ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Disease Control ◽  
Response Rate ◽  
Metastatic Breast ◽  
Disease Control Rate ◽  
First Line ◽  
Line Chemotherapy

Phase III Trial of Epirubicin Plus Paclitaxel Compared With Epirubicin Plus Cyclophosphamide As First-Line Chemotherapy for Metastatic Breast Cancer: United Kingdom National Cancer Research Institute Trial AB01

2005 ◽  
Vol 23 (33) ◽  
pp. 8322-8330 ◽  
Author(s):  
Ruth E. Langley ◽  
James Carmichael ◽  
Alison L. Jones ◽  
David A. Cameron ◽  
Wendi Qian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Survival Time ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Grade 3 ◽  
Line Chemotherapy

Purpose To compare the effectiveness and tolerability of epirubicin and paclitaxel (EP) with epirubicin and cyclophosphamide (EC) as first-line chemotherapy for metastatic breast cancer (MBC). Patients and Methods Patients previously untreated with chemotherapy (except for adjuvant therapy) were randomly assigned to receive either EP (epirubicin 75 mg/m2 and paclitaxel 200 mg/m2) or EC (epirubicin 75 mg/m2 and cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for a maximum of six cycles. The primary outcome was progression-free survival; secondary outcome measures were overall survival, response rates, and toxicity. Results Between 1996 and 1999, 705 patients (353 EP patients and 352 EC patients) underwent random assignment. Patient characteristics were well matched between the two groups, and 71% of patients received six cycles of treatment. Objective response rates were 65% for the EP group and 55% for the EC group (P = .015). At the time of analysis, 641 patients (91%) had died. Median progression-free survival time was 7.0 months for the EP group and 7.1 months for the EC group (hazard ratio = 1.07; 95% CI, 0.92 to 1.24; P = .41), and median overall survival time was 13 months for the EP group and 14 months for the EC group (hazard ratio = 1.02; 95% CI, 0.87 to 1.19; P = .8). EP patients, compared with EC patients, had more grade 3 and 4 mucositis (6% v 2%, respectively; P = .0006) and grade 3 and 4 neurotoxicity (5% v 1%, respectively; P < .0001). Conclusion In terms of progression-free survival and overall survival, there was no evidence of a difference between EP and EC. The data demonstrate no additional advantage to using EP instead of EC as first-line chemotherapy for MBC in taxane-naïve patients.

Paclitaxel plus carboplatin versus paclitaxel plus epirubicin as first-line treatment for metastatic breast cancer: Efficacy and safety results of a randomized, phase III trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1087-1087
Author(s):  
Zhongsheng Tong ◽  
Shufen Li ◽  
Yehui Shi ◽  
Xu Wang ◽  
Chen Wang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Response Rate ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Phase Iii ◽  
First Line ◽  
Free Survival ◽  
Significant Difference

1087 Background: Paclitaxel/carboplatin combinations are highly active in metastatic breast cancer (MBC). We conducted a randomized, phase III, non-inferiority trial comparing paclitaxel/carboplatin (TP) with paclitaxel/epirubicin (TE) as first-line therapy for MBC. Progression-free survival (PFS) was the primary efficacy endpoint. Secondary endpoints included response rate, overall survival, tolerability, and quality of life (QoL). Methods: From June 2009 to January 2015, 231 patients were randomly assigned, 115 of whom were randomized to TP and 116 to TE. Baseline characteristics were relatively well-balanced in the two treatments. Results: After a median follow-up of 29 months, no significant difference was observed between the two treatments in objective response rate (ORR) (38.3% vs. 39.7%, respectively). Both the progression-free survival (p=0.158) and overall survival (p=0.369) were very similar between the two treatments. Both regimens were well tolerated. The main toxicities were myelosuppression, gastrointestinal reactions, and alopecia. TP showed higher grades 3–4 alopecia and higher nausea (p<0.05). TE showed higher incidence of myelosuppression than TP (p<0.05) (Table). Those patients whose epirubicin cumulative dose was more than 1000 mg/m2 did not suffer worse cardiotoxicity. Conclusions: Our study suggests that TP arm is an effective therapeutic alternative for patients with MBC, especially in those previously exposed to epirubicin in the adjuvant setting. TP has some advantages, such as less cost and less side effects (myelosuppression and fatigue). Clinical trial information: NCT02207361. [Table: see text]

scholarly journals A Comparison of Three Methods for the Detection of Circulating Tumor Cells in Patients with Early and Metastatic Breast Cancer

2017 ◽  
Vol 44 (2) ◽  
pp. 594-606 ◽  
Author(s):  
Eleni Politaki ◽  
Sofia Agelaki ◽  
Stella Apostolaki ◽  
Dora Hatzidaki ◽  
Areti Strati ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Tumor Cells ◽  
Prognostic Significance ◽  
Metastatic Breast ◽  
Double Immunofluorescence ◽  
First Line ◽  
Detection Rates ◽  
Line Chemotherapy

Background: We directly compared CTC detection rates and prognostic significance, using three different methods in patients with breast cancer (BC). Methods: Early (n=200) and metastatic (n=164) patients were evaluated before initiating adjuvant or first-line chemotherapy, using the CellSearchTM System, an RT-qPCR for CK-19 mRNA detection and by double immunofluorescence (IF) microscopy using A45-B/B3 and CD45 antibodies. Results: Using the CellSearchTM System, 37% and 16.5% of early BC patients were CTC-positive (at ≥1 and ≥2 CTCs/23 ml of blood), 18.0% by RT-qPCR and 16.9% by IF; no agreement was observed between methods. By the CellSearchTM 34.8% and 53.7% (at≥ 5 and ≥ 2 CTCs/7.5 ml) of metastatic patients were CTC-positive, 37.8% by RT-qPCR and 28.5% by IF. A significant agreement existed only between the CellSearchTM and RT-qPCR. In 60.8% of cases, differential EpCAM and CK-19 expression on CTCs by IF could explain the discrepancies between the CellSearchTM and RT-qPCR. CTC-positivity by either method was associated with decreased overall survival in metastatic patients. Conclusion: A significant concordance was observed between the CellSearchTM and RT-qPCR in metastatic but not in early BC. Discordant results could be explained in part by CTC heterogeneity. CTC detection by all methods evaluated had prognostic relevance in metastatic patients.

Phase II Trial of Nab-Paclitaxel Compared With Docetaxel as First-Line Chemotherapy in Patients With Metastatic Breast Cancer: Final Analysis of Overall Survival

2012 ◽  
Vol 12 (5) ◽  
pp. 313-321 ◽  
Author(s):  
William J. Gradishar ◽  
Dimitry Krasnojon ◽  
Sergey Cheporov ◽  
Anatoly N. Makhson ◽  
Georgiy M. Manikhas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Final Analysis ◽  
First Line ◽  
Line Chemotherapy

Final results of a randomized trial on the role of maintenance chemotherapy with weekly paclitaxel for patients with metastatic breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1001-1001 ◽  
Author(s):  
J. I. Mayordomo ◽  
J. M. Baena ◽  
L. Cirera ◽  
P. Sanchez-Rovira ◽  
M. J. Godes ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Weekly Paclitaxel ◽  
Maintenance Chemotherapy ◽  
First Line ◽  
Free Survival ◽  
Line Chemotherapy

1001 Background: Chemotherapy for patients with metastatic breast cancer is not curative. Anthracyclines and taxanes are among the most active drugs. Optimal duration of chemotherapy in women with metastatic breast cancer is an open issue. Should they receive chemotherapy to progression or should chemotherapy be stopped after a fixed number of courses? The excellent safety profile of weekly paclitaxel prompted us to evaluate its role as maintenance treatment in this setting. The primary objective was to determine if addition of maintenance weekly paclitaxel prolongs progression-free survival in women with metastatic breast cancer on first-line chemotherapy. Secondary objectives included overall survival and toxicity. Methods: Following Ethical Committee approval and informed consent, from 2002 to 2006 180 women with metastatic breast cancer and no prior chemotherapy for metastatic disease were randomized 1:1 in the TASMAN phase III trial to: 3 courses of epirubicin 100 mg/m2 day 1 q 21 days, followed by 3 courses of paclitaxel 225 mg/m2 day 1 q 21 days, without further chemotherapy or hormonal therapy until progression (arm A), or 3 courses of epirubicin followed by 3 courses of paclitaxel and then maintenance with paclitaxel 60 mg/m2 day 1 q 7 days until progression or unacceptable toxicity (arm B). Results: Median age: 51 years (range: 30–73). Median performance status (ECOG): 0 (0–2). Sites of metastases: bone (36%), liver (20%), pleura and/or lung (19%), skin and/or lymph nodes (18%). No grade 3–4 toxicities were seen with maintenance chemotherapy. As of January 1, 2009, 18 patients remained progression-free and 48 were alive, with a minimum follow-up of 2 years. Median progression-free survival was 8 months for arm A versus 12 months for arm B (p = 0.1, logrank). Median overall survival was 24 months for each arm (p = 0.7). Conclusions: Maintenance chemotherapy with weekly paclitaxel following first-line chemotherapy with anthracycline and taxane is well tolerated but does not significantly increase progression-free survival. No significant financial relationships to disclose.

scholarly journals Single arm, phase two study of low-dose metronomic eribulin in metastatic breast cancer

2021 ◽  
Author(s):  
Pavani Chalasani ◽  
Kiah Farr ◽  
Vicky Wu ◽  
Isaac Jenkins ◽  
Alex Liu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Peripheral Neuropathy ◽  
Clinical Benefit ◽  
Low Dose ◽  
Response Rate ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Free Survival

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.

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