scholarly journals Therapeutic Considerations for Docetaxel and Paclitaxel in Metastatic Breast Cancer

2020 ◽  
Vol 10 (1-s) ◽  
pp. 196-204
Author(s):  
Doranala Harshini ◽  
Sreenivas Pasula ◽  
Vesangi Keerthi Vaishnavi ◽  
Shiva Sai Tekula ◽  
M. Rajendar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Metastatic Cancer ◽  
Treatment Options ◽  
Single Agent ◽  
Metastatic Breast ◽  
Complete Response ◽  
Heavily Pretreated ◽  
Combination Regimens ◽  
Refractory Diseases

Breast cancer is the main source of death among women. Currently, 77% of women diagnosed with breast cancer are age 50 and older; however, it is projected that approximately 66% of the new cases diagnosed will occur in women younger than 65. Several clinical trials have assessed the wellbeing and adequacy of taxanes along with their tolerability in patients with metastatic cancer (MBC) The overview of these Paclitaxel and Docetaxel, the mechanism of action, pharmacokinetics and pharmacodynamics, dose and administration, adverse effects, clinical potency, and sufferable profiles combination therapies, the pathological complete response of these taxanes are included. The different novel formulations of taxanes are formulated from nanoparticles, polyglutamate, liposomes to improve the wellbeing and adequacy taxanes to reduce their toxicities. Single-agent research located with docetaxel and paclitaxel in metastatic breast most cancers show clinically huge antitumor motion even in the advanced stage, heavily pretreated, safe, as properly as in refractory diseases. This action is likewise clear with taxane-based combination regimens. Serious hematologic and nonhematologic toxicities are incompatible, with different toxicities noted dependent on the portion and weekly regimen selected.  Weekly docetaxel and paclitaxel regimens speak to important helpful treatment options for women suffering from metastatic breast cancer and have entered assessment as a major aspect of adjuvant treatment for this disease Toxicity associated with taxanes chemotherapy are based totally on the dose schedules and weekly regimen selected and the most frequent toxicities related with these marketers include myalgia, peripheral neuropathy, neutropenia, etc Docetaxel retains in tumor cells for longer duration when compared to paclitaxel because of its slow efflux and large amounts of uptake into the cell which explains its more benefits when compared to paclitaxel. Clinical studies conducted so far suggested a more benefit to risk ratio for docetaxel when compared to paclitaxel. This article reviews mainly different actions exhibited by taxanes in the therapy of metastatic breast cancer and others on stages of cancer along with the toxicities associated with these agents.  

Phase II Evaluation of Thalidomide in Patients With Metastatic Breast Cancer

2000 ◽  
Vol 18 (14) ◽  
pp. 2710-2717 ◽  
Author(s):  
Said M. Baidas ◽  
Eric P. Winer ◽  
Gini F. Fleming ◽  
Lyndsay Harris ◽  
James M. Pluda ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Progressive Disease ◽  
Single Agent ◽  
Metastatic Breast ◽  
Complete Response ◽  
Pharmacokinetic Studies ◽  
Angiogenic Growth Factors ◽  
Heavily Pretreated ◽  
Dose Levels

PURPOSE: To determine the efficacy, safety, pharmacokinetics, and effect on serum angiogenic growth factors of two dose levels of thalidomide in patients with metastatic breast cancer. PATIENTS AND METHODS: Twenty-eight patients with progressive metastatic breast cancer were randomized to receive either daily 200 mg of thalidomide or 800 mg to be escalated to 1,200 mg. Fourteen heavily pretreated patients were assigned to each dose level. Each cycle consisted of 8 weeks of treatment. Pharmacokinetics and growth factor serum levels were evaluated. RESULTS: No patient had a true partial or complete response. On the 800-mg arm, 13 patients had progressive disease at or before 8 weeks of treatment and one refused to continue treatment. The dose was reduced because of somnolence to 600 mg for five patients and to 400 mg for two and was increased for one to 1,000 mg and for four to 1,200 mg. On the 200-mg arm, 12 patients had progressive disease at or before 8 weeks and two had stable disease at 8 weeks, of whom one was removed from study at week 11 because of grade 3 neuropathy and the other had progressive disease at week 16. Dose-limiting toxicities included somnolence and neuropathy. Adverse events that did not require dose or schedule modifications included constipation, fatigue, dry mouth, dizziness, nausea, anorexia, arrhythmia, headaches, skin rash, hypotension, and neutropenia. Evaluation of circulating angiogenic factors and pharmacokinetic studies failed to provide insight into the reason for the lack of efficacy. CONCLUSION: Single-agent thalidomide has little or no activity in patients with heavily pretreated breast cancer. Further studies that include different patient populations and/or combinations with other agents might be performed at the lower dose levels.

Minimal clinical benefit of single agent Orathecin (Rubitecan) in heavily pretreated metastatic breast cancer

2005 ◽  
Vol 57 (4) ◽  
pp. 540-544 ◽  
Author(s):  
Silwan Chedid ◽  
Edgardo Rivera ◽  
Debbie K. Frye ◽  
Nuhad Ibrahim ◽  
Francisco Esteva ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Clinical Benefit ◽  
Single Agent ◽  
Metastatic Breast ◽  
Heavily Pretreated

Phase III Trial of Doxorubicin, Paclitaxel, and the Combination of Doxorubicin and Paclitaxel as Front-Line Chemotherapy for Metastatic Breast Cancer: An Intergroup Trial (E1193)

2003 ◽  
Vol 21 (4) ◽  
pp. 588-592 ◽  
Author(s):  
George W. Sledge ◽  
Donna Neuberg ◽  
Patricia Bernardo ◽  
James N. Ingle ◽  
Silvana Martino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Single Agent ◽  
Metastatic Breast ◽  
Complete Response ◽  
Phase Iii ◽  
Global Quality Of Life ◽  
Intergroup Trial

Purpose: Between February 1993 and September 1995, 739 patients with metastatic breast cancer were entered on an Intergroup trial (E1193) comparing doxorubicin (60 mg/m2), paclitaxel (175 mg/m2/24 h), and the combination of doxorubicin and paclitaxel (AT, 50 mg/m2 and 150 mg/m2/24 h, plus granulocyte colony-stimulating factor 5 mg/kg) as first-line therapy. Patients receiving single-agent doxorubicin or paclitaxel were crossed over to the other agent at time of progression. Patients and Methods: Patients were well balanced for on-study characteristics. Results: Responses (complete response and partial response) were seen in 36% of doxorubicin, 34% of paclitaxel, and 47% of AT patients (P = .84 for doxorubicin v paclitaxel, P = .007 for v AT, P = .004 for paclitaxel v AT). Median time to treatment failure (TTF) is 5.8, 6.0, and 8.0 months for doxorubicin, paclitaxel, and AT, respectively (P = .68 for doxorubicin v paclitaxel, P = .003 for doxorubicin v AT, P = .009 for paclitaxel v AT). Median survivals are 18.9 months for patients taking doxorubicin, 22.2 months for patients taking paclitaxel, and 22.0 months for patients taking AT (P = not significant). Responses were seen in 20% of patients crossing from doxorubicin → paclitaxel and 22% of patients crossing from paclitaxel → doxorubicin (P = not significant). Changes in global quality-of-life measurements from on-study to week 16 were similar in all three groups. Conclusion: (1) doxorubicin and paclitaxel, in the doses used here, have equivalent activity; (2) the combination of AT results in superior overall response rates and time to TTF; and (3) despite these results, combination therapy with AT did not improve either survival or quality of life compared to sequential single-agent therapy.

scholarly journals Complete Response to Single-agent Palbociclib in Metastatic Breast Cancer: A Case Report

2018 ◽  
Vol 18 (3) ◽  
pp. e277-e280 ◽  
Author(s):  
Sri Lakshmi Hyndavi Yeruva ◽  
Mehrbod Som Javadi ◽  
Vered Stearns
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Case Report ◽  
Single Agent ◽  
Metastatic Breast ◽  
Complete Response

scholarly journals Prospective Analysis of Patients with Metastatic Breast Cancer receiving Eribulin Mesylate as Second or More Lines of Chemotherapy: An Indian Experience

2018 ◽  
Vol 12 ◽  
pp. 117955491878247 ◽  
Author(s):  
BJ Srinivasa ◽  
Bhanu Prakash Lalkota ◽  
Girish Badarke ◽  
Diganta Hazarika ◽  
Nasiruddin Mohammad ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Treatment Options ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Microtubule Inhibitor ◽  
Eribulin Mesylate ◽  
Primary Tumors ◽  
Free Survival ◽  
Heavily Pretreated

Background: Eribulin mesylate is a non-taxane microtubule inhibitor which can be used after anthracycline and taxane treatment in patients with metastatic breast cancer (MBC). The purpose of this study was to investigate the efficacy and safety of eribulin monotherapy in heavily pretreated patients with MBC. Methods: In this study, a total of 45 eligible patients with MBC who received eribulin in HCG Cancer Speciality Center from November 2014 to March 2016 were prospectively analyzed. Breslow (generalized Wilcoxon) survival analysis was carried out for progression-free survival and for overall survival. Patients were excluded if they had not taken treatment for 3 cycles and defaulted/expired during the treatment. Results: In this study, median age of patients was 52 years. A total of 27 (60%) patients had estrogen receptor and progesterone receptor (PR) positive primary tumors, whereas HER2 was overexpressed or amplified in 7 (15.6%); a triple negative subtype was recorded in 13 patients (28.9%). Regarding toxicity, 30 patients (66.67%) tolerated treatment well and 3 patients (6.67%) got anemia, 6 patients (13.3%) experienced neutropenia, and 7 (15.62%) patients had neurological toxicity. About 14 (31.1%) patients showed PR, 12 (26.7%) patients had stable disease (SD), whereas 19 (42.25%) patients showed progression disease (PD). Response evaluation at 6 cycles was possible in 18 patients and revealed that 4 (22.5%) patients showed PR, 10 (55.5%) patients had SD, whereas 4 (22.2%) patients had PD. Progression-free survival of the overall study population was 3.95 months. Conclusions: Eribulin mesylate is efficacious and tolerable chemotherapy as second- and third-line treatment options for MBC.

scholarly journals Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1

2020 ◽  
Vol 184 (1) ◽  
pp. 161-172
Author(s):  
Hope S. Rugo ◽  
Veronique Dieras ◽  
Javier Cortes ◽  
Debra Patt ◽  
Hans Wildiers ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Single Agent ◽  
Metastatic Breast ◽  
Clinical Context ◽  
Eligibility Criteria ◽  
The Real ◽  
Heavily Pretreated ◽  
Single Agent Chemotherapy

Abstract Purpose In MONARCH 1 (NCT02102490), single-agent abemaciclib demonstrated promising efficacy activity and tolerability in a population of heavily pretreated women with refractory HR+, HER2− metastatic breast cancer (MBC). To help interpret these results and put in clinical context, we compared overall survival (OS) and duration of therapy (DoT) between MONARCH 1 and a real-world single-agent chemotherapy cohort. Methods The real-world chemotherapy cohort was created from a Flatiron Health electronic health records-derived database based on key eligibility criteria from MONARCH 1. The chemotherapies included in the cohort were single-agent capecitabine, gemcitabine, eribulin, or vinorelbine. Results were adjusted for baseline demographics and clinical differences using Mahalanobis distance matching (primary analysis) and entropy balancing (sensitivity analysis). OS and DoT were analyzed using the Kaplan–Meier method and Cox proportional hazards regression. Results A real-world single-agent chemotherapy cohort (n = 281) with eligibility criteria similar to the MONARCH 1 population (n = 132) was identified. The MONARCH 1 (n = 108) cohort was matched to the real-world chemotherapy cohort (n = 108). Median OS was 22.3 months in the abemaciclib arm versus 13.6 months in the matched real-world chemotherapy cohort with an estimated hazard ratio (HR) of 0.54. The median DoT was 4.1 months in MONARCH 1 compared to 2.9 months in the real-world chemotherapy cohort with HR of 0.76. Conclusions This study demonstrates an approach to create a real-world chemotherapy cohort suitable to serve as a comparator for trial data. These exploratory results suggest a survival advantage and place the benefit of abemaciclib monotherapy in clinical context.

Capecitabine maintenance therapy after docetaxel/capecitabine combination chemotherapy in patients with metastatic breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e12018-e12018
Author(s):  
Pinar Gursoy ◽  
Zeki Gokhan Surmeli ◽  
Burcu Cakar ◽  
Cagatay Arslan ◽  
Baha Zengel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Maintenance Therapy ◽  
Single Agent ◽  
Objective Response ◽  
Metastatic Breast ◽  
Complete Response ◽  
Response To Treatment ◽  
Grade 3 ◽  
Metastatic Sites

e12018 Background: Addition of capecitabine to docetaxel improves survival outcomes compared with single agent docetaxel in metastatic breast cancer (MBC). In this study we analyzed efficacy of maintenance therapy with single agent capecitabine after six cycles of docetaxel/capecitabine chemotherapy in MBC patients. Methods: Patients with metastatic HER2 negative breast cancer were included. Six cycles of docetaxel (75mg/m2 q3wk) / capecitabine (1650mg/m2/day on days 1 to 14) followed by capecitabine (2000 mg/m2/day on days 1 to 14) were administered. Demographic features, progression free (PFS) and overall survival (OS) and response to treatment were recorded. Results: Fifty-four patients were included. Thirty-five patients (65%) were postmenopausal, and 40 (74%) were ER/PR positive. Median age was 53 (range 28 – 70). Number of metastatic sites was one in 23 patients, two in 21, three or more in 10 patients. Most common metastatic sites were bone (67%), lymph nodes (33%), lungs (30%), liver (13%); 13 patients (24%) had bone only disease. Forty-four (81.5%) patients received treatment in first-line, 10 (18.5%) received in second line setting. Median number of cycles applied (including docetaxel/capecitabine combination) was 9 (range 2 – 31, total 576). Median PFS was 9 months (10.4 for hormone receptor positive, 7.3 for negative patients) and median OS was 28 months. Objective response was assessable in 38 patients. Overall response rate (partial + complete response) was 42.6% (95% CI 29.6 – 55.6) with 1 complete response. Toxicities were evaluated in 41 patients; grade 3/4 neutropenia was observed in 10% and grade 3/4 hand-foot syndrome was observed in 24% of patients. Dose reduction was performed in capecitabine in 37%, and in docetaxel in 20% of patients. Conclusions: Maintenance with single agent capecitabine therapy after six cycles of docetaxel/capecitabine chemotherapy is an effective and tolerable treatment option for HER2 negative MBC patients.

Gemcitabine in Combination With Doxorubicin in Advanced Breast Cancer: Final Results of a Phase II Pharmacokinetic Trial

2000 ◽  
Vol 18 (13) ◽  
pp. 2545-2552 ◽  
Author(s):  
G. Pérez-Manga ◽  
A. Lluch ◽  
E. Alba ◽  
J.A. Moreno-Nogueira ◽  
M. Palomero ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Single Agent ◽  
Metastatic Breast ◽  
Complete Response ◽  
Breast Disease ◽  
Advanced Breast ◽  
Weekly Schedule

PURPOSE: Gemcitabine has promising single-agent activity in advanced breast disease. The aim of this phase II study was to determine the efficacy, toxicity, and pharmacokinetic profile of gemcitabine administered with doxorubicin as first-line treatment in patients with metastatic breast cancer. PATIENTS AND METHODS: Of the 42 women with metastatic breast cancer (age 33 to 74 years; mean age, 55 years), 13 were chemotherapy-naive and 29 had received adjuvant chemotherapy. Gemcitabine (800 or 1,000 mg/m2) and doxorubicin (25 mg/m2) were administered intravenously on days 1, 8, and 15 of each 28-day cycle. Blood samples were drawn on day 8 of cycles 1, 2, and 3 and of subsequent odd cycles for gemcitabine pharmacokinetic determinations and before and after the first dose of cycle 1 or 2 for doxorubicin determinations. RESULTS: There were three complete and 20 partial responses, for an overall response rate of 55% (95% confidence interval [CI], 40% to 70%) and a complete response rate of 7%. The median survival time for all 42 patients was 27 months (95% CI, 13.4 to 30.0 months) and the 1-year survival rate was 80%. Toxicity was mainly hematologic. The disposition of both drugs was unchanged when they were administered on the same day compared with when they were given singly. CONCLUSION: The combination of gemcitabine (800 mg/m2) and doxorubicin (25 mg/m2) can be safely administered using a weekly schedule. The disposition of both drugs is unchanged when they are administered on the same day. This combination shows promising activity with acceptable toxicity compared with other combination therapies.

Triple Negative Breast Cancer Pathologic Diagnosis and Current Chemotherapy Treatment Options

2014 ◽  
Vol 10 (01) ◽  
pp. 35 ◽  
Author(s):  
Bernardo L Rapoport ◽  
Simon Nayler ◽  
Georgia S Demetriou ◽  
Shun D Moodley ◽  
Carol A Benn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Hormone Receptors ◽  
Triple Negative ◽  
Treatment Options ◽  
Single Agent ◽  
Metastatic Breast ◽  
Complete Response ◽  
Breast Cancers ◽  
Metastatic Setting

Triple negative breast cancer (TNBC) comprises 12–20 % of all breast cancers and are a heterogeneous group of tumours, both clinically and pathologically. These cancers are characterised by the lack of expression of the hormone receptors oestrogen receptor (OR) and progesterone receptor (PR), combined with the lack of either overexpression or amplification of the human epidermal growth factor receptor-2 (HER2) gene. Conventional cytotoxic chemotherapy and DNA damaging agents continue to be the mainstay of treatment of this disease in the neoadjuvant, adjuvant and metastatic setting. The lack of predictive markers in identifying potential targets for the treatment of TNBC has left a gap in directed therapy in these patients. Platinum agents have seen renewed interest in TNBC based on an increasing body of preclinical and clinical data suggesting encouraging activity. However, comparisons between chemotherapy regimens are mostly retrospective in nature and the best agents or drug combinations for TNBC have not been established in prospective randomised trials. Numerous studies have now shown that TNBC has significantly higher pathological complete response (pCR) rates compared with hormone receptor positive breast cancer when treated with neoadjuvant chemotherapy, and pCR correlates well with better outcomes for these patients. Patients with TNBC account for a larger number of deaths in the setting of metastatic breast cancer. There is no preferred treatment for the first-line metastatic setting. Although individual agents are recommended, given the often aggressive nature of TNBC and the presence of extensive visceral disease, the use of a combination of drugs, rather than a single agent, is often advocated. This review article will outline the pathological diagnosis of TNBC and the treatment options available to these patients in the neoadjuvant, adjuvant and metastatic setting, including an assessment of future directions of treatment.

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