Weekly Docetaxel in the Treatment of Elderly Patients With Advanced Breast Cancer: A Minnie Pearl Cancer Research Network Phase II Trial

2001 ◽  
Vol 19 (15) ◽  
pp. 3500-3505 ◽  
Author(s):  
John D. Hainsworth ◽  
Howard A. Burris ◽  
Denise A. Yardley ◽  
James E. Bradof ◽  
Manuel Grimaldi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Performance Status ◽  
Metastatic Breast ◽  
Poor Performance ◽  
Advanced Breast ◽  
Poor Performance Status ◽  
Line Treatment ◽  
Weekly Docetaxel

PURPOSE: To evaluate the efficacy and toxicity of docetaxel administered weekly to elderly or poor-performance status patients with advanced breast cancer. PATIENTS AND METHODS: Forty-one patients with advanced breast cancer who were either over the age of 65 or considered to be poor candidates for combination chemotherapy received docetaxel 36 mg/m2 weekly for 6 consecutive weeks, followed by 2 weeks without treatment. The median age of patients in this trial was 74 years, and 73% of patients had one or more visceral sites of metastases. Seventy-five percent of patients received weekly docetaxel as first-line treatment for metastatic breast cancer, and the other 25% received it as second-line treatment. Thirty-six patients were assessable for efficacy, and all patients were assessed for toxicity. RESULTS: A total of 448 doses of weekly docetaxel were administered to 41 patients. Thirteen patients (36%) had objective responses to treatment, and an additional 13 patients (36%) had stable disease or minor response. Median time to progression for responding and stable patients was 7 months (range, 3 to 27 months). Median survival for the entire group was 13 months, with 1- and 2-year actuarial survival rates of 61% and 29%, respectively. Severe neutropenia occurred in only 0.4% of courses, and no other hematologic toxicity was observed. Grade 3/4 fatigue was the most common toxicity, occurring in 20% of patients. CONCLUSION: Weekly docetaxel therapy is active and well tolerated by elderly and/or poor-performance status patients with advanced breast cancer. This treatment can be administered with minimal myelosuppression. Weekly docetaxel provides an additional option for treatment in this difficult subgroup of patients with metastatic breast cancer. Well-tolerated combination regimens containing weekly docetaxel merit evaluation for this patient population.

A randomized trial in postmenopausal patients with advanced breast cancer comparing endocrine and cytotoxic therapy given sequentially or in combination. The Australian and New Zealand Breast Cancer Trials Group, Clinical Oncological Society of Australia.

1986 ◽  
Vol 4 (2) ◽  
pp. 186-193 ◽  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Endocrine Therapy ◽  
Performance Status ◽  
Poor Performance ◽  
Advanced Breast ◽  
Poor Performance Status ◽  
Cytotoxic Therapy ◽  
Disease Free Interval ◽  
Single Modality

A prospective randomized clinical trial was performed in 339 postmenopausal patients with advanced breast cancer. Two single modality treatment sequences, doxorubicin plus cyclophosphamide (AC) followed on failure by tamoxifen (TAM), and TAM followed by AC, were compared with combined modality chemo-endocrine therapy (TAM plus AC). The response rate to initial TAM (22.1%) was inferior to that for AC (45.1%), and for TAM plus AC (51.3%). However, patients randomized to the sequence TAM followed by AC showed a 42.5% overall tumor response to sequential protocol therapy, similar to the 46.9% for those randomized to AC followed by TAM. Furthermore, survival in all three arms was almost identical. Adverse prognostic factors for survival were liver metastases, short disease-free interval, poor performance status, and prior adjuvant chemotherapy. In no subgroup was significantly better survival associated with initial cytotoxic therapy. Endocrine therapy followed on failure by cytotoxics is appropriate for postmenopausal patients with advanced breast cancer.

Weekly Epirubicin in Advanced Breast Cancer

1988 ◽  
Vol 74 (6) ◽  
pp. 689-692 ◽  
Author(s):  
Enrico Tucci ◽  
Renato Algeri ◽  
Alfredo Guarnieri ◽  
Fiorella Pepi ◽  
Lidia Sapio ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Performance Status ◽  
Poor Performance ◽  
Cytotoxic Chemotherapy ◽  
Advanced Breast ◽  
Poor Performance Status ◽  
Weekly Schedule ◽  
Breast Cancer Patients ◽  
Duration Of Response

Twenty-nine advanced breast cancer patients, considered unable to tolerate conventional cytotoxic chemotherapy, were treated with a weekly schedule of epirubicin (15 mg/m2 i.v.). All patients were fully evaluable. A remission of 34.5 % was observed (2 CR; 8 PR), with a median duration of response of 9 months (range, 3–24 months). Side effects were mild, and on the whole the toxicity was negligible. This regimen showed a favorable therapeutic ratio in our series and seems active and well tolerated even in elderly and/or poor performance status patients.

Fulvestrant ('Faslodex')--a new treatment option for patients progressing on prior endocrine therapy.

2002 ◽  
pp. 267-276 ◽  
Author(s):  
C Morris ◽  
A Wakeling
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Postmenopausal Women ◽  
Endocrine Therapy ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Phase Iii ◽  
Hormone Receptor Positive

Since its introduction more than 30 years ago, tamoxifen has been the most widely used endocrine therapy for the treatment of women with advanced breast cancer. More recently, a number of alternative endocrine treatments have been developed, including several selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs) and, most recently, fulvestrant ('Faslodex'). Fulvestrant is an estrogen receptor (ER) antagonist, which, unlike the SERMs, has no known agonist (estrogenic) effect and downregulates the ER protein. Tamoxifen is effective and well tolerated, although the non-steroidal AIs, anastrozole and letrozole, are more effective treatments for advanced disease than tamoxifen. Fulvestrant has recently gained US Food and Drug Administration approval for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. In two global phase III clinical trials fulvestrant was at least as effective and as equally well tolerated as anastrozole for the treatment of postmenopausal women with advanced and metastatic breast cancer. In a retrospective analysis of the combined data from these trials, mean duration of response was significantly greater for fulvestrant compared with anastrozole. These new hormonal treatments expand the choice of endocrine therapy for women with advanced breast cancer and offer new options for sequencing and combining treatments.

Phase II evaluation of liposomal doxorubicin combined with docetaxel in patients with metastatic breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1112-1112
Author(s):  
J. Fasano ◽  
D. Hershman ◽  
Y. Novik ◽  
K. Blozie ◽  
A. Tiersten
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Liposomal Doxorubicin ◽  
Performance Status ◽  
Metastatic Breast ◽  
Time To Progression ◽  
Ecog Performance Status ◽  
Weekly Docetaxel ◽  
Mixed Response ◽  
Response To Chemotherapy

1112 Background: The combination of anthracyclines and taxanes are effective in the treatment of metastatic breast cancer. Liposomal doxorubicin has been shown to be as effective as doxorubicin with less toxicity and it can be combined safely with docetaxel. Methods: Monthly liposomal doxorubicin (30 mg/m2) in combination with weekly docetaxel (30 mg/m2) was evaluated in women with metastatic breast cancer. Cycles were continued until disease progression or unacceptable toxicity. Radiologic assessment was performed every two months. The primary outcome was time to progression. Secondary endpoints included overall response rate, median survival and toxicity. Results: Between 12/2002 and 9/2005, 12 women were enrolled and received this combination as front- line chemotherapy for metastatic breast cancer. The mean age was 46.5 (31–60) years. Nine (75%) patients had tumors that were ER+ or PR+. Five (41.7%) women had tumors that over-expressed her-2/neu. Ten women had an EGOG performance status of 1. Two women had an ECOG performance status of 2. The median number of cycles received was 4 (1–12). Four (25%) women were taken off study due to intolerable toxicity and 7 (58.3%) due to progressive disease. One (8.3%) woman remains progression free. Ten (83.3%) women had a partial response, one (8.3%) woman had a mixed response and one (8.3%) was not evaluable for response to chemotherapy. The median time to progression was 21 (6–52) weeks. Three women remain alive with disease. One woman remains alive and progression-free. Ten (83%) patients experienced Grade 3/4 toxicities, including: stomatits 6 (50%), nausea/vomiting 1 (8.3%), neutropenia 3 (25%), infection 3 (25%), dyspnea 2 (16.7%), and PPE 1 (8.3). Conclusions: Monthly liposomal doxorubicin plus weekly docetaxel in women with metastatic breast cancer resulted in an encouraging response, but was difficult to tolerate. Further evaluation of this combination with improved supportive care may be warranted. [Table: see text]

Maximizing metastatic breast cancer therapy selection: Physician practice patterns and competence assessment.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 127-127
Author(s):  
Tina Boyd Stacy ◽  
Maureen E. Haas ◽  
Alison A. Heintz
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Patient Care ◽  
Practice Patterns ◽  
Scientific Information ◽  
Single Agent ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Peer Discussion

127 Background: Due to the volume and pace of scientific advances within oncology, peer discussion and professional reflection regarding appropriate therapeutic decision making is necessary to provide the highest quality patient care. Increasing awareness in the breast cancer community of similarities and differences amongst practice management strategies helps to identify and benchmark individual practice patterns against one’s professional peers, ultimately leading to increased competence in therapy selection. Methods: During 2011 and 2012, educational outcomes assessments were gathered during 85 independent continuing medical education (CME) activities held within community practices and institutions across the USA. Participants were asked a series of case-based questions via an audience response system to assess baseline knowledge, competence, and identify practice patterns. Assessments were repeated post a 1-hour CME certified activity, with an additional 6-week electronic follow-up. Results: To date, over 330 physicians have participated in the program. Number of years in practice ranged from < 10 to > 30. The number of breast cancer patients seen per month ranged from ≤ 10 to > 40. Provider competency and preferences in applying guideline based therapy was assessed. Results of participant preferences including single-agent, combination, first-line, and second-line therapy preferences as well as toxicity management for select patient case scenarios in advanced breast cancer will be presented. Self-rated competence for the physician audience improved by approximately 50% as a result of participation. Conclusions: The results highlight the diversity of clinical opinion in selecting therapy for advanced breast cancer and need for continued dialogue and scientific advancement. Education and peer discussion of how to optimize translation of new scientific information into patient care contributes to maximizing physician competence in therapy selection for metastatic breast cancer.

Tracking evolution of aromatase inhibitor resistance with circulating tumour DNA (ctDNA) in metastatic breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1015-1015
Author(s):  
Charlotte Victoria Fribbens ◽  
Isaac Garcia-Murillas ◽  
Matthew Beaney ◽  
Sarah Hrebien ◽  
Karen Howarth ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Disease Progression ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Plasma Samples ◽  
First Line ◽  
Ras Mutations ◽  
Esr1 Mutations

1015 Background: Selection of resistance mutations may play a major role in the development of endocrine resistance. ESR1 mutations are rare in primary breast cancer but have a high prevalence in patients treated with aromatase inhibitors (AI) for advanced breast cancer. We investigated the evolution of genetic resistance to first line AI therapy using sequential ctDNA sampling in patients with advanced breast cancer. Methods: Seventy-one patients on first line AI therapy for metastatic breast cancer were enrolled in a prospective study to collect plasma samples for ctDNA analysis every three months on therapy, and at disease progression. All plasma samples were analysed with ESR1 multiplex digital PCR assays, and samples at disease progression were analysed by InVision (enhanced tagged-amplicon sequencing). Mutations were tracked back through samples prior to disease progression to study the evolution of mutations on therapy. Results: Of the 34 patients who progressed on first line AI, 53% (18/34) had ESR1 mutations detectable at progression. Sequencing of progression plasma ctDNA identified polyclonal RAS mutations in 10.7% (3/28) progressing patients (2 polyclonal KRAS, 1 monoclonal HRAS), all of whom also had ESR1 mutations, and a patient with an activating p.R248C FGFR3 mutation. ESR1 mutations were subclonal in 78.6% (11/14) patients, with all RAS mutations being rare subclones. In serial tracking prior to progression, ESR1 mutations were detectable in plasma with a median of 5.3 months (95% CI 2.9-NA) prior to clinical progression. Conclusions: ESR1 mutations are found at high frequency in patients progressing on AI, but are frequently sub-clonal and may not be the sole driver of AI resistance in these patients. Poly-clonal KRAS mutations are identified as a novel mechanism of resistance to AI, associated with detection of ESR1 mutations.

Fulvestrant in advanced breast cancer following following failure of tamoxifen and a third generation aromatase inhibitor

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1073-1073
Author(s):  
J. Wang ◽  
S. Jain ◽  
W. Heller ◽  
D. Mackie ◽  
V. Watson ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Aromatase Inhibitor ◽  
Endocrine Therapy ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Third Generation

1073 Background: Endocrine therapy is a key modality in the management of estrogen receptor positive metastatic breast cancer. Fulvestrant (ICI 182,780) is an estrogen receptor downregulator. It has previously been shown to be as effective as anastrozole in patients who had previously progressed on tamoxifen. Methods: A retrospective study was carried out of metastatic breast cancer patients treated at Charing Cross Hospital between 2002–2005 who had received fulvestrant following treatment failure with tamoxifen and a third generation aromatase inhibitor. All patients were postmenopausal and received fulvestrant 250mg IM every 28 days. Measurable disease was assessed by response evaluation criteria in solid tumors (RECIST). Results: A total of 45 patients were identified with a median age of 60 (range 36 to 90). The ER status was known in 95% (n=43) of patients and was positive in all cases, it was unknown in 2% (n=2). At the time of commencing fulvestrant, 96% (n=43) had metastatic disease and 4% (n=2) locally advanced disease. All patients had received at least 2 lines of prior endocrine therapy (including adjuvant therapy), at time of starting fulvestrant the median number of prior regimens was 3 (range 3–5). Fulvestrant was administered for a median of 4 months (range 1 to 20 months), with 4 patients currently still receiving therapy as of 1 November 2006. Of the 45 patients, 2.2% (n=1) achieved a partial response, while 31% (n=14) achieved stable disease for at least 6 months. Thus, 33.3% (n=15) obtained clinical benefit (defined as PR or SD for at least 6 months). The response rates based on line of therapy will be presented. Of the 45 patients, 41 were evaluable for survival data. The median survival of the remaining patients from the start of fulvestrant therapy was 9 months (range 1 to 48 months). Of the 44 patients, 14% (n=6) remain alive. The treatment was well tolerated and toxicity data will be presented. Conclusions: Fulvestrant is well tolerated and is efficacious as treatment for advanced breast cancer that has failed tamoxifen and a third generation aromatase inhibitors. No significant financial relationships to disclose.

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