Epirubicin at two dose levels with prednisolone as treatment for advanced breast cancer: the results of a randomized trial.

Two hundred eleven patients with advanced breast cancer were randomized to receive either epirubicin (E) 50 mg/m2 and prednisolone (LEP) or E 100 mg/m2 and prednisolone (HEP). The intended treatment consisted of 16 courses of LEP or eight courses of HEP given at 3-weekly intervals. Reasons for stopping treatment early included progressive disease, stable disease without symptomatic improvement, or severe toxicity deemed intolerable by either the patient or physician. Toxicity was recorded at 3-weekly and response at 9-weekly intervals using the World Health Organization (WHO) criteria of response and toxicity. Two hundred nine patients were eligible for analysis, 98% of whom have been followed for more than a year. One hundred four patients received LEP and 105 HEP. Significantly worse myelosuppression, alopecia, nausea and vomiting, and mucositis were seen in the high-dose arm (P less than or equal to .001). More patients in the LEP arm stopped treatment before the fourth course than in the HEP arm, and the commonest reason for stopping was progressive disease. A similar median number of courses was given in each arm. There was a significantly higher response in the HEP arm (HEP - complete response [CR] + partial response [PR] = 41%, LEP - CR + PR = 23%). Despite this, no statistically significant differences was seen in overall survival or progression-free interval. The median survival for HEP and LEP was 44 and 46 weeks, respectively.

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Cisplatin and VP16 in Metastatic Breast Carcinoma as a Third-Line Chemotherapy: A Randomized Study Comparing Low versus High Doses of Cisplatin

Tumori Journal ◽

10.1177/030089169508100405 ◽

1995 ◽

Vol 81 (4) ◽

pp. 241-244 ◽

Cited By ~ 11

Author(s):

Guido Ceci ◽

Giancarlo Bisagni ◽

Giorgio Cocconi ◽

Carmelina Rodinò ◽

Virginio Belsanti ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Low Dose ◽

Objective Response ◽

Metastatic Breast ◽

Advanced Breast ◽

High Dose ◽

Severe Toxicity ◽

Third Line ◽

Line Chemotherapy

Aims and background The study was designed to define the activity of the combination of cisplatin and etoposide as third-line chemotherapy for advanced breast cancer and to investigate the role of the dosage of cisplatin on the effectiveness of the combination. Methods Ninety-five eligible patients with advanced breast cancer who had failed or relapsed on two previous lines of chemotherapy were randomized to receive cisplatin at a high dose (100 mg/m2 i.v. day 1, arm A) or a low dose (60 mg/m2 day 1, arm B), combined with etoposide (100 mg/m2 i.v. days 4, 6 and 8). Cycles were repeated every 3 weeks. Results Of the 78 patients evaluable for response (39 in arm A and 39 in arm B), 9 (12%) showed complete or partial response, 5 (13%) in the high-dose arm and 4 (10%) in the low-dose arm. One complete response was seen in the high-dose arm and none in the low-dose arm. The only 2 patients with brain involvement showed an objective response (one CR in arm A and one PR in arm B). Median time to progression was 14 weeks in arm A and 10 weeks in arm B, median duration of remission 28 and 34 weeks, and survival 36 and 35 weeks, respectively. The differences were not significant. As expected, the patients in the high-dose arm experienced more severe toxicity. One toxic death was observed in each arm due to sepsis in agranulocytosis. The difference was statistically significant regarding nausea and vomiting. Neurotoxicity and ototoxicity were not relevant problems in this patient setting. Conclusions Considering the very poor prognostic factors presented by these patients, the combination showed a certain activity, and further evaluation in earlier stages of disease is warranted. A particular responsiveness on brain metastases is suggested. The dose of cisplatin was not proven to be of significant importance.

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A multicenter randomized study comparing vinorelbine plus gemcitabine versus capecitabine monotherapy as salvage treatment in patients with advanced breast cancer pretreated with taxane and anthracycline chemotherapy: A preliminary report

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.658 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 658-658 ◽

Cited By ~ 9

Author(s):

D. Mavroudis ◽

A. Ardavanis ◽

I. Boukovinas ◽

I. Varthalitis ◽

K. Syrigos ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Randomized Study ◽

Complete Response ◽

Salvage Treatment ◽

Advanced Breast ◽

Severe Toxicity ◽

Hand Foot Syndrome ◽

Grade 3 ◽

Anthracycline Chemotherapy

658 Background: Both Vinorelbine plus Gemcitabine (VG) regimen and Capecitabine (C) monotherapy are active salvage treatments in patients (pts) with advanced breast cancer (ABC). In this multicenter study we compared the efficacy and tolerability of the two regimens as salvage treatment in pts with ABC pretreated with taxane and anthracycline chemotherapy. Methods: Pts were randomized to receive either vinorelbine 25 mg/m2 plus gemcitabine 1000 mg/m2 (VG) both on day 1 in cycles every 2 weeks or capecitabine 1250 mg/m2 (C) twice a day on days 1–14 in cycles every 3 weeks. The primary end point of the study was to compare the time to disease progression (TTP). Results: A total of 114 pts were randomized to VG (n=60) and C (n=54). All pts were evaluable for toxicity and 58 VG and 54 C pts for response. Seven (VG) vs 9 (C) pts had stage IIIB disease and 6 vs 5 pts had PS 2. We observed one complete response on each arm and 14(24%) vs 12(22%) partial responses for an overall response rate of 25.8% vs 24.1% (p=0.8) in VG vs C pts, respectively. The median duration of response was 5 vs 12 months (p=0.02) and the median TTP 3.7 vs 5.8 months (p=0.4) for VG and C pts, respectively. A total of 339 VG and 270 C cycles were administered with no toxic deaths. Both regimens were overall well tolerated; grade 3–4 neutropenia 17% vs 4% (p=0.02), anemia 4% vs 2% (p=0.6), grade 3 thrombocytopenia 2% vs 2%, neurotoxicity 3% vs 2%, grade 2–4 hand-foot syndrome 2% vs 15% (p=0.009) for VG and C pts, respectively. Conclusions: In this preliminary analysis the VG and C regimens showed similar activity but different although rarely severe toxicity. Updated results will be presented at the meeting. No significant financial relationships to disclose.

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Gamma knife radiosurgery in patients with advanced breast cancer undergoing bone marrow transplant

Journal of Neurosurgery ◽

10.3171/jns.2002.97.supplement_5.0663 ◽

2002 ◽

Vol 97 ◽

pp. 663-665 ◽

Cited By ~ 5

Author(s):

Kenneth J. Levin ◽

Emad F. Youssef ◽

Andrew E. Sloan ◽

Rajiv Patel ◽

Rana K. Zabad ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Gamma Knife ◽

Gamma Knife Radiosurgery ◽

High Dose Chemotherapy ◽

Advanced Breast ◽

High Dose ◽

Initial Management ◽

Content Type ◽

Fine Print

Object. Recent studies have suggested a high incidence of cognitive deficits in patients undergoing high-dose chemotherapy, which appears to be dose related. Whole-brain radiotherapy (WBRT) has previously been associated with cognitive impairment. The authors attempted to use gamma knife radiosurgery (GKS) to delay or avoid WBRT in patients with advanced breast cancer treated with high-dose chemotherapy and autologous bone marrow transplantation (HDC/ABMT) in whom brain metastases were diagnosed. Methods. A retrospective review of our experience from 1996 to 2001 was performed to identify patients who underwent HDC/ABMT for advanced breast cancer and brain metastasis. They were able to conduct GKS as initial management to avoid or delay WBRT in 12 patients following HDC/ABMT. All patients were women. The median age was 48 years (range 30–58 years). The Karnofsky Performance Scale score was 70 (range 60–90). All lesions were treated with a median prescription dose of 17 Gy (range 15–18 Gy) prescribed to the 50% isodose. Median survival was 11.5 months. Five patients (42%) had no evidence of central nervous system disease progression and no further treatment was given. Four patients were retreated with GKS and three of them eventually received WBRT as well. Two patients were treated with WBRT as the primary salvage therapy. The median time to retreatment with WBRT was 8 months after the initial GKS. Conclusions. Gamma knife radiosurgery can be effectively used for the initial management of brain metastases to avoid or delay WBRT in patients treated previously with HDC, with acceptable survival and preserved cognitive function.

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Study of pathological complete response rates with neoadjuvant concurrent chemoradiation with paclitaxel in locally advanced breast cancer

Annals of Oncology ◽

10.1093/annonc/mdz097.008 ◽

2019 ◽

Vol 30 ◽

pp. iii36

Author(s):

P. Iyer ◽

V. Radhakrishnan ◽

A. Balasubramanian ◽

V. Sridevi ◽

A. Krishnamurthy ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Pathological Complete Response ◽

Locally Advanced Breast Cancer ◽

Locally Advanced ◽

Response Rates ◽

Complete Response ◽

Advanced Breast ◽

Concurrent Chemoradiation

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The Prognostic Impact of Body Composition for Locally Advanced Breast Cancer Patients Who Received Neoadjuvant Chemotherapy

Cancers ◽

10.3390/cancers13040608 ◽

2021 ◽

Vol 13 (4) ◽

pp. 608

Author(s):

Toshiaki Iwase ◽

Aaroh Parikh ◽

Seyedeh S. Dibaj ◽

Yu Shen ◽

Tushaar Vishal Shrimanker ◽

...

Keyword(s):

Breast Cancer ◽

Body Composition ◽

Adipose Tissue ◽

Neoadjuvant Chemotherapy ◽

Advanced Breast Cancer ◽

Locally Advanced Breast Cancer ◽

Locally Advanced ◽

Pathologic Complete Response ◽

Complete Response ◽

Advanced Breast

Our previous study indicated that a high amount of visceral adipose tissue was associated with poor survival outcomes in patients with early breast cancer who received neoadjuvant chemotherapy. However, inconsistency was observed in the prognostic role of body composition in breast cancer treatment outcomes. In the present study, we aimed to validate our previous research by performing a comprehensive body composition analysis in patients with a standardized clinical background. We included 198 patients with stage III breast cancer who underwent neoadjuvant chemotherapy between January 2007 and June 2015. The impact of body composition on pathologic complete response and survival outcomes was determined. Body composition measurements had no significant effect on pathologic complete response. Survival analysis showed a low ratio of total visceral adipose tissue to subcutaneous adipose tissue (V/S ratio ≤ 34) was associated with shorter overall survival. A changepoint method determined that a V/S ratio cutoff of 34 maximized the difference in overall survival. Our study indicated the prognostic effect of body composition measurements in patients with locally advanced breast cancer compared to those with early breast cancer. Further investigation will be needed to clarify the biological mechanism underlying the association of V/S ratio with prognosis in locally advanced breast cancer.

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