Gemcitabine (G) and cisplatin (C) as first-line treatment of metastatic breast cancer (MBC): Results of phase II trial.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 273-273
Author(s):  
M. Karthaus ◽  
I. Poddubnaya ◽  
L. Churilova ◽  
R. Khasanov ◽  
T. Veremeychuk ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Hematological Toxicity ◽  
Line Treatment ◽  
Toxicity Profile ◽  
First Line ◽  
First Line Treatment

273 Background: G has been studied in combination with a variety of agents known to be active in cancer. G has a mild toxicity profile. GC is active in various advanced tumors. Splitting of C dose (D 1 + d8) is better tolerated and can be a good alternative to once a cycle in pts with advanced breast cancer. This phase II trial evaluates G (1000 mg/m2) C (35 mg/ m2) d1+8 repeated every 21 d in the 1st-line treatment of metastatic breast cancer (MBC). The primary objective of the study was to determine the objective tumor response rate (ORR) of 1st-line GC in patients with metastatic breast cancer.The one-stage design tested the null hypothesis that the true response rate for this population should be equal to 50% for efficacy. Overall survival (OS), time to progression (TTP) and toxicity were evaluated. Methods: 70 female MBC pts with the median age of 49.8 ys (range 29.6-80.0) were enrolled. Tumor assessment was performed every other cycle by standard criteria including CT or MRI. 67 pts received a total of 310 cycles GC, out of these 54 pts were evaluable for efficacy. Results: Complete and partial responses were observed in 7/54 (13.0%) and 19/54 (35.2%) evaluable pts, respectively with an overall response of 48.2%. Disease stabilization was noticed in 19/54 (35.2%) pts. Progression was observed in 5/54 (9.3%) pts. TTP was 33.9 weeks (95% CI, 23.9-48.0). OS was 84.0 weeks (95% CI, 58.6-119.3). 1-year overall survival rate was 68.4% (95% CI, 53.6-79.3%). Hematological toxicity G4 was neutropenia in 14.9% (10/67), and no G4 thrombocytopenia. Hypotension G4 (1.5%) was the only severe non-hematological toxicity. Conclusions: GC in the first-line treatment of MBC, demonstrated a substantial overall response rate and had a good toxicity profile. GC is a suitable option for first-line MBC in selected pts.

Gemcitabine (G) and cisplatin (C) as first-line treatment of metastatic breast cancer (MBC): Results of phase II trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11528-e11528
Author(s):  
Meinolf Karthaus ◽  
Irina Poddubnaya ◽  
L. Churilova ◽  
R. Khazanov ◽  
T. Veremeychuk ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Hematological Toxicity ◽  
Line Treatment ◽  
Toxicity Profile ◽  
First Line ◽  
First Line Treatment

e11528 Background: G has been studied in combination with a variety of agents known to be active in cancer. G has a mild toxicity profile. GC is active in various advanced tumors. Splitting of C dose (d1 + d8) is better tolerated and can be a good alternative to once a cycle in pts with advanced breast cancer. This phase II trial evaluates G (1000 mg/m2) C (35 mg/ m2) d1+d8 repeated every 21 d in the 1st-line treatment of metastatic breast cancer (MBC). The primary objective of the study was to determine the objective tumor response rate (ORR) of 1st-line GC in patients with metastatic breast cancer. The one-stage design tested the null hypothesis that the true response rate for this population should be equal to 50% for efficacy. Overall survival (OS), time to progression (TTP) and toxicity were evaluated. Methods: 70 female MBC pts with the median age of 49.8 yrs (range 29.6-80.0) were enrolled. Tumor assessment was performed every other cycle by standard criteria including CT or MRI. 67 pts received a total of 310 cycles GC, out of these 54 pts were evaluable for efficacy. Results: Complete and partial responses were observed in 7/54 (13.0%) and 19/54 (35.2%) evaluable pts, respectively with an overall response of 48.1%. Disease stabilization was noticed in 19/54 (35.2%) pts. Progression was observed in 5/54 (9.3%) pts. Median TTP was 33.9 weeks (95% CI, 23.9-48.0). Median OS was 84.0 weeks (95% CI, 58.6-119.3). 1-year overall survival rate was 68.4% (95% CI, 53.6-79.3%). Hematological toxicity G4 was neutropenia in 14.9% (10/67), and no G4 thrombocytopenia. Hypotension G4 (1.5%) was the only severe non-hematological toxicity. Conclusions: GC in the first-line treatment of MBC demonstrated a substantial overall response rate and had a good toxicity profile. GC is a suitable option for first-line MBC in selected pts.

Anastrozole in combination with fulvestrant in the first line treatment of hormone receptor positive advanced breast cancer: A meta-analysis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e11591-e11591
Author(s):  
Pui San Tan ◽  
Benjamin Haaland ◽  
Alberto J. Montero ◽  
Gilberto Lopes
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Combination Therapy ◽  
Meta Analysis ◽  
Metastatic Breast ◽  
Line Treatment ◽  
First Line ◽  
Hormonal Receptor ◽  
First Line Treatment

e11591 Background: Emerging resistance to single agent aromatase inhibitors (AI) or fulvestrant as first line treatment for postmenopausal women with advanced hormonal receptor positive breast cancer calls for alternative therapeutic options. This meta-analysis studies the effectiveness of combination therapy with fulvestrant and an AI, as compared to an AI alone in first line treatment of postmenopausal patients with hormonal receptor positive relapsed or metastatic breast cancer. Methods: Literature search was performed using PubMed, Google Scholar, Embase, ASCO and ESMO to search for studies published during the last 10 years using relevant keywords. Two prospective randomized clinical trials were found to fulfill the search criteria for combination of fulvestrant + AI vs. AI alone (both studied anastrozole in combination with fulvestrant). Meta-estimates were calculated by combining study estimates using the DerSimonian and Laird random effects model. The linear mixed-effects model was used to generate 95% prediction intervals for study-specific hazard and odds ratios. Results: Pooled hazard ratio for progression free survival was 0.88 (95% CI 0.72-1.09, 95% prediction interval [PI] 0.65-1.21). Pooled HR for overall survival was 0.88 (95% CI 0.72-1.08, 95% PI 0.68-1.14). Pooled odds ratio for response rate was 1.13 (95% CI 0.79-1.63, 95% PI 0.78-1.65). Conclusions: Pooled results showed a small, non-statistically significant, improvement in progression-free and overall survival. These results do not support the use of combination therapy with fulvestrant and anastrozole in the first line treatment of postmenopausal patients with hormonal receptor positive relapsed or metastatic breast cancer.

A Phase II Trial of Vinflunine As Monotherapy or in Combination with Trastuzumab as First-Line Treatment of Metastatic Breast Cancer

2010 ◽  
Vol 28 (9) ◽  
pp. 925-931 ◽  
Author(s):  
Denise A. Yardley ◽  
Michael McCleod ◽  
Fred Schreiber ◽  
Patrick Murphy ◽  
Jeffrey Patton ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment
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