First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2− advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial

2018 ◽  
Vol 169 (3) ◽  
pp. 469-479 ◽  
Author(s):  
Wolfgang Janni ◽  
Emilio Alba ◽  
Thomas Bachelot ◽  
Sami Diab ◽  
Miguel Gil-Gil ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Postmenopausal Women ◽  
Tumor Response ◽  
Pain Reduction ◽  
Advanced Breast ◽  
First Line ◽  
Phase 3 ◽  
Cancer Tumor

Phase III Study of Letrozole Versus Tamoxifen as First-Line Therapy of Advanced Breast Cancer in Postmenopausal Women: Analysis of Survival and Update of Efficacy From the International Letrozole Breast Cancer Group

2003 ◽  
Vol 21 (11) ◽  
pp. 2101-2109 ◽  
Author(s):  
Henning Mouridsen ◽  
Mikhail Gershanovich ◽  
Yan Sun ◽  
Ramón Pérez-Carrión ◽  
Corrado Boni ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Postmenopausal Women ◽  
Endocrine Therapy ◽  
Advanced Breast ◽  
Phase Iii ◽  
Karnofsky Performance Score ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

Purpose: To analyze overall survival (OS) and update efficacy data for letrozole versus tamoxifen as first-line therapy in postmenopausal women with locally advanced or metastatic breast cancer. Patients and Methods: This multicenter phase III trial randomly assigned 916 patients with hormone receptor–positive or unknown tumors letrozole 2.5 mg (n = 458) or tamoxifen 20 mg (n = 458) daily until disease progression. Optional cross-over was permitted at the treating physician’s discretion. This report updates efficacy at a median follow-up of 32 months. Results: The superiority of letrozole to tamoxifen was confirmed for time to progression (median, 9.4 v 6.0 months, respectively; P < .0001), time to treatment failure (median, 9 v 5.7 months, respectively; P < .0001), overall objective response rate (32% v 21%, respectively; P = .0002), and overall clinical benefit. Median OS was slightly prolonged for the randomized letrozole arm (34 v 30 months, respectively). Although this difference in OS is not significant, survival was improved in the randomized letrozole arm over the first 2 years of the study. Approximately one half of the patients in each arm crossed over. Total duration of endocrine therapy (“time to chemotherapy”) was significantly longer (P = .005) for patients initially on letrozole (median, 16 months) than for patients initially on tamoxifen (median, 9 months). Time to worsening of Karnofsky performance score was significantly delayed with letrozole compared with tamoxifen (P = .001). Conclusion: This study documents the superiority of letrozole over tamoxifen in first-line endocrine therapy in postmenopausal women with advanced breast cancer.

scholarly journals First-line fadrozole HCI (CGS 16949A) versus tamoxifen in postmenopausal women with advanced breast cancer

1996 ◽  
Vol 7 (5) ◽  
pp. 471-479 ◽  
Author(s):  
B. Thürlimann ◽  
K. Beretta ◽  
M. Bacchi ◽  
M. Castiglione-Gertsch ◽  
A. Goldhirsch ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Postmenopausal Women ◽  
Advanced Breast ◽  
First Line

Capecitabine Versus Classical Cyclophosphamide, Methotrexate, and Fluorouracil As First-Line Chemotherapy for Advanced Breast Cancer

2011 ◽  
Vol 29 (34) ◽  
pp. 4498-4504 ◽  
Author(s):  
Martin R. Stockler ◽  
Vernon J. Harvey ◽  
Prudence A. Francis ◽  
Michael J. Byrne ◽  
Stephen P. Ackland ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Advanced Breast Cancer ◽  
Tumor Response ◽  
Progression Free Survival ◽  
Advanced Breast ◽  
First Line ◽  
Serious Adverse Events ◽  
Objective Tumor Response ◽  
Line Chemotherapy

Purpose We compared oral capecitabine, administered intermittently or continuously, versus classical cyclophosphamide, methotrexate, and fluorouracil (CMF) as first-line chemotherapy for women with advanced breast cancer unsuited to more intensive regimens. Patients and Methods Three hundred twenty-three eligible women were randomly assigned to capecitabine administered intermittently (1,000 mg/m2 twice daily for 14 of every 21 days; n = 107) or continuously (650 mg/m2 twice daily for 21 of every 21 days; n = 107), or to classical CMF (oral cyclophosphamide 100 mg/m2 days 1 to 14 with intravenous methotrexate 40 mg/m2 and fluorouracil 600 mg/m2 on days 1 and 8 every 28 days; n = 109). The primary end point was quality-adjusted progression-free survival (PFS); secondary end points included PFS, overall survival (OS), objective tumor response, and adverse events. Intermittent and continuous capecitabine were to be compared first and, if similar (P > .05), combined for definitive comparisons versus CMF. Results Quality-adjusted PFS (P = .2), objective tumor response rate (20%; P = .8), and PFS (median, 6 months; hazard ratio [HR], 0.86; 95% CI, 0.67 to 1.10; P = .2) were similar in women assigned capecitabine versus CMF. OS was longer in women assigned capecitabine rather than CMF (median, 22 v 18 months; HR, 0.72; 95% CI, 0.55 to 0.94; P = .02). Febrile neutropenia, infection, stomatitis, and serious adverse events were more common with CMF; hand-foot syndrome was more common with capecitabine. Conclusion Capecitabine improved OS by being similarly active, less toxic, and more tolerable than CMF. Capecitabine is a good first-line chemotherapy option for women with advanced breast cancer who are unsuited to more intensive regimens.

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