Randomized Phase III Study of Docetaxel Compared With Paclitaxel in Metastatic Breast Cancer

2005 ◽  
Vol 23 (24) ◽  
pp. 5542-5551 ◽  
Author(s):  
S.E. Jones ◽  
J. Erban ◽  
B. Overmoyer ◽  
G.T. Budd ◽  
L. Hutchins ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Open Label ◽  
Global Quality ◽  
Global Quality Of Life ◽  
Phase Iii Study ◽  
Over Time

PurposeThis randomized, controlled, multicenter, open-label, phase III study compared docetaxel versus paclitaxel in patients with advanced breast cancer that had progressed after an anthracycline-containing chemotherapy regimen.Patients and MethodsPatients (n = 449) were randomly assigned to receive either docetaxel 100 mg/m2(n = 225) or paclitaxel 175 mg/m2(n = 224) on day 1, every 21 days until tumor progression, unacceptable toxicity, or withdrawal of consent.ResultsIn the intent-to-treat population, both the median overall survival (OS, 15.4 v 12.7 months; hazard ratio [HR], 1.41; 95% CI, 1.15 to 1.73; P = .03) and the median time to progression (TTP, 5.7 months v 3.6 months; HR, 1.64; 95% CI, 1.33 to 2.02; P < .0001) for docetaxel were significantly longer than for paclitaxel, and the overall response rate (ORR, 32% v 25%; P = .10) was higher for docetaxel. These results were confirmed by multivariate analyses. The incidence of treatment-related hematologic and nonhematologic toxicities was greater for docetaxel than for paclitaxel; however, quality-of-life scores were not statistically different between treatment groups over time.ConclusionDocetaxel was superior to paclitaxel in terms of OS and TTP. ORR was higher for docetaxel. Hematologic and nonhematologic toxicities occurred more frequently in the docetaxel group. The global quality-of-life scores were similar for both agents over time.

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.

QUALITY OF LIFE FOR PATIENTS WITH METASTATIC BREAST CANCER TREATED BY DOXORUBICIN AND PACLITAXEL

2014 ◽  
pp. 246-252
Author(s):  
Van Cau Nguyen ◽  
Ngoc Thanh Cao
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Side Effects ◽  
Metastatic Breast ◽  
Emotional Function ◽  
Global Quality ◽  
Global Quality Of Life ◽  
Eortc Qlq

Background: Metastatic breast cancer is still remains essentially incurable. Palliative chemotherapy with the combination of Doxorubicin and Paclitaxel is to reduce the burden of disease, prolong overall survival and maintain quality of life for patients. The objectives of this study to evaluate the clinical effectiveness of this regimen for patients with metastatic breast cancer and the impact on the quality of life of patients. Patients and methods: Included 26 patients with metastatic breast cancer treated by Doxorubicin and Paclitaxel at the Hue University Hospital from 2010 to 1014. Patient characteristics and response rates were recorded. Quality of life questionnaires was assessed with the EORTC QLQ-C30 for general cancer patients and EORTC QLQ-BR23 for breast cancer. Results: Clinical response was achieved in 14 patients (53.8%), including 11.5% complete response, 43.4% partial remission and stable disease is 34.6%. The number of patients with response and stable disease are for at least 4 months prior to progression. Quality of life changes significantly statistical including: physical function decreased slightly (mean change 7.6 points) after 4 cycles of chemotherapy, cognitive function decreased slightly after the 8th cycle (8.1 points). Emotional function improved partially (7.7 points). However, the global quality of life has not changed. Changes in body image can adversely affect patients with a decrease of 15.9 points. These symptoms have been reported in breast including pain, swelling and discomfort with little difference of 2.9 points. The side effects of chemotherapy in organs such as the reduction or loss of appetite, headache, menstrual disorders vary in significance with an increase of 18.8 points. Distress associated with hair loss also increased significantly with 75.5 points. Conclusion: Paclitaxel and doxorubicin for patients with metastatic breast cancer showed significant clinical improvement and well-tolerated toxicity. Emotional function have been improved. Some aspects slightly decreased such as physical, cognitive, and distress of body image changes, side effects of chemotherapy and hair loss. However, global quality of life of was maintained. Although sample in this study was still small but routinely assess the quality of life for patients with metastatic breast cancer receiving chemotherapy should be routinely recommended.

scholarly journals Dutch Breast Cancer Trialists' Group (BOOG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 61-79
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Metastatic Breast ◽  
Phase Iii ◽  
List Type ◽  
First Line ◽  
Open Label ◽  
Phase Iii Study

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Dutch breast cancer trialists' group (BOOG). Clinical trials include:An open label randomized (inter)national multicenter comparative trial of 5 years adjuvant endocrine therapy with an LHRH agonist plus an aromatase inhibitor (goserelin + anastrozole) versus five courses FE90C chemotherapy followed by the same endocrine therapy in pre- or perimenopausal patients with hormone receptor-positive primary breast cancer (PRemenopausal Optimal Management IS Endocrine therapy). BOOG 2002-01/PROMISE. ISRCTN23561723Open label, comparative, randomized, multicenter, study of trastuzumab (Herceptin) given with docetaxel (Taxotere) versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for metastatic breast cancer (MBC) patients with HER2neu overexpression. BOOG 2002-02/HERTAX ISRCTN13770586Micro-metastases and Isolated tumour cells: Robust and Relevant Or Rubbish? The MIRROR study in BREAST CANCER. BOOG 2003-03/ZonMW 3214Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed. BOOG 2004-01/Young Boost SRCTN45066831Microarray analysis in breast cancer to Tailor Adjuvant Drugs Or Regimens, a randomized phase III study. MATADOR, BOOG 2005-02, CKTO 2004-04 ISRCTN61893718A prospective randomised, open, multicentre, phase III study to assess different Durations of Anastrozole therapy after 2–3 years Tamoxifen as Adjuvant therapy in postmenopausal women with breast cancer. 2006-01/DATAA randomized, open-label phase III study of first line chemotherapy in elderly metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine; and the incorporation of a complete geriatric assessment. 2006-02/OMEGABOOG participation in International studies:. BOOG 2001-01/TEAM trial. BOOG 2001-02/AMAROS (EORTC 10981/22023). BOOG 2002-04/HERA (BIG 1-01/EORTC 10011/BO16348B). BOOG 2003-02 (BIG 1-02/IBCSG 27-02). BOOG 2003-04 (GBG 29). BOOG 2004-02/TBP (GBG 26, BIG 3-05). BOOG 2005-01/CASA (IBCSG 32-05/BIG 1-05). BOOG 2005-03/MINDACT (EORTC 10041, BIG 3-04). BOOG 2006-03/SUPREMO (BIG 2-04). BOOG 2006-04/Adjuvant lapatinib study (BIG 2-06/EGF106708)

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