A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer

Fountzilas, George; Dafni, Urania; Dimopoulos, Meletios Α.; Koutras, Angelos; Skarlos, Dimosthenis; Papakostas, Pavlos; Gogas, Helen; Bafaloukos, Dimitrios; Kalogera‐Fountzila, Anna; Samantas, Epaminontas; Briasoulis, Evangelos; Pectasides, Dimitrios; Maniadakis, N; Matsiakou, F.; Aravantinos, G.; Papadimitriou, C.; Karina, M.; Christodoulou, Christos; Kosmidis, P.; Kalofonos, Haralabos P.

doi:10.1007/s10549-008-0047-9

Cited by 74 publications

(61 citation statements)

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“…These patients participated in ten trials designed and run consecutively by HeCOG, exploring different first-line treatment options for patients with MBC [8][9][10][11][12][13][14][15][16][17]. Information was collected prospectively according to the corresponding trial protocol and deposited in the central HeCOG office database.…”

Section: Methodsmentioning

confidence: 99%

“…Dose dense monotherapy, incorporation of paclitaxel and more recently of trastuzumab represent the concepts tested in the consecutive clinical trials. The most recent study starting in 2002, a randomized Phase III trial, compares three non-anthracycline containing regimens, shown in earlier studies of this group and others to have significant activity and manageable toxicity in MBC (HE1102) [17]. The ten trials span the experience of HeCOG in Greek patients with MBC and represent the treatment options and their evolution for over 15 years.…”

Section: Methodsmentioning

confidence: 99%

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Fifteen-year trends in metastatic breast cancer survival in Greece

Dafni

Grimani

Xyrafas

et al. 2009

Breast Cancer Res Treat

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In the metastatic setting, a detected time trend to improved prognosis could be attributed to the corresponding recent advances in the therapeutic approaches. The aim of the current study was to first assess, in a large cohort of well over a thousand patients, the time trends in survival in MBC for the last 15 years and second to explore its association to prognostic factors affecting outcome including therapeutic regimen. This meta-analysis uses individual patient data collected from all the trials on MBC (6 nonrandomized, 4 randomized) conducted by HeCOG from 1991 through 2006. Four 4-year time periods (1991-1994, 1995-1998, 1999-2002, and 2003-2006) were constructed for exploration of time trends in survival according to the patient's date of metastatic diagnosis. Different first line regimens in the 10 trials include anthracycline monotherapy (epirubicin, in the early 1990s) and taxanecontaining regimens either as monotherapy or in different combinations with anthracyclines or other drugs. In two phase II studies and in the last randomized study, trastuzumab was administered in all the patients with HER2 overexpressing tumors. In this study, information is based on a total of 1361 patients with a median follow up of 3.7 years and median survival of 1.9 years (median survival 1.28, 1.68, 2.20, and 2.57 years for 1991-1994, 1995-1998, 1999-2002, and 2003-2006, respectively). Survival improved significantly across diagnosis time periods, by 25, 44, and 51%, respectively, in each time period (1995)(1996)(1997)(1998) (1991)(1992)(1993)(1994). The effect of metastatic diagnosis time period remains almost unchanged in the presence of the following significant prognostic factors: performance status, hormonal receptor status, previous adjuvant chemotherapy, previous adjuvant hormonal treatment, visceral metastasis at entry, and number of metastatic sites. When exploring the effect of new systemic treatment introduction, taking into account the same significant prognostic factors, the effect of diagnosis time period disappears, and the survival improvement is explained directly by the introduction of new agents (hormonal treatment for metastatic disease: yes vs. no: HR = 0.72, P \ 0.001; taxanes at first line: yes vs. no: HR = 0.69, P = 0.002; trastuzumab at first line: yes vs. no: HR = 0.63, P \ 0.001). The results of this study provide significant evidence of improvement in prognosis of MBC patients within the last 15 years, taking into account all the important significant prognostic factors, and this improvement can be attributed to the use of new systemic treatment agents in the management of the disease.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Fifteen-year trends in metastatic breast cancer survival in Greece

Dafni

Grimani

Xyrafas

et al. 2009

Breast Cancer Res Treat

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“…The combina- 32 However, only 15% of patients in the paclitaxel-only arm crossed over to gemcitabine when their disease progressed, 33 and the reported median OS for both treatment arms was lower than currently expected for patients with newly diagnosed MBC (18-36 months). [34][35][36][37] Nevertheless, on the basis of the results of this phase 3 trial, gemcitabine combined with paclitaxel was approved in the United States as first-line treatment of patients with MBC after failure of previous adjuvant chemotherapy containing anthracycline. 38 Gemcitabine has also shown efficacy in treating patients with MBC when given in combination with docetaxel.…”

Section: Treatment Options After Exposure To Anthracycline and Taxanementioning

confidence: 99%

Treatment Options for Breast Cancer Resistant to Anthracycline and Taxane

Moreno-Aspitia

Perez

2009

Mayo Clinic Proceedings

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Breast cancer is the most common noncutaneous malignancy among every major ethnic group of women in the United States. Anthracyclines and taxanes are the most active and widely used chemotherapeutic agents for breast cancer, but the increased use of these agents at an early stage of disease often renders tumors resistant to these drugs by the time the disease recurs, thereby reducing the number of treatment options for metastatic disease. Moreover, even when these agents can be used in the metastatic setting, treatment failure occurs in most cases, and as a result the 5-year survival rates of patients with metastatic breast cancer are low. This outcome underscores the need for new, effective treatments of metastatic breast cancer and has led to investigation of novel ways to overcome the problem of drug resistance. This article reviews the current treatment options for breast cancer resistant to anthracycline and taxane and provides recommendations for disease management. Published sources for this review were found by searching PubMed (https://www.ncbi.nlm.nih.gov/pubmed) and congress Web sites.Mayo Clin Proc. 2009;84(6):533-545 B reast cancer is the most common noncutaneous malignancy among every major ethnic group of women in the United States, annually causing nearly 40,000 deaths in the United States and more than 400,000 deaths worldwide.1,2 Anthracyclines and taxanes are the most active and widely used chemotherapeutic agents for treating breast cancer in hormone receptor-negative patients and those whose disease progresses while they are taking hormone therapy.3 These agents are commonly used in the adjuvant setting, either in combination or sequentially.4 A metaanalysis of 13 clinical trials involving nearly 23,000 women with high-risk, early-stage breast cancer showed that incorporating taxanes into anthracycline-based regimens significantly improves disease-free survival and overall survival (OS) rates. 5,6 This benefit is evident regardless of hormone receptor status, degree of nodal involvement, age, menopausal status, and type of taxane or administration schedule. Anthracyclines and taxanes, either alone or in combination, are also the preferred option for hormone receptor-negative patients with metastatic breast cancer (MBC). 7 Response rates of 25% to 69% have been reported when taxanes (paclitaxel or docetaxel) are used as ABC = ATP-binding cassette; BCRP = breast cancer resistance protein; CI = confidence interval; EGFR = epidermal growth factor receptor; FDA = Food and Drug Administration; HER2 = human epidermal growth factor receptor 2; IRR = independent radiology review; MBC = metastatic breast cancer; MDR = multidrug resistance protein; NCCN = National Comprehensive Cancer Network; ORR = overall response rate; OS = overall survival; PARP-1 = poly-ADP-ribose polymerase 1; PFS = progression-free survival; TN = triple negative; TTP = time to progression; VEGF = vascular endothelial growth factor

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“…3,[8][9][10][11] Current guidelines recommend it for the treatment of HER2+ recurrent or metastatic breast cancer.…”

Section: Indicationsmentioning

confidence: 99%