Adjuvant Docetaxel for High-Risk, Node-Negative Breast Cancer

Martı́n, Miguel; Seguí, Miguel Àngel; Antón, Antonio; Ruı́z, Amparo; Ramos, Manuel; Adrover, Encarna; Aranda, Ignacio; Rodríguez-Lescure, Álvaro; Große, R; Calvo, Lourdes; Barnadas, Agustí; Isla, Dolores; Martín, Miguel; Ruíz-Borrego, Manuel; Załuski, J.; Arcusa, Àngels; Muñoz, Montserrat; Vega, José Manuel López; Mel, J. R.; Munárriz, Blanca; Llorca, Cristina; Jara, Carlos; Alba, Emilio; Florián, Jesús; Li, Junfang; García-Asenjo, José Antonio López; Sáez, Amparo; Rios, María; Almenar, S.; Peiró, Gloria; Lluch, Aña

doi:10.1056/nejmoa0910320

Cited by 182 publications

(130 citation statements)

References 21 publications

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“…8,9 The decision to test four cycles versus six cycles of therapy was based on the use of four or six cycles in previous studies without evidence to support one duration over the other. [3][4][5][6][7] The results of the duration of therapy question have been previously published and have shown no difference in outcome for six cycles versus four cycles of therapy. 10 Our article outlines the results from the T versus AC component of the study.…”

Section: Journal Of Clinical Oncology O R I G I N a L R E P O R T V Omentioning

confidence: 99%

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Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance)

Shulman

Berry

Cirrincione

et al. 2014

JCO

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Purpose Optimal adjuvant chemotherapy for early-stage breast cancer balances efficacy and toxicity. We sought to determine whether single-agent paclitaxel (T) was inferior to doxorubicin and cyclophosphamide (AC), when each was administered for four or six cycles of therapy, and whether it offered less toxicity. Patients and Methods Patients with operable breast cancer with 0 to 3 positive nodes were enrolled onto the study to address the noninferiority of single-agent T to AC, defined as the one-sided 95% upper-bound CI (UCB) of hazard ratio (HR) of T versus AC less than 1.30 for the primary end point of relapse-free survival (RFS). As a 2 × 2 factorial design, duration of therapy was also addressed and was previously reported. Results With 3,871 patients enrolled onto the trial, a median follow-up period of 6.1 years, and 437 RFS events, we achieved an HR of 1.26 (one sided 95% UCB, 1.48; favoring AC does not allow a conclusion of noninferiority of T with AC; UCB > 1.3). With 266 patient deaths, the HR for overall survival (OS) was 1.27 favoring AC (UCB, 1.56). The estimated absolute advantage of AC at 5 years is 3% for RFS (91 v 88%) and 1% for OS (95 v 94%). All nine treatment-related deaths were patients receiving AC and are included in the analyses of both RFS and OS. Hematologic toxicity was more common in patients treated with AC, and neuropathy was more common in patients treated with T. Conclusion This trial did not show noninferiority of T to AC, a conclusion that is unlikely to change with additional events and follow-up. T was less toxic than AC.

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Section: Journal Of Clinical Oncology O R I G I N a L R E P O R T V Omentioning

confidence: 99%

“…Some studies have investigated four cycles of therapy while others have used six cycles. [3][4][5][6][7] …”

Section: Introductionmentioning

confidence: 99%

Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance)

Shulman

Berry

Cirrincione

et al. 2014

JCO

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“…In addition, some reports have concluded that TAC improves disease free and overall survival compared to FAC (12,17) . Similar results were observed in our study.…”

Section: Discussionmentioning

confidence: 99%

Study to Compare TAC versus FAC Regimen as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancers

S¹

2018

jmscr

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“…Long-term follow-up of docetaxel-based adjuvant chemotherapy (docetaxel, doxorubicin, and cyclophosphamide [TAC]) on DFS rates for patients with high-risk node-negative breast cancer showed added benefit regardless of HR status, menopausal status, or number of high-risk factors compared with standard fluorouracil-doxorubicin-cyclophosphamide [8]. On the contrary, results at 5 years for the PACS04 trial, which evaluated the concurrent administration of docetaxel and epirubicin versus FEC100 for patients with node-positive early-stage breast cancer, did not evidence any advantage for DFS and OS rates compared with standard FEC100 [9].…”

Section: Discussionmentioning

confidence: 99%

Extended Benefit from Sequential Administration of Docetaxel after Standard Fluorouracil, Epirubicin, and Cyclophosphamide Regimen for Node-Positive Breast Cancer: The 8-Year Follow-Up Results of the UNICANCER-PACS01 Trial

et al. 2012

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Adjuvant Docetaxel for High-Risk, Node-Negative Breast Cancer

Abstract: As compared with adjuvant FAC, adjuvant TAC improved the rate of disease-free survival among women with high-risk, node-negative breast cancer. (Funded by GEICAM and Sanofi-Aventis; ClinicalTrials.gov number, NCT00121992.).

Cited by 182 publications

References 21 publications

Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance)

Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance)

Study to Compare TAC versus FAC Regimen as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancers

Extended Benefit from Sequential Administration of Docetaxel after Standard Fluorouracil, Epirubicin, and Cyclophosphamide Regimen for Node-Positive Breast Cancer: The 8-Year Follow-Up Results of the UNICANCER-PACS01 Trial

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