Phase III Trial Comparing Doxorubicin Plus Cyclophosphamide With Docetaxel Plus Cyclophosphamide As Adjuvant Therapy for Operable Breast Cancer

Jones, Stephen E.; Savin, Michael A.; Holmes, Frankie A.; O’Shaughnessy, Joyce; Blum, Joanne L.; Vukelja, Svetislava J.; McIntyre, Kristi; Pippen, John; Bordelon, James H.; Kirby, Robert; Sandbach, John F.; Hyman, William; Khandelwal, Pankaj; Negron, Angel G.; Richards, Donald A.; Anthony, Stephen P.; Mennel, Robert G.; Boehm, Kristi A.; Meyer, Walter G.; Asmar, Lina

doi:10.1200/jco.2006.06.5391

Cited by 495 publications

(388 citation statements)

References 14 publications

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“…The inability of other studies to show improvement in the results might be related to the reduction in each drug dose in order to safely and concurrently administer docetaxel and anthracycline [11]. On the other hand, the value of docetaxel administration in the adjuvant setting was also documented in a study where docetaxel combined with cyclophosphamide led to an increase in the five-year DFS to 86% as compared with 80% for the doxorubicincyclophosphamide combination [12].…”

Section: Discussionmentioning

confidence: 99%

FEC versus sequential docetaxel followed by epirubicin/cyclophosphamide as adjuvant chemotherapy in women with axillary node-positive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG)

Polyzos

Malamos²,

Boukovinas

et al. 2009

Breast Cancer Res Treat

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International audienceA randomized multicenter phase III study was conducted to compare the sequential docetaxel followed by epirubicin/cyclophosphamide combination with that of FEC regimen as adjuvant chemotherapy in women with axillary node-positive early breast cancer. Seven hundred and fifty-six women with axillary lymph node-positive breast cancer were randomized to receive either 4 cycles of docetaxel (100 mg/m) followed by 4 cycles of epirubicin (75 mg/m) plus cyclophosphamide (700 mg/m) (experimental arm) or 6 cycles of FEC (epirubicin 75 mg/m, cyclophosphamide 700 mg/m, and 5-fluorouracil 700 mg/m; control arm). All regimes were administered every 3 weeks. The primary end point was five-year disease-free survival (DFS). After a median follow-up period of 5 years, 233 (30.8%) relapses had occurred (108 and 125 in the experimental and control arms, respectively; = 0.181). The five-year DFS was 72.6% (95% CI 63.8–81.3%) and 67.2% (95% CI 58.0–76.4%) for women randomized in the experimental and control arms, respectively ( = 0.041; log rank test). There was no difference in the overall survival between the two arms (83.8 and 81.4% in the experimental and control arms, respectively; = 0.533). The experimental arm was associated with increased neutropenia requiring administration of granulocyte colony-stimulating factor in 90.5% of the patients as compared with 74.1% in the control arm ( = 0.0001). The sequential docetaxel followed by epirubicin/cyclophosphamide adjuvant chemotherapy regimen resulted in improved five-year DFS in women with axillary node-positive early breast cancer at the expense of increased but manageable myelotoxicity

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Section: Discussionmentioning

confidence: 99%

FEC versus sequential docetaxel followed by epirubicin/cyclophosphamide as adjuvant chemotherapy in women with axillary node-positive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG)

Polyzos

Malamos²,

Boukovinas

et al. 2009

Breast Cancer Res Treat

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“…That trial compared adjuvant docetaxel plus cyclophosphamide (TC) with doxorubicin plus cyclophosphamide (AC) given every 3 weeks for four cycles in patients with both HER-2 ϩ and HER-2 Ϫ disease [10]. In that study, 160 of the 1,016 enrolled patients (16%) were aged Ն65 years.…”

Section: Discussionmentioning

confidence: 99%

Perspectives and Attitudes on the Use of Adjuvant Chemotherapy and Trastuzumab in Older Adults with HER-2+ Breast Cancer: A Survey of Oncologists

et al. 2009

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Background. Substantial evidence supports the use of adjuvant trastuzumab with chemotherapy for patients with human epidermal growth factor receptor (HER)-2 ؉ breast cancer; however, a lesser amount of data is available to guide use of this therapy in older patients and in those with significant medical comorbidities. The goal of the current study was to understand how patient age and health status impact oncologists' decisions to recommend adjuvant therapy in older women with HER-2 ؉ breast cancer.Methods. Medical oncologists (n ‫؍‬ 151) participated in an online survey regarding treatment recommendations for a hypothetical patient of varying age and health status with tumor stage 2, nodal stage 2, estrogen receptor-negative, HER-2 ؉ breast cancer. Survey respondents recommended either chemotherapy plus trastuzumab, chemotherapy alone, trastuzumab alone, or no therapy. The effect of age and health

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“…** Rate for dose-dense regimen assumed to be the same as for AC + P. 24 model, along with incidence of febrile neutropenia associated with the regimens according to literature. [21][22][23][24][25][26][27] Types and doses of antiemetics, G-CSF and antibiotics were obtained from the survey with medical oncologists.…”

Section: Source Of Data For Economic Analysesmentioning

confidence: 99%

Potential economic impact of the 21-gene expression assay on the treatment of breast cancer in brazil

Bacchi¹,

Prisco²,

Carvalho³

et al. 2010

Rev. Assoc. Med. Bras.

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SummaryObjective. The 21-gene expression assay may support the decision regarding use of chemotherapy in early breast cancer. We sought to investigate the potential impact of incorporating the 21-gene expression assay into private practice in Brazil, from the perspective of third party payers. MethOds. We conducted a web-based survey with 30 (of a total of approximately 700) Brazilian medical oncologists, who were stratified by State according to the proportion of patients with breast cancer and private health insurance. We evaluated the possible treatment of first choice for patients with lymph-node-negative, estrogen-receptor-positive breast cancer, regardless of menopausal status. Interviewees were not aware of the objective of the study. Responses permitted a quantitative assessment of the care patterns regarding use of different chemotherapy regimens, type of premedication, use of growth factors, and use of intravenous antibiotics for febrile neutropenia. We calculated medication costs using the manufacturer's recommended prices. Other direct medical expenses, indirect medical costs, and non-medical costs were not included. Results. Considering a hypothetical cohort of 100 patients without access to the 21-gene expression assay, the survey showed that 84 patients would receive chemotherapy. Reclassifying patient eligibility for chemotherapy according to the 21-gene expression assay would lower this number to 49. For a hypothetical cohort of 100 patients with access to the test, US$ 79,361.43 would be saved in main direct medical costs. Such results, however, would greatly vary according to tumor size: the 21-gene expression assay could increase direct medical costs in T1 tumors, and decrease costs in cases with T >2 cm. cOnclusiOn. Considering the current price for the 21-gene expression assay in Brazil, our economic analysis suggests that such testing is an overall cost-saving, from the perspective of third party payers. Further, optimal use of resources would entail targeted use of the 21-gene expression assay.

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Phase III Trial Comparing Doxorubicin Plus Cyclophosphamide With Docetaxel Plus Cyclophosphamide As Adjuvant Therapy for Operable Breast Cancer

Abstract: At 5 years, TC was associated with a superior DFS and a different toxicity profile compared with AC.

Cited by 495 publications

References 14 publications

FEC versus sequential docetaxel followed by epirubicin/cyclophosphamide as adjuvant chemotherapy in women with axillary node-positive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG)

FEC versus sequential docetaxel followed by epirubicin/cyclophosphamide as adjuvant chemotherapy in women with axillary node-positive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG)

Perspectives and Attitudes on the Use of Adjuvant Chemotherapy and Trastuzumab in Older Adults with HER-2+ Breast Cancer: A Survey of Oncologists

Potential economic impact of the 21-gene expression assay on the treatment of breast cancer in brazil

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