Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial

Mackey, John R.; Martín, Miguel; Pieńkowski, Tadeusz; Rolski, Janusz; Guastalla, Jean Paul; Sami, Amer; Glaspy, John A.; Juhos, É; Wardley, Andrew M; Fornander, Tommy; Hainsworth, John D.; Coleman, Robert E.; Modiano, Manuel; Vinholes, J.; Pintér, Tamás; Rodríguez-Lescure, Álvaro; Colwell, Bruce; Pierre, Whitlock; Provencher, Louise; Laing, Kara; Walde, David; Price, C. H. G.; Hugh, Judith; Childs, Barrett H.; Bassi, Kimberly; Lindsay, Mary Ann; Wilson, Véronique; Rupin, Matthieu; Houé, Vincent; Vogel, Charles L.

doi:10.1016/s1470-2045(12)70525-9

Cited by 196 publications

(159 citation statements)

References 28 publications

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“…The introduction of cmf (cyclophosphamide-methotrexate-5-fluorouracil) chemotherapy 4 , and eventually anthracyclinecontaining 5 and anthracycline-taxane 6,7 regimens sequentially improved disease-free (dfs) and overall (os) survival for breast cancer patients [6][7][8][9] . Strong evidence supports the use of concurrent 6,7 or sequential 8,9 anthracycline-taxane regimens for the treatment of node-positive breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Real-World Adjuvant TAC or FEC-D for HER2-Negative Node-Positive Breast Cancer in Women Less Than 50 Years of Age

et al. 2016

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Purpose We compared the efficacy, toxicity, and use of granulocyte colony-stimulating factor (g-csf) with tac (docetaxel-doxorubicin-cyclophosphamide) and fec-d (5-fluorouracil-epirubicin-cyclophosphamide followed by docetaxel) in women less than 50 years of age. MethodsThe study included all women more than 18 years but less than 50 years of age with her2-negative, ResultsThe patient groups were well-balanced, except that radiotherapy use was higher in the tac group (91.9% vs. 79.9%, p < 0.001). At a median follow-up of 49.6 months, disease-free survival was 91.4% for tac and 92.0% for fec-d (p = 0.76). Overall survival (os) was 96% with tac and 95.3% with fec-d (p = 0.86).The incidences of grades 3 and 4 toxicities were similar in the two groups (all p > 0.05). Overall, febrile neutropenia (fn) was reported in 11.6% of tac patients and 15.7% of fec-d patients (p = 0.26). However, use of g-csf was higher in the tac group than in the fec-d group (96.4% vs. 71.5%, p < 0.001). Hospitalization for fn was required in 10.5% of tac patients and 13.0% of fec-d patients (p = 0.41). In g-csf-supported and -unsupported patients receiving tac, fn occurred at rates of 11.1% and 33.3% respectively (p = 0.08); in patients receiving the fec portion of fec-d, those proportions were 2.9% and 8.1% respectively (p = 0.24); and in patients receiving docetaxel after fec, the proportions were 4.1% and 17.6% respectively (p < 0.001). ConclusionsIn women less than 50 years of age receiving adjuvant tac or fec-d, we observed no differences in efficacy or other nonhematologic toxicities. Based on the timing and rates of fn, use of prophylactic g-csf should be routine for the docetaxel-containing portion of treatment; however, prophylactic g-csf could potentially be avoided during the fec portion of fec-d treatment.

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Section: Introductionmentioning

confidence: 99%

Real-World Adjuvant TAC or FEC-D for HER2-Negative Node-Positive Breast Cancer in Women Less Than 50 Years of Age

et al. 2016

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“…It is sometimes challenging to motivate patients to continue participation in such trials, as shown by varying completeness percentages that are reported in randomized clinical trials with a 10-year followup, ranging from 96% to only 43% (1)(2)(3)(4)(5)(6)(7)(8). Continued participation may depend on the burden and content of scheduled study visits, type of disease, and the results of study intervention, as well as on the care and motivational efforts from the study team.…”

Section: Introductionmentioning

confidence: 99%

“…At every visit, a physical examination was ClinicalTrials.gov identifier: NTR262 and NTR265. Supported by a grant from the Dutch Insurance Companies with additional funding from Schering-Plough B. V. and Janssen B. V. 1 performed by a study nurse, as were laboratory tests, and multiple questionnaires were completed. At yearly intervals, radiographs and joint imaging with other techniques were obtained.…”

Section: Introductionmentioning

confidence: 99%

Continued Participation in a Ten‐Year Tight Control Treat‐to‐Target Study in Rheumatoid Arthritis: Why Keep Patients Doing their Best?

Markusse

Dirven

Han

et al. 2015

Arthritis Care & Research

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Objective. To identify risk factors for early study termination and motivators for adherence to a long-term followup trial and to improve completeness of long-term studies. Methods. Risk factors for early termination in 508 included patients were identified through Cox regression analysis. Patients completing the 10-year followup filled in a questionnaire on possible motives for continued study participation. Results. Risk factors for early termination were higher age (hazard ratio [HR] 1.03, 95% confidence interval [95% CI] 1.02-1.04), functional disability during the preceding year (HR 1.54, 95% CI 1.20-1.99), having achieved drug-free remission (HR 6.62, 95% CI 2.07-21.14), limited joint damage (HR 0.98, 95% CI 0.97-0.995 for actual damage; HR 0.83, 95% CI 0.73-0.94 for damage progression), and few adverse events (HR 0.35, 95% CI 0.26-0.47). A total of 288 of 313 patients (92%) attending the last visit answered the questionnaire. The majority mentioned contributing to scientific research (97% agreed), helping other patients (91%), and learning about new treatment strategies (84%) and their disease (85%) as reasons to continue participation. Next, patients mentioned tight control (202 of 278 patients), good treatment strategy (128 of 278), good medication (117 of 278), and good half-term results (102 of 278) as motivators. More than 95% of patients experienced participation "as expected" or "better than expected." Additional examinations during yearly visits (extra questionnaires, imaging) were mentioned as "worse than expected" (10%), as was answering routine questionnaires (7%). Conclusion. Continued participation was relatively high in the Treatment Strategies for Rheumatoid Arthritis (BeSt) Study. Higher age, functional disability, drug-free remission, little joint damage, and few adverse events predicted early study termination. Main motives for continued participation were a willingness to contribute to research, help future patients, and because patients had good experiences with the study protocol.

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“…They are used in the treatment of solid tumors in ovarian cancer, breast cancer, small cell lung cancer, and head and neck cancers. In many recent studies on adjuvant therapy of breast cancer, it has been demonstrated that chemotherapy regimens including taxane improve survival and decrease recurrence compared with standard FAC (5-fluorouracil, doxorubicin, and cyclophosphamide) chemotherapy (1,2). Nevertheless, in addition to side effects such as neutropenia, arthralgia, and cardiotoxicity, they may cause acral erythema, pustular dermatitis, erythema multiforme, and scleroderma-like mucocutaneous lesions (3).…”

Section: Introductionmentioning

confidence: 99%

Docetaxel-induced Scleroderma in A Breast Cancer Patient: A Case Report

et al. 2015

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Paclitaxel and docetaxel are antineoplastic drugs derived from the yew tree, Taxus brevifolia. They are the members of the taxane family and act by inhibiting mitotic activity due to the suppression of microtubule depolymerization. They are used in the treatment of ovarian cancer, breast cancer, gastric cancer, small cell lung cancer, and head and neck cancer. In addition to side effects such as cardiotoxicity, neutropenia, arthralgia, and myalgia, they may also cause alopecia, urticaria, mucositis, acral erythema, pustular dermatitis, erythema multiforme, and scleroderma-like mucocutaneous lesions. Scleroderma is among the uncommon side effects of taxane antineoplastic agents. As was the case in few cases in literature, it usually begins with edematous changes in the proximal aspect of the extremities, and subsequently, sclerosis is developed in the skin. Scleroderma, which usually regresses with the discontinuation of the drug and with steroid therapy, may lead to severe contractions that require physical therapy and rehabilitation in some patients. In this paper, we presented a 60-year-old female patient in whom scleroderma developed because docetaxel chemotherapy for breast cancer because it is encountered rarely.

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Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial

Cited by 196 publications

References 28 publications

Real-World Adjuvant TAC or FEC-D for HER2-Negative Node-Positive Breast Cancer in Women Less Than 50 Years of Age

Real-World Adjuvant TAC or FEC-D for HER2-Negative Node-Positive Breast Cancer in Women Less Than 50 Years of Age

Continued Participation in a Ten‐Year Tight Control Treat‐to‐Target Study in Rheumatoid Arthritis: Why Keep Patients Doing their Best?

Docetaxel-induced Scleroderma in A Breast Cancer Patient: A Case Report

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