Definitive Results of a Phase III Adjuvant Trial Comparing Six Cycles of FEC-100 to Four Cycles of AC in Women with Operable Node-negative Breast Cancer: The NSABP B-36 Trial (NRG Oncology)
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Le résumé fourni par la source
Abstract PURPOSE: Results from adjuvant trials evaluating 6 cycles of epirubicin-based chemotherapy regimens suggested these programs may be more effective than 4 cycles of doxorubicin-based chemotherapy. METHODS: NSABP B-36 was a phase III clinical trial originally designed as a 2x2 factorial study comparing 6 cycles of FEC-100 (5-FU, epirubicin, cyclophosphamide) to 4 cycles of conventional AC (Adriamycin/cyclophosphamide) with celecoxib or placebo. Shortly after activation, concerns regarding increased cardiovascular risks among selective COX-2 inhibitors resulted in a decision to remove the celecoxib/placebo from the trial. Women with histologically node-negative invasive breast cancer who had undergone primary surgery with a lumpectomy or total mastectomy were eligible. Primary endpoint was disease-free survival (DFS).RESULTS: Between May 2004-July 2008, 2,722 patients were enrolled. Administration of FEC-100 did not result in improvement in DFS compared to AC (HR=1.09; 95% CI 0.92-1.29, p-value=0.31). The effect of FEC-100 compared to AC on DFS was significantly different for receptor-positive (HR=1.32, 95% CI=1.05-1.66) compared to receptor-negative patients (HR=0.86, 95% CI=0.66-1.11) (treatment-by-receptor status interaction p-value=0.02). There was no statistically significant difference in the effect of treatment on overall survival (OS) with FEC-100 compared to AC (HR=1.06; 95% CI 0.84-1.35, p-value=0.61). Overall, Grade 3 and 4 adverse events were more frequent in the FEC-100 group.CONCLUSIONS: The results of B-36 do not support use of six-cycle anthracycline-based regimens in node-negative breast cancer. Prolongation of anthracycline-based therapy with FEC-100 does not improve DFS or OS, relative to AC for 4 cycles, and was associated with expected increases in toxicity. A statistically significant interaction between treatment and hormone receptor status favoring AC in hormone-receptor-positive breast cancers is consistent with the hypothesis that optimal duration of chemotherapy may be four cycles in these patients. Late cardiac events and deaths prior to recurrence or second cancer were infrequent on both arms, but slightly higher with FEC-100.ClinicalTrials.gov: NCT00087178
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Definitive Results of a Phase III Adjuvant Trial Comparing Six Cycles of FEC-100 to Four Cycles of AC in Women with Operable Node-negative Breast Cancer: The NSABP B-36 Trial (NRG Oncology)
- Date Crossref
- 30/08/2021
- Éditeur
- Springer Science and Business Media LLC
- Type
- posted-content
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Methodist Hospital pays non établi dans la noticeÉtablissement de santé
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University of Pittsburgh NSABP/NRG Oncology pays non établi dans la noticeUniversité ou école supérieure
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NRG Oncology pays non établi dans la noticeOrganisation à but non lucratif
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Magee-Womens Hospital and UMPC Hillman Cancer Center pays non établi dans la noticeÉtablissement de santé
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Centre Hospitalier de l’Université de Montréal NSABP/NRG Oncology pays non établi dans la noticeÉtablissement de santé
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Southwest Women's Oncology pays non établi dans la noticeÉtablissement de santé
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Kaiser Permanente pays non établi dans la noticeOrganisation à but non lucratif
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Université Laval NSABP/NRG Oncology pays non établi dans la noticeUniversité ou école supérieure
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Cancer Institute (WIA) pays non établi dans la noticeÉtablissement de santé
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Cancer Research for the Ozarks pays non établi dans la noticeOrganisation à but non lucratif
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U-M Rogel Cancer Center pays non établi dans la noticeÉtablissement de santé
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Allegheny Health Network NSABP/NRG Oncology pays non établi dans la noticeÉtablissement de santé
Methodist Hospital, NSABP/NRG Oncology — University of Pittsburgh et NRG Oncology, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.