Abstract | PURPOSE: METHOD: RESULTS: Between May 2004 and July 2008, 2722 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00087178.
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Authors | Charles E Geyer Jr, Hanna Bandos, Priya Rastogi, Samuel A Jacobs, André Robidoux, Louis Fehrenbacher, Patrick J Ward, Jonathan Polikoff, Adam M Brufsky, Louise Provencher, Alexander H G Paterson, John T Hamm, Robert L Carolla, Luis Baez-Diaz, Thomas B Julian, Sandra M Swain, Eleftherios P Mamounas, Norman Wolmark |
Journal | Breast cancer research and treatment
(Breast Cancer Res Treat)
Vol. 193
Issue 3
Pg. 555-564
(Jun 2022)
ISSN: 1573-7217 [Electronic] Netherlands |
PMID | 35230585
(Publication Type: Journal Article)
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Copyright | © 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. |
Chemical References |
- Anthracyclines
- Epirubicin
- Doxorubicin
- Cyclophosphamide
- Celecoxib
- Fluorouracil
|
Topics |
- Anthracyclines
(therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects)
- Breast Neoplasms
(drug therapy, pathology, surgery)
- Celecoxib
(therapeutic use)
- Chemotherapy, Adjuvant
- Cyclophosphamide
- Disease-Free Survival
- Doxorubicin
(adverse effects)
- Epirubicin
- Female
- Fluorouracil
- Humans
- Mastectomy
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