Journal Article
. 2006 Nov;24(36).
doi: 10.1200/JCO.2006.07.3916.

Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial

Henri Roché 1 Pierre Fumoleau  Marc Spielmann  Jean-Luc Canon  Thierry Delozier  Daniel Serin  Michel Symann  Pierre Kerbrat  Patrick Soulié  Françoise Eichler  Patrice Viens  Alain Monnier  Anita Vindevoghel  Mario Campone  Marie-Josèphe Goudier  Jacques Bonneterre  Jean-Marc Ferrero  Anne-Laure Martin  Jean Genève  Bernard Asselain  
  • PMID: 17116941
  •     146 citations


Purpose: The PACS 01 trial compared six cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) with a sequential regimen of three cycles of FEC followed by three cycles of docetaxel (FEC-D) as adjuvant treatment for women with node-positive early breast cancer.

Patients And Methods: Between June 1997 and March 2000, 1,999 patients with operable node-positive breast cancer were randomly assigned to either FEC every 21 days for six cycles, or three cycles of FEC followed by three cycles of docetaxel, both given every 21 days. Hormone-receptor-positive patients received tamoxifen for 5 years after chemotherapy. The primary end point was 5-year disease-free survival (DFS).

Results: Median follow-up was 60 months. Five-year DFS rates were 73.2% with FEC and 78.4% with FEC-D (unadjusted P = .011; adjusted P = .012). Multivariate analysis adjusted for prognostic factors showed an 18% reduction in the relative risk of relapse with FEC-D. Five-year overall survival rates were 86.7% with FEC and 90.7% with FEC-D, demonstrating a 27% reduction in the relative risk of death (unadjusted P = .014; adjusted P = .017). The incidence of grade 3 to 4 neutropenia, the need for hematopoietic growth factor, and incidence of nausea/vomiting were higher with FEC. Docetaxel was associated with more febrile neutropenia in the fourth cycle, stomatitis, edema, and nail disorders. Though rare overall, there were fewer cardiac events after FEC-D (P = .03), attributable mainly to the lower anthracycline cumulative dose.

Conclusion: Sequential adjuvant chemotherapy with FEC followed by docetaxel significantly improves disease-free and overall survival in node-positive breast cancer patients and has a favorable safety profile.

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Myelodysplastic syndrome and acute myeloid leukemia following adjuvant chemotherapy with and without granulocyte colony-stimulating factors for breast cancer.
Gregory S Calip, Judith A Malmgren, +2 authors, Henry G Kaplan.
Breast Cancer Res Treat, 2015 Oct 10; 154(1). PMID: 26450505    Free PMC article.
Immunohistochemical subtypes predict the clinical outcome in high-risk node-negative breast cancer patients treated with adjuvant FEC regimen: results of a single-center retrospective study.
S Rahal, J M Boher, +12 authors, A Gonçalves.
BMC Cancer, 2015 Oct 16; 15. PMID: 26466893    Free PMC article.
Breast Cancer: State of the Art and New Findings.
C Melcher, C Scholz, +3 authors, W Janni.
Geburtshilfe Frauenheilkd, 2012 Mar 01; 72(3). PMID: 26640286    Free PMC article.
Efficacy of chemotherapy after hormone therapy for hormone receptor-positive metastatic breast cancer.
Ryutaro Mori, Yasuko Nagao.
SAGE Open Med, 2014 Jan 01; 2. PMID: 26770749    Free PMC article.
Lymphocyte depletion and repopulation after chemotherapy for primary breast cancer.
Rashmi Verma, Ruth E Foster, +5 authors, Clive R D Carter.
Breast Cancer Res, 2016 Jan 27; 18(1). PMID: 26810608    Free PMC article.
Randomised phase III trial of FEC120 vs EC-docetaxel in patients with high-risk node-positive primary breast cancer: final survival analysis of the ADEBAR study.
W Janni, N Harbeck, +9 authors, M Kiechle.
Br J Cancer, 2016 Apr 01; 114(8). PMID: 27031854    Free PMC article.
Taxane acute pain syndrome (TAPS) in patients receiving taxane-based chemotherapy for breast cancer-a systematic review.
Ricardo Fernandes, Sasha Mazzarello, +6 authors, Mark Clemons.
Support Care Cancer, 2016 May 06; 24(8). PMID: 27146496
Systematic Review.
Toxicity Assessment of a Phase III Study Evaluating FEC-Doc and FEC-Doc Combined with Gemcitabine as an Adjuvant Treatment for High-Risk Early Breast Cancer: the SUCCESS-A Trial.
L Schröder, B Rack, +13 authors, C Scholz.
Geburtshilfe Frauenheilkd, 2016 May 31; 76(5). PMID: 27239063    Free PMC article.
Real-world adjuvant TAC or FEC-D for HER2-negative node-positive breast cancer in women less than 50 years of age.
S Lupichuk, D Tilley, X Kostaras, A A Joy.
Curr Oncol, 2016 Jun 23; 23(3). PMID: 27330344    Free PMC article.
Should Sentinel Lymph Node Biopsy for Patients with Early Breast Cancer Be Abandoned? Not So Fast.
Quyen D Chu, Prakash Peddi.
Clin Med Insights Oncol, 2016 Jul 12; 10. PMID: 27398043    Free PMC article.
Sensor-controlled scalp cooling to prevent chemotherapy-induced alopecia in female cancer patients.
M K Fehr, J Welter, +2 authors, R Felberbaum.
Curr Oncol, 2017 Jan 05; 23(6). PMID: 28050147    Free PMC article.
Timing of paclitaxel treatment in pre-operative or post-operative does not affect survival in breast cancer patients.
Jiayu Wang, Shanshan Chen, +8 authors, Qiao Li.
Thorac Cancer, 2017 Apr 13; 8(3). PMID: 28402606    Free PMC article.
Advanced Stage at Presentation Remains a Major Factor Contributing to Breast Cancer Survival Disparity between Public and Private Hospitals in a Middle-Income Country.
Yek-Ching Kong, Nirmala Bhoo-Pathy, +7 authors, Cheng-Har Yip.
Int J Environ Res Public Health, 2017 Apr 20; 14(4). PMID: 28420149    Free PMC article.
Long-Term Follow-Up of the Intergroup Exemestane Study.
James P Morden, Isabel Alvarez, +18 authors, R Charles Coombes.
J Clin Oncol, 2017 May 04; 35(22). PMID: 28467729    Free PMC article.
Neoadjuvant chemotherapy combined with limb salvage surgery in patients with limb osteosarcoma of Enneking stage II: a retrospective study.
Guangke Yuan, Jingming Chen, Dongjin Wu, Chunzheng Gao.
Onco Targets Ther, 2017 Jun 13; 10. PMID: 28603424    Free PMC article.
A prospective study of docetaxel-associated pain syndrome.
Nicholas Chiu, Liying Zhang, +13 authors, Carlo DeAngelis.
Support Care Cancer, 2017 Jul 25; 26(1). PMID: 28733699
Influence of chemotherapeutic drug-related gene polymorphisms on toxicity and survival of early breast cancer patients receiving adjuvant chemotherapy.
Vienna Ludovini, Cinzia Antognelli, +13 authors, Stefania Gori.
BMC Cancer, 2017 Jul 28; 17(1). PMID: 28747156    Free PMC article.
A nation-wide multicenter 10-year (1999-2008) retrospective study of chemotherapy in Chinese breast cancer patients.
Qiao Li, Zhao Yang, +8 authors, Pin Zhang.
Oncotarget, 2017 Nov 05; 8(44). PMID: 29100275    Free PMC article.
Long-term safety and survival outcomes from the Scandinavian Breast Group 2004-1 randomized phase II trial of tailored dose-dense adjuvant chemotherapy for early breast cancer.
Alexios Matikas, Sara Margolin, +12 authors, Jonas Bergh.
Breast Cancer Res Treat, 2017 Dec 01; 168(2). PMID: 29190004    Free PMC article.
Phase II study of neoadjuvant anthracycline combined with nanoparticle albumin-bound paclitaxel for human epidermal growth factor receptor 2-negative breast cancer.
Emi Ishigami, Masahiro Sakakibara, +8 authors, Masayuki Otsuka.
Mol Clin Oncol, 2017 Dec 30; 7(6). PMID: 29285378    Free PMC article.
Recent Improvement in the Long-term Survival of Breast Cancer Patients by Age and Stage in Japan.
Akiyo Yoshimura, Hidemi Ito, +8 authors, Yuri Ito.
J Epidemiol, 2018 Feb 27; 28(10). PMID: 29479003    Free PMC article.
Taxane acute pain syndrome (TAPS) in patients receiving chemotherapy for breast or prostate cancer: a prospective multi-center study.
R Fernandes, S Mazzarello, +11 authors, Mark Clemons.
Support Care Cancer, 2018 Mar 23; 26(9). PMID: 29564623
The 21-gene Recurrence Score® assay predicts distant recurrence in lymph node-positive, hormone receptor-positive, breast cancer patients treated with adjuvant sequential epirubicin- and docetaxel-based or epirubicin-based chemotherapy (PACS-01 trial).
Frédérique Penault-Llorca, Thomas Filleron, +12 authors, Henri Roché.
BMC Cancer, 2018 May 08; 18(1). PMID: 29728098    Free PMC article.
Febrile neutropenia in adjuvant and neoadjuvant chemotherapy for breast cancer: a retrospective study in routine clinical practice from a single institution.
Joy Bacrie, Marc Laurans, +9 authors, Delphine Lefeuvre.
Support Care Cancer, 2018 Jun 02; 26(12). PMID: 29855772
Comparable efficacy and less toxicity of pegylated liposomal doxorubicin versus epirubicin for neoadjuvant chemotherapy of breast cancer: a case-control study.
Minjun Dong, Liang Luo, +4 authors, Linbo Wang.
Onco Targets Ther, 2018 Aug 09; 11. PMID: 30087568    Free PMC article.
Prognostic Significance of Adjuvant Chemotherapy Induced Amenorrhea in Luminal A and B Subtypes.
Çetin Ordu, Kezban Nur Pilancı, +14 authors, Vahit Özmen.
Eur J Breast Health, 2018 Aug 21; 14(3). PMID: 30123884    Free PMC article.
Primary Febrile Neutropenia Prophylaxis for Patients Who Receive FEC-D Chemotherapy for Breast Cancer: A Systematic Review.
Ricardo Fernandes, Sasha Mazzarello, +10 authors, Mark Clemons.
J Glob Oncol, 2018 Sep 23; 4. PMID: 30241156    Free PMC article.
Systematic Review.
Febrile neutropenia (FN) occurrence outside of clinical trials: occurrence and predictive factors in adult patients treated with chemotherapy and an expected moderate FN risk. Rationale and design of a real-world prospective, observational, multinational study.
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BMC Cancer, 2018 Sep 27; 18(1). PMID: 30249215    Free PMC article.
Taxanes for adjuvant treatment of early breast cancer.
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Systematic Review.
Comparing docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in the treatment of breast cancer (DHA WIN): protocol of a double-blind, phase II, randomised controlled trial.
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BMJ Open, 2019 Sep 19; 9(9). PMID: 31530611    Free PMC article.
Cost-utility analysis of 21-gene assay for node-positive early breast cancer.
L Masucci, S Torres, +5 authors, W Isaranuwatchai.
Curr Oncol, 2019 Nov 12; 26(5). PMID: 31708649    Free PMC article.
Tumor-Infiltrating Lymphocytes and Prognosis: A Pooled Individual Patient Analysis of Early-Stage Triple-Negative Breast Cancers.
Sherene Loi, Damien Drubay, +19 authors, Stefan Michiels.
J Clin Oncol, 2019 Jan 17; 37(7). PMID: 30650045    Free PMC article.
Highly Cited.
Ambulatory Toxicity Management (AToM) in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer - a pragmatic cluster randomized trial protocol.
Monika K Krzyzanowska, Jim A Julian, +6 authors, Eva Grunfeld.
BMC Cancer, 2019 Sep 07; 19(1). PMID: 31488084    Free PMC article.
The Impact of Adding Taxanes to Anthracyclines on Women with Breast Cancer Receiving Adjuvant Chemotherapy.
Erina Hilaj, Alketa Ymeri, Kleva P Shpati.
Cureus, 2020 Apr 08; 12(2). PMID: 32257663    Free PMC article.
Early Triple Negative Breast Cancer: Conventional Treatment and Emerging Therapeutic Landscapes.
Anna Diana, Francesca Carlino, +5 authors, Michele Orditura.
Cancers (Basel), 2020 Apr 03; 12(4). PMID: 32235297    Free PMC article.
Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial.
Junjie Li, Keda Yu, +37 authors, CBCSG010 Study Group.
J Clin Oncol, 2020 Apr 11; 38(16). PMID: 32275467    Free PMC article.
Clinical outcome of patients with brain metastases from breast cancer - A population based study over 21 years.
Anna Thulin, Elisabeth Rönnerman, +7 authors, Barbro Linderholm.
Breast, 2020 Mar 08; 50. PMID: 32145571    Free PMC article.
Proteomic Analysis of Breast Cancer Resistance to the Anticancer Drug RH1 Reveals the Importance of Cancer Stem Cells.
Dalius Kuciauskas, Nadezda Dreize, +7 authors, Mindaugas Valius.
Cancers (Basel), 2019 Jul 25; 11(7). PMID: 31336714    Free PMC article.
Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer-results from the randomized phase III SUCCESS-A trial.
Amelie de Gregorio, Lothar Häberle, +22 authors, Wolfgang Janni.
Breast Cancer Res, 2020 Oct 25; 22(1). PMID: 33097092    Free PMC article.
Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial.
William Jacot, Antoine Arnaud, +18 authors, Laurence Vanlemmens.
Nutrients, 2020 Oct 15; 12(10). PMID: 33050321    Free PMC article.
NC-6300, an epirubicin-incorporating micelle, extends the antitumor effect and reduces the cardiotoxicity of epirubicin.
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Cancer Sci, 2013 Mar 19; 104(7). PMID: 23495762    Free PMC article.
Interdisciplinary Screening, Diagnosis, Therapy and Follow-up of Breast Cancer. Guideline of the DGGG and the DKG (S3-Level, AWMF Registry Number 032/045OL, December 2017) - Part 2 with Recommendations for the Therapy of Primary, Recurrent and Advanced Breast Cancer.
Achim Wöckel, Jasmin Festl, +94 authors, Stephanie Stangl.
Geburtshilfe Frauenheilkd, 2018 Dec 26; 78(11). PMID: 30581198    Free PMC article.
Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial.
Marion Carayol, Gregory Ninot, +7 authors, William Jacot.
BMC Cancer, 2019 Jul 28; 19(1). PMID: 31345179    Free PMC article.
Pathologic response at the epicenter of the treatment decision-making process in Human Epidermal Receptor-Type 2 overexpressing (Her2+) Early Breast Cancer (EBC): Challenges and opportunities for financially-constrained healthcare systems.
Max S Mano.
Breast, 2020 Dec 07; 54. PMID: 33279792    Free PMC article.
Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial.
Suzette Delaloge, Martine Piccart, +27 authors, MINDACT investigators and the TRANSBIG Consortium.
J Clin Oncol, 2020 Feb 23; 38(11). PMID: 32083990    Free PMC article.