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Ann Oncol. 2015 Aug;26(8):1692-7. doi: 10.1093/annonc/mdv216. Epub 2015 May 5.

UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer.

Author information

1
Department of Medical Oncology, Institut Paoli-Calmettes, Marseille Centre de Recherche en Cancérologie de Marseille, INSERM U1068, CNRS 7258, Aix-Marseille Univ, Marseille.
2
Department of Medical Oncology, Institut Curie, Université Paris Descartes, Paris.
3
Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
4
Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand.
5
Department of Medical Oncology, Centre Léon Bérard, Lyon.
6
Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Angers.
7
Department of Medical Oncology, Institut du Cancer de Montpellier, Montpellier.
8
Department of Medical Oncology, Institut Curie, Hôpital René Huguenin, Saint-Cloud.
9
Department of Medical Oncology, Hôpital Tenon, Paris.
10
Department of Medical Oncology, CHU, Tours.
11
Department of Medical Oncology, Polyclinique Bordeaux Nord-Aquitaine, Bordeaux.
12
Department of Medical Oncology, Institut Jean Godinot, Reims.
13
Department of Medical Oncology, CHG, Brive-la-Gaillarde.
14
Unicancer, Paris.
15
Department of Medical Oncology, Institut Paoli-Calmettes, Marseille Centre de Recherche en Cancérologie de Marseille, INSERM U1068, CNRS 7258, Aix-Marseille Univ, Marseille viensp@ipc.unicancer.fr.
16
Department of Medical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse-Oncopole,Toulouse, France.

Abstract

BACKGROUND:

Inflammatory breast cancer (IBC) is a rare and aggressive disease requiring a multimodal treatment. We evaluated the benefit of adding docetaxel-5-fluorouracil (D-5FU) regimen after preoperative dose-intense (DI) epirubicin-cyclophosphamide (EC) and locoregional treatment in IBC patients.

PATIENTS AND METHODS:

PEGASE 07 was a national randomized phase III open-label study involving 14 hospitals in France. Women with nonmetastatic IBC were eligible and randomly assigned to receive either four cycles of DI EC (E 150 mg/m(2) and C 4000 mg/m(2) every 3 weeks with repeated hematopoietic stem cell support), then mastectomy with axillary lymph node dissection, and radiotherapy (arm A) or the same treatment followed by four cycles of D-5FU (D 85 mg/m(2), day 1 and 5FU 750 mg/m(2)/day continuous infusion, days 1-5 every 3 weeks) administered postradiotherapy (arm B). Patients with hormone receptor-positive tumors received hormonal therapy. Disease-free survival (DFS) was the primary end point. Secondary end points included tolerance, pathological complete response (pCR) rate, and overall survival (OS).

RESULTS:

Between January 2001 and May 2005, 174 patients were enrolled and treated (87 in each arm). Median follow-up was similar in both arms: 59.6 months [95% confidence interval (CI) 58.4-60.3] in arm A and 60.5 months (95% CI 58.3-61.4) in arm B. The estimated 5-year DFS rates were not different: 55% (95% CI 43.9-64.7) in arm A and 55.5% (95% CI 44.3-65.3) in arm B [hazard ratio (HR) = 0.94 (0.61-1.48); P = 0.81]. Identical results were observed for 5-year OS: 70.2% (95% CI 59.1-78.8) in arm A and 70% (95% CI 58.8-78.7) in arm B [HR = 0.93 (0.55-1.60); P = 0.814]. Following DI EC induction, in-breast and global (breast plus nodes) pCR were 28.9% and 20.1%, respectively. Estrogen receptor and pCR status were independently associated with survival.

CONCLUSION:

The addition of D-5FU after preoperative DI EC and standard local therapy did not improve DFS in IBC.

CLINICAL TRIAL NUMBER:

ClinicalTrials.gov identifier: NCT02324088.

KEYWORDS:

docetaxel; dose-intense chemotherapy; inflammatory breast cancer

PMID:
25943350
DOI:
10.1093/annonc/mdv216
[Indexed for MEDLINE]

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