Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2011 Feb;137(2):221-8.
doi: 10.1007/s00432-010-0878-8. Epub 2010 Apr 13.

Neoadjuvant sequential epirubicin and docetaxel followed by surgery-radiotherapy and post-operative docetaxel or gemcitabine/vinorelbine combination based on primary response: a multimodality approach for locally advanced breast cancer

Panteleimon Kountourakis  1 , Ioannis Missitzis, Dimitrios Doufexis, Vassileios Zobolas, Georgios Pissakas, Niki Arnogiannaki, Savoula Maliou, Anastasia Sotiropoulou, Alexandros Ardavanis
Affiliations
Clinical Trial

Neoadjuvant sequential epirubicin and docetaxel followed by surgery-radiotherapy and post-operative docetaxel or gemcitabine/vinorelbine combination based on primary response: a multimodality approach for locally advanced breast cancer

Panteleimon Kountourakis et al. J Cancer Res Clin Oncol. 2011 Feb.

Abstract

Background: Locally advanced breast cancer (LABC) remains a major clinical issue despite progress achieved in recent years. Herein, we present the mature results of a multimodality treatment program tailoring epirubicin (EPI), docetaxel (DOC) and gemcitabine-vinorelbine (GEV) peri-operatively in LABC.

Patients and methods: Stage III, Eastern Cooperative Oncology Group-Performance status ≤2 patients were eligible. A biopsy documentation had to be performed before the start of chemotherapy (CT). Treatment consisted of four EPI (100 mg/m(2), d1q2w) followed by three DOC (100 mg/m(2), d1q3w); surgery 3-4 weeks from CT completion, followed by radiation therapy (RT) and CT according to response; partial or complete (PR/CR):DOC, no change or progressive disease (NC/PD):GEV. Primary endpoints were: (a) response and conversion to operability/conservative surgery and (b) overall survival (OS) and time to recurrence (TTR).

Results: Fifty-six women, aged 32-75 (median 52 years), 24 IIIA and 32 IIIB were enrolled; 53 patients completed the entire program. Toxicity was acceptable and no treatment-related death was observed.

Efficacy: clinical response rate (RR) 71.4% (40 patients); clinical complete response rate 33.9% (19 patients). Pathological response rate (RR) 67.8% (38 patients); pathological complete response rate 21.4% (12 patients). 33 (58.9%) and 19 (33.9%) patients, respectively, had radical and conservative operations without increased morbidity. After a median follow-up of 62 months, median OS has not yet been reached, while median TTR was 42 months. OS was longer in patients with clinical (p = 0.004) and pathological response (p = 0.002), RT (p < 0.0001) and post-operative DOC (p = 0.038). TTR was favorably affected by pR (p < 0.0001), RT (p < 0.0004) and post-operative DOC (p = 0.005). Pre-operative CT seemed to be equally active throughout all subgroups according to histology, ER/PR and HER2 status.

Conclusion: The treatment program of the present study allowed for the completion of an effective therapy at the cost of acceptable toxicity. The results of this study suggest a central role of CT for LABC and the value of eventually dose-dense, EPI- and DOC-based CT in a large proportion of LABC patients, regardless of biological tumor profile. Furthermore, tumor response (cR, pR) is an important surrogate for patients survival and further therapy management.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
a Patients with clinical response have better OS (median OS has not yet been reached) in comparison with patients with no clinical response [OS = 56 months (15–78)], p = 0.004. b Patients with assessed pathological response have better OS (median OS has not been reached yet) than patients with no pathological response [OS = 50 months (12–64)], p = 0.002
Fig. 2
Fig. 2
Patients with pathological response have longer TTR [48 months (17–84)] than patients with no pathological response [22 months (7–72)], p < 0.0001
Fig. 3
Fig. 3
Patients received post-operatively DOC have better OS [median OS has not yet been reached vs. 60 months (12–83), p = 0.038] and TTR [45 months (22–84) vs. 36 months (7–82), p = 0.005] than patients received GEV
See this image and copyright information in PMC

References

    1. Ardavanis A, Scorilas A, Tryfonopoulos D et al (2006) Multidisciplinary therapy of locally far-advanced or inflammatory breast cancer with fixed perioperative sequence of epirubicin, vinorelbine, and Fluorouracil chemotherapy, surgery, and radiotherapy: long-term results. Oncologist 11(6):563–573 - PubMed
    1. Ardavanis A, Kountourakis P, Maliou S et al (2007) Gemcitabine and oral vinorelbine as salvage treatment in patients with advanced anthracycline- and taxane-pretreated breast cancer. Anticancer Res 27(4C):2989–2992 - PubMed
    1. Bear HD, Anderson S, Smith RE et al (2006) Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: national surgical adjuvant breast and bowel project protocol B-27. J Clin Oncol 24(13):2019–2027 - PubMed
    1. Bonnefoi H, Diebold-Berger S, Therasse P et al (2003) Locally advanced/inflammatory breast cancers treated with intensive epirubicin-based neoadjuvant chemotherapy: are there molecular markers in the primary tumour that predict for 5 year clinical outcome? Ann Oncol 14:406–413 - PubMed
    1. Buzdar AU, Valero V, Theriault RL et al (2003) Pathological complete response to chemotherapy is related to hormone receptor status [abstract]. In: 26th San Antonio Breast Cancer Symposium Abstr. 302. Breast Cancer Res Treat, vol 85, p 2

MeSH terms