Study Examines Fluorouracil With Dose-Dense Chemo For Early Breast Cancer Interview with:
Dr. Lucia Del Mastro MD

Department of Medical Oncology
Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy

Medical Research: What is the background for this study? What are the main findings?

Response: Adjuvant chemotherapy regimens with anthracyclines and taxanes improve the outcome of patients with early breast cancer. Among the most widely used anthracycline-based chemotherapy in sequential combinations with the taxane paclitaxel (P) there are epirubicin and cyclophosphamide (EC) and fluorouracil, epirubicin, and cyclophosphamide (FEC). The contribution of fluorouracil to the anthracycline-cyclophosphamide regimen (EC) was unclear until now.

Various randomized trials attempted to assess the role of a more intense schedule of chemotherapy (i.e. dose-dense chemotherapy with cycles administered every 2 weeks instead of every 3 weeks) in patients with early breast cancer. However, most of these trials compared dose-dense chemotherapy with regimens that use standard intervals but with different drugs or dose in the treatment groups, thus making difficult to extrapolate the true role of the dose-dense strategy.

The results of GIM2 study show that the addition of fluorouracil to  a sequential regimen with epirubicin, cyclophosphamide and paclitaxel increases the toxicity, in terms of neutropenia, fever, nausea, and vomiting, and is not associated with an improved outcome compared with the same treatment without fluorouracil.

Medical Research: What should clinicians and patients take away from your report?

Response: The results of our study strongly support the notion that fluorouracil can be safely discarded from adjuvant regimens for early breast cancer patients. Moreover the study supports the increased efficacy of dose-dense chemotherapy and suggests that the benefit is present in both hormone-receptor-negative and hormone-receptor-positive tumors.

Medical Research: What recommendations do you have for future research as a result of this study?

Response: Long-term follow-up of dose-dense studies is necessary to report long term toxic effects. Additional studies comparing paclitaxel every 2 weeks with weekly paclitaxel are necessary to evaluate which of these two schedules is the winner in terms of both efficacy and safety in the adjuvant treatment of early breast cancer patients.


Fluorouracil and dose-dense chemotherapy in adjuvant treatment of patients with early-stage breast cancer: an open-label, 2 × 2 factorial, randomised phase 3 trial
randomised phase 3 trial

Del Mastro, Lucia et al.

The Lancet Published Online: 01 March 2015

DOI: Interview with: Dr. Lucia Del Mastro MD,  Department of Medical Oncology (2015). Study Examines Fluorouracil With Dose-Dense Chemo For Early Breast Cancer 

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