Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer—results from the randomized phase III SUCCESS-A trial

Abstract

Background When chemotherapy is indicated in patients with early breast cancer, regimens that contain anthracyclines and taxanes are established standard treatments. Gemcitabine has shown promising effects on the response and prognosis in patients with metastatic breast cancer. The SUCCESS-A trial (NCT02181101) examined the addition of gemcitabine to a standard chemotherapy regimen in high-risk early breast cancer patients. Methods A total of 3754 patients with at least one of the following characteristics were randomly assigned to one of the two treatment arms: nodal positivity, tumor grade 3, age ≤ 35 years, tumor larger than 2 cm, or negative hormone receptor status. The treatment arms received either three cycles of 5-fluorouracil, epirubicin, and cyclophosphamide, followed by three cycles of docetaxel (FEC → Doc); or three cycles of FEC followed by three cycles of docetaxel and gemcitabine (FEC → Doc/Gem). The primary study aim was disease-free survival (DFS), and the main secondary objectives were overall survival (OS) and safety. Results No differences were observed in the 5-year DFS or OS between FEC → Doc and FEC → Doc/Gem. The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94 (95% CI, 0.74 to 1.19; P = 0.60) for OS. For patients treated with FEC → Doc and FEC → Doc/Gem, the 5-year probabilities of DFS were 86.6% and 87.2%, and the 5-year probabilities of OS were 92.8% and 92.5%, respectively. Conclusion Adding gemcitabine to a standard chemotherapy does not improve the outcomes in patients with high-risk early breast cancer and should therefore not be included in the adjuvant treatment setting. Trial registration Clinicaltrials.gov NCT02181101 and EU Clinical Trials Register EudraCT 2005-000490-21. Registered September 2005.

MUC1 (CA27.29) before and after Chemotherapy and Prognosis in High-Risk Early Breast Cancer Patients

“…In the SUCCESS-A open-label phase 3 trial, patients were randomly assigned at a ratio of 1:1 to either an anthracycline/taxane-based chemotherapy or to this chemotherapy regimen plus gemcitabine [ 21 ]. Further treatment specifications are provided in the Supplementary methods .…”

PD-1 Cellular Nanovesicles Carrying Gemcitabine to Inhibit the Proliferation of Triple Negative Breast Cancer Cell

“…Thus, lowdose 0.1 µM gemcitabine was chosen for following experiments. Furthermore, research has revealed that gemcitabine possesses promising effects on chemotherapy in patients with breast cancer [25]. Afterwards, we developed a combined immunotherapy and chemotherapy therapy of PD-1 NVs carrying gemcitabine by the effect of targeting and carrier of NVs.…”

Synchronous Operable Pancreatic and Breast Cancer Without Genetic Mutation: A Literature Review and Discussion

“…The current indication for its use (Gemcitabine and carboplatin) is relegated to patients who have already had first line treatment (anthracycline and taxane), or to those for whom there is a contraindication to an anthracycline and/or taxane only (46). The addition of Gemcitabine to standard anthracycline and taxane chemotherapy has been evaluated, and failed to show any improvement in 5-year DFS or OS (47).…”