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.
Geburtshilfe Frauenheilkd
; 76(5): 542-550, 2016 May.
Article
em En
| MEDLINE
| ID: mdl-27239063
ABSTRACT
Introduction:
This paper aims to evaluate the toxicity profile of additive gemcitabine to adjuvant taxane-based chemotherapy in breast cancer patients.Methods:
Patients enrolled in this open-label randomized controlled Phase III study were treated with 3 cycles of epirubicin-fluorouracil-cyclophosphamide (FEC) chemotherapy followed by 3 cycles of docetaxel with those receiving 3 cycles of FEC followed by 3 cycles of gemcitabine-docetaxel (FEC-DG). 3690 patients were evaluated according to National Cancer Institute (NCI) toxicity criteria (CTCAE). The study medications were assessed by the occurrence of grade 3-4 adverse events, dose reductions, postponements of treatment cycles and granulocyte colony-stimulating factor (G-CSF) support.Results:
No differences in neutropenia or febrile neutropenia were demonstrated. However, thrombocytopenia was significantly increased with FEC-DG treatment (2.0 vs. 0.5â%, p < 0.001), as was leukopenia (64.1 vs. 58.5â%, p < 0.001). With FEC-DG significantly more G-CSF support in cycles 4 to 6 (FEC-DG 57.8â%, FEC-D 36.3â%, p < 0.001) was provided. Transaminase elevation was significantly more common with FEC-DG (SGPT 6.3â%, SGOT 2â%), whereas neuropathy (1.2â%), arthralgia (1.6â%) and bone pain (2.6â%) were more common using FEC-D. Dose reductions > 20â% (4 vs. 2.4â%) and postponement of treatment cycles (0.9 vs. 0.4â%) were significantly more frequent in the FEC-DG arm. Eight deaths occurred during treatment in the FEC-DG arm and four in the FEC-D arm.Conclusion:
The addition of gemcitabine increased hematological toxicity and was associated with more dose reductions and postponements of treatment cycles.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
6_ODS3_enfermedades_notrasmisibles
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Idioma:
En
Revista:
Geburtshilfe Frauenheilkd
Ano de publicação:
2016
Tipo de documento:
Article