passages: 1279
passages: document
passages: Feasibility of two dose-dense FEC regimens with growth factor support for adjuvant therapy in patients with early breast cancer : results from a randomised study of the Central European Cooperative Oncology Group ( CECOG ) . Addition of epirubicin to adjuvant chemotherapy can provide important benefits for patients with early breast cancer , but the optimal dose remains unclear . Further improvements can be achieved with dose-dense regimens , but densification of fluorouracil/epirubicin/cyclophosphamide ( FEC ) has proved difficult , with FEC ( 60 ) providing little benefit over standard chemotherapy and FEC ( 100 ) associated with toxicity . We investigated the feasibility of two intermediate dose-dense FEC regimens . Patients were randomised to six cycles of FEC ( 75 ) or FEC ( 90 ) , with all three drugs given on day 1 of each 14-day cycle . Patients also received pegfilgrastim 6 mg as a single subcutaneous injection on day 2 of each cycle . The primary efficacy endpoint was the proportion of subjects receiving > or =85 % relative dose intensity and was achieved by 96 % and 88 % of patients in the FEC ( 75 ) and FEC ( 90 ) arms , respectively . Of 147 FEC ( 75 ) infusions , 4.1 % were delayed , while 9.8 % of 143 FEC ( 90 ) infusions were delayed . The most common reasons for delay were adverse events and personal/logistical reasons . One dose reduction occurred during the study ( FEC ( 90 ) ) , related to diarrhoea . Grade 3-4 haematological toxicities were reported in two patients in the FEC ( 90 ) arm . There were no incidences of febrile neutropenia during the study . The most common adverse events were increases in liver enzymes and gastrointestinal events ; no event resulted in discontinuation . Only one patient ( FEC ( 90 ) ) experienced serious adverse events ( vomiting and throat oedema ) . In conclusion , dose-dense FEC ( 75 ) and FEC ( 90 ) are feasible with pegfilgrastim support . These regimens are associated with a very low risk of Grade 3-4 toxicity .
entities: 1280
entities: Intervention_Pharmacological
entities: FEC
entities: 1281
entities: Intervention_Pharmacological
entities: epirubicin
entities: 1282
entities: Intervention_Pharmacological
entities: fluorouracil/epirubicin/cyclophosphamide ( FEC )
entities: 1283
entities: Intervention_Pharmacological
entities: FEC ( 100 )
entities: 1284
entities: Intervention_Pharmacological
entities: FEC
entities: 1285
entities: Intervention_Pharmacological
entities: FEC ( 75 )
entities: 1286
entities: Intervention_Pharmacological
entities: FEC ( 90 )
entities: 1287
entities: Intervention_Pharmacological
entities: pegfilgrastim
entities: 1288
entities: Intervention_Pharmacological
entities: FEC ( 75 )
entities: 1289
entities: Intervention_Pharmacological
entities: FEC ( 90 )
entities: 1290
entities: Intervention_Pharmacological
entities: FEC ( 90 )
entities: 1291
entities: Intervention_Pharmacological
entities: FEC ( 90 )
entities: 1292
entities: Intervention_Pharmacological
entities: ( FEC ( 90 ) )
entities: 1293
entities: Intervention_Pharmacological
entities: FEC ( 75
entities: 1294
entities: Intervention_Pharmacological
entities: FEC ( 90 )
entities: 1295
entities: Outcome_Other
entities: proportion of subjects receiving > or =85 % relative dose intensity
entities: 1296
entities: Outcome_Adverse-effects
entities: adverse events
entities: 1297
entities: Outcome_Adverse-effects
entities: diarrhoea .
entities: 1298
entities: Outcome_Adverse-effects
entities: haematological toxicities
entities: 1299
entities: Outcome_Adverse-effects
entities: febrile neutropenia
entities: 1300
entities: Outcome_Adverse-effects
entities: liver enzymes and gastrointestinal events
entities: 1301
entities: Outcome_Adverse-effects
entities: serious adverse events ( vomiting and throat oedema ) .
entities: 1302
entities: Participant_Condition
entities: patients with early breast cancer :
entities: 1303
entities: Participant_Condition
entities: patients with early breast cancer