| 摘 要： | Objective This study was initially designed to evaluate the effect of celecoxib on the regimen of 5-fluorouracil,epirubicin,and cyclophosphamide（FEC）combination,followed by docetaxel（T）in neoadjuvant setting.An unplanned preliminary review on safety was conducted after a halt of the study due to the concerned potential cardiovascular risk of using COX-2 inhibitors.Methods We studied 23 consecutive cases of operable breast cancer having received four cycles of FEC（500 mg/m2,100 mg/m2,500 mg/m2）followed by four cycles of T（100 mg/m2）with concurrent celecoxib（400 mg twice daily）（group A）or same chemotherapy regimen but without concurrent celecoxib（group B）.These combined chemotherapies were administered every 3 weeks.The Chi-square test or Fisher＇s exact test were used to assess the difference in incidence of limiting hematological toxicites between groups.Results 23 patients（group A：n=12;group B,n=11）received a total of 183 out of 184 planned treatment cycles;one（4%,1/23）of them omitted the fourth cycle of FEC owing to repeated incidences of febrile neutropenia.Received dose intensity（RDI）for FEC in group A（90%±11%）was higher than that in group B（80%±8%）while RDI for T was similar between group A（93%±8%）and group B（96%±9%）.Of the first 91 treatment cycles of FEC,limiting hematological toxicity,severe neutropenia including febrile neutropenia,was significantly different between group A and B [（10.4%,5/48）vs.（32.6%,14/43）,P=0.009].Other toxicities commonly observed in chemotherapy receiving patients were manageable.Conclusions Neoadjuvant use of FEC followed by T with concurrent celecoxib appeared to be safe for treatment of operable invasive breast cancer.The observed lower incidence of chemotherapy-induced neutropenia is possibly contributed by the administration of COX-inhibitor.We believe that further investigation might provide more evidence on the use of COX-2 inhibitors in breast cancer.
|
