| Objective :Preoperative chemotherapy is also defined as neoadjuvant chemotherapy and primary chemotherapy. It was first described in the 1970s, began to be used only to those potentially operable locally advanced breast cancer patients in order to achieve downstaging to allow mastectomy in some patients. At present the applications of neonadjuvant chemotherapy are: to improve with the possibility in some cases of downstaging the primary tumour to mastectomy or to breast-conserving surgery, to be used as a measure of response in vivo, in order to chose an effective chemotherapeutic agent; elimination of potential metastasis tumor at early stage through systemic therapy. All above, are probably helped to get advantage of longer survival, especially for those who achieve pathological complete response.Anthracycline is defined as the foundation of combination chemotherapy of breast cancer. Nowadays, almost all neoadjuvant chemotherapy regimen contain of anthracycline. The OR of 4cycles of anthracycline-based regimen is 60%-80%, and pCR is l0%-15%. It confimes that a higher dose intensity of anthracycline associated with better outcomes. In clinical application, we must consider of the toxicity.In this trial we try to compare the efficacy and toxicity of two different does of epirubicin(75mg/m2 or 100mg/ m2) plus cyclophosphamide in EC regimen as preoperative chemotherapy for breast cancer, in order to gulid the clincial treatment.Methods: This study recruited patients from July 2008 to March 2010 at Breast Center of 4th hospital of Hebei Medical University. Women with breast cancer that had tumors of stage II-IV were prospectively randomized to receive E100C or E75C regimen (epirubicin75mg/ m2 or 100mg/m2, d1; cyclophosphamide 600mg/ m2 , d1; every 3 weeks). Evluate the efficacy and toxicity during chemotherapy after 2 cycles.Results:A total of 41 patients were assessable for efficacy and toxicity,the Overall clinical response was observed in 70.7% and the pCR rate was 12.2% in all. Of the 41 cases, there were 38 cases assessable for evaluating chemotherapy response in MP grading system postoperative, and grade 4/5 in MP grading system was 14 (36.8%). There were 21 cases in E100C arm, and 20 cases in E75C arm. The mean age of E100C and E75C arm were 48.33 years and 51.63 years, respectivily. Patients'characteristics between groups were well balanced, had no statistical difference.1 The result of treament: Of E100C arm, there were 18 cases completed their scheduled four cycles of chemotherapy. 1 case completed three cycles. 1 case completed two cycles. 1 case had a 25% dose reduction of epiribucin for anoter two cycles after the second cycle. Of E75C arm,there were 16 cases completed their scheduled four cycles of chemotherapy. 3 cases completed three cycles. One case completed 2 cycles .2 Clinical response evluation:By physical palpation:Of the 41 cases, there were 11 cases cannon find any tumor in the end of schedualed chemotherapy, 9 in E100C arm (42.9%) and 2 in E75C arm (10%).By ultrasound: Of the 41 cases, there was no one get complete respond in the end of schedualed chemotherapy.Oral respond rate in E100C arm was 80.1% and in E75C arm 60%, P =0.141.3 Pathological response:3.1 pCR .pCR was observed in 23.8% (5/21) with E100C and none with E75C (P =0.048).3.2 Count of lymph nodesThere were 38 cases were assessable for axillary lymph nodes postoperative. There were 20 people in E100C arm, and 18 people in E75C arm. The median count of lymph nodes in E100C and E75C arm were both 20.5, P =0.965. The median count of involved lymph nodes in E100C arm and E75C arm were 1.5 and 2.0, P =0.209.3.3 Response in Miller and Payne (MP) grading systemAssessed by the standard method of Miller and Payne (MP) grading system, Grade 4/5 response was found 60.0% in E100C arm and 11.1% in E75C arm, P=0.002.4 Relationship between subgroups of breast cancer and response to chemotherapy.All cases had been classified into 3 subgroups (ER- positive, triple-negtive, and HER2-positive) based on gene expression profiles. In ER-positive and HER2-positive tumer the OR rate was 65.4% , 71.4% (P=1.000) and pCR rate was 7.7%, 14.3% (P=0.523) respectivily. OR were observed in 65.4% in patients with ER-positive tumors and 87.5% in patients with triple-negative tumors, P=0.385, and pCR rate was 7.7% and 25.0%, P=0.229.5 Relationship between Ki-67 and response to chemotherapy.In Ki-67 overexpressed and low-expressed tumor OR was 73.1% , 66.7%,P=0.730, and pCR was was11.5%, 13.3% , P=1.000.6 Toxicity6.1 Nonhematologic toxicity;The most common nononhematologic toxicity was gastrointestinal aid effect. The most common side effects were nausea/vomiting, and diarrhoea. Alopecia happened in all cases, and all of grade 2/3. There was no obvious cardiotoxcity happened. Grade3/4 gastrointestinal toxicity was observed in 9.5% in E100C and none in E75C, P=0.488. Grade3/4 hepatotoxicity was observed in 4.8% in E100C and none in E75C, P=1.000.6.2 Hematologic toxicityThere was no apparente anaemia and thrombocytopenia happened in both the two arm. Grade 3/4 neutropenia appeared in 14.3% in E100C arm and none in E75C arm, P=0.232.Conclusion:1 Epirubicin plus cyclophosphamide as preoperative chemotherapy regimen, E100C enhances the rates of pCR rate compares with E75C.2 There are more cases of grade 4/5 response in MP grading system in E100C arm compares with E75C.3 Compared with E75C, E100C dose not increas treatment-related toxicities in pre-operative chemotherapy.4 There is a tendency to enhance OR in E100C arm compared with E75C, but with no statistical difference.5 Triple-negative and HER2-positive tumors have a better response to chemotherapy than the type of ER-positive, but there is no statistical difference.6 In this trial, Ki-67 is not associated with response to chemotherapy.
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