| Backgrouds:Paclitaxel plus cisplatin is currently the first line chemotherapy for recurrent, persistent, or metastatic cervical carcinoma. The effective rate is29.1%. However, most patients who accepted this therapy would progress, that another new effective chemotherapy is in need. Albumin-bound paclitaxel (ABRAXANE) is a new type of taxane chemotherapy drug which use human serum albumin as carrier. The partial remission rate of ABRAXANE alone is28.6%for recurrent or metastatic cervical cancer. It has been reported that the effective rate of Nedaplatin (NDP) alone is46.3%. There were no clinical reports about ABRAXANE plus NDP for cervical cancer chemotherapy up to now. In order to evaluate the short term effects and safety of ABRAXANE plus NDP in recurrent, persistent, or metastatic cervical carcinoma, a monocentric, prospective and open clinical trial were conducted.Objectives:To evaluated the short term effects and safety of ABRAXANE plus NDP in late stage or recurrent or metastatic cervical cancer.Methord:27pathology confirmed cases of IVB or recurrent,metastatic cervical cancer patients were give175mg·m-2di ABRAXANE plus80mg·m-2d1NDP by intravenous drip after informed consent of herself and her family in Cancer Hospital of Chinese Academy of Medical Sciences from August2010to February2014. A course of treatment is as long as21days until the cancer progressed or intolerable adverse effects were observed. The principal endpoint of this study was the objective response rate (ORR) and the safety. The minor endpoint is the progress free survival (PFS) and the overall survival (OS).Results:27cases of recurrent, persistent, or metastatic cervical carcinoma were included (5for late stage,22recurrent or metastatic cases). The curative effect of26cases and safety of27cases could be evaluated. The median age is46years old.25of them were squamous carcinoma (92.6%),2adenocarcinoma (7.4%).5IVB patients (18.5%) and22recurrent or metastatic cancer patients (81.5%) in total.21(77.8%) of them adopted radiotherapy before.10(37.0%) of them have had surgery.18cases adopted platiniferous chemotherapy and the average courses of treatment is3(1-9courses).26cases of them finished92courses of treatment, the average number is3.4.2cases were complete response (7.7%).11were partial response (42.3%).6stable disease (23.1%) and7progression disease (26.9%). The ORR is50.0%,15death. And the median PFS was9.1months, median OS was16.6months.The stage of cancer, whether received radiotherapy or chemotherapy before, whether the recurrent focus within the range of radiotherapy or not and the time interval of the last chemotherapy were included in statistical analysis. No statistical significance were found of the ORRs (p>0.05). However, the time intervals that longer than12months between the last chemotherapy and this study showed statistical significance (71.4%vs25.0%, P=0.034)The main side effects of chemotherapy were bone marrow suppression, gastrointestinal reactions, fatigue and peripheral nerve paresthesia. Bone marrow suppression is more common, the incidence of Ⅲ neutropenia reduction was33.3%, with l case (3.7%) of fever, the incidence were7.4%and18.5%for grade3platelets and hemoglobin reduction respectively, no case of IV myelosuppression were found.81.5%of them had nausea and vomiting.22.2%of them had diarrhea,18.5%of the women had Ⅰ-Ⅱ constipation. Fatigue is observed in88.9%cases and grade Ⅲ-Ⅳ were found in3.7%women. The incidence of Ⅰ-Ⅱ peripheral nerve paresthesia was as high as51.9%. No case was found allergic to the therapy.Conclusion:our study suggests that the short term effect of ABRAXANE plus NDP for late stage or recurrent or metastatic cervical cancer is satisfactory. The adverse effects are tolerable. However data of follow up should be collected to evaluating the long term effects. Objective To investigate the efficacy and prognostic factors in patients with stage Ⅰb and Ⅱa cervical carcinoma by radical radiotherapy.Methods Between January1999and January2012,108patients with stage Ⅰb and Ⅱa cervical carcinoma received radical radiotherapy in Cancer Hospital,Peking Union Medical college,Chinese Academy of Medical Sciences were included in the retrospective analysis.Patients of stage Ⅰbl,Ⅰb2,Ⅱal and Ⅱa2were18(16.7%),38(35.2%),33(30.6%)and19(17.6%),respectively.Results The5-year overall survival rate is76.2%and the5-year disease free survival rate is75.6%.25(23.1%) patients developed recurrent disease,of that16(64.0%) had local recurrences,6(24.0%) had distant metastases and3(12.0%) had both local recurrence and distant metastases.Among patients with recurrent disease,23died and2survive with tumor.24patients died, of that23died due to tumor recurrence and the other one died of other reason.In univariate analysis, lymph node metastasis, squamous cell carcinoma antigen (SCC-Ag) levels before treatment, SCC-Ag levels after treatment1month have relation with overall survival time in patients with stage Ⅰb and Ⅱa cervical carcinoma. In multivariate analysis, lymph node metastasis and SCC-Ag levels after treatment l month were the independent prognostic factors for overall survival time for the cervical squamous cell carcinoma.Conclusion By means of radical radiotherapy, patiens(Ⅰb and Ⅱa) with lymph node metastasis and SCC-Ag levels≥.5ng/ml after treatment1month have poor prognosis. Patients(Ⅰb and Ⅱa) with concurrent chemoradiotherapy after neoadjuvant chemotherapy did not affect the prognosis. The5-year survival rate with concurrent chemoradiotherapy was higher than that of radiotherapy. |
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