| Background: Renal cell carcinoma referred to as renal carcinoma, is the mostcommon type of renal malignant tumor, which accounting for about80to90percent ofthe total renal malignant tumor. Renal carcinoma is not sensitive to radiotherapy andchemotherapy, therefore, radiotherapy and chemotherapy are not as the conventionaltreatment for metastatic renal cell carcinoma. Previous cytokine therapy such asinterferon alpha and leukocyte interleukin-2did have some activity for mRCC, but themedian survival time of the patients treated by them is10months, and the overallclinical benefit is less than10%, furthermore, it brings more toxic effects. In recentyears, molecular-targeted drugs have achieved impressive results in the treatment ofmetastatic renal carcinoma. Everolimus(RAD001) is an oral mTOR inhibitor, whichhas direct(inhibition of tumor growth) and indirect (inhibit the growth of blood vessels)anti-tumor effect.On March30,2009, The U.S. Food and Drug Administration(FDA)approved Everolimus for the treatment of mRCC patients who failed the therapy ofSutent or Sorafenib.Objective:①To evaluate the characteristics of safety and tolerability ofEverolimus in the treatment of the Chinese single-center mRCC patients who progressduring or after initial vascular endothelial growth factor receptor-tyrosine kinaseinhibitor therapy or can not tolerate such treatment.②To evaluate the Disease ControlRate(DCR), Overall Response Rate(ORR), Progression-Free Survival(PFS)and OverallSurvival (OS).Methods:①Patients:From June2010to December2010, patients with metastaticrenal cell carcinoma were selected in our hospital. All the patients were diagnosed asrenal clear cell carcinoma by pathological examination, and that they could not tolerateVEGF targeted therapy or had progressed during or after VEGF targeted therapy. After the ethics examination and signed an informed consent, all the patients receivedscreening and baseline evaluation. The patients who meet the selected conditions werebringing into trials.②Methods:Everolimus was administered continuously to theselected patients as a once-daily oral10mg dose. A treatment cycle is28days induration. The follow-up was taken on the first day of each cycle,including vital signs,laboratory tests, imaging studies(every two cycles) until disease progression(as definedby RECIST) or unacceptable toxicity, death, discontinuation for any other reason takesplace.③Data Analysis: Collect safety and effectiveness data, use SPSS13.0statisticalsoftware for statistical analysis. Summed up the number and percentage of patientswith adverse events and disease control rate, overall response rate, progression-freesurvival, overall survival.Results:①P atient Characteristics:a total of7patients were bringing into trials,4males and3females, age are40to74years, average56.5years.3patients receivedSorafenib therapy,4patients received Pazopanib therapy previously. Of all the7patients,5of them could not tolerate VEGF targeted therapy,2of them had progressedduring VEGF targeted therapy. Location of metastatic lesions include: lung metastasesin3patients, contralateral or ipsilateral renal metastases in2patients, hepaticmetastasis in1patients, bone metastasis in1patients, perirenal metastasis in1patients,supraclavicular lymph node metastasis in2patients, Hilar lymph node metastasis in2patients, mediastinal lymph node metastasis in2patients,retroperitoneal lymph nodemetastasis in1patients, abdominal subcutaneous metastasis in1patients. Treatmenttime is0.33to12.13months, median treatment time is2.17months. Follow-up time is1.6to16months so far, average follow-up time is9.2months. Of7patients,3patientsdead: all3patients died of multiple organ failure after withdrew from the trial.②Safety outcomes: Every patients suffered at least1adverse event. Most commonlyobserved adverse events were grades1to2, which can be controlled and tolerated bygiven symptomatic treatment or reduce dose. The most common adverse eventsinclude: cough (85.71%), fever(71.43%), canker sore(57.14%), asthenia (57.14%),diarrhoea(42.86%), nausea(42.86%), dermatitis(42.86%).The most common laboratory abnormalities include: hyperglycaemia(71.43%), hypertriglyceridemia(57.14%),anaemia(57.14%), elevated alkaline phosphatase(42.86%), hypocalcemia(42.86%).Grade3adverse events include: Non-infectious pneumonia in1patient(28.57%),anaemia(28.57%), hyperglycaemia in1patient(28.57%), elevated GGT in1patient(28.57%). Grade4adverse events include: severe anaemia (28.57%).③Efficacyoutcomes: According to the RECIST, The best overall response to everolimus is stabledisease in6patients(85.71%), progressive disease in1patients(14.29%), no completeremission and partial remission patient was Observed. Disease control rate is85.71%.Overall Response Rate is zero. The median progression-free survival is6.0months(95%CI:4.4～7.6months). The median overall survival (OS) still can not be evaluated.Conclusions: Everolimus has a better disease control rate in the treatment ofChinese mRCC patients who progress during or after initial vascular endothelialgrowth factor receptor-tyrosine kinase inhibitor therapy or can not tolerate suchtreatment. Most patients can benefit from treatment. Most commonly observed adverseevents are grades1to2, which can be effectively controlled by giving the doseadjustment and symptomatic treatment. Background: Retroperitoneal fibrosis（RPF）, also known as Ormond’s disease,isa rare diseases which is characterized by chronic non-specific inflammation withfibrous tissue proliferation of retroperitoneal tissue. The lesions often involving theblood vessels, nerves, gastrointestinal tract, ureters and cause corresponding clinicalsymptoms, one of the most common is hydronephrosis and renal insufficiency which iscaused by the fibrous tissue surrounded and oppressed urinary tract. In the past, themainly surgical treatment of RPF is open surgery.Along with the extensive applicationof laparoscopic techniques in the field of surgery, especially urology, the laparoscopicsurgery has opened up a brand new road for the surgical treatment of disease,simultaneously, it has become the trend of surgical treatment.Objective: In this study, we are going to evaluate the clinical effectiveness andvalue of laparoscopic ureterolysis in the treatment of retroperitoneal fibrosis bycomparing the clinical data collected from the retroperitoneal fibrosis patients who hasunderwent laparoscopic or traditional open ureterolysis. The clinical data includingoperative preparing time, operating time, estimated blood loss, recovery of intestinalfunction, ambulation activities after operation,postoperative length of hospital stay,total length of hospital stay.Methods: From September2001to September2010, a total of23patients wereselected in our hospital. All the patients have underwent laparoscopic ureterolysis oropen ureterolysis and confirmed as retroperitoneal fibrosis by pathologicalexamination. According to the surgical approach, they were divided into laparoscopicsurgery(LS)group and open surgery(OS)group. The clinical data of this two groupswere collected respectively, including:①general Informations: gender, age, height,weight, Body Mass Index(BMI).②laboratory tests results: pre and postoperative creatinine, blood urea nitrogen, hemoglobin.③p erioperative data: operative preparingtime,operating time, estimated blood loss, recovery of intestinal function, ambulationactivities after operation,postoperative length of hospital stay, total length of hospitalstay and complications. The data of two groups which list above were comparedrespectively, all statistical analysis was performed using SPSS13.0software,normallydistributed variables were analyzed using the independent sample t-test andnonnormally distributed variables were analyzed using the Wilcoxon rank-sum test.Count variables were analyzed using Fisher’s exact test.All results under the premise ofP<0.05was considered statistically significant.Results：①No significant difference was seen between the two groups in terms of generalInformations and laboratory tests results(P＞0.05).②The estimated blood, recovery of intestinal function, postoperative length ofhospital stay, total length of hospital stay in LS group [59.50(18.00)ml,2.70±0.82d,8.70±1.42d,17.40±5.64d] were all better than those in OS group [100.00(24.00)ml,3.85±1.07d,11.62±3.18d,23.38±5.45d](P＜0.05). The operative preparing time in LSgroup(29.25±11.43min)was longer than that in OS group(19.85±7.36min)(P＜0.05).No statistical significant difference existed between the two groups in the operatingtime[185.00(29.50)min vs.150.00(32.00)min] and ambulation activities after operation(3.40±1.35d vs.4.69±1.84d)(P＞0.05).③No transfusion was required and no serious complication occurred in bothgroups.④No conversion to open surgery case in LS group.⑤Of all the23patients,19patients were followed up,4patients lost to follow-up,the follow-up time was18months.During the follow-up time,4patients appearedcontralateral hydronephrosis due to the fibrosis recurrence, one of them underwentpercutaneous renal puncture nephrostomy, others underwent contralateral ureterolysis,no recurrence in situ and no obstruction were observed of all the followed up patients.Conclusions：The open ureterolysis has been the”gold standard” of surgical treatment of retroperitoneal fibrosis.After compared the laparoscopic ureterolysis andthe open ureterolysis, we found that laparoscopic ureterolysis not only can achieve theaim of release ureter, relieve the obstruction and protect renal function, but also hasadvantages of less blood loss, rapid recovery of intestinal function, shorter hospitalstay;moreover, no complication occurred and no obstruction recurred after operations,but there are also shortcoming of longer operative preparing time.In addition, there isno significant difference existed between two groups in the operating tim, this mayhave business with low incidence of the disease, the number of cases are rare, surgeonexperience accumulated slowly, high requirements on laparoscopic technology ofsurgeon and learning curve of laparoscopic surgery is relatively long. |
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