Methods
Patients
Patients collected in the present study should meet the following inclusion criteria: (1) The patients were pathologically diagnosed with primary tumor. (2) The collected patients were confirmed as tumors with malignant effusion. (3) The patients did not receive chemotherapy or radiotherapy within the latest two months after the operation treatment. (4) The Karnofsky scores of patients were all over 40 and their expected survival time was more than 3 months. The patients who met the following conditions would be excluded from the present study: (1) Functional impairment of major organs (2) Received cavity injection drugs before the study (3) Age under 18 years. According to the criteria,84 malignant tumor patients at advanced stage wereenrolledin this study between May 2010 and April 2013: 47 patients from Affiliated Zhongshan Hospital of Dalian University, 20 patients from The Third People’s Hospital of Dalian and 17 patients from the Second Affiliated Hospital of Baotou Medical College. Based on diagnosis of histopathology, cytological testing and B-ultrasound or CT examinations, all patients had been confirmed as tumors with malignant effusionand the detail information of the patients was shown in Table 1. This study was approved by the Ethics Committee of Dalian Universityand all patients or their family voluntarily signed informed consents.
Therapeutic methods
The patients were randomly divided into three groups, including monotherapy group (n=31),in which the patients were only given Endostar, combination group (n=29),in which the cases received Endostar combined with cisplatin treatment, and control group (n=24),in which the patients was only treated with cisplatin. The administration of Endostar was according to the previous research results obtained in our team and the related reports [18, 19]. Effusion location was identified by ultrasonographic localization and all patients were under local anesthesia before surgical puncture. Then single lumen central venous catheter was inserted and effusion was thoroughly released through the catheter within 24-48h followed by infusion of drugs into the cavity. The monotherapy and combination group received Endostar respectively, 30mgfor pleural and pericardial cavity and 45mg for abdominal cavity. Endostar was instilled into cavity once every other day for 1 to 2 weeks. Meanwhile, combination group was also instilled 30-40mg/m2 cisplatin after Endostar added 24h and control group was only given 30-40mg/m2 cisplatin. 5mg tropisetron was recommended for premedication and the second day to minimize emetogenic responses. 3 weeks were considered as one cycle of treatment and the whole treatment included five cycles.
Efficacy evaluation
Objective response rate (ORR) was assessed by evaluation of non-target lesion of Response evaluation criteria in solid tumors (RECIST 1.1). The criteria included complete response (CR), partial response (PR) and progressive disease (PD). CR plus PR was defined as ORR. Overall survival (OS) was considered as the time from first treatment to death of patients and progression-free survival (PFS) was analyzed from the beginning of treatment to disease progression or death caused by any result. The analysis was explored until the last day of follow-up in our study. Karnofsky performance status (KPS, 1-100 point) was used to assess the quality of life (QOL) of patients between pre- and post-treatment. After therapy, the increased scores of KPS ≥10 was indicated as improved, the KPS reduction by ≥10 points was considered as a decline, patients with KPS increased or decreased less than 10 points represented as stable. Adverse reactions were evaluated via NCI CTC3.0 criteria, including 0-Ⅳ level.
Statistical data analysis
SPSS 18.0 software (SPSS Inc., Chicago, IL, USA)was used for data analysis and all data were presented as mean ± standard deviation (SD). OS and PFS were evaluated by Kaplan-Meier analysis. The enumeration data were evaluated by χ2test. P<0.05 was considered as statistical significant.