117 cases of advanced malignancies treated with recombinant human endostatin plus chemotherapy

Objective: The aim of this study was to evaluate the recent efficacy and adverse reactions of recombinant human endostatin (Endostar) plus chemotherapy in the treatment of advanced malignancies. Methods: One hundred and seventeen cases of advanced malignancies were diagnosed and confirmed by histopathological examination, patients were treated with Endostar combined with chemotherapeutic drugs with no cross-resistance. Evaluate the efficacy and adverse reactions after finished two cycles of combination therapy. Results: All the 117 cases of patients were evaluated according to relevant standards, and there were 12 cases of complete remission (CR), 30 cases of partial remission (PR), 58 cases of stable disease (SD), 17 cases of progressive disease (PD). The response rate (RR) was 35.8%, disease control rate (DCR) was 85.4%. Conclusion: The protocol of Endostar combined with chemotherapy could improve the quality of life of patients with malignances, it also has the advantage of low toxicity. Considering the time span of the study, the long-term efficacy remains to be observed.

Oral Xeloda plus bi-platinu two-way combined chemotherapy in treatment of advanced gastrointestinal malignancies

AIM： To compare the effect, adverse events, cost-effectiveness and dose intensity （DI） of oral Xeloda vs calcium folinate （CF）/5-FU combination chemotherapy in patients with advanced gastrointestinal malignancies, both combined with bi-platinu two-way chemotherapy.METHODS： A total of 131 patients were enrolled and randomly selected to receive either oral Xeloda （X group） or CF/5-FU （control group）. Oral Xeloda 1 000 mg/m^2 was administered twice daily from d 1 to 14 in X group, while CF 200 mg/m^2 was taken as a 2-h intravenous infusion followed by 5-FU 600 mg/m^2 intravenously for 4-6 h on d 1-5 in control group. Cisplatin and oxaliplatin were administered in the same way to both the groups： cisplatin 60-80 mg/m^2 by hyperthermic intraperitoneal administration, and oxaliplatin 130 mg/m^2 intravenouslyfor 2 h on d 1. All the drugs were recycled every 21 d, with at least two cycles. Pyridoxine 50 mg was given t.i.d. orally for prophylaxis of the hand-foot syndrome （HFS）. Then the effect, adverse events, cost-effectiveness and DI of the two groups were evaluated.RESULTS： Hundred and fourteen cases （87.0%） finished more than two chemotherapy cycles. The overall response rate of them was 52.5% （X group） and 42.4% （control group） respectively. Tumor progression time （TTP） was 7.35 mo vs5.95 too, and 1-year survival rate was 53.1% vs 44.5%. There was a remarkable statistical significance of TTP and 1-year survival between the two groups. The main Xelocla-related adverse events were myelosuppression, gastrointestinal toxicity, neurotoxicity and HFS, which were mild and well tolerable. Therefore, no patients withdrew from the study due to side effects before two chemotherapy cycles were finished. Both groups finished pre-arranged DI and the relative DI was nearly 1.0. The average cost for 1 patient in one cycle was ￥9 137.35 （X group） and ￥8 961.72 （control group）, or US ＄1 100.89 in X group and ＄1 079.73 in control group. To add 1% to the response rate costs ￥ 161.44 vs ￥210.37 respectively （US ＄19.45 vs ＄25.35）. One-month prolongation of TTP costs ￥1 243.18 vs ￥1 506.17 （US ＄149.78 vs ＄181.47）. Escalation of 1% of 1-year survival costs ￥172.74 vs ￥201.64 （US ＄20.75 vs ＄24.29）. CONCLUSION： Oral Xeloda combined with bi-platinu two-way combination chemotherapy is efficient and tolerable for patients with advanced gastrointestinal malignancies; meanwhile the expenditure is similar to that of CF/5-FU combined with bi-platinu chemotherapy, and will be cheaper if we are concerned about the increase of the response rate, TTP or 1-year-survival rate pharmacoeconomically.

Clinical significance of serum vascular endothelial growth factor in advanced malignant tumors

Objective： To elucidate the clinical significance of serum vascular endothelial growth factor （VEGF） level in pa- tients with advanced cancer. Methods： Enzyme linked immunosorbent assay （ELISA） was used to determine the serum VEGF concentration in 40 patients with advanced cancer [non-small cell rung cancer （NSCLC）, esophageal cancer （EC） and nasopharyngeal carcinoma （NPC）] before and after chemotherapy and 10 healthy volunteers as control group. Results： The serum VEGF concentrations in 40 cases of advanced cancer patients were significantly higher than those of 10 healthy control cases [（477.07 ± 374.10 ） pg/mL vs （139.09 ± 133.41 ） pg/mL; P = 0.016]. The serum VEGF concentrations in patients with NSCLC, EC and NPC were （518.53 _± 378.99） pg/mL, （399.21 ± 393.69） pg/mL and （500.68 ± 348.48） pg/mL, respectively. The differences were all statistically significant as compared with healthy control group （P values were 0.011,0.044 and 0.019, respectively）. The serum VEGF concentrations of the patients in response to chemotherapy was significantly lower than those of the same patients before they undergoing chemotherapy [（400.41 ± 332.84） pg/mL vs （777.10 ± 666.01） pg/mL; P = 0.034]. Conclusion： The serum VEGF level might be a novel and promising tumor marker of advanced malignancies and a predictor of disease progression, prognosis and therapeutic efficacy,

VARIOUS DOSES OF CISPLATIN (DDP) COMBINED WITH MULTI-DRUG CHEMOTHERAPY FOR ADVANCED MALIGNANT SOLID TUMOR

Two hundred and thirty-six patinets with various advanced malignant solid tumors treated by combined chemotherapy with routine doses of cisplatin (DDP) from 1980 to 1986 are presented. According to different doses of cisplatin everyday, the patients were divided into 4 groups: (1) 20 ing/day×4- 5, 80 cases; (2) 30 mg day × 3 - 5, 91 cases; (3) 40 mg/ day 3 -4, 37 cases; (4) 50 mg/day×2 - 3, 28 cases. Each group was repeated for 3 weeks. The effect and toxicity were analysed and compared with 22 cases treated by single DDP in 1975. The response (CR+PR) rate was 39.2% in 194 evaluated patients. The response rate was similar in group 20 mg and single DDP (29.2% and 27.3%). Ths response rate was lower than that of group 30 mg, 40 mg, and 50 mg 43.4% and 50%) (P<0.05). The remissions in various groups were not significantly different.The toxicity of combined chemotherapy was not severe. 91.1% of patients had nausea and vomiting. There was no statistical difference in the various groups. Bone marrow suppresion was less in single DDP group than that of combined chemotherapy group (P<0.05), DDP 30-50 mg 1/d×5-3 was better than HD-DDP in some patients.

Survival benefit with extended lymphadenectomy for advanced renal malignancy: A population-based analysis

Objective:We used population-based data to examine the possible benefit of extended lymphadenectomy for patients with renal malignancy in the setting of more advanced disease.Methods:The Surveillance,Epidemiology,and End Results(SEER)database was utilized to identify non-metastatic,T3-T4 renal cancer patients from 2004-2015 treated with removal of≥1 lymph node at the time of nephrectomy.Non-parametric bivariate statistics were used to assess associations between covariates of interest and extended lymphadenectomy(≥10 lymph nodes removed).Cancer-specific survival(CSS)and overall survival(OS)benefit was evaluated using Kaplane-Meier analysis.Results:Of the 4397 patients identified,816(18.6%)underwent extended lymphadenectomy.For patients with T3a disease,5-year CSS and OS benefit with extended lymphadenectomy did not reach statistical significance(CSS:hazard ratio[HR]0.98,95%confidence interval[CI]0.77-1.24;OS:HR 0.96,95%CI 0.77-1.20).Conversely,for those with T3b-T3c disease,extended lymphadenectomy led to statistically significant improvements in both 5-year CSS and OS compared to non-extended lymphadenectomy(CSS:HR 0.78,95%CI 0.61-0.99;OS:HR 0.72,95%CI 0.58-0.90).Finally,for those with T4 disease,use of extended lymphadenectomy had OS benefit after 5 years(OS:HR 0.51,HR 0.29-0.90,p = 0.02).Conclusion:Based on population-level data,extended lymphadenectomy was associated with improved survival in select patients with advanced renal malignancy treated with surgical nephrectomy.Understanding the basis of these real-world findings in the face of conflicting randomized trial results will be key,moving forward.

An open-labeled, randomized, multicenter phase Ⅱa study of gambogic acid injection for advanced malignant tumors

Background Gambogic acid is a pure active compound isolated from the traditional Chinese medicinal plant gamboge （Garcinia morella Desv.）. Based on the preliminary results of a phase I study, this phase Ila study compared the efficacy and safety of different dosage schedules of gambogic acid in patients with advanced malignant tumors. Methods Patients with advanced or metastases cancer who had not received any effective routine conventional treatment or who had failed to respond to the existing conventional treatment were randomly assigned to receive either 45 mg/m2 gambogic acid intravenously from Days 1 to 5 of a 2-week cycle （Group A）, or 45 mg/m2 every other day for a total of five times during a 2-week cycle （Group B）. The primary endpoint was objective response rate （ORR）. Results Twenty-one patients assigned to Group A and 26 to Group B were included in the final analysis. The ORRs were 14.3% in Group A and 0% in Group B. It was not possible to analyze the significant difference because one of the values was zero. The disease control rates （DCRs） were 76.2% in Group A and 61.5% in Group B （P=0.0456）. The observed adverse reactions were mostly Grades I and II, and occurred in most patients after administration of the trial drug. There was no significant difference in the incidence of adverse reactions between the two arms. Conclusions The preliminary results of this phase Ila exploratory study suggest that gambogic acid has a favorable safety profile when administered at 45 mg/m2. The DCR was greater in patients receiving gambogic acid on Days 1-5 of a 2-week cycle, but the incidence of adverse reactions was similar irrespective of the administration schedule.

Craniofacial resection of advanced oral and maxillofacial malignant tumors

Objective To evaluate the clinical outcome of craniofacial resection for advanced malignant tumors in oral and maxillofacial regions.Methods Forty-six patients who underwent craniofacial resection for malignancies involving the anterior and middle cranial fossa over a 20-year period between June 1978 and December 1997 at our department were evaluated. Twenty patients received radiation therapy and an adjuvant therapy after the operation. Eleven patients received chemotherapy of various types as an adjuvant therapy.Results The 3- and 5-year survival rates were 48.8% (20/41) and 35.1% (13/37), respectively, while the 10-year survival rate was 20% (4/20).Conclusions Our results revealed good prospects of using craniofacial resection on patients with advanced malignancies in the oral and maxillofacial regions.

A NEW EXPERIMENTAL AND CLINICAL APPROACH OF COMBINING USAGE OF HIGHLY ACTIVE TUMOR-INFILTRATING LYMPHOCYTES AND HIGHLY SENSITIVE ANTITUMOR DRUGS FOR THE ADVANCED MALIGNANT TUMOR

In recent years, tumor-nfiltrating lymphocytes (TILs) have been reported to be effective for tumors in experimental and clinical research. In order to increase the therapeutical effect, we modified some steps of Rosenberg's approach a. cold digestion with collagenase at 4C for 24 hours; b. sedimentation instead of centrifugation; c. elimination of tumor cells before the cultivation procedure. Compared with the original approach, the proliferation, activity and cytotoxicity of TILs obtained by the modified procedure were much improved. TILs' expansion-old was greater than that with the original approach. Cytotoxicity against rumor cells was more potent. Increased TILs' subsets were CD3 and CD8 cells. Meanwhile, we took tumor cells from tumor tissues to test their in vitro chemosensitivities to different drugs in order to select highly sensitive antitumor drugs for treatment of cases with advanced tumors. According to the design of using highly active TILs and highly sensitive drugs (H & H therapy), preliminary clinical results of 50 cases showed higher response rates than those in treatment with TIL / IL2, LAK / 1L2 and TIL+IL2+CTX. Less toxic side effects were observed in 14 patients.

Clinical Study on Effect of Kang'aibao Oral Liquid(抗癌宝口服液) in Treating 103 Patients of Malignant Tumor

Objective: To observe the clinical efficacy of Kang'aibao oral liquid (KABL), a Chinese herbal preparation in treating malignant tumor of middle or advanced stage. Methods: A comparative study was done by observing the effect of 103 patients treated with KABL, and another 90 patients treated with chemotherapy at the same time were taken as the control group.Results: The immunologic function, short term effective rate (complete relieved rate and partial relieved rate), survival quality, 1 , 2 and 3 year survival rate, median survival time, and carcinoembryonic antigen (CEA) declining rate of the KABL group were significantly higher than those of the control group. Conclusion: KABL has the effects of inhibiting tumor growth, prolonging survival time and improving survival quality of tumor patients.