Clinical application of serum tumor associated material (TAM) from non-small cell lung cancer patients.

OBJECTIVE: To explore the associations of serum tumor associated material (TAM) with other common tumor markers like carcinoembryonic antigen (CEA), carbohydrate antigen 125 (CA125), carbohydrate antigen19-9 (CA19-9) and its clinical application in non-small cell lung cancer (NSCLC) patients. METHODS: A total of 87 patients were enrolled into this study, all with histologically or cytologically confirmed NSCLC. With the method of chemical colorimetry, the level of TAM was determined and compared, while chemiluminescence was used to measure the levels of common tumor markers. RESULTS: The level of TAM decreased after chemotherapy compared with before chemotherapy when CT or MRI scans showed disease control. Furthermore, it increased when disease progressed and there was no statistically significant difference in monitoring of TAM and common tumor markers (P>0.05). CONCLUSIONS: Detecting TAM in NSCLC patients has a higher sensitivity and specificity, so it can be used as an indicator for clinical monitoring of lung cancer chemotherapy.

Comparison of serum tumor associated material (TAM) with conventional biomarkers in cancer patients.

OBJECTIVE: To compare expression level of serum tumor associated materials (TAM) with several conventional serum tumor biomarkers, eg., carcinoembryonic antigen (CEA), carbohydrate antigen19-9 (CA19-9), carbohydrate antigen 15-3 (CA15-3), alpha-fetoprotein(AFP), in selected solid tumors. METHODS: Patients diagnosed histologically or cytologically with liver, breast, esophageal, gastric, colorectal or pancreatic cancers were enrolled into this study. After diagnosis, the level of TAM was determined by chemical colorimetry, and levels of conventional tumor markers was measured by chemiluminescence methods. RESULTS: A total of 560 patients were enrolled into this study. No statistically significant difference was detected in TAM and the above mentioned tumor biomarkers in terms of their positivity and negativity (P>0.05). CONCLUSIONS: Detection of TAM in liver, breast, esophageal, gastric, colorectal, and pancreatic cancer patients demonstrates a good accordance with CEA, CA199, CA153, and AFP, thus suggesting that further study is warranted to verify whether TAM could be a surrogate for these conventional biomarkers.

Clinical observations on safety and efficacy of OxyContin® administered by rectal route in treating cancer related pain.

OBJECTIVE: To determine the efficacy and adverse reactions of OxyContin® administered by rectal route in advanced cancer patients. METHODS: Patients were enrolled into this study in which OxyContin was administered by the rectal route. The visual analogue scale (VAS) was applied to score pain intensity, separated into five degrees. National Cancer Institute-Common Toxicity Criteria (NCI-CTC) were adopted to record the side effects. RESULTS: VAS scores were 10 before treatment, and decreased to 5-6 after OxyContin application by the rectal route.The main side effects were constipation, flatulence and fatigue,with no elevation of transaminases and creatinine. CONCLUSION: OxyContin admistered by rectal route is safe for advanced cancer patients with satisfactory pain control effects, thus deserving further clinical observation.

MDR1 gene C3435T polymorphism is associated with clinical outcomes in gastric cancer patients treated with postoperative adjuvant chemotherapy.

OBJECTIVE: To evaluate the impact of the multi-drug resistance 1(MDR1) C3435T polymorphism on clinical outcomes in gastric cancer patients treated with postoperative adjuvant chemotherapy. METHODS: From January 2005 to December 2008, 102 patients with surgically resected gastric cancers were enrolled into this study in the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University. The polymorphism was tested using real time polymerase chain reaction (RT-PCR) cycling probes and the relationship with clinical outcomes after postoperative adjuvant chemotherapy was analyzed by SPSS 17.0. RESULTS: The CT/TT genotype of C3435T was significantly associated with a shorter progression-free survival (PFS) and overall survival (OS) compared with the CC genotype [PFS: adjusted hazard ratio (HR) = 2.01, 95% confidence intervals (CI): 1.17-3.45, P = 0.012; OS: adjusted HR = 2.37, 95% CI: 1.31-4.28, P = 0.004]. TNM stage was also associated with PFS (adjusted HR = 2.33, 95% CI: 1.34-4.05, P = 0.003) and OS (adjusted HR = 2.62, 95% CI: 1.44-4.76, P = 0.002) in gastric cancer patients treated with postoperative adjuvant chemotherapy. CONCLUSION: Our results suggest that the MDR1 gene C3435T polymorphism is associated with clinical outcomes in gastric cancer patients treated with postoperative adjuvant chemotherapy. This now needs to be confirmed by a randomized prospectively controlled study.

Ubenimex capsule improves general performance and chemotherapy related toxicity in advanced gastric cancer cases.

OBJECTIVE: To evaluate the effect of ubenimex capsule on general performance and chemotherapy related toxicity in patients with advanced gastric cancer undergoing chemotherapy. METHODS: Patients with advanced gastric cancer were randomly divided into two groups: with or without ubenimex. All received the following regimen for 2 cycles: docetaxel 40mg/m(2) intravenous infusion on days 1 and 8, cisplatin 15mg/m(2) and tegafur 600mg/m(2) intravenous infusion from days 1 to 5. Oral ubenimex capsule at 30mg daily was continued for 8 weeks from the start of chemotherapy. Study targets included Karnofsky performance status (KPS), body weight, leukocytes, hemoglobin, variation of several immunologic index prior,during and after chemotherapy. RESULTS: Sixty-three patients were recruited into this study, 32 randomly entered into the ubenimex capsule and 31 into the control group. KPS score and body weight after chemotherapy were more stable in the treatment group (P <0.05), and myelosuppression, including reduction of leukocytes, hemoglobin and platelets, was milder (P <0.05). T lymphocytes (CD3 +), T assisted- induced lymphocytes (CD3 +, CD4 +), T suppressor and NK cells (CD16 +, CD56 +) all increased after ubenimex capsule intake, while decreasing in the control group (P <0.05). CONCLUSION: Ubenimex capsule could improve general performance and reduce chemotherapy related toxicity in patients with advanced gastric cancer.

Clinical observation of Endostar® combined with chemotherapy in advanced colorectal cancer patients.

OBJECTIVE: Endostar® (Rh-endostatin injection) is a new recombinant human endostatin developed by Shandong Simcere-Medgenn Bio-Pharmaceutical Co., Ltd in China. This study was performed to evaluate the efficacy and safety of Endostar plus leucovorin calcium/ 5-fluorouracil/oxaliplatin (FOLFOX4) in treating patients with advanced colorectal cancer. METHODS: Thirty-six patients with advanced colorectal cancer were retrospectively assigned to one of two treatment groups: FOLFOX4 (control) or FOLFOX4 plus Endostar (Endostar) according to patient accreditation. The observational end points were overall response rate, overall survival, progression-free survival and toxicity. RESULTS: The response rate and progression-free survival of Endostar were significantly better than those of control group (P <0.05), but significance was not observed for median survival. In addition, gastrointestinal side effects and incidence of leucopenia were not lower than in the control group (P<0.05). CONCLUSIONS: The addition of Endostar to FOLFOX4 resulted in a higher objective response rate and longer time to disease progression. Hypertension and cardiac ischemia were the principal safety concerns, but were manageable. Endostar deserves to be further investigated by randomized controlled clinical trails.

Weekly TP regimen as a postoperative adjuvant chemotherapy for completely resected breast cancer in China: final result of a phase II trial.

OBJECTIVES: To investigate the safety and long-term survival with weekly paclitaxel combined with cisplatin (wTP) as a postoperative adjuvant chemotherapy regimen for breast cancer. METHODS: Patients with breast cancer were treated postoperatively with paclitaxel 40 mg/m2 intravenously on days 1, 8 and 15, cisplatin 25 mg/ m2 also intravenously on days 1,8 and 15, repeated every 21-28 days as a cycle. Toxicity and survival rate were evaluated after chemotherapy. RESULTS: Between September 1993 and August 2001, 20 patients were enrolled. Median age was 52 years (range, 35-71 years). According to the TNM stage system, all patients were staged II or III. Median number of chemotherapy cycles was 3 (range, 1-6), and 10 patients received 4 to 6 cycles of wTP. After a median follow-up of 83 months, 2 deaths and 6 relapses were documented. The five year overall survival rate was 90%. All patients could be evaluated with regard to toxicity. No treatment related deaths were recorded. Neutropenia occurred in 75% of patients during treatment, all recovering after G-CSF injection. Other symptoms included nausea/vomiting, elevation of transaminase, urea nitrogen/creatinine and alopecia. CONCLUSIONS: wTP is safe and effective at the doses tested. However, a randomized clinical trial is needed to compare wTP with other conventional adjuvant regimens of breast cancer postoperatively.

A clinical study on safety and efficacy of Aidi injection combined with chemotherapy.

OBJECTIVE: To observe the efficacy, side effects and impact on the quality of life of Aidi Injection combined with leucovorin calcium/5-fluorouracil/oxaliplatin (FOLFOX4 regimen) in the treatment of advanced colorectal cancer patients. METHODS: A consecutive cohort of 100 patients were divided into two groups: the experimental group was treated with Aidi injection and FOLFOX4 while the control group was only administered FOLFOX4. After more than two courses of treatment, efficacy, quality of life and side effects were evaluated. RESULTS: The response rate of experimental group was not significantly different with that of control group (P>0.05), but differences were significant in clinical benefit response and KPS score. Iin addition, gastrointestinal reaction and the incidence of leukopenia were lower than that of control group (P<0.05). CONCLUSIONS: Aidi injection combined with FOLFOX4 is associated with reduced toxicity of chemotherapy, enhanced clinical benefit response and improved quality of life of patients with advanced colorectal cancer. Aidi injection deserves to be further investigated by randomized control clinical trails.