Yan-Yan Lu

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 Safety and Efficacy of Kanglaite ® (Coix Seed Oil) Injection Combined with Chemotherapy in Treating Patients with Gastric Cancer

OBJECTIVE To observe efficacy and side effects, as well as the impact on quality of life, of Kanglaite® (Coix Seed Oil) injections combined with chemotherapy in the treatment of advanced gastric cancer patiensts. METHOD A consecutive cohort of 60 patients were divided into two groups:the experimental group receiving Kanglaite® Injection combined with chemotherapy and the control group with chemotherapy alone. After more than two courses of treatment, efficacy, quality of life and side effects were evaluated. RESULTS The response rate and KPS score of experimental group were significantly improved as compared with those of the control group(P<0.05). In addition, gastrointestinal reactions and bone marrow suppression were significantly lower than in the control group(P<0.05). CONCLUSIONS Kanglaite® Injection enhanced efficacy and reduced the side effects of chemotherapy, improving quality of life of gastric cancer patients; use of Kanglaite® injections deserves to be further investigated in randomized control clinical trails.

Intrapleural or Intraperitoneal Lobaplatin for Treatment of Patients with Malignant Pleural Effusion or Ascites

AIMS To explore efficacy and side effects of intrapleural or intraperitoneal lobaplatin for treating patients with malignant pleural or peritoneal effusions. METHODS Patients in Jiangsu Cancer Hospital and Research Institute with cytologically confirmed solid tumors complicated with malignant pleural effusion or ascites were enrolled into this study. Lobaplatin (20-30 mg/m2) was intrapleurally or intraperitoneally infused for patients with malignant pleural effusion or ascites. RESULTS From 2012 to 2013, intrapleural or intraperitonea lobaplatin was administered for patients with colorectal or uterus cancer who were previous treated for malignant pleural effusion or ascites. Partial response was achieved for them. Main side effects were nausea/vomiting, and bone marrow suppression. No treatment related deaths occurred. CONCLUSION Intrapleural or intraperitoneal infusion of lobaplatin is a safe treatment for patients with malignant pleural effusion or ascites, and the treatment efficacy is encouraging.

Phase II Study of Pemetrexed as Second or Third Line Combined Chemotherapy in Patients with Colorectal Cancer

PURPOSE To investigate the safety and efficacy of pemetrexed combined with chemotherapy as second or third line in patients with stage IV colorectal cancer (CRC). PATIENTS AND METHODS This trial was conducted to evaluate the effectiveness and safety of pemetrexed given to patients with recurrent or metastatic colorectal carcinoma who previously received 5-FU-based chemotherapy. All patients were required to have a histological diagnosis of colorectal adenocarcinoma with measurable metastatic disease and prior chemotherapy. Patients received pemetrexed at a dose of 500 mg/m2 by 10 minute infusion on day 1, repeated every 21 days. Doses were modified depending on nadir counts. Combined chemotherapy included Oxaliplatin, Irinotecan and cis-platinum. RESULTS Thirty patients were enrolled and twenty-nine were evaluable for response. One patient did not have repeat radiological testing to determine response because he went off study after only one cycle of treatment for economic reasons. For 29 evaluable patients, 1 partial response, 6 stable disease and 22 progressive disease were recorded. Response rate was 3.45% (1/29). All responses occurred in patients receiving a starting dose of pemetrexed 500 mg/m2. Median time to progression for all eligible patients was 2.5 months. The most common toxicities experienced were mild to moderate fever, hepatic damage, myelosuppression, nausea, vomiting, constipation, abdominal pain, diarrhea, and skin rash. CONCLUSION Pemetrexed at 500 mg/m2 given every three weeks combined with chemotherapy is associated with moderate response and good tolerability in patients with stage IV CRC.

Potential predictors of sensitivity to pemetrexed as first-line chemotherapy for patients with advanced non-squamous NSCLCs.

BACKGROUND Pemetrexed (PEM) is effective in first-line treatment for patients with non-squamous non-small cell lung cancer (NSCLC). However there are currently no definitive determinants to certify which patients could benefit from PEM. To improve the efficacy of PEM combined with platinum as first-line therapy for advanced non-squamous NSCLC, we conducted this retrospective study to detect potential determinants of this regimen. METHODS We recruited 109 patients with advanced non-squamous NSCLC who received PEM with a platinum as first-line therapy from June 2006 to February 2013 in Jiangsu Cancer Hospital. Multiple variables (age, sex, smoking, degree of cell differentiation, hemoglobin, platinum drugs combined, positions of metastasis) were selected. Logistic regression analysis was used to analyse relationships between these variables and tumor response. RESULT In univariate analysis, we found that age and platinum significantly influenced the results of PEM therapy (P<0.05). In multivariable analysis, no factors were independently significant. CONCLUSION Our analysis did not suggest that the age, sex, metastasis of liver or other organs, hemoglobin, smoking history and pathological differentiation are associated with the response of PEM. We should conduct further analyses with larger sample size to reconfirm this issue.

Phase II Study on Safety and Efficacy of Yadanzi ® (Javanica oil emulsion injection) Combined with Chemotherapy for Patients with Gastric Cancer

OBJECTIVE To investigate the efficacy and safety of Yadanzi® (Javanica oil emulsion injection) combined with chemotherapy for treatment of patients with advanced gastric cancer. METHODS From January 2011 to December 2012, we recruited 75 patients with advanced gastric cancer, who received javanica oil emulsion injection together with chemotherapy. After two cycles of treatment, efficacy and safety of the combined therapies were evaluated. RESULTS Overall response rate of 75 patients after treatment was 85.3% (CR+PR+SD). Treatment related side effects were recorded. No treatment related death occurred. CONCLUSIONS Javanica oil emulsion injection combined with chemotherapy could be considered as a safe and effective regimen in treating patients with advanced gastric cancer. Further randomized clinical trials should be conducted to confirm whether the addition of Yadanzi® to chemotheraphy could be associated with reduced toxicity, enhanced tolerability and improved quality of life for patients with advanced gastric cancer.

Clinical study on safety and efficacy of Qinin® (cantharidin sodium) injection combined with chemotherapy in treating patients with gastric cancer.

OBJECTIVES To assess the efficacy, side effects, and the impact on quality of life with Qinin® (Cantharidin sodium) injection combined with chemotherapy for gastric cancer patients. METHOD A consecutive cohort of 70 patients were divided into two groups: experimental group with cantharidin sodium injection combined with chemotherapy, while the control group received chemotherapy alone. 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 from that of the control group (P>0.05), but differences were significant in clinical benefit response and KPS score. In addition, gastrointestinal reactions and the incidence of leukopenia were lower than in the control group (P<0.05). CONCLUSIONS Qinin® (Cantharidin sodium) injection combined with chemotherapy enhances clinical benefit response, improving quality of life of gastric cancer patients and reducing side effects of chemotherapy. Thus Qinin® (Cantharidin sodium) injection deserves to be further investigated in randomized control clinical trails.

Pemetrexed as a Component of First-, Second- and Third- line Chemotherapy in Treating Patients with Metastatic Lung Adenocarcinoma

PURPOSE The current research was conducted to investigate the efficacy and safety of pemetrexed given continuously as a basement agent for first-, second- to third line chemotherapy of patients with metastatic lung adenocarcinoma. PATIENTS AND METHODS Patients with metastatic lung adenocarcinoma who were diagnosed in Jiangsu Cancer Hospital and Research Insitute, were enrolled. All received pemetrexed 500 mg/m2 (intravenous; on day 1), and another chemotherapieutic agent every 3 weeks until disease progression, or intolerable toxicity. Then the patients were changed to a second line chemotherapy that was still based on pemetrexed 500 mg/m2 and another chemotherapeutic agent differing from the first line example, until disease progression, or intolerable toxicity. When third line chemotherapy was needed, pemetrexed 500 mg/m2 and another new chemotherapeutic agent were combined until disease progression. Evaluation of efficacy was conducted after two cycles of chemotherapy using the Response Evaluation Criteria for Solid Tumors. Toxicity was recorded according to NCI Criteria for Adverse Events version 3.0. RESULTS From January 2010 to September 2013, 15 patients were enrolled. Their median age was 56 years (range 43 to 77 years). Eight patients were male and 7 female. Five patients (33.3%) achieved PR, while 6 patients (40.0%) remained stable, no CR on first line; and 1 PR (7.7%), 5 stable (38.5%) were recorded when pemetrexed was ordered in second line; 5 patients (41.7%) were stable after pemetrexed was combined in third line; no complete response was observed. Main side effects were grade 1 to 2 neutrophil suppression and thrombocytopenia. Other toxicities included elevated transaminase and oral mucositis, but no treatment related death occurred. CONCLUSIONS Pemetrexed continuously as a basement agent from first-, second- to third line chemotherapy is mildly effective in treating patients with metastatic lung adenocarcinoma with tolerable toxicity.

Phase II Study on Javanica Oil Emulsion Injection (Yadanzi®) Combined with Chemotherapy in Treating Patients with Advanced Lung Adenocarcinoma

PURPOSE To investigate the efficacy and safety of Javanica oil emulsion injection (Yadanzi®) combined with pemetrexed and platinum (PP) for treating patients with advanced lung cancer. PATIENTS AND METHODS From June 2011 to June 2013, we recruited 58 patients with advanced lung cancer, and divided them into two groups. Twenty eight patients received Yadanzi® (from ZheJiang Jiuxu Pharmaceutical Co., Ltd.) together with PP chemotherapy (combined group), while the others were given only PP chemotherapy (control group). After two cycles of treatment, efficacy and safety of treatment were evaluated. RESULTS The overall response rate [(CR+PR+SD)/(CR+PR+SD+PD)] of the combined group was higher than that of control group (89.7% vs. 86.2%, p>0.05). Regarding rate of life improvement, it was 82.8% in combined group, and 51.7% in the control group (p<0.05). In terms of side effects, leukopenia in combined group was less frequent than that in control group (p<0.05). More patients in the control group were found to suffer liver toxicity. CONCLUSIONS Javanica oil emulsion injection combined with chemotherapy could be considered as a safe and effective regimen in treating patients with advanced lung adenocarcinoma. It can improve the quality of life and reduce the possibility of leukopenia. Further clinical trials with a large sample size should be conducted to confirm whether addition of Yadanzi® to chemotherapy could increase the response rate, reduce toxicity, enhance tolerability and improve quality of life for patients with advanced lung cancer.