Search

Objective: To explore the efficacy and safety of real-world eribulin in the treatment of metastatic breast cancer. Methods: From December 2019 to December 2020, patients with advanced breast cancer were selected from Beijing Chaoyang District Sanhuan Cancer Hospital, Shandong Cancer Hospital, Peking University Cancer Hospital, Baotou Cancer Hospital, Shengjing Hospital Affiliated to China Medical University, and Cancer Hospital of Chinese Academy of Medical Sciences. Kaplan-Meier method and Log rank test were used for survival analysis, and Cox regression model was used for multivariate analysis. Results: The median progression-free survival (PFS) of 77 patients was 5 months, the objective response rate (ORR) was 33.8%, and the disease control rate (DCR) was 71.4%. The ORR of patients with triple-negative breast cancer was 23.1%, and the DCR was 57.7%; the ORR of patients with Luminal breast cancer was 40.0%, and the DCR was 77.8%; the ORR of patients with HER-2 overexpression breast cancer was 33.3%, and the DCR was 83.3%. ORR of 50.0% and DCR of 66.7% for patients treated with eribulin as first to second line treatment, ORR of 29.4% and DCR of 76.5% for patients treated with third to fourth line and ORR of 28.6% and DCR of 71.4% for patients treated with five to eleven line. The ORR of patients in the eribulin monotherapy group was 40.0% and the DCR was 66.0%; the ORR of patients in the combination chemotherapy or targeted therapy group was 22.2% and the DCR was 81.5%. Patients with a history of treatment with paclitaxel, docetaxel, or albumin paclitaxel during the adjuvant phase or after recurrent metastasis had an ORR of 32.9% and a DCR of 69.9% when treated with eribulin. The treatment efficacy is an independent prognostic factor affecting patient survival ( P <0.001). The main adverse reactions in the whole group of patients were Grade Ⅲ-Ⅳ neutrophil decline [29.9% (23/77)], and other adverse reactions were Grade Ⅲ-Ⅳ fatigue [5.2% (4/77)], Grade Ⅲ-Ⅳ peripheral nerve abnormality [2.6% (2/77)] and Grade Ⅲ-Ⅳ alopecia [2.6% (2/77)]. Conclusions: Eribulin still has good antitumor activity against various molecular subtypes of breast cancer and advanced breast cancer that has failed multiple lines of chemotherapy, and the adverse effects can be controlled, so it has a good clinical application value.

Objective: To evaluate the clinical efficacy and safety of recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine in patients with HER2 positive metastatic breast cancer. Methods: Patients were randomized 2∶1 to test group and control group. Patients in test group received Cipterbin (4 mg/kg loading dose and 2 mg/kg maintenance dose each week, IV) combined with vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV). Patients in control group received vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV).The primary end point was progression free survival (PFS). Results: A total of 315 patients were enrolled from Jan 2009 to Jan 2013 (212 in test group and 103 in control group). The median PFS of test group was significantly longer than that of control group, 39.1 weeks vs 14.0 weeks ( HR =0.24; 95 %CI , 0.16-0.36; P< 0.000 1). The objective response rate (ORR) and disease control rate (DCR) in test group were significantly higher than those in control group, ORR was 46.7% vs 18.45% ( P< 0.000 1) and DCR was 79.72% vs 45.63% ( P< 0.000 1). The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.The most common adverse events associated with Cipterbin were infusion reactions. Left ventricular ejection fraction reduced to less than 50% in 5 patients, which were recovered. No serious cardiotoxicity. Conclusion: The recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine has significant efficacy and good safety. It is the optimized therapy regime for patients with taxane-pretreated HER2 positive metastatic breast cancer, which provides more targeted therapy opportunities for HER2 positive breast cancer patients in China.

Objective: Pyrotinib, a novel irreversible pan-ErbB receptor tyrosine kinase inhibitor, showed promising antitumor activity and acceptable tolerability in phase II and phase III randomized clinical trials. We assessed the activity and safety of oral pyrotinib for human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer patients in the real world., Methods: We retrospectively analyzed 72 HER2 positive metastatic breast cancer (MBC) patients who received oral pyrotinib based regimens at Beijing Cancer Hospital and other four hospitals (Peking University First Hospital, China-Japan Friendship Hospital, General Hospital of PLA, Peking University Third Hospital) from August 2018 to September 2019. Progression free survival (PFS), objective response rate (ORR), adverse events (AE) of pyrotinib were investigated., Results: Seventy-two patients with HER2 positive MBC were enrolled. The median age of the patients was 55 years (range: 32-79 years). Sixty-nine (95.8%) patients had received anti-HER2 treatment in the metastatic and/or (neo) adjuvant settings; 61 (84.7%) patients had received anti-HER2 treatments in the metastatic setting in terms of trastuzumab 56 (77.8%) patients, lapatinib 36 (50.0%) patients, and T-DM1 4 (5.6%) patients. Among these 72 patients who received oral pyrotinib based regimens, 62 (86.1%) patients received pyrotinib (±trastuzumab) in combination with chemotherapy, 6 (8.3%) patients received pyrotinib (± trastuzumab) in combination with endocrine therapy and 4 (5.6%) patients received pyrotinib (±trastuzumab). Sixty-five (90.3%) patients received 400 mg pyrotinib once daily as initial dose, and 7 (9.7%) patients received 320 mg. OBJECTIVE response and safety to pyrotinib based therapy were evaluable in all the 72 patients. One (1.4%) patient achieved complete response (CR), 18 (25.0%) patients achieved partial response (PR), 41 (56.9%) patients had stable disease (SD), and 12 (16.7%) patients had progressive disease (PD). The ORR (CR+PR) was 26.4% and the median PFS was 7.6 months (95%CI: 5.5-9.7 months). Among the 36 patients with prior lapatinib therapy, the median PFS was 7.9 months (95%CI: 4.1-11.7 months). Among the 15 patients with brain metastasis, the median PFS was 6.0 months (95%CI: 2.2-9.8 months). The main toxicities related to pyrotinib were diarrhea in 57 (79.2%) cases, and 48 (66.7%) cases with grade 1-2 as well as 9 (12.5%) cases with grade 3., Conclusion: Pyrotinib based therapy is an effective treatment for patients with HER2 positive MBC, including patients with lapatinib treatment failure and brain metastasis, and the toxicities can be tolerated.

Objective: To detect the proportion of lymphocyte subsets in peripheral blood of the advanced breast cancer patients before and after chemotherapy with docetaxel and thiotepa, as well as the association between the proportion of peripheral blood lymphocyte subsets with the response rate and prognosis., Methods: The proportions of lymphocyte subsets (CD3+ T cell, CD3+/CD4+ T cell, CD3+/CD8+ T cell, CD3-/CD16+56+ NK cell, CD3+/CD16+56+ T cell, CD19+ B cell, CD4+/CD25+ T cell, CD8+/CD28- T cell, CD8+/CD28+ T cell) in the peripheral blood of 86 patients were analyzed with flowcytometry before and after chemotherapy. The result was analyzed in combination with clinicopathological data., Results: The proportion of regulatory T cells (Treg) after chemotherapy in the disease control patients decreased significantly compared with that of the progressive patients (P=0.034). The difference of the proportions of Treg before and after chemotherapy affected significantly the overall survival (OS). The OS of the patients with decreased proportion of Treg was significantly longer than that of the patients with increased proportion of Treg, which was 23.5 and 9.4 months respectively (P<0.05)., Conclusion: The patients with decreased proportion of Treg after chemotherapy had higher response rate and better survival benefit.

Objective: To analyze the efficiency of diuretic renography in the management of unilateral ureteropelvic junction obstruction (UPJO) patients, by observing the affected kidney relative renal function (RRF) and drainage in the period of follow-up., Methods: In the study, 76 patients diagnosed as unilateral UPJO were retrospectively collected. Diuretic renography was performed on all the patients initially, and during the period of follow-up. No morphological or functional abnormalities were detected on the contralateral kidney. Changes of affected renal RRF and drainage were observed during the follow-up period. The correlations of initial RRF (RRFinitial) and drainage type with RRF improvement were analyzed., Results: In the operative group (57 cases), the RRFinitial of affected kidney was 40.81%±12.96%, and the RRF in the last follow-up (RRFrecent) was 44.63%±13.21% (P<0.05). Drainage improvements was found in 54.00% of the obstructive patients (27/50), and unchanged in 71.43% of the non-obstructive patients (5/7). In the conservative group (19 cases), the RRFinitial was 46.47%±12.84%, and the RRFrecent was 46.95%±11.86% (P>0.05). One obstructive patient (1/10) was found with improved drainage, and the other 9 obstructive patients (9/10) and all of the non-obstructive patients (9/9) were observed with unchanged drainage. Four patients with deteriorated RRF in the conservative group received surgery. There were no significant differences in the changes of affected renal RRF in different RRFinitial and drainage types in both operative and conservative groups., Conclusion: Diuretic renography could be effectively applied in the follow-up of unilateral UPJO patients. Operation could improve affected kidney's RRF, and better some patients' drainage conditions. However, for those patients with no or minor clinical symptoms, conservative management could be accepted if RRF remains stable during the period of follow up.

Objective: To perform Multiple Linear Regression analysis of X-ray measurement and WOMAC scores of knee osteoarthritis, and to analyze their relationship with clinical and biomechanical concepts., Methods: From March 2011 to July 2011, 140 patients (250 knees) were reviewed, including 132 knees in the left and 118 knees in the right; ranging in age from 40 to 71 years, with an average of 54.68 years. The MB-RULER measurement software was applied to measure femoral angle, tibial angle, femorotibial angle, joint gap angle from antero-posterir and lateral position of X-rays. The WOMAC scores were also collected. Then multiple regression equations was applied for the linear regression analysis of correlation between the X-ray measurement and WOMAC scores., Results: There was statistical significance in the regression equation of AP X-rays value and WOMAC scores (P<0.05), while there was no statistical significance in the regression equation of lateral X-ray value and WOMAC scores (P>0.05)., Conclusion: 1) X-ray measurement of knee joint can reflect the WOMAC scores to a certain extent. 2) It is necessary to measure the X-ray mechanical axis of knee, which is important for diagnosis and treatment of osteoarthritis. 3) The correlation between tibial angle,joint gap angle on antero-posterior X-ray and WOMAC scores is significant, which can be used to assess the functional recovery of patients before and after treatment.

Objective: To test for circulating tumor cells (CTCs) relying on epithelial cellular adhesion molecule (EpCAM) expression in metastatic breast cancer by quantitative real-time reverse transcription-PCR., Methods: In the study,47 metastatic breast cancer patients were evaluated by quantitative real-time PCR for detecting EpCAM mRNA. In addition, analyses were carried out for their correlation with patients' clinicopathologic features, response, and the time to progression (TTP)., Results: The sensitivity of EpCAM mRNA in the metastatic breast cancer patients was about 40%. However, the specificity of EpCAM mRNA for 20 healthy controls was 100%. TTP was calculated, and compared with that between EpCAM mRNA-positive and EpCAM mRNA-negative groups. For the retrospective study, the median TTP was 7.1 months and 11.1 months (P=0.013) for patients with EpCAM mRNA-positive and EpCAM mRNA-negative, respectively, after the first cycle chemotherapy. Moreover, a statistically significant correlation was demonstrated between EpCAM mRNA and TTP in patients who underwent the first or the second-line chemotherapy (P=0.018), but there was no significance in the patients pretreated with two or more previous chemotherapy lines (P=0.471)., Conclusion: This study provides evidence of the presence of EpCAM mRNA in approximately 40% of patients with metastatic breast cancer. There is a strong correlation between EpCAM mRNA results after the first cycle therapy and TTP in metastatic breast cancer patients, and EpCAM mRNA positive after chemotherapy may predict shorter TTP.

Objective: To compare the temperature distribution of both sides of shoulder, provide objective reference for the application thermoview in the diagnosis of cervicodynia in teenagers., Methods: Forty-five adolescents with cervicodynias from March 2009 to December 2009 were collected. There were 23 males and 22 females, with an average age of 21 years (ranged from 19 to 22 years). The course of disease ranged from 2 to 20 weeks (averaged 13 weeks). C7 horizontal line were used to divide the back into the neck area and shoulders area, and the midline to subdivide the chosen area into left and right area. Thermal infrared imaging was used to observe the temperature both sides of neck and shoulders, the data was analyzed by the computer., Results: The temperature of shoulder was higher than neck. There were significant differences in the highest and average temperature both of the left and right side of neck and shoulder (P < 0.05), but no difference in the lowest temperature both of left and right side of neck., Conclusion: The thermal infrared imaging is important for diagnosing cervical imbalance syndrome, finding the sign of abnormal muscle metabolism of shoulder and providing the basis for prevention.

Objective: To infect dendritic cells (DC) by recombinant human adeno-associated virus (rh-AAV) vector with CEA gene to generate antigen-specific CTL cells in vitro and to assay the CEA specific cytotoxic T lymphocyte(CTL), response to CD44(+)CD24(-/low) breast cancer stem cells., Methods: Peripheral blood mononuclear cells were induced to generate DCs by cytokines interleukin-4(IL-4), granulocyte-macrophage colony-stimulating factor(GM-CSF)and tumor necrosis factor-alpha(TNF-α) while T lymphocytes were cultured with cytokines interleukin-2(IL-2). DCs were infected by CEA gene containing rh-AAV. After being matured, DCs were co-cultured with T cells to generate CTL cells. CD44(+)CD24(-/low) breast cancer stem cells were sorted out from MCF-7 and MDA-MB-231 cells. CEA specific CTL response to CD44(+)CD24(-/low) breast cancer stem cells was assayed by MTT method., Results: The percentages of CD44(+)CD24(-/low) breast cancer stem cells subsets in MCF-7 and MDA-MB-231 were 5.1% and 76.3% respectively. DCs transfected with CEA gene could induce CEA antigen CTLs response. The killing ratio of MCF-7 cells in CEA gene transfection group was 46.5% plusmn; 15.0% with significant difference (P=0.009) as compared with that of CEA gene untransfection group. As for CD44(+)CD24(-/low) breast cancer stem cells subset from MCF-7 cells, CEA gene transfection group resulted in a higher killing ratio of 44.7% ± 28.2% as compared with that of CEA untransfection group. While the inhibitory rate of non-breast cancer stem cells subset from MCF-7 cells in CEA gene transfection group was 50.6% ± 22.2% (P=0.05). CTL cells generated by DCs transfected with CEA gene did not show inhibitory activity to MDA-MB-231 breast cancer cells (without CEA expression) as compared with CEA gene untransfection group. It was the same in CD44(+)CD24(-/low) breast cancer stem cells subset and non-breast cancer stem cells subset from MDA-MB-231 breast cancer cells (P>0.05)., Conclusion: DCs infected by rh-AAV with CEA gene could induce antigen-specific CTL response to kill CEA expressing breast cancer cells involved in CD44(+)CD24(-/low) breast cancer stem cells subset. It suggests that immune therapy might be a potential treatment of breast cancer stem cells.

Objective: To evaluate the efficacy and safety of docetaxel plus thiotepa(TXT/TSPA) and docetaxel plus capecitabine(TXT/CAPE) in patients with metastatic breast cancer., Methods: The patients were randomized to give intravenous TXT 35 mg/m2 on days 1 and 8 plus intravenous TSPA 60-65 mg/m(2) on day 1 every 3 weeks, or intravenous TXT 35 mg/m(2) on days 1 and 8 plus oral CAPE 1 000 mg/m(2) twice daily on days 1 to 14 every 3 weeks, at least 2 cycles applied., Results: TXT/TSPA group (22 patients) and TXT/CAPE group (24 patients) had consistent baseline. Docetaxel thiotepa group (21 cases) and docetaxel combined with capecitabine group (22 cases) were evaluated for their clinical responses, which showed that 2 of the 21 (9.52%) from TXT/TSPA group and 6 of the 22 (27.27%) from TXT/CAPE group had achieved partial remission; 11 of the 21 (52.38%) from TXT/TSPA group versus 7 of the 22 (31.82%) from TXT/CAPE group for stable diseases; 8 of the 21 (38.10%) from TXT/TSPA group versus and 9 of the 22 (40.91%) from TXT/CAPE group for progressive diseases, respectively. The disease control rate was 61.90% (13/21) and 59.09% (13/22) for TXT/TSPA and TXT/CAPE groups, the median progression-free survival(PFS) was 7.9 months [95% confidence interval(CI) 0.77 to 15.03] from TXT/TSPA group versus 8.3 months (95% CI 4.01 to 11.79) from TXT/CAPE group. One year survival rate was 88.20% for TXT/TSPA versus 81.00% for TXT/CAPE group, respectively. P values all exceeded 0.05, and the two groups showed no difference. No chemotherapy-related deaths occurred. Myelosuppression was the major side effect. The adverse events of grades 3 to 4 respectively occurred in TXT/TSPA and TXT/CAPE groups:leucocytopenia was 45.45% vs. 26.09%; neutropenia 45.45% vs. 21.74%; thrombocytopenia 9.09% vs. 0%; hand-foot syndrome 0% vs. 13.04%. P values all exceeded 0.05, and the two groups showed no difference., Conclusion: Combination of docetaxel and thiotepa in the treatment of metastatic breast cancer has some curative effect and adverse reactions can be tolerated. It can be used as an economical and effective rescue plan.

Objective: To evaluate the efficacy, survival and toxicity in patients with brain metastases from non-small cell lung cancer (NSCLC), treated with concurrent systemic chemotherapy and whole brain radiation therapy (WBRT) or sequential systemic chemotherapy/WBRT., Methods: A total of 60 NSCLC patients with brain metastases were divided into two groups in this prospective clinical study: concurrent systemic chemotherapy and WBRT group (concurrent group) and sequential systemic chemotherapy/WBRT group (sequential group)., Results: Of 59 assessable patients, the overall response rate was 22.0%, and the brain response rate was 35.6%; the median progression-free survival time was 3.0 months, and the overall 1- and 2-year survival rates were 55% and 24.4%, respectively, with a median survival time of 16.0 months. The overall response rate was 20.0% in the concurrent group and 24.1% in sequential group (P > 0.05). The brain response rates of 43.3% in concurrent group and 27.6% in sequential group were also not significantly different (P > 0.05). The median progression-free survival time for the patients in the concurrent group was 3.0 months versus 4.0 months in the sequential group, and the median survival time was 16.0 months versus 13.0 months (all P > 0.05). The 1- and 2-year survival rates were 58.5% and 37.2% versus 52.9% and 18.9%, respectively, with a significant difference in the 2-year survival rate between the two groups (P = 0.011). In the sequential group, leukopenia was more frequent during chemotherapy than that in the concurrent group (P = 0.029)., Conclusion: Concurrent systemic chemotherapy and WBRT is effective with tolerable adverse events in treating brain metastasis from NSCLC with an encouraging survival, and deserves further large sample and randomized multicenter clinical trials.

Objective: To investigate the expression status of Sonic Hedgehog signaling genes and molecules in human hepatocellular carcinomas(HCC), and to explore the relationship between these genes and clinical prognosis., Methods: HCC tissue and adjacent normal tissue from 29 HCC patients were assayed for the expression of hedgehog signaling genes by reverse transcription-polymerase chain reaction chain reaction (RT-PCR) techniques and for the expression of hedgehog signaling molecules by immunohistochemistry. The expressions of Shh, Ptch, Smoh, Gli-1 mRNA were assayed as well as Shh, Ptch proteins in 29 cases of HCC and in 29 liver tissues adjacent to the tumor., Results: Expression of Shh mRNA was detectable in about 51% of HCCs examined. Consistent with this, hedgehog target genes Ptch, Smoh and Gli-1 mRNA were expressed in over 68%, 48% and 62% of the tumors, respectively, and the expressions of Shh and Ptch proteins in HCC tumor tissues correlated with those of Shh and Ptch mRNA in tumor tissues (P=0.041 and P=0.035). This suggested that the hedgehog pathway was frequently activated in HCCs. The simultaneous expression of Gli-1 in HCC and liver tissues adjacent to the tumor had significantly relationship with poor prognosis., Conclusion: Hedgehog signaling activation is an important event for development of human HCCs. It also suggests that markers for hedgehog signaling activation may be useful for the determination of prognosis.

Objective: To isolate and identify breast cancer initiating cells (CD44(+)/CD24(-/low) cells) in breast cancer cell lines MCF-7 and MDA-MB-231, and to evaluate the activity of the Hedgehog signaling pathway in different subpopulations., Methods: CD44+/CD24(-/low) subpopulation and non-CD44+/CD24(-/low) subpopulation from breast cancer cell lines of MCF-7 and MDA-MB-231 were separated by fluorescence-activated cell sorting (FACS). Laser Scanning Confocal Microscope was used to identify CD44+/CD24(-/low) cells. Reverse transcription-polymerase chain reaction (RT-PCR) was employed to analyze the expression of Human Patched gene (PTCH), Sonic Hedgehog (SHH), glioma-associated oncogene homoglog-1(GIi-1), smoothened homolog (SMOH) and GAPDH of CD44+/CD24(-/low) subpopulation and non-CD44+/CD24(-/low) subpopulation from MCF-7 and MDA-MB-231., Results: The CD44+/CD24(-/low) subpopulation in MCF-7 and MDA-MB-231 cell lines were (1.70+/-1.43)% and (94.2+/-1.2)% respectively. The Hedgehog signaling pathways were active in CD44+/CD24(-/low) subpopulation of MCF-7 and MDA-MB-231 cell lines. The expression of transcription factor GIi-1, which was downstream components of the hedgehog pathway, was assayed and the results showed that the level of GIi-1 mRNA of CD44+/CD24(-/low) cells was much higher than that of non-CD44+/CD24(-/low) cells (P = 0.007 in MCF-7, and 0.005 in MDA-MB-231)., Conclusion: Breast cancer initiating cells (CD44+/CD24(-/low) subpopulation) exist in MCF-7 and MDA-MB-231 cell lines. The Hedgehog signaling pathway is active in the subpopulation of MCF-7 and MDA-MB-231 cell lines.

Objective: To evaluate the effect and side effects of CD34+ originated dendritic cells (DCs) infusion to treat malignant effusions., Methods: Twenty-three patients with 26 malignant effusions received chemotherapy and granulocyte colony-stimulating factor (G-CSF) or G-CSF alone to mobilize peripheral blood hematopoietic stem cells. CD34+ stem cells were induced to differentiate into DCs by cytokines interleukin 4 (IL-4), granulocyte-macrophage colony stimulating factor (GM-CSF), and tumor necrosis factor-alpha (TNF-alpha). After being cultured for 10 to 14 days to stimulate proliferation and grow mature, DCs were refused into the body cavity by drainage tube weekly for 3 weeks., Results: The response rate was 54% (14/26) and the benefit rate 81%. The median duration of response was 20 weeks (range:4-45 weeks). Karnofsky performance score (KPS) was improved in 15 patients. The response rate was 50% for the naive patients and 57% for the refractory patients. There were no severe side-effects., Conclusion: This pilot study demonstrates that DCs derived in vitro can exist viably after intropleural injection and can mediate biologic activity to malignant effusions. DCs immunotherapy is promising to treat malignant effusions with good tolerance.

The outer space Saposhnikovia divaricata of the fourth generation was studied and compared with the ground group and comparison group for the first time. The intensity of carbonyl absorption peak at 1640 cm(-1) is stronger than the other two, indicating that chromone content was enhanced obviously. The peaks at 2927 and 2856 cm(-1) were assigned to --CH2-- groups, the peak at 1050 cm(-1) was due to the C-O groups, and the intensities at 2927, 2856 and 1050 cm(-1) were stronger than other samples, indicating that polysaccharide and glycoside contents were enhanced obviously. The intensity of lactone absorption peak at 1743 cm(-1) was stronger than the ground group and weaker than the comparison, indicating that coumarin content was higher than ground group and lower than the comparison. The major components and the structures remained intact, and the effective component contents were enhanced in the outer space Saposhnikovia divaricata. Using FTIR can analyse and characterize the intrinsic quality of the outer space medicinal materials.

Background & Objective: Advanced pancreatic cancer has a poor prognosis. Gemcitabine (GEM) can improve the quality of life of pancreatic cancer patients. However, the efficacy of gemcitabine-based combination chemotherapy is uncertain. This study was to compare the efficacy of GEM-based combination therapy and GEM alone on advanced pancreatic cancer., Methods: Clinical data of 40 patients with pathologically or clinically diagnosed advanced pancreatic cancer were analyzed. Of the 40 patients, 15 were treated with GEM (1,000 mg/m(2)) alone weekly for 7 weeks followed by a 2-week rest, then received cycles of 3-week administration with 1-week rest; 25 were treated with GEM (1,000 mg/m(2)) weekly for 2 weeks plus 5-fluorouracil (5-FU) (425-600 mg/m(2)) as bolus at Day 1-5 or 120-hour infusion every 21 days, or cisplatin (DDP) (30-37.5 mg/m(2)) at Day 1-2 every 21 days, or oxaliplatin (85-130 mg/m(2)) at Day 1 every 21 days, or capecitabine (1,000 mg/m(2)) twice a day at Day 1-14 every 21 days, respectively. The survival was analyzed by Kaplan-Meier method. Median time to progression (mTTP), clinical benefit response (CBR), disease control rate, median overall survival (mOS) and toxicity were assessed according to World Health Organization criteria., Results: The rate of CBR was 56.0% in GEM-combination group and 46.7% in GEM alone group. There were no significant differences in disease control rate, mOS, CBR, and adverse events between the two groups (all P>0.05). However, for the patients with stage III-IV advanced pancreatic cancer, the disease control rate was higher in GEM-combination group than in GEM alone group (75.0% vs. 45.5%, P=0.13)., Conclusion: GEM-combination regimens and GEM alone have similar efficacy, and lead to similar clinical benefit response and mOS for the patients with advanced pancreatic cancer.

Objective: To investigate the response rate (RR), time to tumor progression (TTP), quality of life (QOL) and adverse reaction in the treatment of pretreated advanced non-small cell lung cancer (NSCLC) using escalated doses of rh-endostatin (YH-16), and to determine the optimal dose for clinical application., Methods: In this phase II randomized, controlled, multicenter trial, the patients were randomly divided into two groups to receive daily 3 hours intravenous infusion of either 7.5 mg x m(-2) or 15 mg/m(2) YH-16 for 28 days., Results: Totally, 68 patients were entered and 60 patients were evaluable. There were no differences in RR (3.0% in both groups, P > 0.05), median TTP (ITT: 60 days versus 71 days, P > 0.05), QOL and incidence rate of adverse reactions (48.6% versus 38.7%, P > 0.05). No significant unexpected adverse events were observed., Conclusion: Rh-endostatin may have anti-tumor activity with high clinical benefit rate and is well tolerated in pretreated advanced NSCLC patients. The dose of 7.5 mg x (m(2))(-1) x d(-1) is clinically recommended.

Objective: To evaluate the efficacy and safety of domestic Gemcitabine in the treatment of patients with stage IIIB approximately IV non-small cell lung cancer (NSCLC)., Methods: 124 NSCLC patients were randomized into three groups: Group A: single drug group, 40 cases, gemcitabine 1 000 mg/m(2) + NS 100 ml or 200 ml was infused within 30 approximately 60 minutes on D1, 8 and 15, with 28 days taken as one cycle. Group B: combined treatment group, 36 cases, in addition to the above protocol, cisplatin 30 mg/m(2) was infused within 60 approximately 120 min, on D1, 2 and 3. Group C: combined control group: 39 cases, the protocol applied was the same as group B except domestic gemcitabine being replaced by imported gemzar. The efficacy and side effects of treatment were evaluated after 8 weeks of treatment., Results: 115 patients could be evaluated for response rate. PR was observed in 9/40 (22.5%) of group A, 15/36 (41.6%) in group B and 15/39 (38.36%) in group C. There was no significant difference of PR rates between group B and group C (P = 0.552). 117 patients who received the second cycle of treatment were evaluated for toxicity. The incidence of grade III approximately IV nausea, vomiting and loss of appetite was much higher in group B. Hematological toxicity of groups B and C was higher than that of group A. There was no significant difference between groups B and C., Conclusion: The efficacy and incidence of side effects between domestic gemcitabine and the imported gemzar are similar.

Background & Objective: Oxaliplatin is effective for the advanced colorectal cancer (CRC) as a second-line drug; however, the efficiency and adverse reaction of oxaliplatin made in China are not yet clear. The aim of this project was to evaluate the efficacy and the toxicities of oxaliplatin made in China in the treatment of the patients with advanced CRC who were resistant to 5-fluorouracil (5-Fu)., Methods: The previously 5-FU-resistant patients with CRC were treated with single agent of oxaliplatin 130 mg/m(2), i.v., d1, repeated every 3 weeks., Results: A total of 31 cases with advanced CRC resistant to 5-Fu were enrolled, and 28 cases were valuable for efficacy assessment. One patient reached complete response (CR), 3 reached partial response (PR), and the overall response rate was 14.29% (with ITT equal to 12.9%). The major adverse effects were mild neuro-sensory toxicity, mild myelosuppression,and nausea/vomiting., Conclusion: The oxaliplatin made in China is effective in the treatment of advanced CRC resistant to 5-Fu, and the adverse effects are mild.