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Objective To study the guided interstitial implantation of125I seeds combined with S-1 in the treatment of elderly patients with pancreatic cancer treatment in CT, to evaluate the clinical value of the actual.Methods60 cases of elderly patients with pancreatic cancer in Pujiang People's Hospital from January 2013 to December 2016 were selected as the research object in this study.They were randomly divided into two groups, the control group and the experimental group, each with a total of 30 cases.The control group of patients with S-1 in the treatment.The experimental group with,125I implantation combined with S-1 treatment.Comparative analysis of the control group and the experimental group of patients with treatment effect and toxicity.ResultsAfter different treatment, 30 patients in the experimental group, 9 patients were invalid, the total effective number of cases was 21 cases, the effective rate was 70%.The control group of 30 patients, 19 patients were invalid, the total effective number of cases was 11 cases, the effective rate was 36.7%.Therefore, the effective rate of the experimental group was significantly higher than that of the control group, with statistical difference (P<0.05).The disease control rate of the experimental group was 90%, the clinical benefit rate was 50%, the control rate of the patients in the control group was 60%, and the clinical benefit rate was about 23.3%,.The control rate of patientsand the clinical benefit rate of the experimental group was significantly higher than that of the control group, with statistical difference (P<0.05).There was no significant difference between the experimental group and the control group.ConclusionCT guided interstitial implantation of125I seeds combined with S-1 in the treatment of elderly patients with pancreatic cancer can improve the treatment efficiency to a great extent, to help alleviate the suffering of patients, with further clinical promotion and application significance.
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Objective:To analyze the efficacy and safety of targeted drug apatinib combined with tegafur, gimeracil and oteracil capsules (TS-1) in the second-line treatment of advanced gastric mucinous adenocarcinoma. Methods: Totally 48 patients with ad-vanced gastric mucinous adenocarcinoma treated with the second-line regimen were randomly divided into the control group and the treatment group with 24 ones in each. The control group received the chemotherapy of TS-1, and the treatment group received apatinib additionally. The adverse reactions and objective effects were observed. Results:The objective response rate (ORR) was 54. 1% and 33. 3% in the treatment and the control group, respectively. The disease control rate (DCR) was 83. 3% and 54. 2% in the treatment and the control group, respectively. There were significant differences on ORR and DCR in both groups(P<0. 05), while no statisti-cal difference was shown in the adverse reactions (P>0. 05) between the two groups. Conclusion:Apatinib combined with TS-1 ex-hibits evident short-term therapeutic effect on advanced gastric mucinous adenocarcinoma, and the adverse reactions can be tolerated.
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Objective:To analyze the efficacy and safety of targeted drug apatinib combined with tegafur, gimeracil and oteracil capsules (TS-1) in the second-line treatment of advanced gastric mucinous adenocarcinoma. Methods: Totally 48 patients with ad-vanced gastric mucinous adenocarcinoma treated with the second-line regimen were randomly divided into the control group and the treatment group with 24 ones in each. The control group received the chemotherapy of TS-1, and the treatment group received apatinib additionally. The adverse reactions and objective effects were observed. Results:The objective response rate (ORR) was 54. 1% and 33. 3% in the treatment and the control group, respectively. The disease control rate (DCR) was 83. 3% and 54. 2% in the treatment and the control group, respectively. There were significant differences on ORR and DCR in both groups(P<0. 05), while no statisti-cal difference was shown in the adverse reactions (P>0. 05) between the two groups. Conclusion:Apatinib combined with TS-1 ex-hibits evident short-term therapeutic effect on advanced gastric mucinous adenocarcinoma, and the adverse reactions can be tolerated.
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Objective To investigate the effect of Tegafur, Gimeracil and Oteracil Potassium Capsules ( TS-1 ) on peripheral blood tissue polypeptide antigen (TPS), soluble MHC class I chain-related molecules A (sMICA), hypoxia-inducible factor-1 (HIF-1α) and human epidermal growth factor receptor 2 ( Her-2 ) in the treatment of patients with advanced cervical cancer.Methods 80 cases with advanced cervical cancer were selected and divided into two groups, 40 cases in the control group were treated with routine clinical therapy, 40 cases in the experimental group were treated with TS-1.Tumor markers, TPS,sMICA,HIF-1αand Her-2 were compared before and after the treatment.Results Compared with the control group, the levels of tumor antigen TA-4,carcinoembryonic antigen (CEA) and squamous cell carcinoma antigen (SCCA) in the experimental group were lower (P<0.05); the TPS, HIF-1, sMICA and Her-2 were lower (P<0.05), and the total effective rate in the treatment group was higher (P<0.05).Conclusion TS-1 has a obvious clinical efficacy in the treatment of advanced cervical cancer.It is speculated that the possible mechanism may reduce the serum tumor marker levels via reducing the TPS and SMICA, HIF-1 alpha, HER-2 levels.
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Objective To evaluate the effect and toxicity of cyberknife therapy combined with titanium silicalite-1 (TS-1) in treatment of local advanced pancreatic cancer (LAPC). Methods Ninety-five patients with LAPC were divided into two groups: cyberknife group (control group, n=45) received cyberknife therapy only, and combination group (n=50) received cyberknife therapy combined with TS-1. The adjuvant chemotherapy was performed 3 weeks after radiotherapy, and lasted for 4-6 cycles continuously. The effect, side effect, progression-free survival (PFS) and overall survival (OS) were recorded. Results In cyberknife group and combination group, the objective response rates (ORR, CR+PR) were 75.6% and 86.0% (P0.05) respectively. The indexes of total bilirubin and CA19-9 were significantly improved in the both groups after than before treatment with statistical significance (P0.05). In the median follow-up time of 20 months, the median PFS was 10.1 and 11.2 months and the median OS was 15.5 and 16.7 months in cyberknife and combination group, respectively (P>0.05). The incidences of digestive tract adverse reaction and myelosuppression in cyberknife group and combination group were 48.9% and 56.0%, 11.1% and 20.0%, respectively (P>0.05). There was no grade 3-4 serious adverse reaction. Conclusion Cyberknife combined with TS-1 is effective and safe for patients with LAPC, may improve local control rate, effective rate, PFS and OS.
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Objective To investigate the clinical efficacy and safety of two chemotherapy regimens based on oxaliplatin combined with TS-1 or capecitabine in the treatment of advanced colon cancer.Methods 53 advanced colon cancer patients were involved in this study.26 patients were given the regimen of SOX:oxaliplatin (130 mg/m2) was administered intravenously in three hours on day 1,while S-1 (40 mg/m2) was administered orally twice daily for 14 consecutive days.27 patients were given the regimen of XELOX:oxaliplatin capecitabine was administered intravenously in three hours on day 1,while capecitabine (1000 mg/m2)was administered orally twice daily for 14 consecutive days.The regimens were repeated every 3 weeks.The efficacy and toxicy were evaluated after 2 cycles teatment.Results All the 53 patients were eligible for enrollment and the patients were appreciable for efficacy and toxicy.The objective response rates (RR) were 46.1％ (12/26) and 48.1％ (13/27) in the SOX group and XELOX group respectively.The disease control rates (DCR) were 76.9 ％ (20/26) and 74.1％ (20/27).There was no significant difference in RR.The objective side effects associated with the two regimens were bone marrow suppressive,digestive system reaction (diarrhea or vomiting),peripheral neuropathy and hand-foot syndrome on mostly graded 1 or 2.Compared to the XELOX group,nausea vomiting of the SOX group were higher (x2 =4.462,P =0.035),but diarrhea and hand-foot syndrome of XELOX group was obviously higher than that of SOX group [44.4 ％ (12/27) vs.19.2 ％ (5/26) (x2 =4.366,P =0.001),44.4 ％ (12/27) vs.3.8 ％ (1/26) (x2 =11.699,P=0.037)].Conclusion There are no significant difference in the efficacy of the two chemotherapy regimens and the side toxicities are all well tolerable.
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Objective: To evaluate the efficacy and safety of triplecombination therapy with paclitaxel, cisplatin (intra-abdominal administration) and TS-1 in patients with advanced gastric cancer. Methods: Fifty eligible inpatients with advanced gastric cancer were recruited between January 2008 and January 2011 and treated with triple-combination therapy with paclitaxel (intravenous administration), cisplatin (intra-abdominal administration) and TS-1 (oral administration). The short-term response and adverse reactions were evaluated. The average follow-up time was 11.4 months. The PFS (progression-free survival) and OS (overall survival) were calculated. Results: Of 50 patients, 5 patients achieved complete response and 23 patients achieved partial response, and the objective response rate was 56%. The median PFS was 6.0 months (95% confidence interval: 3.4-8.6 months) and the median OS was 13.0 months (95% confidence interval: 7.9-18.1 months). The major adverse reactions were gastrointestinal reactions, hematologic toxicities and fatigue. Most of these adverse reactions were grades II Grades II adverse reactions were observed in three patients (one had serious vomiting, two had liver dysfunction). The bowel obstruction was relieved after two cycles of chemotherapy in 2 patients who had incomplete bowel obstruction before chemotherapy, and the chemotherapy-associated bowel obstruction after two cycles of chemotherapy occurred in another patient who had no bowel obstruction before chemotherapy. Conclusion: The triple combination therapy with paclitaxel, cisplatin and TS-1 demonstrates benefits in short-term response and the survival for patients with advanced gastric cancer, and it is also well-tolerated. © 2012 by Tumor.
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PURPOSE: Titanium silicate (TS)-1 chemotherapy has been widely used against gastric cancer in Japan. The aim of the present study was to assess the efficacy and hematological safety of TS-1 as treatment for advanced and recurrent gastric cancer. METHODS: From September 2006 to February 2011, 51 advanced or recurrent gastric cancers were treated with TS-1. One course of treatment consisted of 40, 50, or 60 mg/m2 of TS-1 twice a day for 28 days, followed by withdrawal for two weeks. The primary end point was progression-free survival (PFS), and the secondary end point was overall survival (OS). RESULTS: The disease control rate was 39.2% (complete response, 0/51; partial response, 6/51; stable disease, 14/51; progressive disease, 23/51; not evaluable, 8/51). The median PFS was 4.0 months (95% confidence interval [CI], 2.2 to 5.7); the median PFS of the advanced group was 6.0 months (95% CI, 2.8 to 9.1), and the median PFS of the recurrent group was 3.0 months (95% CI, 1.8 to 4.1). The median OS was 11.0 months (95% CI, 6.3 to 15.6); the median OS of the advanced group was 10.0 months (95% CI, 4.9 to 15.0), and the median OS of the recurrent group was 14.0 months (95% CI, 4.1 to 23.8). Grade 3 or 4 hematological toxicity occurred in three patients (5.9%), anemia occurred in two patients (3.9%), and thrombocytopenia occurred in one patient (2%). CONCLUSION: TS-1 chemotherapy was safe and effective, with relatively long PFS and OS in patients with advanced and recurrent gastric cancers.
Subject(s)
Humans , Anemia , Disease-Free Survival , Japan , Silicates , Stomach Neoplasms , Thrombocytopenia , TitaniumABSTRACT
TS-1 is an oral anti-cancer agent for gastric cancer with a high response rate and low toxicity. We report a case of long-term drug retention of TS-1 causing interstitial lung disease (ILD) as a fatal adverse reaction. A 65-year-old woman underwent a total gastrectomy with pathologic confirmation of gastric adenocarcinoma. She received 6 cycles of TS-1 and low-dose cisplatin for post-operative adjuvant chemotherapy followed by single-agent maintenance therapy with TS-1. After 8 months, the patient complained of a productive cough with sputum and mild dyspnea. A pulmonary evaluation revealed diffuse ILD in the lung fields, bilaterally. In spite of discontinuing chemotherapy and the administration of corticosteroids, the pulmonary symptoms did not improve, and the patient died of pulmonary failure. TS-1-induced ILD can be caused by long-term drug retention that alters the lung parenchyma irreversibly, the outcome of which can be life-threatening. Pulmonary evaluation for early detection of disease is recommended.
Subject(s)
Aged , Female , Humans , Adenocarcinoma , Adrenal Cortex Hormones , Chemotherapy, Adjuvant , Cisplatin , Cough , Dyspnea , Early Diagnosis , Gastrectomy , Lung , Lung Diseases, Interstitial , Retention, Psychology , Silicates , Sputum , Stomach Neoplasms , TitaniumABSTRACT
Implementation of the ICH E2E Guideline is based on the Notification dated September 16, 2005 concerning pharmacovigilance planning. The E2E Guideline requires post-marketing safety measures, observational studies, and clinical trials to be performed according to the profile of a particular drug.<br> Development of specific pharmacovigilance plans has remained incomplete because of the limited available experience on which planning can be based.<br> Examples of safety measures taken, observational studies, and clinical trials conducted with the anticancer drug TS-1 are explained from the view point of the E2E Guideline.<br> Important risks identified after the market launch of TS-1 include a significant difference from similar drugs in adverse drug reaction profile, contraindication of concomitant medication with 5-FU-containing drugs due to interactions, and an increase in side effects resulting from renal disorders. Examples of missing information include lack of data on concomitant medication with other anticancer drugs and on the efficacy and safety of post-operative medication. Data on long-term medication were also lacking. How these issues were addressed will be explained.<br> Plans for post-marketing safety measures, observational studies, and clinical trials cannot be standardized; risks and other specific factors for each particular drug need to be taken into consideration.
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PURPOSE: Although several chemotherapy regimens used against advanced gastric cancer (AGC) have been studied extensively in an attempt to further improve the prognosis of patients, to date, no standard chemotherapeutic regimens have been established. The aim of this study was to determine the anti-tumor efficacy and safety of TS-1 or TS-1 plus cisplatin (CDDP). MATERIAL AND METHODS: We treated 78 patients with AGC either with 80 mg/m2 of TS-1 for 28 days, which was followed by a 2-week rest, or with 80 mg/m2 of TS-1 for 21 days and 60 mg/m2 of CDDP on day 8 every 5 weeks. RESULTS: Tumor response rates in the neoadjuvant chemotherapy group and in the recurrent or post-palliative surgery group were 87.5% and 32.4%, respectively, and they were 28.6% and 48.4%, respectively, in the TS-1 group and the TS-1 plus CDDP group. The survival rates in the recurrent and the post-palliative surgery group were significantly different according to the degree of tumor response (P=0.0016), but the one-year survival rates according to the kinds of regimens (TS-1 or TS-1/CDDP group) were not significantly different. The incidences of grade 3 or 4 adverse effects in the TS-1 and the TS-1/CDDP groups were 14.3% and 36.8%, respectively. CONCLUSION: The anti-tumor efficacy and safety of TS-1 and TS-1 plus CDDP in Korean patients with AGC seemed to be high with modest adverse effects, thus suggesting the possible use of this regimen as a standard chemotherapy for gastric cancer.
Subject(s)
Humans , Cisplatin , Drug Therapy , Incidence , Prognosis , Stomach Neoplasms , Survival RateABSTRACT
Warfarin is one of the most commonly used oral anticoagulant. It is well established that a wide range of drugs, including the anticancer drug 5-fluorouracil, interact with warfarin; this results in altered coagulation parameters and bleeding sequelae. To date, any drug interaction between warfarin and TS-1 has not been reported on. A 58-yr old woman visited emergency department with gross hematuria and soft tissue swelling involving her left thigh and buttock. She had been diagnosed as having advanced colon cancer (Duke's classification D); she had undergone right hemicolectomy and partial hepatectomy, and she had received 5-FU/leucovorin chemotherapy two years prior to admission. Recurrent disease was revealed in the liver and lungs, and so 6 cycles of FOLFIRI (5-FU, leucovorin and irinotecan) chemotherapy were given. Follow-up abdominal CT scan showed progressive disease and then TS-1 oral chemotherapy was started. She took warfarin 2mg per day because of partial thrombosis in the lower inferior vena cava and left ovarian vein. The initial laboratory tests revealed a prothrombin time of 120 seconds and an international normalized ratio of 35. Fresh frozen plasma and a parenteral vitamin K injection were given. After resorption of the subcutaneous hematoma, warfarin was restarted at a dose of 1mg per day. This case shows the significant increased bleeding tendency following the combined administration of warfarin and TS-1. Because of the potential severity of this interaction, close monitoring of the coagulation parameters is recommended for patients receiving warfarin together with TS-1.