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Economic Evaluation of Gemcitabine-cisplatin Chemotherapy for Non Small-Cell Lung Cancer Patient in an Outpatient Setting (비용-효과 분석 기법을 이용한 Gemcitabine 외래 항암 치료의 경제성 평가)

  • Min, Su-Hyun;Ko, Su-Kyoung;Lim, Ji-Young
    • Journal of Korean Academy of Nursing
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    • v.38 no.3
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    • pp.363-371
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    • 2008
  • Purpose: This analysis was conducted to evaluate the cost-effectiveness of gemcitabine-cisplatin chemotherapy for non small-cell lung cancer patients in an outpatient setting compared with the traditional inpatient setting. Methods: A cost-effective analysis was conducted from a societal perspective. The effects of treatment, which was measured as an adverse event rate, were abstracted from a published literature search and empirical data from one university hospital. The costs included both direct and indirect costs. Direct costs included hospitalizations, outpatient visits, and lab tests. Pharmaceutical costs were excluded in analysis because they were same for both options. Indirect costs included productivity loss of patients as well as care-givers. In order to determine the robustness of the results, sensitivity analysis on treatment protocol was conducted. Results: Literature search showed no difference in adverse effect rates between inpatient treatment protocol and outpatient treatment protocol. Therefore, this analysis is a cost-minimization analysis. Cost-savings in the outpatient setting was 555,936 won for one treatment cycle. Our sensitivity analysis indicated that the outpatient chemotherapy still showed cost-savings, regardless of changes in treatment protocol. Conclusion: The outpatient gemcitabine-cisplatin chemotherapy for non small-cell lung cancer resulted in cost savings compared to inpatient chemotherapy. More importantly, outpatient chemotherapy could improve the utilization of health service resources in terms of available beds.

Phase II Clinical Study on the GEMOX Regimen as Second-line Therapy for Advanced Ovarian Cancer

  • Yuan, Shao-Fei;Zhang, Lian-Ping;Zhu, Lin-Jia;Chen, Wen-Jun;Zheng, Wei-E;Xiong, Jian-Ping
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.6
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    • pp.3949-3953
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    • 2013
  • Aim: To investigate the effectiveness and adverse effects of gemcitabine by fixed-dose rate infusion plus oxaliplatin (GEMOX regimen) as second-line therapy for advanced ovarian cancer. Methods: 64 patients with advanced ovarian cancer were divided into an experimental group (44 cases) and a control group (20 cases). The experimental group was treated with continuous intravenous infusion of gemcitabine at 1000 $mg/m^2$ with a fixed-dose rate of 10 $mg/m^2/min$, on days 1 and 8 and oxaliplatin at 100 $mg/m^2$ on day 1, IVGTT, repeated every 3 weeks. The control group was treated with intravenous infusion of gemcitabine at 1000 $mg/m^2$ within 30 min on days 1 and and oxaliplatin at 100 $mg/m^2$ on day 1, IVGTT, again repeated every 3 weeks. CT scans or MRI were used for review every 1-2 cycles. Results: The effective rate in the experimental group was significantly high than control group (43.2% vs 35.0%; P < 0.05), with no obvious difference of hematologic or non-hematologic toxicity between the two groups (P > 0.05). Conclusion: GEMOX regimen is very effective to treat advanced ovarian cancer, with low toxicity, good tolerance and improved life quality in patients.

Metastatic Pancreatic Carcinoma and Experience with FOLFIRINOX - a Cross Sectional Analysis From a Developing Country

  • Zahir, Muhammad Nauman;Jabbar, Adnan Abdul
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.6001-6006
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    • 2015
  • Background: Pancreatic cancer is the fourth leading cause of cancer related death with median survival ranging from 3 to 6 months for metastatic disease. Palliative chemotherapy has been the backbone of treatment in advanced stage and has evolved over time. Data pertaining to the disease are scarce from our part of the world where treatment poses a significant challenge due to lack of resources. Materials and Methods: A retrospective chart review was performed for all patients presenting with stage IV pancreatic carcinoma at a tertiary care hospital in Karachi, Pakistan between January 2008 and December 2012. Data were collected using a pre-designed, coded questionnaire looking at patient characteristics, treatment given and outcome. Results: 101 patients were found to be eligible. Mean age was $56.7{\pm}12.8years$, the male to female ratio was 2:1 and most patients had a good performance status. More than half of the tumors were located in the head (57%, n=58) and almost all were adenocarcinomas (95%, n=96). Some 58% (n=59) received first line chemotherapy of which 49% (n=29) received gemcitabine-based regimens and 39% (n=23) received FOLFIRINOX. The median progression free survival for gemcitabine based treatment was 2.9 months (IQR=1.6-5.6) as opposed to 7.3 months (IQR=4.5-9.2) for FOLFIRINOX (P=0.02). Median overall survival was 4.9 months (IQR=2.3-9.5) for first line gemcitabine based treatment and 10.5 months (IQR=7.0-13.2) for first line FOLFIRINOX therapy (P=0.002). Patients on FOLFIRINOX had better survival across all subgroups. Inpatient admissions and dose reductions were more frequent with FOLFIRINOX but the difference between the two regimens was not statistically significant. FOLFIRINOX could be successfully administered as outpatient therapy to a number of patients. Conclusions: FOLFIRINOX remains a suitable first line option in patients with metastatic pancreatic cancer with good performance status even in a resource-poor country where diagnostic and supportive care facilities may be less than optimal and cost is a limitation.

Efficacy and Survival-associated Factors with Gefitinib Combined with Cisplatin and Gemcitabine for Advanced Non-small Cell Lung Cancer

  • Fang, Hong;Lin, Rong-Yan;Sun, Ming-Xia;Wang, Qian;Zhao, Yu-Liang;Yu, Jing-Lin;Tian, Yan;Wang, Xiao-Yun
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.24
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    • pp.10967-10970
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    • 2015
  • Objective: To analyze the efficacy and survival associated factors of gefitinib combined with cisplatin and gemcitabine for advanced non-small cell lung cancer. Materials and Methods: A total of 57 patients with advanced non-small cell lung cancer (NSCLC), who received platinum-based chemotherapy regimens for more than 1 cycle, were treated with gefitinib combined with cisplatin and gemcitabine until disease progression. Efficacy, survival time and adverse reactions were observed. The Kaplan-Meier method was adopted for analysis of survival and Cox regression for associated influencing factors. Results: The patients were followed up until October 31, 2013, and the median follow-up time was 19 months. Of 57 patients, there were 4 (7.0%) with complete remission (CR), 8 (14.0%) with partial remission, 31 (54.4%) with stable disease, and 14 (24.6%) with disease progression. The remission rate was 21.1% and the disease control rate was 75.4%. The median progression-free survival (PFS) time and the median overall survival time were 10 months and 15.2 months. The one-year, two-year and three-year survival rates were 47.4%, 23.3% and 10.0%. Gender and pathological types were the independent risk factors influencing PFS time (P=0.028, P=0.009). Tumor pathological type and early efficacy were independent factors for the prognosis (P=0.018, P=0.000). Adverse reactions were mostly rashes of I~II degree and diarrhea and slightly increasing level of aminopherase. The skin adverse event incidence of III degree or above was 1.8% (1/57) and brain metastasis was foudn in 31.6% (18/57). Conclusions: Gefitinib combined with cisplatin andgemcitabine, is effective for patients with IIIb~IV NSCLC who received multiple cycles of chemotherapy.

Long Term Survivors with Metastatic Pancreatic Cancer Treated with Gemcitabine Alone or Plus Cisplatin: a Retrospective Analysis of an Anatolian Society of Medical Oncology Multicenter Study

  • Inal, Ali;Ciltas, Aydin;Yildiz, Ramazan;Berk, Veli;Kos, F. Tugba;Dane, Faysal;Unek, Ilkay Tugba;Colak, Dilsen;Ozdemir, Nuriye Yildirim;Buyukberber, Suleyman;Gumus, Mahmut;Ozkan, Metin;Isikdogan, Abdurrahman
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.5
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    • pp.1841-1844
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    • 2012
  • Background: The majority of patients with pancreatic cancer present with advanced disease. Systemic chemotherapy has limited impact on overall survival (OS) so that eligible patients should be selected carefully. The aim of this study was to analyze prognostic factors for survival in Turkish advanced pancreatic cancer patients who survived more than one year from the diagnosis of recurrent and/or metastatic disease and receiving gemcitabine (Gem) alone or gemcitabine plus cisplatin (GemCis). Methods: This retrospective evaluation was performed for patients who survived more than one year from the diagnosis of recurrent and/or metastatic disease and who received gemcitabine between December 2005 and August 2011. Twenty-seven potential prognostic variables were chosen for univariate and multivariate analyses to identify prognostic factors associated with survival. Results: Among the 27 variables in univariate analysis, three were identified to have prognostic significance: sex (p = 0.04), peritoneal dissemination (p =0.02) and serum creatinine level (p=0.05). Multivariate analysis by Cox proportional hazard model showed only peritoneal dissemination to be an independent prognostic factor for survival. Conclusion: In conclusion, peritoneal metastasis was identified as an important prognostic factor in metastatic pancreatic cancer patients who survived more than one year from the diagnosis of recurrent and/or metastatic disease and receiving Gem or GemCis. The findings should facilitate pretreatment prediction of survival and can be used for selecting patients for treatment.

Two-Week Combination Chemotherapy with Gemcitabine, High-Dose Folinic Acid and 5 Fluorouracil (GEMFUFOL) as First-Line Treatment of Metastatic Biliary Tract Cancers

  • Unal, Olcun Umit;Oztop, Ilhan;Unek, Ilkay Tugba;Yilmaz, Ahmet Ugur
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.9
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    • pp.5263-5267
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    • 2013
  • Background: The aim of this study was to evaluate the efficacy and tolerability of a gemcitabine, 5-fluorouracil and leucovorin (GEMFUFOL) chemotherapy regimen as first line treatment of metastatic biliary tract cancer. Materials and Methods: All patients received folinic acid $400mg/m^2$ on day 1, 5-fluorouracil bolus $400mg/m^2$ on day 1, IV infusion of 5-fluorouracil $2400mg/m^2$ over 46 hours, and gemcitabine $1250mg/m^2$ on day 1. Results: A total of 29 patients with metastatic biliary tract cancer received GEMFUFOL regimen as the firstline treatment. The mean follow-up was 22.1 months (95%CI, 12.5-31.8). One patient (3.4%) achieved complete response, 5 (17.2%) had partial response, and 4 (13.8%) had stable disease. The median progression-free survival was 3.3 months (95%CI, 2.9-3.7), and the median overall survival was 8.8 months (95%CI, 3.5-14). The 1-year and 2-year survival rates were 58.6% and 30%, respectively. Grade 3 and 4 toxicity included neutropenia in 4 patients (13.7%), thrombocytopenia in 2 (6.8%), anemia2 (6.8%), and alopecia in 1 (3.4%). Two patients (6.8%) developed febrile neutropenia. A dose reduction was achieved in 8 patients (27.6%) while 5 patients had extended-interval dosage (17.2%) for toxicity. Conclusions: The GEMFUFOL chemotherapy regimen was generally efficacious and tolerable as a first-line treatment of metastatic biliary tract cancer.

A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

  • Jeon, Ye Won;Kim, Tae Hyun;Youn, Hyun Jo;Han, Sehwan;Jung, Yongsik;Gwak, Geumhee;Park, Young Sam;Kim, Jeong Soo;Suh, Young Jin
    • Journal of Breast Cancer
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    • v.20 no.4
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    • pp.340-346
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    • 2017
  • Purpose: The current multicenter phase II study was conducted to evaluate the efficacy and safety of the combination of docetaxel and gemcitabine as neoadjuvant chemotherapy (NAC) for locally advanced breast cancer. Methods: A total of 98 patients with stage II-III breast cancer were enrolled. The primary endpoint was pathological complete response (pCR) rate of invasive cancer after the completion of the fourth cycle of NAC. The secondary endpoints included response rate (RR), rate of breast-conserving surgery, toxicity, and disease-free survival (DFS). This study is registered with ClinicalTrials.gov (NCT01352494). Results: pCR in the breast and the axillary lymph node was observed in seven of the 98 enrolled patients (7.1%). The overall clinical RR, including partial responses, was 65.3%. Breast-conserving surgery was performed in 75 of the 98 assessable patients (76.5%). Neutropenia was frequent and was observed in 92 of the 98 patients (93.9%), including grade 3 and 4 in 24 patients (24.5%) and 63 patients (64.3%), respectively. Dose reductions were required for 30 of the 92 patients (32.6%). After a median follow-up of 24 months, the overall DFS of the group was 86.7%. Conclusion: The combination of docetaxel and gemcitabine did not improve pCR. However, this regimen has shown potential as a NAC by producing a reasonable rate of breast-conserving surgery and favorable responses in patients with locally advanced breast cancer. The therapeutic efficacy of this regimen will be determined in additional trials to overcome the limitations of the current study.

Combination of Doxorubicin with Gemcitabine-Incorporated G-Quadruplex Aptamer Showed Synergistic and Selective Anticancer Effect in Breast Cancer Cells

  • Joshi, Mili;Choi, Jong-Soo;Park, Jae-Won;Doh, Kyung-Oh
    • Journal of Microbiology and Biotechnology
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    • v.29 no.11
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    • pp.1799-1805
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    • 2019
  • Doxorubicin (DOX) is one of the most effective anticancer agents used for the treatment of multiple cancers; however, its use is limited by its short half-life and adverse drug reactions, especially cardiotoxicity. In this study, we found that the conjugate of DOX with APTA12 (Gemcitabine incorporated G-quadruplex aptamer) was significantly more cancer selective and cytotoxic than DOX. The conjugate had an affinity for nucleolin, with higher uptake and retention into the cancer cells than those of DOX. Further, it was localized to the nucleus, which is the target site of DOX. Owing to its mechanism of action, DOX has the ability to intercalate into the nucleotides thus making it a suitable drug to form a conjugate with cancer selective aptamers such as APTA12. The conjugation can lead to selectively accumulate in the cancer cells thus decreasing its potential nonspecific as well as cardiotoxic side effects. The aim of this study was to prepare a conjugate of DOX with APTA12 and assess the chemotherapeutic properties of the conjugate specific to cancer cells. The DOX-APTA12 conjugate was prepared by incubation and its cytotoxicity in MCF-10A (non-cancerous mammary cells) and MDA-MB-231 (breast cancer cells) was assessed. The results indicate that DOX-APTA12 conjugate is a potential option for chemotherapy especially for nucleolin expressing breast cancer with reduced doxorubicin associated side effects.

Preparation of Gemcitabine-Loaded Methoxy Poly(ethylene glycol)-b-Poly(L-lactide) Microparticles Using W/O/W Double Emulsion (W/O/W 다중유화법을 이용한 젬시타빈 함유 Methoxy Poly(ethylene glycol)-b-Poly(L-lactide) 미립자 제조)

  • Ryu, Jong-Hoon;Jung, In-Il;Lee, Ji-Eun;Lim, Gio-Bin
    • KSBB Journal
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    • v.26 no.4
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    • pp.333-340
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    • 2011
  • In this study, gemcitabine-loaded methoxy poly(ethylene glycol)-b-poly(L-lactide) (MPEG-PLLA) microparticles with different PEG block lengths were prepared by a W/O/W double emulsion technique. The present study focuses on the investigation of the influence of various preparative parameters such as the ratio of internal water phase and oil phase, polymer concentration, solvent composition of organic phase and salt concentration of external water phase on the morphology and encapsulation efficiency of the microparticles. The microparticles fabricated at high volume ratios of internal water phase to oil phase and at high polymer concentrations showed a relatively high encapsulation efficiency and low porosity. When a dichloromethane/ethyl acetate mixture was used as solvent, both the encapsulation efficiency and drug loading of the microparticles decreased as the level of ethyl acetate increased. The addition of a salt (NaCl) to the external water phase significantly improved the encapsulation efficiency up to 40%, and the microparticles became more spherical with their size and porosity decreased.

Early Detection and Gemcitabine/Cisplatin Combination Positively Effect Survival in Sarcomatoid Carcinoma of the Urinary Bladder

  • Baseskioglu, Barbaros;Duman, Berna Bozkurt;Kara, I. Oguz;Can, Cavit;Yildirim, Mustafa;Acikalin, Mustafa
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.11
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    • pp.5729-5733
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    • 2012
  • Background and Objectives: This study aimed to present the clinicopathological characteristics and treatment of patients with bladder carcinoma with sarcomatoid differentiation at our institution. Methods: Between 1995-2009, 950 patients were followed-up for bladder carcinoma. Among them, 14 patients with sarcomatoid carcinoma were retrospectively reviewed, and their clinical, pathological features and treatment were recorded. Results: Median age of the patients was 65 years (range: 41-86 years), 12 (86%) being male and 2 (14%) female. All the patients presented with hematuria and 11 (88%) had a history of smoking. The tumor growth pattern was solid in 10 patients, papillary in 2, and mixed in 2. In all, 5 of the patients had urothelial carcinoma with sarcomatoid differentiation and 9 were diagnosed with sarcomatoid carcinoma. Five patients underwent radical cystectomy with ileal conduit surgery, 2 patients refused cystectomy, and 8 patients underwent re-TUR. Following diagnosis, 12 of the patients died in mean 10.7 months (range: 1-48 months). Conclusion: Urothelial carcinomas with sarcomatoid features are aggressive and are usually at advanced stage at the time of diagnosis. The outcomes of multimodal treatment are not satisfactory. Significant findings of the present study are that early diagnosis positively affect survival and that gemcitabine and cisplatin in combination can positively affect survival.