• Title/Summary/Keyword: clinical benefit rates

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Comparative Analysis of Endovascular Stroke Therapy Using Urokinase, Penumbra System and Retrievable (Solitare) Stent

  • Choi, Jae-Hyung;Park, Hyun-Seok;Kim, Dae-Hyun;Cha, Jae-Kwan;Huh, Jae-Taeck;Kang, Myongjin
    • Journal of Korean Neurosurgical Society
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    • v.57 no.5
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    • pp.342-349
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    • 2015
  • Background : Higher reperfusion rates have been established with endovascular treatment for acute ischemic stroke patients. There are limited data on the comparative performance of mechanical thrombectomy devices. This study aimed to analyse the efficacy and safety of the stent retriever device (Solitaire stent) by comparing procedure time, angiographic outcome, complication rate and long term clinical outcome with previous chemical thrombolysis and mechanical thrombectomy using penumbra system. Method : A retrospective single-center analysis was undertaken of all consecutive patients who underwent chemical thrombolysis and mechanical thrombectomy using Penumbra or Solitaire stent retriever from March 2009 to March 2014. Baseline characteristics, rate of successful recanalization (modified Thrombolysis in Cerebral Infarction score 2b-3), symptomatic intracerebral hemorrhage, procedure time, mortality and independent functional outcomes ($mRS{\leq}2$) at 3 month were compared across the three method. Results : Our cohort included 164 patients, mechanical thrombectomy using stent retriever device had a significant impact on recanalization rate and functional independence at 3 months. In unadjusted analysis mechanical thrombectomy using Solitaire stent retriever showed higher recanalization rate than Penumbra system and chemical thrombolysis (75% vs. 64.2% vs. 49.4%, p=0.03) and higher rate of functional independence at 3 month (53.1% vs. 37.7% vs. 35.4%, p=0.213). In view of the interrelationships between all predictors of variables associated with a good clinical outcome, when the chemical thrombolysis was used as a reference, in multiple logistic regression analysis, the use of Solitaire stent retriever showed higher odds of independent functional outcome [odds ratio (OR) 2.62, 95% confidence interval (CI) 0.96-7.17; p=0.061] in comparison with penumbra system (OR 1.57, 95% CI 0.63-3.90; p=0.331). Conclusion : Our initial data suggest that mechanical thrombectomy using stent retriever is superior to the mechanical thrombectomy using penumbra system and conventional chemical thrombolysis in achieving higher rates of reperfusion and better outcomes. Randomized clinical trials are needed to establish the actual benefit to specific patient populations.

Comparative Effectiveness of Risk-adapted Surveillance vs Retroperitoneal Lymph Node Dissection in Clinical Stage I Nonseminomatous Germ Cell Testicular Cancer: A Retrospective Follow-up Study of 81 Patients

  • Fan, Gang;Zhang, Lin;Yi, Lu;Jiang, Zhi-Qiang;Ke, Yang;Wang, Xiao-Shan;Xiong, Ying-Ying;Han, Wei-Qin;Zhou, Xiao;Liu, Chun;Yu, Xie
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.8
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    • pp.3267-3272
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    • 2015
  • Purpose: To retrospective assess the potential predictors for relapse and create an effective clinical mode for surveillance after orchidectomy in clinical stage I non-seminomatous germ cell testicular tumors (CSI-NSGCTs). Materials and Methods: We analyzed data for CSI-NSGCTs patients with non-lymphatic vascular invasion, %ECa < 50% (percentage of embryonal carcinoma < 50%), and negative or declining tumor markers to their half-life following orchidectomy (defined as low-risk patients); these patients were recruited from four Chinese centers between January 1999 and October 2013. Patients were divided into active surveillance group and retroperitoneal lymph node dissection (RPLND) group according to different therapeutic methods after radical orchidectomy was performed. The disease-free survival rates (DFSR) and overall survival rates (OSR) of the two groups were compared by Kaplan-Meier analysis. Results: A total of 121 patients with CSI-NSGCT were collected from four centers, and 81 low-risk patients, including 54 with active surveillance and 27 with RPLND, were enrolled at last. The median follow-up duration was 66.2 (range 6-164) months in the RPLND group and 65.9 (range 8-179) months in the surveillance group. OSR was 100% in active surveillance and RPLND groups, and DFSR was 89.8% and 87.0%, respectively. No significant difference was observed between these two groups ($X_2=0.108$, P=0.743). No significant difference was observed between the patients with a low percentage of embryonal carcinoma (<50%) and those without embryonal carcinoma (87.0% and 91.9%, $X_2=0.154$, P=0.645). No treatment-related complications were observed in the active surveillance group whereas minor and major complications were observed in 13.0% and 26.1% of the RPLND group, respectively. Conclusions: Active surveillance resulted in similar DFSR and OSR compared with RPLND in our trial. Patients with low-risk CSI-NSGCTs could benefit from risk-adapted surveillance after these patients were subjected to radical orchidectomy.

The Comparison of Survival Rates of Postoperative Adjuvant Chemotherapies in The Stage III Gastric Cancer Patients (3기 위암환자에서 시행한 술 후 보조항암화학요법들의 생존율 비교)

  • Kim, Eun-Mi;Kim, Se-Won;Kim, Sang-Woon;Song, Sun-Kyo
    • Journal of Yeungnam Medical Science
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    • v.23 no.2
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    • pp.193-204
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    • 2006
  • Purpose: Various postoperative adjuvant chemotherapy regimens have been proposed for the patients with advanced gastric cancer. The majority of clinical trials have shown no significant difference in the survival benefit. The aim of this study was to compare the survival rates of postoperative adjuvant chemotherapies used in stage III gastric cancer patients who received curative gastrectomy. Materials and Methods: Between 1990 and 1999, a survival analysis was performed in 260 patients who received curative gastric resection and postoperative adjuvant chemotherapy. The patients were divided into four groups according to the chemotherapeutic regimens received. The groups were: the F group: furtulon alone, FM group: furtulon and mitomycin, FAM group: 5-FU, adriamycin and mitomycin, FLEP group: 5-FU, leucovorin, etoposide and cisplatin. The survival rates were analyzed using the Kaplan-Meier method and the Cox proportional hazards model. Results: There were no differences among the groups of patients with regard to tumor characteristics except for lymph node metastasis and the ratio of metastasis to lymph nodes. In the FLEP group, the ratio of metastasis to lymph nodes was higher than in the other groups. The five and ten year survival rates of F, FM, FAM and FLEP were 51.9%, 28.9%, 59.5%, 49.8%, 66.1%, 57.4% and 30.0%, 27.5%, respectively. The univariate analysis showed that age, Borrmann type, lymph node metastasis, ratio of metastasis to lymph nodes, postoperative adjuvant chemotherapy and recurrence were significant factors for survival. For the multivariate analysis, recurrence, age, Borrmann type, ratio of lymph node metastasis and lymph node dissection were independent prognostic factors; however, the postoperative adjuvant chemotherapy was not an independent prognostic factor. Conclusion: The FAM regimen was the most beneficial postoperative adjuvant chemotherapy for improved survival rates; the FM regimen was the second and the FLEP regimen was the last. In order to determine the effectiveness of postoperative adjuvant chemotherapy in stage III gastric cancer, well designed prospective studies including a surgery only group will be needed.

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Pichia pastoris: A Recombinant Microfactory for Antibodies and Human Membrane Proteins

  • Goncalves, A.M.;Pedro, A.Q.;Maia, C.;Sousa, F.;Queiroz, J.A.;Passarinha, L.A.
    • Journal of Microbiology and Biotechnology
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    • v.23 no.5
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    • pp.587-601
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    • 2013
  • During the last few decades, it has become evident that the compatibility of the yeast biochemical environment with the ability to process and translate the RNA transcript, along with its capacity to modify a translated protein, are relevant requirements for selecting this host cell for protein expression in several pharmaceutical and clinical applications. In particular, Pichia pastoris is used as an industrial host for recombinant protein and metabolite production, showing a powerful capacity to meet required biomolecular target production levels in high-throughput assays for functional genomics and drug screening. In addition, there is a great advantage to using P. pastoris for protein secretion, even at high molecular weights, since the recovery and purification steps are simplified owing to relatively low levels of endogenous proteins in the extracellular medium. Clearly, no single microexpression system can provide all of the desired properties for human protein production. Moreover, chemical and physical bioprocess parameters, including culture medium formulation, temperature, pH, agitation, aeration rates, induction, and feeding strategies, can highly influence product yield and quality. In order to benefit from the currently available wide range of biosynthesis strategies using P. pastoris, this mini review focuses on the developments and technological fermentation achievements, providing both a comparative and an overall integration analysis. The main aim is to highlight the relevance and versatility of the P. pastoris biosystem to the design of more cost-effective microfactories to meet the increasing demands for recombinant membrane proteins and clinical antibodies for several therapeutic applications.

Utility of PET in follow-up of patients with colorectal cancer (대장 직장암 환자의 수술 후 추적 관찰에서 PET의 유용성)

  • Ryu, Young-Hoon;Yun, Mi-Jin;Lee, Jong-Doo
    • 대한핵의학회:학술대회논문집
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    • 2002.05a
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    • pp.17-24
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    • 2002
  • Recurrence of colorectal cancer after apparently curative resection remains common, with reported relapse rates of up to 40%. Because complete resection of solitary metastases or local recurrence may improve long-term survival, surgical management of such cases has become increasingly aggressive but has led to only modest survival benefit. The limitations of current approaches based on structural imaging are well documented, with over half of the patients who are thought suitable for curative surgery being found to have unresectable disease at operation. Therefore, better preoperative assessment is crucial. The increasing use of FDG-PET as an oncologic staging investigation has significantly improved the assessment of patients with suspected colorectal cancer recurrence. Several studios show that substantial and largely appropriate changes in patient management occur, often soaring patients the significant morbidity and mortality associated with aggressive but futile therapies while also saving scarce community resources. Nevertheless, the clinical relevance of these findings has still been questioned. The utility of PET in routine clinical practice will likely depend on its ability to provide incremental information compared with CT in selected patients rather than to serve as a replacement for CT. In conclusion, in patients with suspected recurrent or metastatic colorectal carcinoma, FDG-PET should be performed (1) when there is rising carcinoembryonic antigen levels in the absence of a known source, (2) to increase the specificity of structural imaging when there is an equivocal lesion, and (3) as a screening method for the entire body in the preoperative staging before curative resection of recurrent disease.

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Pemetrexed Continuation Maintenance versus Conventional Platinum-Based Doublet Chemotherapy in EGFR-Negative Lung Adenocarcinoma: Retrospective Analysis

  • Paik, Seung Sook;Hwang, In Kyoung;Park, Myung Jae;Lee, Seung Hyeun
    • Tuberculosis and Respiratory Diseases
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    • v.81 no.2
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    • pp.148-155
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    • 2018
  • Background: Although targeted therapy and immuno-oncology have shifted the treatment paradigm for lung cancer, platinum-based combination is still the standard of care for advanced non-small cell lung cancer (NSCLC). Pemetrexed continuation maintenance therapy has been approved and increasingly used for patients with nonsquamous NSCLC. However, the efficacy of this strategy has not been proven in patients without driving mutations. The objective of this study was to compare the clinical benefit of pemetrexed continuation maintenance to conventional platinum-based doublet in epidermal growth factor receptor (EGFR)-negative lung adenocarcinoma. Methods: A total of 114 patients with EGFR-negative lung adenocarcinoma who were treated with platinum doublet were retrospectively enrolled. We compared the survival rates between patients received pemetrexed maintenance after four-cycled pemetrexed/cisplatin and those received at least four-cycled platinum doublet without maintenance chemotherapy as a first-line treatment. Results: Forty-one patients received pemetrexed maintenance and 73 received conventional platinum doublet. Median progression-free survival (PFS), which was defined as the time from the day of response evaluation after four cycles of chemotherapy to disease progression or death, was significantly higher in the pemetrexed maintenance group compared to conventional group (5.8 months vs. 2.2 months, p<0.001). Median overall survival showed an increasing trend in the pemetrexed maintenance group (22.3 months vs. 16.1 months, p=0.098). Multivariate analyses showed that pemetrexed maintenance chemotherapy was associated with better PFS (hazard ratio, 0.73; 95% confidence interval, 0.15-0.87). Conclusion: Compared to conventional platinum-based chemotherapy, premetrexed continuation maintenance treatment is associated with better clinical outcome for the patients with EGFR wild-type lung adenocarcinoma.

Fertility Issues in Patients with Myoma (자궁근종과 생식력)

  • Kim, So-Ra;Chae, Hee-Dong
    • Clinical and Experimental Reproductive Medicine
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    • v.37 no.3
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    • pp.191-198
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    • 2010
  • Uterine myomas are heterogeneous tumors in composition, size, location, and number; variation in any of these factors could possibly alter the effect on a woman's fertility status. The effect of myomas on fertility has been the subject of many studies. However, a definitive answer is still missing. The location and size of the myomas are the two parameters that influence the success of a future pregnancy. Subserosal myomas seem to have little effect on reproductive outcome. Myomas that compress the uterine cavity with an intramural portion and submucosal myomas significantly reduce pregnancy rates, and should be removed before assisted reproductive techniques are performed. Patients with intramural myomas also may have a poorer reproductive outcome, but the lacks of quality evaluations make this conclusion tenuous at best. Removal of myomas with an intra-cavitary component seems to be of benefit. However there are as yet no data to support myomectomy in the treatment of intramural myomas to improve fertility outcomes. Treatment modality for myomas located at intramural sites should be determined according to clinical status of the patient and doctor's experience.

Proof-of-concept study of the caninized anti-canine programmed death 1 antibody in dogs with advanced non-oral malignant melanoma solid tumors

  • Masaya Igase;Sakuya Inanaga;Shoma Nishibori;Kazuhito Itamoto;Hiroshi Sunahara;Yuki Nemoto;Kenji Tani;Hiro Horikirizono;Munekazu Nakaichi;Kenji Baba;Satoshi Kambayashi;Masaru Okuda;Yusuke Sakai;Masashi Sakurai;Masahiro Kato;Toshihiro Tsukui;Takuya Mizuno
    • Journal of Veterinary Science
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    • v.25 no.1
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    • pp.15.1-15.15
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    • 2024
  • Background: The anti-programmed death 1 (PD-1) antibody has led to durable clinical responses in a wide variety of human tumors. We have previously developed the caninized anti-canine PD-1 antibody (ca-4F12-E6) and evaluated its therapeutic properties in dogs with advance-staged oral malignant melanoma (OMM), however, their therapeutic effects on other types of canine tumors remain unclear. Objective: The present clinical study was carried out to evaluate the safety profile and clinical efficacy of ca-4F12-E6 in dogs with advanced solid tumors except for OMM. Methods: Thirty-eight dogs with non-OMM solid tumors were enrolled prospectively and treated with ca-4F12-E6 at 3 mg/kg every 2 weeks of each 10-week treatment cycle. Adverse events (AEs) and treatment efficacy were graded based on the criteria established by the Veterinary Cooperative Oncology Group. Results: One dog was withdrawn, and thirty-seven dogs were evaluated for the safety and efficacy of ca-4F12-E6. Treatment-related AEs of any grade occurred in 13 out of 37 cases (35.1%). Two dogs with sterile nodular panniculitis and one with myasthenia gravis and hypothyroidism were suspected of immune-related AEs. In 30 out of 37 dogs that had target tumor lesions, the overall response and clinical benefit rates were 6.9% and 27.6%, respectively. The median progression-free survival and overall survival time were 70 days and 215 days, respectively. Conclusions: The present study demonstrated that ca-4F12-E6 was well-tolerated in non-OMM dogs, with a small number of cases showing objective responses. This provides evidence supporting large-scale clinical trials of anti-PD-1 antibody therapy in dogs.

DIAGNOSIS OF MICROMETASTASIS IN LYMPH NODE AND CLINICAL EVALUATION OF PROGNOSTIC FACTOR OF ORAL SCC USING RT-PCR AND IMMUNOHISTOCHEMISTRY FOR CYTOKERATIN (Cytokeratin의 RT-PCR 및 면역조직화학적 분석을 이용한 구강편평세포암종의 임파절 미세전이 진단과 예후인자 효용성 평가)

  • Park, Sung-Jin;Lee, Won-Deok;Lim, Ku-Young;Kang, Jin-Han;Myung, Hoon;Lee, Jong-Ho;Kim, Myung-Jin
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.31 no.2
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    • pp.105-115
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    • 2005
  • Purpose: The lymph node status assessed by conventional histological examination is the most important prognostic factor in patients undergoing surgery for oral squamous cell carcinoma. The presence of lymph node metastasis has a strong adverse impact on patient survival even after extended radical resection. Despite these findings, tumour recurrence is not rare after surgery, even when histological examination shows no lymph node metastasis. Recently, molecular-genetically and immunohistochemically demonstrated micrometastasis to the lymph nodes has been shown to have a significant adverse influence on survival in patients with squamous cell carcinoma and histologically negative nodes. The present study sought to determine the incidence and clarify the clinical significance of molecular-genetically and immunohistochemically demonstrated nodal micrometastases and to correlate these data with the stage of oral cancer. Methods: Lymph nodes systematically removed from 71 patients who underwent curative resection between 1998 and 2003 with head and neck squamous cell carcinoma were examined molecular-genetically to detect cytokeratin 5 mRNA with RT-PCR and immunohistochemically to detect cells that stained positively for cytokeratins with the monoclonal antibody cocktail AE1/AE3. The postoperative course and survival rates were compared among patients with and without micrometastases, after numerical classification of overt metastatic nodes. Results: micrometastases were detected in 43(60%) of 71 patients by RT-PCR and 26(36%) of 71 patients by immunohistochemistry. By RT-PCR analysis, patients exhibiting a positive band for CK 5 mRNA had a significantly worse prognosis than those were RT-PCR negative. By immunohistochemistry, the presence of micrometastasis did not predict patient outcome. Conclusion: Micrometastases detected by RT-PCR may be of clinical value in identifying patients who may be at high risk for recurrence and who are therefore likely to benefit from systemic adjuvant therapy.

Comparison of Vinorelbine, Ifosfamide and Cisplatin (NIP) and Etoposide and Cisplatin (EP) for Treatment of Advanced Combined Small Cell Lung Cancer (cSCLC) Patients: A Retrospective Study

  • Luo, Jie;Wu, Feng-Ying;Li, Ai-Wu;Zheng, Di;Liu, Jin-Ming
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.9
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    • pp.4703-4706
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    • 2012
  • Objective: To compare efficacy and safety profile of vinorelbine, ifosfamide and cisplatin (NIP) with etoposide and cisplatin (EP) in the treatment of advanced combined small cell lung cancer (c-SCLC). Methods: From January 2006 to December 2010, 176 patients with advanced c-SCLC were enrolled. The primary endpoint was overall survival (OS) and the secondary endpoints were progression free survival (PFS), response rate (RR) and toxicity. Results: Overall RR was 30.0% in the NIP and 38.5% in the EP group; there was no significant difference (P=0.236). The PFS in the EP group was little longer than that of NIP group, with 6.5 months for EP and 6.0 months for NIP group, but the difference was statistically non-significant (P=0.163). The median OS and one year survival rates were 10.4 months and 36.3% for NIP group, and 10.8 months and 49.0% for EP respectively, EP showing a survival benefit, although this was not statistically significant. Both groups well tolerated the adverse effects. The incidence of grade I-II leucopenia and alopecia in the NIP group was significantly higher than that of EP group (32.5% vs. 10.4% (P<0.001, 35.0% vs. 12.5%, P<0.001). Conclusion: the ORR, PFS and OS in NIP were slightly inferior to traditional regimen EP. The toxicity of NIP can be considered tolerable. The usage of three drugs combination in the treatment of mixed SCLC remains uncertain. Nevertheless, the results need to be further confirmed by large, prospective clinical trials.