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Toshiaki Watanabe - One of the best experts on this subject based on the ideXlab platform.

  • cell free and concentrated Ascites reinfusion therapy cart for management of massive Malignant Ascites in gastric cancer patients with peritoneal metastasis treated with intravenous and intraperitoneal paclitaxel with oral s 1
    Ejso, 2015
    Co-Authors: Hironori Yamaguchi, Joji Kitayama, Hironori Ishigami, Shigenobu Emoto, Norio Hanafusa, Tetsuya Ito, Toshiaki Watanabe
    Abstract:

    Abstract Background Massive Malignant Ascites originating from peritoneal metastasis of gastric cancer is difficult to control and resistant to chemotherapy. Cell-free and Concentrated Ascites Reinfusion Therapy (CART) is one of the types of apheresis therapy, by which filtered and concentrated Ascites containing albumin and globulin is reinfused intravenously to patients. We retrospectively studied the feasibility of intraperitoneal (IP) chemotherapy combined with CART in gastric cancer patients with massive Malignant Ascites. Methods Paclitaxel (PTX) was administered via an IP access port implanted in the subcutaneous space. If patient had massive Ascites at the start of treatment, paracentesis was performed through a percutaneous IP catheter and then CART was performed. PTX was administered through the catheter until the Ascites diminished. Results A total of 127 CART procedures in 30 patients were analyzed. The average volume of processed Ascites was 3.1 L, which was concentrated to 0.33 L containing 85.5 g protein on average. Significant increases in urine volume, serum total protein and albumin level were found after the CART. Increase in body temperature (0.3 °C), decrease in platelet count (3.8 × 104/μl), and changes in blood pressure (2 mm Hg) were found after the CART procedure, but no clinically significant adverse event was experienced. The median survival time and 1-year survival of 30 patients who received IP chemotherapy combined with the CART procedure was 10.2 months and 43.3% respectively. Conclusions IP chemotherapy combined with CART might be a promising strategy for patients with massive Malignant Ascites originating from peritoneal metastasis of gastric cancer.

  • salvage gastrectomy after intravenous and intraperitoneal paclitaxel ptx administration with oral s 1 for peritoneal dissemination of advanced gastric cancer with Malignant Ascites
    Annals of Surgical Oncology, 2014
    Co-Authors: Joji Kitayama, Hiroharu Yamashita, Hironori Ishigami, Hironori Yamaguchi, Shigenobu Emoto, Shoich Kaisaki, Toshiaki Watanabe
    Abstract:

    Background Peritoneal metastasis of gastric cancer has extremely poor clinical outcomes. Recently, we developed a combination chemotherapy that used intraperitoneal (IP) paclitaxel (PTX) and produced excellent antitumor effects against peritoneal lesions. However, no information is available about the benefit of gastrectomy in cases with Malignant Ascites.

Joji Kitayama - One of the best experts on this subject based on the ideXlab platform.

Grace Carolanrees - One of the best experts on this subject based on the ideXlab platform.

  • pleurx peritoneal catheter drainage system for vacuum assisted drainage of treatment resistant recurrent Malignant Ascites a nice medical technology guidance
    Applied Health Economics and Health Policy, 2012
    Co-Authors: Judith White, Grace Carolanrees
    Abstract:

    The PleurX peritoneal drainage catheter for drainage of Malignant Ascites in a community setting has been evaluated by the NICE Medical Technologies Evaluation Programme. This article outlines the evidence included in the Sponsor’s submission, the independent critique by the External Assessment Centre (EAC) and the recommendations made by the Medical Technologies Advisory Committee (MTAC). In accordance with the scope issued by NICE, the intervention technology was the indwelling PleurX peritoneal catheter drainage system, the comparator was large-volume paracentesis (LVP; inpatient or outpatient) and the population was patients with treatment-resistant, recurrent Malignant Ascites. Nine studies (ten papers) were identified with a total of 180 PleurX-treated patients; six were case series with more than four patients that, despite being low in the hierarchy of evidence, provided useful safety information. Technical success of the initial PleurX placement procedure was 100% across five studies which reported this outcome. One study reported equal complication rates between patients treated with indwelling PleurX catheters (40 patients and 40 catheters) and those receiving repeated LVPs (67 patients and 392 procedures), 7.5% (3/40; 95% CI 1.6, 20) and 7.5% (5/67; 95% CI 2.2, 15), respectively. All remaining studies were single-arm and reported complication rates of between 0% and 59%; this wide range was largely due to variation in the definition of complications and adverse events. Using validated tools, one case series reported improvements in several Ascites-related symptoms after placement of the PleurX catheter; however, an overall quality-of-life improvement at 12 weeks was not demonstrated. Positive patient opinions relating to improved symptom control and convenience were reported in a qualitative study. Cost analysis demonstrated that PleurX offered savings to the NHS when compared with repeated LVPs performed in an inpatient setting. This saving of d679 per patient was driven primarily by reducing hospital bed days (year 2009–2010 values), but would require 23.5 additional community nurse visits. Advice from clinical experts was that additional home visits were overestimated as many patients would receive such visits regardless of whether a PleurX drain had been fitted. The model demonstrated that PleurX would be more expensive than LVP procedures performed in a setting where one or less hospital bed days were used (e.g. day case or outpatient). There was uncertainty surrounding the number of patients for whom insertion of a PleurX drain would be appropriate as well as the point in the care pathway at which such treatment should be administered. MTAC supported the case for adoption and considered that the available evidence showed PleurX was clinically effective, has low complication rates, can improve quality of life and is less costly than inpatient LVP. In Medical Technology Guidance 9 (MTG9), NICE recommended that PleurX peritoneal catheter drainage system be considered for use in patients with treatment-resistant, recurrent Malignant Ascites. Copyright Springer International Publishing AG 2012

  • pleurx peritoneal catheter drainage system for vacuum assisted drainage of treatment resistant recurrent Malignant Ascites a nice medical technology guidance
    Applied Health Economics and Health Policy, 2012
    Co-Authors: Judith White, Grace Carolanrees
    Abstract:

    The PleurX peritoneal drainage catheter for drainage of Malignant Ascites in a community setting has been evaluated by the NICE Medical Technologies Evaluation Programme. This article outlines the evidence included in the Sponsor’s submission, the independent critique by the External Assessment Centre (EAC) and the recommendations made by the Medical Technologies Advisory Committee (MTAC). In accordance with the scope issued by NICE, the intervention technology was the indwelling PleurX peritoneal catheter drainage system, the comparator was large-volume paracentesis (LVP; inpatient or outpatient) and the population was patients with treatment-resistant, recurrent Malignant Ascites. Nine studies (ten papers) were identified with a total of 180 PleurX-treated patients; six were case series with more than four patients that, despite being low in the hierarchy of evidence, provided useful safety information. Technical success of the initial PleurX placement procedure was 100% across five studies which reported this outcome. One study reported equal complication rates between patients treated with indwelling PleurX catheters (40 patients and 40 catheters) and those receiving repeated LVPs (67 patients and 392 procedures), 7.5% (3/40; 95% CI 1.6, 20) and 7.5% (5/67; 95% CI 2.2, 15), respectively. All remaining studies were single-arm and reported complication rates of between 0% and 59%; this wide range was largely due to variation in the definition of complications and adverse events. Using validated tools, one case series reported improvements in several Ascites-related symptoms after placement of the PleurX catheter; however, an overall quality-of-life improvement at 12 weeks was not demonstrated. Positive patient opinions relating to improved symptom control and convenience were reported in a qualitative study. Cost analysis demonstrated that PleurX offered savings to the NHS when compared with repeated LVPs performed in an inpatient setting. This saving of d679 per patient was driven primarily by reducing hospital bed days (year 2009–2010 values), but would require 23.5 additional community nurse visits. Advice from clinical experts was that additional home visits were overestimated as many patients would receive such visits regardless of whether a PleurX drain had been fitted. The model demonstrated that PleurX would be more expensive than LVP procedures performed in a setting where one or less hospital bed days were used (e.g. day case or outpatient). There was uncertainty surrounding the number of patients for whom insertion of a PleurX drain would be appropriate as well as the point in the care pathway at which such treatment should be administered. MTAC supported the case for adoption and considered that the available evidence showed PleurX was clinically effective, has low complication rates, can improve quality of life and is less costly than inpatient LVP. In Medical Technology Guidance 9 (MTG9), NICE recommended that PleurX peritoneal catheter drainage system be considered for use in patients with treatment-resistant, recurrent Malignant Ascites.

Hironori Yamaguchi - One of the best experts on this subject based on the ideXlab platform.

Markus M. Heiss - One of the best experts on this subject based on the ideXlab platform.

  • The Role of Relative Lymphocyte Count as a Biomarker for the Effect of Catumaxomab on Survival in Malignant Ascites Patients: Results from a Phase II/III Study
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2014
    Co-Authors: Markus M. Heiss, Carsten Bokemeyer, Michael A. Ströhlein, D. Arnold, Simon L. Parsons, D. Seimetz, Horst Lindhofer, Elisabeth Schulze, Michael Hennig
    Abstract:

    Purpose: We report the role of relative lymphocyte count (RLC) as a potential biomarker with prognostic impact for catumaxomab efficacy and overall survival (OS) based on a post hoc analysis of the pivotal phase II/III study of intraperitoneal catumaxomab treatment of Malignant Ascites. Experimental Design: The impact of treatment and RLC on OS was evaluated using multivariate Cox models. Kaplan–Meier and log-rank tests were used for group comparisons. Survival analyses were performed on the safety population [patients with paracentesis plus ≥1 dose of catumaxomab ( n = 157) and paracentesis alone ( n = 88)]. Determination of the optimal cutoff value for RLC was based on five optimality criteria. Results: OS was significantly longer with catumaxomab versus paracentesis alone ( P = 0.0219). The 6-month OS rate with catumaxomab was 28.9% versus 6.7% with paracentesis alone. RLC had a positive impact on OS and was an independent prognostic factor ( P 13% ( n = 159: catumaxomab, 100 and control, 59), catumaxomab was associated with a favorable effect on OS versus paracentesis alone ( P = 0.0072), with a median/mean OS benefit of 41/131 days and an increased 6-month survival rate of 37.0% versus 5.2%, respectively. In patients with RLC ≤ 13% at screening ( n = 74: catumaxomab, 50 and control, 24), the median (mean) OS difference between the catumaxomab and the control group was 3 (16) days, respectively ( P = 0.2561). Conclusions: OS was significantly improved after catumaxomab treatment in patients with Malignant Ascites. An RLC > 13% at baseline was a significant prognostic biomarker. Clin Cancer Res; 20(12); 3348–57. ©2014 AACR .

  • IJC International Journal of Cancer
    2013
    Co-Authors: Markus M. Heiss, Pawel Murawa, Piotr Koralewski, Elzbieta Kutarska, Olena O. Kolesnik, Vladimir V. Ivanchenko, Birute Aleknaviciene, Arturas Razbadauskas, Er S. Dudnichenko, Martin Gore
    Abstract:

    The trifunctional antibody catumaxomab for the treatment of Malignant Ascites due to epithelial cancer: results of

  • quality of life assessment in patients with Malignant Ascites results of a multicenter phase ii iii study comparing paracentesis plus catumaxomab with paracentesis alone
    Journal of Clinical Oncology, 2011
    Co-Authors: A Gonschior, Markus M. Heiss, S L Parsons, Markus Moehler, H Gilet
    Abstract:

    9113 Background: Patients with Malignant Ascites (MA) have a poor prognosis and therapeutic options are limited to palliative treatment. Quality of life (QoL) assessment is therefore of particular ...

  • The trifunctional antibody catumaxomab for the treatment of Malignant Ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial
    International journal of cancer, 2010
    Co-Authors: Markus M. Heiss, Pawel Murawa, Piotr Koralewski, Elzbieta Kutarska, Olena O. Kolesnik, Vladimir V. Ivanchenko, Alexander S. Dudnichenko, Birute Aleknaviciene, Arturas Razbadauskas, Martin Gore
    Abstract:

    Malignant Ascites is a common manifestation of advanced cancers, and treatment options are limited. The trifunctional antibody catumaxomab (anti-epithelial cell-adhesion molecule x anti-CD3) represents a targeted immunotherapy for the intraperitoneal (i.p.) treatment of Malignant Ascites secondary to epithelial cancers. In this phase II/III trial (EudraCT 2004-000723-15; NCT00836654), cancer patients (n = 258) with recurrent symptomatic Malignant Ascites resistant to conventional chemotherapy were randomized to paracentesis plus catumaxomab (catumaxomab) or paracentesis alone (control) and stratified by cancer type (129 ovarian and 129 nonovarian). Catumaxomab was administered as an i.p. infusion on Days 0, 3, 7 and 10 at doses of 10, 20, 50 and 150 μg, respectively. The primary efficacy endpoint was puncture-free survival. Secondary efficacy parameters included time to next paracentesis, Ascites signs and symptoms and overall survival (OS). Puncture-free survival was significantly longer in the catumaxomab group (median 46 days) than the control group (median 11 days) (hazard ratio = 0.254: p < 0.0001) as was median time to next paracentesis (77 versus 13 days; p < 0.0001). In addition, catumaxomab patients had fewer signs and symptoms of Ascites than control patients. OS showed a positive trend for the catumaxomab group and, in a prospectively planned analysis, was significantly prolonged in patients with gastric cancer (n = 66; 71 versus 44 days; p = 0.0313). Although adverse events associated with catumaxomab were frequent, they were manageable, generally reversible and mainly related to its immunologic mode of action. Catumaxomab showed a clear clinical benefit in patients with Malignant Ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile.

  • immunotherapy of Malignant Ascites with trifunctional antibodies
    International Journal of Cancer, 2005
    Co-Authors: Markus M. Heiss, Michael A. Ströhlein, M Jager, R Kimmig, A Burges, Alexandra Schoberth, Karlwalter Jauch, F W Schildberg, Horst Lindhofer
    Abstract:

    A new class of intact bispecific antibodies shows unmet effector qualities by activation of not only T cells but also simultaneous activation of Fcgamma receptor type I/III+ cells (macrophages, NK-cells and DC). These trifunctional antibodies (trAb) lead to efficient specific killing of targeted tumor cells without any pre- or co-stimulation. This concept was investigated in vivo in patients with Malignant Ascites in a clinical situation that allowed monitoring of tumor cell elimination and correlation with clinical effects. In a prospective study, 8 patients with Malignant Ascites due to peritoneal carcinomatosis were treated with intraperitoneal application of trAb, which bound either the EpCAM- or Her2/neu-antigen on tumor cells. Treatment consisted of 4-6 applications within 9-23 days with a total amount of 145-940 microg. Seven of eight patients required no further paracentesis during follow-up or until death with a mean paracentesis-free interval of 38 weeks (median = 21.5, range = 4-136). Tumor cell monitoring showed a complete elimination of tumor cells in Ascites already at total doses as low as 40-140 microg. Clinical response with disappearance of Ascites accumulation was seen in all patients, which was correlated with elimination of tumor cells (p = 0.0014). Severe adverse events were not observed. Clinically relevant side effects were fever, moderate abdominal pain and skin reactions. Intraperitoneal immunotherapy with trAb showed convincing efficacy in patients with Malignant Ascites. This treatment offers new therapeutic options for patients with peritoneal carcinomatosis.