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Bang Y.-J.,Seoul National University | Van Cutsem E.,University Hospital Gasthuisberg | Feyereislova A.,Hoffmann-La Roche | Chung H.C.,Yonsei University | And 12 more authors.
The Lancet | Year: 2010

Background Trastuzumab, a monoclonal antibody against human epidermal growth factor receptor 2 (HER2; also known as ERBB2), was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer. Methods ToGA (Trastuzumab for Gastric Cancer) was an open-label, international, phase 3, randomised controlled trial undertaken in 122 centres in 24 countries. Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation. Participants were randomly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumab. Allocation was by block randomisation stratified by Eastern Cooperative Oncology Group performance status, chemotherapy regimen, extent of disease, primary cancer site, and measurability of disease, implemented with a central interactive voice recognition system. The primary endpoint was overall survival in all randomised patients who received study medication at least once. This trial is registered with ClinicalTrials.gov, number NCT01041404. Findings 594 patients were randomly assigned to study treatment (trastuzumab plus chemotherapy, n=298; chemotherapy alone, n=296), of whom 584 were included in the primary analysis (n=294; n=290). Median follow-up was 18·6 months (IQR 11-25) in the trastuzumab plus chemotherapy group and 17·1 months (9-25) in the chemotherapy alone group. Median overall survival was 13·8 months (95 CI 12-16) in those assigned to trastuzumab plus chemotherapy compared with 11·1 months (10-13) in those assigned to chemotherapy alone (hazard ratio 0·74; 95 CI 0·60-0·91; p=0·0046). The most common adverse events in both groups were nausea (trastuzumab plus chemotherapy, 197 [67] vs chemotherapy alone, 184 [63]), vomiting (147 [50] vs 134 [46]), and neutropenia (157 [53] vs 165 [57]). Rates of overall grade 3 or 4 adverse events (201 [68] vs 198 [68]) and cardiac adverse events (17 [6] vs 18 [6]) did not differ between groups. Interpretaion Trastuzumab in combination with chemotherapy can be considered as a new standard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer. Funding F Hoffmann-La Roche. © 2010 Elsevier Ltd. Source

Iwanaga T.,Tokyo Metropolitan Cancer and Infectious Diseases Center
Gan to kagaku ryoho. Cancer & chemotherapy | Year: 2012

CXCR4, one of the chemokine receptors, plays a major role in cell migration in metastasis and cancer dissemination. However, it is not known whether CXCR4 is associated with tumor growth in vivo. In the present study, we investigated the inhibitory effect of CXCR4 blockers on CXCR4-expressing gastric cancer in vivo. Cells of a CXCR4-expressing gastric cancer cell line, K-MK-2, were transplanted into nude mice. A CXCR4 blocker, AMD3100 (2 mg/kg), was injected and another blocker, KRH3955 (1 mg/kg or 10 mg/kg), was administered orally. Both drugs were administered for 5 days followed by 2 days of rest. The mice were sacrificed on the 35th day following transplantation and the weights of the tumors were measured. The mean weights of the tumors were 7.092±1.221 g in the control mice, 5.137±1.001 g in the ADM3100-injected mice, 3.895±2.120 g in mice treated with 1 mg/kg of KRH3955, and 4.257±1.169 g in mice treated with 10 mg/kg of KRH3955. The 2 CXCR4 blockers significantly inhibited the growth of gastric cancer cells transplanted into the nude mice. The CXCR4 blockers AMD3100 and KRH3955 inhibit tumor growth in vivo. These drugs are possible candidates for personalized therapy of gastric cancer. Source

Honda G.,Tokyo Metropolitan Cancer and Infectious Diseases Center
Journal of hepato-biliary-pancreatic sciences | Year: 2013

Even during laparoscopic hepatectomy, a technique is often required to expose the major vessels, for example, in anatomical hepatectomy. We have standardized and performed such laparoscopic hepatectomy as successfully as open hepatectomy. We divide the liver parenchyma without pre-coagulation, exposing the major vessels using CUSA. To control the bleeding, we keep the central venous pressure low and often perform Pringle's maneuver. Over 49 months, we performed totally laparoscopic hepatectomies in 41 patients with the technique of exposing the major vessels. These included major hepatectomy in 7, sectorectomy in 17, segmentectomy in 14, and others in 3. The median operative time was 361 (range 176-605) minutes, with median blood loss of 216 (range 0-1600) g. The conversion rate was 4.9 %. Postoperative morbidity rate was 9.8 % (prolonged ascites in 1, port site infection in 1, peroneal palsy in 2). Mortality was zero. The median length of hospital stay after surgery was 8 (range 5-28) days. No local recurrence was found at the time of writing. By using our standardized procedure exposing the major vessels, we could raise the quality of laparoscopic hepatectomy toward the level of open hepatectomy significantly. Source

Doki N.,Tokyo Metropolitan Cancer and Infectious Diseases Center
[Rinshō ketsueki] The Japanese journal of clinical hematology | Year: 2015

The need for guidance regarding appropriate systematic long-term follow-up (LTFU) of hematopoietic cell transplantation (HCT) survivors has been recognized. Guidelines for screening and preventive practices for HCT survivors were published in 2006. An international group of transplantation experts updated the recommendations in 2011. Several points regarding the management of late complications must be addressed. Therefore, it is difficult to assess them all at routine visits to the hospital. We herein report the LTFU system employed in the Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital. The main purposes include the assessment of chronic GVHD severity, the management of late complications, and patient education for the prevention of infections. We created handbooks for the management of late complications. The questionnaire answered by patients revealed that 93% could understand the necessity for screening of second malignancies and that 84% were satisfied with the LTFU system. The LTFU system is used to provide long-term support according to the patients' social circumstances. Source

Iwasaki Y.,Tokyo Metropolitan Cancer and Infectious Diseases Center
Gan to kagaku ryoho. Cancer & chemotherapy | Year: 2012

We evaluated the safety of preoperative chemotherapy against advanced gastric cancer with para-aortic lymph node metastasis. In this study, we compared 11 patients who received preoperative chemotherapy(PC group) to 56 patients who did not receive preoperative chemotherapy (NPC group). We performed 47 total gastrectomies and 2 distal gastrectomies in the PC group and 9 total gastrectomies and 9 distal gastrectomies in the NPC group. In the PC group, the mean operation time was 275 min for distal gastrectomy and 297 min for total gastrectomy. In the NPC group, the mean operation time was 265 min for distal gastrectomy and 296 min for total gastrectomy. Regarding blood loss during operation, in the PC group, the mean blood loss was 650 mL for distal gastrectomy and 760 mL for total gastrectomy. In the NPC group, the mean blood loss was 530 mL for distal gastrectomy and 825 mL for total gastrectomy. No significant differences were seen between the 2 groups. In conclusion, preoperative chemotherapy against advanced gastric cancer with para-aortic lymph node metastasis appears to be a safe treatment, but we need to conduct clinical trials for confirmation. Source

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