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  • 1
    Language: Japanese
    In: Gan to kagaku ryoho. Cancer & chemotherapy, May 2010, Vol.37(5), pp.777-81
    Description: The use of cetuximab, a mouse chimeric immunoglobulin G1 monoclonal antibody, is approved as anti-epidermal growth factor receptor(EGFR)therapy for the treatment of metastatic colorectal cancer in Japan. Further, panitumumab, matuzumab, nimotuzumab and zalutumumab which also target EGFR, are currently under clinical development. Cetuximab is the first that has been developed as an anti-EGFR antibody. Approximately 30% of the protein which constructs the mouse chimeric antibodies is from mouse, which yields the possibility that the mouse chimeric antibodies induce host immune-reaction. After cetuximab, the humanized monoclonal antibodies such as matuzumab and nimotuzumab, and fully humanized monoclonal antibodies such as panitumumab and zalutumumab, have been developed. In this article, we will introduce the current status of development of these four anti-EGFR antibodies, by focusing on the individual clinical trials using each anti-EGFR antibody.
    Keywords: Antibodies, Monoclonal -- Therapeutic Use ; Antineoplastic Agents -- Therapeutic Use ; Colorectal Neoplasms -- Drug Therapy ; Erbb Receptors -- Immunology
    ISSN: 0385-0684
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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  • 2
    Language: English
    In: International Journal of Radiation Oncology, Biology, Physics, 01 November 2012, Vol.84(3), pp.786-792
    Description: The 7th edition of the American Joint Committee on Cancer staging system does not include lymph node size in the guidelines for staging patients with esophageal cancer. The objectives of this study were to determine the prognostic impact of the maximum metastatic lymph node diameter (ND) on survival and to develop and validate a new staging system for patients with esophageal squamous cell cancer who were treated with definitive chemoradiotherapy (CRT). Information on 402 patients with esophageal cancer undergoing CRT at two institutions was reviewed. Univariate and multivariate analyses of data from one institution were used to assess the impact of clinical factors on survival, and recursive partitioning analysis was performed to develop the new staging classification. To assess its clinical utility, the new classification was validated using data from the second institution. By multivariate analysis, gender, T, N, and ND stages were independently and significantly associated with survival ( 〈 0.05). The resulting new staging classification was based on the T and ND. The four new stages led to good separation of survival curves in both the developmental and validation datasets ( 〈 0.05). Our results showed that lymph node size is a strong independent prognostic factor and that the new staging system, which incorporated lymph node size, provided good prognostic power, and discriminated effectively for patients with esophageal cancer undergoing CRT.
    Keywords: Esophageal Cancer ; Chemoradiotherapy ; Tnm ; Recursive Partitioning Analysis ; Prognostic Factor ; Medicine
    ISSN: 0360-3016
    E-ISSN: 1879-355X
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  • 3
    Language: English
    In: International Journal of Radiation Oncology, Biology, Physics, 01 February 2012, Vol.82(2), pp.946-952
    Description: The new 7th edition of the American Joint Committee on Cancer TNM staging system is based on pathologic data from esophageal cancers treated by surgery alone. There is no information available on evaluation of the new staging system with regard to prognosis of patients treated with chemoradiotherapy (CRT). The objective of this study was to evaluate the prognostic impact of the new staging system on esophageal cancer patients treated with CRT. A retrospective review was performed on 301 consecutive esophageal squamous cell carcinoma patients treated with CRT. Comparisons were made of the prognostic impacts of the 6th and 7th staging systems and the prognostic impacts of stage and prognostic groups, which were newly defined in the 7th edition. There were significant differences between Stages I and III ( 〈 0.01) according to both editions. However, the 7th edition poorly distinguishes the prognoses of Stages III and IV (  = 0.36 by multivariate analysis) in comparison to the 6th edition (  = 0.08 by multivariate analysis), although these differences were not significant. For all patients, T, M, and gender were independent prognostic factors by multivariate analysis ( 〈 0.05). For the Stage I and II prognostic groups, survival curves showed a stepwise decrease with increase in stage, except for Stage IIA. However, there were no significant differences seen between each prognostic stage. Our study indicates there are several problems with the 7th TNM staging system regarding prognostic factors in patients undergoing CRT.
    Keywords: Esophageal Cancer ; Chemoradiotherapy ; American Joint Committee on Cancer ; Tnm ; Prognostic Factor ; Medicine
    ISSN: 0360-3016
    E-ISSN: 1879-355X
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  • 4
    Language: English
    In: Gastric Cancer, 2012, Vol.15(2), pp.137-143
    Description: Byline: Kohei Shitara (1), Junko Ikeda (1), Chihiro Kondo (1), Daisuke Takahari (1), Takashi Ura (1), Kei Muro (1), Keitaro Matsuo (2) Keywords: Chemotherapy; Gastric cancer; Prognostic factor; Randomized trial; Stratification Abstract: Background There is no consensus on which patient characteristics are the most suitable to report or to be used as stratification factors in clinical trials for advanced gastric cancer (AGC), to our knowledge. Methods We conducted a comprehensive review of published randomized trials for AGC to examine the patient characteristics that were reported. Results Among the 67 analyzed trials, age, gender, performance status, proportion of patients with measurable disease, and previous gastrectomy were frequently reported (〉69%). Histology, number of disease sites, and adjuvant treatment were reported in less than 50% of trials. Although the reporting of second-line chemotherapy has increased in recent trials, it remains at less than 50%. Notably, recent trials have tended to include patients with better performance status and less locally advanced disease, with Asian trials more frequently including patients with more diffuse histology and less locally advanced disease or liver metastasis than non-Asian trials. Stratification was conducted in approximately 60% of the trials, using quite variable stratifying factors. Conclusion Inconsistency exists in the reporting of patient characteristics, the characteristics themselves, and the use of stratification factors in clinical trials for AGC. A consensus set of important patient characteristics and strata may be necessary to conduct and interpret quality randomized studies. Author Affiliation: (1) Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan (2) Division of Epidemiology and Prevention, Aichi Cancer Center Research Institute, Nagoya, Japan Article History: Registration Date: 25/07/2011 Received Date: 14/05/2011 Accepted Date: 24/07/2011 Online Date: 13/08/2011 Article note: Electronic supplementary material The online version of this article (doi: 10.1007/s10120-011-0083-8) contains supplementary material, which is available to authorized users.
    Keywords: Chemotherapy ; Gastric cancer ; Prognostic factor ; Randomized trial ; Stratification
    ISSN: 1436-3291
    E-ISSN: 1436-3305
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  • 5
    Language: Japanese
    In: 鉄と鋼, 2013, Vol.99(12), pp.700-708
    Description: Zn electrodeposition was performed galvanostatically on a steel sheet at 1500 A/m〈sup〉2〈/sup〉 in an agitated sulfate solution at 40°C to investigate the effect of preadsorption of organic additives on the lightness and morphology of Zn. The organic additives preadsorbed were classified into two types: 1) polyethylene glycol (PEG), gelatin and stearyl dimethyl benzyl ammonium chloride (SDBAC) (type I), which exhibit the polarization effect on Zn deposition ; 2) saccharin and sodium lauryl sulfate (type II), which exhibit no polarization effect on Zn deposition. The platelet crystals of deposited Zn became small by preadsorption of all kinds of organic additives. The decrease in size of platelet crystals of Zn with the preadsorption is attributed to both the increase in overpotential for Zn deposition and the decrease in epitaxial growth of Zn. The orientation of {0001} Zn basal plane decreased significantly because of an increase in overpotential for Zn deposition by the preadsorption of PEG and gelatin, and the orientation decreased slightly by saccharin and sodium lauryl sulfate in spite of no polarization effect on Zn deposition. The surface roughness of deposited Zn decreased by the preadsorption of organic additives with the exception of SDBAC. This is due to decrease in size of platelet crystals of Zn. The lightness of deposited Zn was increased by the preadsorption of organic additives with the exception of SDBAC. Because Zn deposited ununiformly by the preadsorption of SDBAC, the surface roughness of Zn increased and the lightness decreased.
    Keywords: Zn ; electrodeposition ; preadsorption ; morphology ; crystal orientation ; overpotential ; lightness ; surface roughness ; organic additive ; Zn ; Electrodeposition ; Preadsorption ; Morphology ; Crystal Orientation ; Overpotential ; Lightness ; Surface Roughness ; Organic Additive
    ISSN: 0021-1575
    E-ISSN: 18832954
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  • 6
    Language: English
    In: ISIJ International, 2014, Vol.54(7), pp.1653-1660
    Description: Zn electrodeposition was performed galvanostatically on steel sheets at 1500 A/m〈sup〉2〈/sup〉 in an agitated sulfate solution at 40°C to investigate the effect of preadsorption of organic additives on the lightness and morphology of Zn. The organic additives employed were classified into two types: 1) polyethylene glycol (PEG), gelatin, and stearyl dimethylbenzyl ammonium chloride (SDBAC) (Type I), which exhibit a polarization effect for Zn deposition; and 2) saccharin and sodium lauryl sulfate (Type II), which exhibit no polarization effect for Zn deposition. The platelet crystals of deposited Zn were reduced in size with preadsorption of all the organic additives considered. The observed decrease in the size of Zn platelet crystals with preadsorption is attributed to both an increase in the overpotential for Zn deposition and a decrease in the epitaxial growth of Zn on steel substrates. The preferred orientation of the {0001} Zn basal plane significantly decreased because of an increase in Zn deposition overpotential owing to preadsorption of PEG and gelatin, and the orientation slightly decreased with saccharin and sodium lauryl sulfate in spite of the absence of a polarization effect on Zn deposition. The surface roughness of deposited Zn decreased with preadsorption of organic additives with the exception of SDBAC. This is due to a decrease in the size of Zn platelet crystals. The lightness of deposited Zn was increased by preadsorption of organic additives with the exception of SDBAC. Because Zn deposited nonuniformly with preadsorption of SDBAC, the surface roughness of Zn increased and the lightness decreased.
    Keywords: Zn ; Electrodeposition ; Preadsorption ; Morphology ; Crystal Orientation ; Overpotential ; Lightness ; Surface Roughness ; Organic Additive ; Epitaxial Growth
    ISSN: 0915-1559
    E-ISSN: 13475460
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  • 7
    Language: English
    In: European Journal of Cancer, December 2011, Vol.47(18), pp.2673-2680
    Description: The aim of this study was to evaluate the association of sensitivity to previous irinotecan-based chemotherapy with efficacy of cetuximab plus irinotecan therapy in metastatic colorectal cancer (MCRC) patients with wild-type . We analysed a pooled data set consisting of data from 87 MCRC patients from two previous phase II studies ( = 60) and a group given off-protocol treatment ( = 27) following irinotecan-, oxaliplatin-, and fluoropyrimidine-based chemotherapy. Overall objective response rate to cetuximab plus irinotecan was 28.7%, median progression-free survival (PFS) was 5.3 months, and median overall survival was 12.2 months. Objective response rate did not significantly differ between patients with a favourable response to previous irinotecan ( = 23), stable disease ( = 38), or progressive disease ( = 26), with observed rates of 29.2%, 31.6%, and 23.1%, respectively. Additionally, the non-parametric Spearman rank correlation coefficients ( ) between the PFS of previous irinotecan-based chemotherapy and that of cetuximab plus irinotecan were quite low ( = 0.067 and 0.057 in patients with previous irinotecan as first- and second-line therapies, respectively). Although exploratory nature and small sample size may be limitations of this study, these findings indicate that the efficacy of irinotecan plus cetuximab in MCRC patients with wild-type did not differ by previous sensitivity to irinotecan.
    Keywords: Colorectal Cancer ; Chemotherapy ; Cetuximab ; Irinotecan ; Medicine
    ISSN: 0959-8049
    E-ISSN: 1879-0852
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  • 8
    Language: English
    In: Cancer Chemotherapy and Pharmacology, 2013, Vol.72(3), pp.643-652
    Description: Byline: Toshihiko Doi (1), Kei Muro (2), Takayuki Yoshino (1), Nozomu Fuse (1), Takashi Ura (2), Daisuke Takahari (2), Hwa-ping Feng (3), Takashi Shimamoto (4), Kazuo Noguchi (4), Atsushi Ohtsu (1) Keywords: Colorectal cancer; MK-0646; Anti-IGF-1R antibody; Pharmacokinetic interactions; Phase I study Abstract: Purpose The safety, tolerability, and pharmacokinetic (PK) interactions of MK-0646 in combination with cetuximab and irinotecan were investigated in Japanese patients with advanced colorectal cancer. Methods Twenty patients were treated in the following study arms in combination with cetuximab and irinotecan: A [MK-0646 (10 mg/kg) weekly starting on Day 22], B [MK-0646 (15 mg/kg) on Day 8, followed by 7.5 mg/kg every 2 weeks], or C [MK-0646 (10 mg/kg) on Day 1 and weekly starting on Day 22]. Dose limiting toxicities (DLTs) were evaluated during a prespecified 4-week period in arms A and B. Full PK sampling was performed to evaluate the PK interactions. Results One of the 6 evaluable patients in arm A developed a DLT (grade 3 hyperglycemia) no DLTs occurred in the 6 patients in arm B. Common treatment-related adverse events included leukopenia, neutropenia, dermatitis acneiform, paronychia, nausea, stomatitis, diarrhea, and decreased appetite. The co-administration of cetuximab and irinotecan with MK-0646 increased the MK-0646 AUC.sub.0--168h by 25 %, with MK-0646 accumulation from the previous dose contributing to the observed increase. The co-administration of MK-0646 with cetuximab and irinotecan did not affect the PK of cetuximab and irinotecan, but reduced the C .sub.max (from 16.8 to 13.0 ng/mL) and the AUC.sub.0--24h (by 13 %) of SN-38, the active metabolite of irinotecan. Conclusions The triple combination of MK-0646, cetuximab, and irinotecan was well tolerated in Japanese patients with advanced colorectal cancer. These results indicate a minimal potential for PK interactions between MK-0646 and cetuximab and between MK-0646 and irinotecan/SN-38. Author Affiliation: (1) National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan (2) Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan (3) Merck & Co., Inc., Whitehouse Station, NJ, USA (4) MSD K.K., Kitanomaru Square, 1-13-12, Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan Article History: Registration Date: 21/07/2013 Received Date: 07/06/2013 Accepted Date: 21/07/2013 Online Date: 07/08/2013
    Keywords: Colorectal cancer ; MK-0646 ; Anti-IGF-1R antibody ; Pharmacokinetic interactions ; Phase I study
    ISSN: 0344-5704
    E-ISSN: 1432-0843
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  • 9
    Language: English
    In: International Journal of Clinical Oncology, 2013, Vol.18(3), pp.539-546
    Description: Byline: Kohei Shitara (1), Akira Sawaki (2,3), Keitaro Matsuo (4), Chihiro Kondo (1), Daisuke Takahari (1), Takashi Ura (1), Masahiro Tajika (2), Yasumasa Niwa (2), Kei Muro (1) Keywords: Capecitabine; Chemotherapy; Cisplatin; Gastric cancer; S-1 Abstract: Background Based on the results of the SPIRITS trial, combination chemotherapy of S-1 plus cisplatin (SP) is now considered the standard treatment for patients with advanced gastric cancer (AGC) in Japan. On the other hand, several non-Japanese studies have shown the efficacy of capecitabine plus cisplatin (XP), which has been used as the reference arm in recent global studies of AGC. Methods We retrospectively compared the efficacy and safety of SP and XP in first-line treatment for patients with AGC. Results From August 2006 to November 2008, 26 AGC patients received XP in the context of 2 global trials (AVAGAST and ToGA), and 50 patients received SP during the same period. The objective response rate was 43.2 % in the SP group and 50 % in the XP group, with no significant difference (p = 0.62). There were also no significant differences in progression-free survival (median 5.8 vs. 5.2 months p = 0.91) and overall survival (median 13.8 vs. 13.5 months p = 0.97) between the SP and XP groups. The frequencies of hematological toxicities of grade 3 or more and non-hematological toxicities were not significantly different between the 2 groups. Although grade 1 or 2 hand--foot syndrome was more common in the XP group, no patients experienced grade 3 or more. Conclusions Although the retrospective nature of this study and the small number of patients is a major limitation, SP and XP were associated with similar efficacy and safety in patients with AGC. Author Affiliation: (1) Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan (2) Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan (3) Nagoya Daini Red Cross Hospital, Nagoya, Japan (4) Division of Epidemiology and Prevention, Aichi Cancer Center Research Institute, Nagoya, Japan Article History: Registration Date: 18/04/2012 Received Date: 06/03/2012 Accepted Date: 16/04/2012 Online Date: 03/05/2012
    Keywords: Capecitabine ; Chemotherapy ; Cisplatin ; Gastric cancer ; S-1
    ISSN: 1341-9625
    E-ISSN: 1437-7772
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  • 10
    Language: English
    In: International Journal of Clinical Oncology, 2011, Vol.16(6), pp.766-769
    Description: Disseminated intravascular coagulation (DIC) is a complication that may be experienced by patients with solid tumors. The prognosis of solid tumors with DIC is much poorer than those without DIC. Although treatment of the underlying disease is critical for improvement of DIC, the efficacy and safety of chemotherapy in patients with DIC associated with colorectal cancer are not clear. A 50-year-old man with advanced rectal cancer and multiple liver metastases experienced DIC during third-line treatment with cetuximab plus irinotecan, following 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab and 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus bevacizumab. Combination chemotherapy consisting of FOLFOX plus bevacizumab was reintroduced. Although platelet and fresh-frozen plasma transfusions were required daily before chemotherapy, the patient’s laboratory values improved after two cycles of chemotherapy, without severe toxicity. The patient was discharged, and FOLFOX plus bevacizumab has been continued on an outpatient basis without sign of recurrence of DIC as of December 2010 (4 months after initiation of chemotherapy). This case suggests that reintroduction of combination chemotherapy with FOLFOX plus bevacizumab is effective and feasible in patients with colorectal cancer with DIC and that chemotherapy may be a treatment option for such patients.
    Keywords: Colorectal cancer ; Disseminated intravascular coagulation ; FOLFOX ; Reintroduction ; Bevacizumab
    ISSN: 1341-9625
    E-ISSN: 1437-7772
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