Abstract:
BACKGROUND:SmithKline Beecham synthesized camptothecin analogs and identified nogitecan hydrochloride (topotecan) with a broad spectrum of antitumor activity and less toxicity than camptothecin. Because preclinical and overseas clinical data indicated the antitumor effect of nogitecan hydrochloride with a 5-day repeat-dose schedule, we carried out phase I studies in Japan to determine the maximum tolerated dose (MTD), pharmacokinetics, and antitumor effect of nogitecan hydrochloride. METHODS:Phase I studies of nogitecan hydrochloride given by single and 5-day repeat dosing were carried out in patients with various solid tumors at 15 medical institutions in Japan. Pharmacokinetic evaluations were performed for both single and 5-day repeated dosing. RESULTS:The dose-limiting factor (DLF) was reversible leucopenia, and the maximum tolerated dose (MTD) was higher than 22.5 mg/m2 in the single-dose study. In the 5-day repeat-dose study, the DLF was also reversible leucopenia, and the MTD was estimated to be 1.5 mg/m2 per day. The plasma concentration of nogitecan hydrochloride increased with increasing dose, and the half-life after single dosing ranged from 3 to 5h. There was no evidence of accumulation or delayed excretion during 5-day repeat dosing. CONCLUSION:Based on these results and the finding that there were responders among patients treated at 1.5 mg/m2 per day by 5-day repeat dosing in overseas studies, 5-day repeat dosing of 1.2mg/m2 per day, one dose level lower than the MTD, was selected for phase II studies in Japan.
journal_name
Int J Clin Oncoljournal_title
International journal of clinical oncologyauthors
Kobayashi K,Hino M,Fukuoka M,Takeuchi K,Furuse K,Yoneda S,Hasegawa K,Noda K,Kinoshita H,Kimura I,Taguchi T,Kanamaru R,Horikoshi N,Niitani Hdoi
10.1007/s101470200026subject
Has Abstractpub_date
2002-06-01 00:00:00pages
177-86issue
3eissn
1341-9625issn
1437-7772journal_volume
7pub_type
临床试验,杂志文章,多中心研究abstract:BACKGROUND:Resection of hepatocellular carcinoma (HCC) is potentially curative; however, recurrence is common. To date, few or no effective adjuvant therapies have been adequately investigated. This study evaluates the efficacy of adjuvant iodine-131-lipiodol after hepatic resection through the experience of a single-c...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-010-0143-9
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abstract:BACKGROUND:We evaluated the association between subclinical interstitial lung disease (ILD) and fatal radiation pneumonitis (RP) in patients with thoracic tumors treated with thoracic radiotherapy (RT). METHODS:Sixty-two consecutive patients with thoracic tumors treated with thoracic RT were retrospectively analyzed. ...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-014-0679-1
更新日期:2015-02-01 00:00:00
abstract:BACKGROUND:The purpose of this study was to identify the role of Bcl-2 protein and adrenomedullin (AM) expression in relation to apoptosis in the neoplastic changes of squamous epithelium of the uterine cervix. METHODS:Apoptosis in sections of normal cervical epithelium, cervical intraepithelial neoplasia (CIN), and i...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s101470300015
更新日期:2003-04-01 00:00:00
abstract:BACKGROUND:The influence of resection of the primary lesion on the prognosis of patients with incurable stage IV colorectal cancer is unclear. METHODS:We retrospectively analyzed 158 asymptomatic patients with incurable stage IV colorectal cancer who received systemic chemotherapy in our center from 2002 to 2009, eith...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-014-0662-x
更新日期:2014-12-01 00:00:00
abstract::Total gastrectomy and chemotherapy with S-1 after surgery were performed in a 50-year-old woman with gastric cancer associated with acquired immunodeficiency syndrome (AIDS). She was given a diagnosis of gastric cancer at the lesser curvature of the body of the stomach, and distal gastrectomy was performed in December...
journal_title:International journal of clinical oncology
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doi:10.1007/s10147-010-0114-1
更新日期:2011-02-01 00:00:00
abstract:BACKGROUND:Obese women with estrogen receptor (ER)-positive breast cancer may experience worse disease-free and overall survival. We hypothesize that this observation is due to intrinsically aggressive disease and that obesity will be associated with higher histologic grade and Ki67. METHODS:A sequential cohort of wom...
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doi:10.1007/s10147-014-0712-4
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abstract:BACKGROUND:The Randomized Phase III Study Comparing Oxaliplatin plus S-1 with Cisplatin plus S-1 in Chemotherapy-naïve Patients with Advanced Gastric Cancer (G-SOX) showed the noninferiority of S-1 (an oral fluoropyrimidine-derivative dihydropyrimidine dehydrogenase inhibitor) plus oxaliplatin combination therapy (SOX)...
journal_title:International journal of clinical oncology
pub_type: 杂志文章,meta分析,评审
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abstract::Among head and neck squamous cell carcinoma (HNSCC), the incidence of oropharyngeal SCC (OPSCC) is increasing in contrast to carcinoma with origin in other subsites. Human papillomavirus (HPV) is now recognized as a significant risk factor of the carcinogenesis of OPSCC. The HPV-related OPSCC patients tend to be relat...
journal_title:International journal of clinical oncology
pub_type: 杂志文章,评审
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abstract:BACKGROUND:Phase I study of weekly administration of low-dose docetaxel/cisplatin concurrent with conventionally fractionated radiotherapy for locally advanced head and neck squamous cell carcinoma suggested the recommended dose of docetaxel at 10 mg/m2 and cisplatin at 20 mg/m2. Phase II study of the concurrent chemor...
journal_title:International journal of clinical oncology
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abstract:BACKGROUND:It is expected that cell-free and concentrated ascites reinfusion therapy (CART) will relieve the symptoms caused by ascites. To date, however, no report of objective changes in patients' symptoms has been published. We have therefore evaluated symptom management by CART. METHODS:From April 2011 to July 201...
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abstract:BACKGROUND:We aimed to compare the impact of systematic uncertainties in patient setup and prostate motion on three different external-beam radiotherapy protocols for prostate cancer. METHODS:To simulate possible near-maximum systematic errors, the isocenter position was shifted to eight points with +/-1.65 SD of the ...
journal_title:International journal of clinical oncology
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doi:10.1007/s10147-007-0724-4
更新日期:2008-02-01 00:00:00
abstract::Approximately 10% of all extra-pulmonary small cell carcinoma (EPSCC) arises in the prostate either as de novo mixed adenocarcinoma with small cell components or a pure small cell carcinoma. Extensive disease carries a median survival of about 10 months in retrospective studies. We present a case managed aggressively ...
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abstract:BACKGROUND:Retrospective evaluation of the effectiveness and adverse events (AEs) of a sequential chemotherapy regimen using gemcitabine + carboplatin (GCarbo) followed by GCarbo + docetaxel (GCarboD) for advanced upper-tract urothelial carcinoma (UTUC). METHODS:We treated 56 patients with advanced UTUC. Mean patient ...
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pub_type: 杂志文章
doi:10.1007/s10147-015-0846-z
更新日期:2015-12-01 00:00:00
abstract::Specific allelic losses in the DNA of tumor cells are potential indicators of postoperative prognosis. Patients whose tumors showed allelic losses at 1p34, 3p25, 8p22, 13q12, 17p13.3, or 17q21.1 had a significantly higher risk of postoperative mortality than women whose tumors retained both alleles at those loci (the ...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
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更新日期:2001-02-01 00:00:00
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journal_title:International journal of clinical oncology
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更新日期:2012-10-01 00:00:00
abstract::We report a patient with avascular necrosis of the bilateral femoral head resulting from long-term steroid administration for radiation pneumonitis that occurred after tangential irradiation of the breast. The patient was a 50-year-old postmenopausal woman with breast cancer, stage IIIB (T4bN0M0) in the right C area. ...
journal_title:International journal of clinical oncology
pub_type: 杂志文章
doi:10.1007/s10147-006-0607-0
更新日期:2006-12-01 00:00:00
abstract:BACKGROUND:To avoid the loss of fertility, chemotherapy should be chosen as an adjuvant treatment after trachelectomy. Our study evaluated the effectiveness and safety of adjuvant chemotherapy after abdominal trachelectomy for cervical cancer. METHODS:Our institutional review board approved this clinical study, and in...
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journal_title:International journal of clinical oncology
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:International journal of clinical oncology
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更新日期:2011-12-01 00:00:00
abstract::Plasmacytoma is a blood disease featuring the proliferation of abnormal plasmacytes accompanied by the production of monoclonal immunoglobulins. It usually arises in the medulla; thus, extramedullary plasmacytoma is rare, and metastatic testicular tumors are also infrequent. In this report, we present a case of testic...
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更新日期:2006-10-01 00:00:00
abstract:BACKGROUND:Diagnosis of secondary ovarian tumors originating from colorectal cancer has previously been based upon history of malignancy and radiological findings of bilateral masses with a "stained glass appearance." The purpose of this study was to perform a detailed investigation of the radiological and macroscopic ...
journal_title:International journal of clinical oncology
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journal_title:International journal of clinical oncology
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abstract::Combination chemotherapy with cisplatin and pemetrexed is the most active first-line regimen for malignant pleural mesothelioma (MPM). However, no drugs have been approved for second-line treatment of MPM, with effective regimens remaining to be identified for patients in relapse. We have now evaluated the combination...
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abstract:BACKGROUND:Pulmonary metastasectomy in patients with renal cell carcinoma (RCC) remains controversial. The purpose of our analysis was to explore the outcome of patients with RCC who underwent pulmonary metastasectomy at our institution. METHODS:We reviewed data on 25 patients who underwent resection of lung metastasi...
journal_title:International journal of clinical oncology
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abstract:BACKGROUND:Cancer patients are at high risk of developing a second cancer after the treatment of initial cancers. Understanding the characteristics of multiple primary cancer is important to establish an effective surveillance program for the early detection of second cancers. METHODS:We analyzed the cancer registry r...
journal_title:International journal of clinical oncology
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abstract:BACKGROUND:The combination of a new oral dihydropyrimidine dehydrogenase-inhibitory fluoropyrimidine (S-1) and cisplatin (CDDP) is one of the most active chemotherapy regimens for gastric cancer. However, the optimum schedule for this combination has not yet been determined. This study was conducted to establish the ma...
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