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dc.contributor.author | AOKI, Tomokazu | en |
dc.contributor.author | ARAKAWA, Yoshiki | en |
dc.contributor.author | UEBA, Tetsuya | en |
dc.contributor.author | ODA, Masashi | en |
dc.contributor.author | NISHIDA, Namiko | en |
dc.contributor.author | AKIYAMA, Yukinori | en |
dc.contributor.author | TSUKAHARA, Tetsuya | en |
dc.contributor.author | IWASAKI, Koichi | en |
dc.contributor.author | MIKUNI, Nobuhiro | en |
dc.contributor.author | MIYAMOTO, Susumu | en |
dc.contributor.alternative | 荒川, 芳輝 | ja |
dc.contributor.alternative | 宮本, 享 | ja |
dc.date.accessioned | 2017-08-23T05:57:46Z | - |
dc.date.available | 2017-08-23T05:57:46Z | - |
dc.date.issued | 2017-01 | - |
dc.identifier.issn | 0470-8105 | - |
dc.identifier.uri | http://hdl.handle.net/2433/226823 | - |
dc.description.abstract | The objective of this phase I/II study was to examine the efficacy and toxicity profile of temozolomide (TMZ) plus nimustine (ACNU). Patients who had received a standard radiotherapy with one or two previous chemo-regimens were enrolled. In phase I, the maximum-tolerated dose (MTD) by TMZ (150 mg/m2/day) (Day 1-5) plus various doses of ACNU (30, 35, 40, 45 mg/m2/day) (Day 15) per 4 weeks was defined on a standard 3 + 3 design. In phase II, these therapeutic activity and safety of this regimen were evaluated. Forty-nine eligible patients were enrolled. The median age was 50 years-old. Eighty percent had a KPS of 70–100. Histologies were glioblastoma (73%), anaplastic astrocytoma (22%), anaplastic oligodendroglioma (4%). In phase I, 15 patients were treated at four cohorts by TMZ plus ACNU. MTD was TMZ (150 mg/m2) plus ACNU (40 mg/m2). In phase II, 40 patients were treated at the dose of cohort 3 (MTD). Thirty-five percent of patients experienced grade 3 or 4 toxicities, mainly hematologic. The overall response rate was 11% (4/37). Sixty-eight percent (25/37) had stable disease. Twenty-two percent (8/37) showed progression. Progression-free survival (PFS) rates at 6 and 12 months were 24% (95% CI, 12–35%) and 8% (95% CI, 4–15%). Median PFS was 13 months (95% CI, 9.2–17.2 months). Overall survival (OS) at 6 and 12 were 78% (95% CI, 67–89%) and 49% (95% CI, 33–57%). Median OS was 11.8 months (95% CI, 8.2–14.5 months). This phase I/II study showed a moderate toxicity in hematology and may has a promising efficacy in OS, without inferiority in PFS. | en |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Japan Neurosurgical Society | en |
dc.publisher.alternative | 日本脳神経外科学会 | ja |
dc.rights | This article is applied Creative Commons Attribution Non-Commercial-NoDerivs License (CC BY-NC-ND) by the publisher. | en |
dc.subject | temozolomide | en |
dc.subject | nimustine | en |
dc.subject | recurrent malignant gliomas | en |
dc.subject | phase I/II study | en |
dc.title | Phase I/II Study of Temozolomide Plus Nimustine Chemotherapy for Recurrent Malignant Gliomas: Kyoto Neuro-oncology Group | en |
dc.type | journal article | - |
dc.type.niitype | Journal Article | - |
dc.identifier.jtitle | Neurologia medico-chirurgica | - |
dc.identifier.volume | 57 | - |
dc.identifier.issue | 1 | - |
dc.identifier.spage | 17 | - |
dc.identifier.epage | 27 | - |
dc.relation.doi | 10.2176/nmc.oa.2016-0162 | - |
dc.textversion | publisher | - |
dc.identifier.pmid | 27725524 | - |
dcterms.accessRights | open access | - |
出現コレクション: | 学術雑誌掲載論文等 |
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