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タイトル: | Phase I/II Study of Temozolomide Plus Nimustine Chemotherapy for Recurrent Malignant Gliomas: Kyoto Neuro-oncology Group |
著者: | AOKI, Tomokazu ARAKAWA, Yoshiki ![]() ![]() ![]() UEBA, Tetsuya ODA, Masashi NISHIDA, Namiko AKIYAMA, Yukinori TSUKAHARA, Tetsuya IWASAKI, Koichi MIKUNI, Nobuhiro MIYAMOTO, Susumu |
著者名の別形: | 荒川, 芳輝 宮本, 享 |
キーワード: | temozolomide nimustine recurrent malignant gliomas phase I/II study |
発行日: | Jan-2017 |
出版者: | Japan Neurosurgical Society |
誌名: | Neurologia medico-chirurgica |
巻: | 57 |
号: | 1 |
開始ページ: | 17 |
終了ページ: | 27 |
抄録: | 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. |
著作権等: | This article is applied Creative Commons Attribution Non-Commercial-NoDerivs License (CC BY-NC-ND) by the publisher. |
URI: | http://hdl.handle.net/2433/226823 |
DOI(出版社版): | 10.2176/nmc.oa.2016-0162 |
PubMed ID: | 27725524 |
出現コレクション: | 学術雑誌掲載論文等 |
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