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ニワ ユキコ
NIWA Yukiko
丹羽 由紀子 所属 医学部 医学科（附属八千代医療センター） 職種 講師 |
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| 論文種別 | 原著 |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer. |
| 掲載誌名 | 正式名：Cancer chemotherapy and pharmacology 略 称：Cancer Chemother Pharmacol ISSNコード：14320843/03445704 |
| 掲載区分 | 国外 |
| 巻・号・頁 | 81(5),pp.815-821 |
| 著者・共著者 | Yamada Suguru, Fujii Tsutomu, Yokoyama Yukihiro, Kawashima Hiroki, Maeda Osamu, Suzuki Kojiro, Okada Tohru, Ono Eizaburo, Yamaguchi Junpei, Takano Nao, Takami Hideki, Hayashi Masamichi, Niwa Yukiko, Hirooka Yoshiki, Ito Yoshiyuki, Naganawa Shinji, Ando Yuichi, Nagino Masato, Goto Hidemi, Kodera Yasuhiro |
| 発行年月 | 2018/05 |
| 概要 | PURPOSE:For unresectable locally advanced (UR-LA) pancreatic cancer, chemoradiotherapy has been recommended by the NCCN guidelines. We designed a chemoradiotherapy protocol using nab-paclitaxel combined with gemcitabine (GnP) for patients with UR-LA pancreatic cancer. The purpose of this phase I study was to determine a recommended dose (RD) for this novel regimen.METHODS:Patients with UR-LA pancreatic cancer were eligible. The frequency of dose-limiting toxicities (DLTs) was evaluated, and the RD was determined. Patients were classified according to the designated dose levels of chemoradiotherapy using the GnP regimen. After additional 6 cycles of the GnP regimen were administered, surgery was considered if the patients had stable disease and tumor marker levels had normalized.RESULTS:DLT (grade 4 thrombocytopenia) was observed only in 1 of 12 patients, and the RD was set at level 3. Grade 3-4 leukopenia was observed in 9 (75.0%) patients, and neutropenia in 7 (58.3%). The response rate was 41.7%, and the disease control rate was 100%. Conversion surgery was performed in 6 (50%) patients, and curative resection (R0) was performed in all 6 patients (100%). Stratification according to the Evans classification system demonstrated one patient with grade 1b, one with grade 2, two with grade 3, and two with grade 4 disease.CONCLUSION:The RD for weekly administration was 800 mg/m2 for gemcitabine and 100 mg/m2 for nab-paclitaxel with a 50.4 Gy radiation. The GnP regimen at this dosage was promising with 6 of 12 patients proceeding to conversion surgery, and should be evaluated further in a phase II trial. |
| DOI | 10.1007/s00280-018-3554-3 |
| PMID | 29502139 |