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Yukiko Niwa
Department School of Medicine(Yachiyo Medical Center), School of Medicine Position Assistant Professor |
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| Article types | Original article |
| Language | English |
| Peer review | Peer reviewed |
| Title | Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer. |
| Journal | Formal name：Cancer chemotherapy and pharmacology Abbreviation：Cancer Chemother Pharmacol ISSN code：14320843/03445704 |
| Domestic / Foregin | Foregin |
| Volume, Issue, Page | 81(5),pp.815-821 |
| Author and coauthor | 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 |
| Publication date | 2018/05 |
| Summary | 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 |