Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer

Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer

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 stu...

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Bibliographic Details
Published in:Cancer chemotherapy and pharmacology Vol. 81; no. 5; pp. 815 - 821
Main Authors: 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
Format: Journal Article
Language:English
Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-05-2018
Springer Nature B.V
Subjects:
Cancer
Cancer Research
Chemoradiotherapy
Chemotherapy
Conversion
Disease control
Gemcitabine
Leukopenia
Medicine
Medicine & Public Health
Neutropenia
Oncology
Original Article
Paclitaxel
Pancreatic cancer
Patients
Pharmacology/Toxicology
Radiation
Radiation therapy
Surgery
Thrombocytopenia
Toxicity
Tumor markers
Phase I study
Gemcitabine
Unresectable locally advanced pancreatic cancer
Nab-paclitaxel
Radiation
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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/m 2 for gemcitabine and 100 mg/m 2 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.
ISSN:0344-5704
1432-0843
DOI:10.1007/s00280-018-3554-3