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Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis

PURPOSE: We designed a phase I/II trial of intraperitoneal (IP) docetaxel plus S-1 to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate its efficacy and safety in gastric cancer patients with peritoneal carcinomatosis (PC). METHODS: Patients with PC confirmed by la...

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Autores principales: Fushida, S., Kinoshita, J., Kaji, M., Hirono, Y., Goda, F., Yagi, Y., Oyama, K., Sudo, Y., Watanabe, Y., Fujimura, T.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer-Verlag 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3636429/
https://www.ncbi.nlm.nih.gov/pubmed/23423490
http://dx.doi.org/10.1007/s00280-013-2122-0
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author Fushida, S.
Kinoshita, J.
Kaji, M.
Hirono, Y.
Goda, F.
Yagi, Y.
Oyama, K.
Sudo, Y.
Watanabe, Y.
Fujimura, T.
author_facet Fushida, S.
Kinoshita, J.
Kaji, M.
Hirono, Y.
Goda, F.
Yagi, Y.
Oyama, K.
Sudo, Y.
Watanabe, Y.
Fujimura, T.
author_sort Fushida, S.
collection PubMed
description PURPOSE: We designed a phase I/II trial of intraperitoneal (IP) docetaxel plus S-1 to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate its efficacy and safety in gastric cancer patients with peritoneal carcinomatosis (PC). METHODS: Patients with PC confirmed by laparoscopy or laparotomy received IP docetaxel on days 1 and 15 and S-1 (80 mg/m(2)) on days 1–14 every 4 weeks. RESULTS: In the phase I part (n = 12), each cohort received escalating doses of docetaxel (35–50 mg/m(2)); the MTD was determined to be 50 mg/m(2) and the RD was determined to be 45 mg/m(2). Dose-limiting toxicities included grade 3 febrile neutropenia and grade 3 diarrhea. In the phase II part (n = 27), the median number of courses was 4 (range 2–11). The 1-year overall survival (OS) rate was 70 % (95 % confidence interval 53–87 %). The overall response rate was 22 % and peritoneal cytology turned negative in 18 of 22 (81 %) patients. The most frequent grade 3/4 toxicities included anorexia (19 %), neutropenia (7 %), and leukopenia (7 %). CONCLUSION: IP docetaxel plus S-1 is active and safety in gastric cancer patients with PC.
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spelling pubmed-36364292013-04-29 Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis Fushida, S. Kinoshita, J. Kaji, M. Hirono, Y. Goda, F. Yagi, Y. Oyama, K. Sudo, Y. Watanabe, Y. Fujimura, T. Cancer Chemother Pharmacol Original Article PURPOSE: We designed a phase I/II trial of intraperitoneal (IP) docetaxel plus S-1 to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate its efficacy and safety in gastric cancer patients with peritoneal carcinomatosis (PC). METHODS: Patients with PC confirmed by laparoscopy or laparotomy received IP docetaxel on days 1 and 15 and S-1 (80 mg/m(2)) on days 1–14 every 4 weeks. RESULTS: In the phase I part (n = 12), each cohort received escalating doses of docetaxel (35–50 mg/m(2)); the MTD was determined to be 50 mg/m(2) and the RD was determined to be 45 mg/m(2). Dose-limiting toxicities included grade 3 febrile neutropenia and grade 3 diarrhea. In the phase II part (n = 27), the median number of courses was 4 (range 2–11). The 1-year overall survival (OS) rate was 70 % (95 % confidence interval 53–87 %). The overall response rate was 22 % and peritoneal cytology turned negative in 18 of 22 (81 %) patients. The most frequent grade 3/4 toxicities included anorexia (19 %), neutropenia (7 %), and leukopenia (7 %). CONCLUSION: IP docetaxel plus S-1 is active and safety in gastric cancer patients with PC. Springer-Verlag 2013-02-20 2013 /pmc/articles/PMC3636429/ /pubmed/23423490 http://dx.doi.org/10.1007/s00280-013-2122-0 Text en © The Author(s) 2013 https://creativecommons.org/licenses/by/2.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Article
Fushida, S.
Kinoshita, J.
Kaji, M.
Hirono, Y.
Goda, F.
Yagi, Y.
Oyama, K.
Sudo, Y.
Watanabe, Y.
Fujimura, T.
Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis
title Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis
title_full Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis
title_fullStr Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis
title_full_unstemmed Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis
title_short Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis
title_sort phase i/ii study of intraperitoneal docetaxel plus s-1 for the gastric cancer patients with peritoneal carcinomatosis
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3636429/
https://www.ncbi.nlm.nih.gov/pubmed/23423490
http://dx.doi.org/10.1007/s00280-013-2122-0
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