Prospective multicenter study to investigate the introduction rate of second-line S-1 in gemcitabine-refractory unresectable pancreatic cancer

Hiroki Kawashima, Akihiro Itoh, Eizaburo Ohno, Masanao Nakamura, Ryoji Miyahara, Naoki Ohmiya, Kazuo Hara, Akira Kanamori, Terutomo Itoh, Tomoyuki Taki, Takanori Hirai, Senju Hashimoto, Kinichi Takeda, Hidemi Goto, Yoshiki Hirooka

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Abstract

Purpose: S-1 is one of the second-line candidate agents for gemcitabine-refractory unresectable pancreatic cancer. Two phase II studies have been reported for second-line chemotherapy with S-1, but these studies did not investigate introduction rate and suitable dose of second-line S-1. Therefore, we conducted a prospective multicenter study in which chemo-naïve patients were enrolled and had two levels of S-1 dose. Methods: Chemo-naïve patients with unresectable pancreatic cancer were enrolled. This study started with 80 mg/m2/day dose of S-1 as second-line chemotherapy and tolerability was checked. When tolerability was not confirmed in initial patients, the dose of S-1 was shifted to 60 mg/m2/day. When tolerability was confirmed at 80 or 60 mg/m2/day, the study continued, and up to 20 patients were accumulated with the dose. In addition, the introduction rate of second-line S-1 was examined. Results: Six of the initial 7 patients with 80 mg/m2/day dose of S-1 completed one course of second-line chemotherapy. Twenty patients were accumulated with an 80 mg/m2/day dose of S-1. With the exception of one patient continued gemcitabine chemotherapy, two of the remaining 19 patients withdrew from this study because of toxicity during the period of gemcitabine chemotherapy. Fifteen of the remaining 17 gemcitabine-refractory patients could complete one course of S-1 as second-line chemotherapy with acceptable toxicity. Conclusions: This prospective multicenter study showed that 15 (78.9%) out of 19 chemo-naïve unresectable pancreatic cancer patients could complete one course of 80 mg/m2/day dose of S-1 as second-line chemotherapy after first-line gemcitabine chemotherapy failure with tolerable toxicity.

Original languageEnglish
Pages (from-to)677-683
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume68
Issue number3
DOIs
Publication statusPublished - 01-09-2011
Externally publishedYes

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gemcitabine
Chemotherapy
Pancreatic Neoplasms
Refractory materials
Multicenter Studies
Prospective Studies
Drug Therapy
Toxicity

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

Kawashima, Hiroki ; Itoh, Akihiro ; Ohno, Eizaburo ; Nakamura, Masanao ; Miyahara, Ryoji ; Ohmiya, Naoki ; Hara, Kazuo ; Kanamori, Akira ; Itoh, Terutomo ; Taki, Tomoyuki ; Hirai, Takanori ; Hashimoto, Senju ; Takeda, Kinichi ; Goto, Hidemi ; Hirooka, Yoshiki. / Prospective multicenter study to investigate the introduction rate of second-line S-1 in gemcitabine-refractory unresectable pancreatic cancer. In: Cancer Chemotherapy and Pharmacology. 2011 ; Vol. 68, No. 3. pp. 677-683.
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title = "Prospective multicenter study to investigate the introduction rate of second-line S-1 in gemcitabine-refractory unresectable pancreatic cancer",
abstract = "Purpose: S-1 is one of the second-line candidate agents for gemcitabine-refractory unresectable pancreatic cancer. Two phase II studies have been reported for second-line chemotherapy with S-1, but these studies did not investigate introduction rate and suitable dose of second-line S-1. Therefore, we conducted a prospective multicenter study in which chemo-na{\"i}ve patients were enrolled and had two levels of S-1 dose. Methods: Chemo-na{\"i}ve patients with unresectable pancreatic cancer were enrolled. This study started with 80 mg/m2/day dose of S-1 as second-line chemotherapy and tolerability was checked. When tolerability was not confirmed in initial patients, the dose of S-1 was shifted to 60 mg/m2/day. When tolerability was confirmed at 80 or 60 mg/m2/day, the study continued, and up to 20 patients were accumulated with the dose. In addition, the introduction rate of second-line S-1 was examined. Results: Six of the initial 7 patients with 80 mg/m2/day dose of S-1 completed one course of second-line chemotherapy. Twenty patients were accumulated with an 80 mg/m2/day dose of S-1. With the exception of one patient continued gemcitabine chemotherapy, two of the remaining 19 patients withdrew from this study because of toxicity during the period of gemcitabine chemotherapy. Fifteen of the remaining 17 gemcitabine-refractory patients could complete one course of S-1 as second-line chemotherapy with acceptable toxicity. Conclusions: This prospective multicenter study showed that 15 (78.9{\%}) out of 19 chemo-na{\"i}ve unresectable pancreatic cancer patients could complete one course of 80 mg/m2/day dose of S-1 as second-line chemotherapy after first-line gemcitabine chemotherapy failure with tolerable toxicity.",
author = "Hiroki Kawashima and Akihiro Itoh and Eizaburo Ohno and Masanao Nakamura and Ryoji Miyahara and Naoki Ohmiya and Kazuo Hara and Akira Kanamori and Terutomo Itoh and Tomoyuki Taki and Takanori Hirai and Senju Hashimoto and Kinichi Takeda and Hidemi Goto and Yoshiki Hirooka",
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Kawashima, H, Itoh, A, Ohno, E, Nakamura, M, Miyahara, R, Ohmiya, N, Hara, K, Kanamori, A, Itoh, T, Taki, T, Hirai, T, Hashimoto, S, Takeda, K, Goto, H & Hirooka, Y 2011, 'Prospective multicenter study to investigate the introduction rate of second-line S-1 in gemcitabine-refractory unresectable pancreatic cancer', Cancer Chemotherapy and Pharmacology, vol. 68, no. 3, pp. 677-683. https://doi.org/10.1007/s00280-010-1531-6

Prospective multicenter study to investigate the introduction rate of second-line S-1 in gemcitabine-refractory unresectable pancreatic cancer. / Kawashima, Hiroki; Itoh, Akihiro; Ohno, Eizaburo; Nakamura, Masanao; Miyahara, Ryoji; Ohmiya, Naoki; Hara, Kazuo; Kanamori, Akira; Itoh, Terutomo; Taki, Tomoyuki; Hirai, Takanori; Hashimoto, Senju; Takeda, Kinichi; Goto, Hidemi; Hirooka, Yoshiki.

In: Cancer Chemotherapy and Pharmacology, Vol. 68, No. 3, 01.09.2011, p. 677-683.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Prospective multicenter study to investigate the introduction rate of second-line S-1 in gemcitabine-refractory unresectable pancreatic cancer

AU - Kawashima, Hiroki

AU - Itoh, Akihiro

AU - Ohno, Eizaburo

AU - Nakamura, Masanao

AU - Miyahara, Ryoji

AU - Ohmiya, Naoki

AU - Hara, Kazuo

AU - Kanamori, Akira

AU - Itoh, Terutomo

AU - Taki, Tomoyuki

AU - Hirai, Takanori

AU - Hashimoto, Senju

AU - Takeda, Kinichi

AU - Goto, Hidemi

AU - Hirooka, Yoshiki

PY - 2011/9/1

Y1 - 2011/9/1

N2 - Purpose: S-1 is one of the second-line candidate agents for gemcitabine-refractory unresectable pancreatic cancer. Two phase II studies have been reported for second-line chemotherapy with S-1, but these studies did not investigate introduction rate and suitable dose of second-line S-1. Therefore, we conducted a prospective multicenter study in which chemo-naïve patients were enrolled and had two levels of S-1 dose. Methods: Chemo-naïve patients with unresectable pancreatic cancer were enrolled. This study started with 80 mg/m2/day dose of S-1 as second-line chemotherapy and tolerability was checked. When tolerability was not confirmed in initial patients, the dose of S-1 was shifted to 60 mg/m2/day. When tolerability was confirmed at 80 or 60 mg/m2/day, the study continued, and up to 20 patients were accumulated with the dose. In addition, the introduction rate of second-line S-1 was examined. Results: Six of the initial 7 patients with 80 mg/m2/day dose of S-1 completed one course of second-line chemotherapy. Twenty patients were accumulated with an 80 mg/m2/day dose of S-1. With the exception of one patient continued gemcitabine chemotherapy, two of the remaining 19 patients withdrew from this study because of toxicity during the period of gemcitabine chemotherapy. Fifteen of the remaining 17 gemcitabine-refractory patients could complete one course of S-1 as second-line chemotherapy with acceptable toxicity. Conclusions: This prospective multicenter study showed that 15 (78.9%) out of 19 chemo-naïve unresectable pancreatic cancer patients could complete one course of 80 mg/m2/day dose of S-1 as second-line chemotherapy after first-line gemcitabine chemotherapy failure with tolerable toxicity.

AB - Purpose: S-1 is one of the second-line candidate agents for gemcitabine-refractory unresectable pancreatic cancer. Two phase II studies have been reported for second-line chemotherapy with S-1, but these studies did not investigate introduction rate and suitable dose of second-line S-1. Therefore, we conducted a prospective multicenter study in which chemo-naïve patients were enrolled and had two levels of S-1 dose. Methods: Chemo-naïve patients with unresectable pancreatic cancer were enrolled. This study started with 80 mg/m2/day dose of S-1 as second-line chemotherapy and tolerability was checked. When tolerability was not confirmed in initial patients, the dose of S-1 was shifted to 60 mg/m2/day. When tolerability was confirmed at 80 or 60 mg/m2/day, the study continued, and up to 20 patients were accumulated with the dose. In addition, the introduction rate of second-line S-1 was examined. Results: Six of the initial 7 patients with 80 mg/m2/day dose of S-1 completed one course of second-line chemotherapy. Twenty patients were accumulated with an 80 mg/m2/day dose of S-1. With the exception of one patient continued gemcitabine chemotherapy, two of the remaining 19 patients withdrew from this study because of toxicity during the period of gemcitabine chemotherapy. Fifteen of the remaining 17 gemcitabine-refractory patients could complete one course of S-1 as second-line chemotherapy with acceptable toxicity. Conclusions: This prospective multicenter study showed that 15 (78.9%) out of 19 chemo-naïve unresectable pancreatic cancer patients could complete one course of 80 mg/m2/day dose of S-1 as second-line chemotherapy after first-line gemcitabine chemotherapy failure with tolerable toxicity.

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U2 - 10.1007/s00280-010-1531-6

DO - 10.1007/s00280-010-1531-6

M3 - Article

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