Literature DB >> 24146260

Phase II clinical study of alternate-day oral therapy with S-1 as first-line chemotherapy for locally advanced and metastatic pancreatic cancer.

Hiroki Yamaue1, Sohei Satoi, Takamasa Kanbe, Motoki Miyazawa, Masaji Tani, Manabu Kawai, Seiko Hirono, Kenichi Okada, Hiroaki Yanagimoto, A-Hon Kwon, Tomoyuki Mukouyama, Hiroaki Tsunoda, Kazuo Chijiiwa, Jiro Ohuchida, Jun Kato, Kazuki Ueda, Taketo Yamaguchi, Shinichi Egawa, Kazuhiko Hayashi, Tetsuhiko Shirasaka.   

Abstract

PURPOSE: Based on the results of first-line chemotherapy for advanced pancreatic cancer, S-1 was confirmed to be non-inferior to gemcitabine. However, the recommended regimen of 4 weeks of administration followed by 2 weeks of drug withdrawal frequently causes adverse effects. On the other hand, we experienced in clinical practice that alternate-day administration of S-1 reduced adverse effects and were tolerable for advanced pancreatic cancer patients unwilling to continue the standard daily administration. We therefore conducted a multicenter cooperative prospective study to compare daily with alternate-day administration of S-1 for advanced pancreatic cancer.
METHODS: Patients with advanced pancreatic cancer were eligible for enrollment in this trial. S-1 was administered at a dose of 40-60 mg twice daily, calculated according to body surface area, on Monday, Wednesday, Friday, and Sunday. Each treatment cycle was 42 days. The primary end point was overall survival (OS). Secondary end points were safety, response rate (RR), progression-free survival (PFS), and time to treatment failure (TTF).
RESULTS: Forty-eight patients were evaluable for response. OS as the primary end point was 8.4 months (95 % CI 5.4-10.8), and the 1-year survival rate was 29.2 %. PFS was 5.5 months, and TTF was 3.9 months. RR was 10.4 %, and the disease control rate was 79.2 %. Grade 3/4 hematological and non-hematological toxicities were minor. All of these adverse reactions were tolerable and reversible.
CONCLUSIONS: The current data demonstrate the mitigation of adverse effects with alternate-day administration of S-1, and this appears to be a more sustainable option for advanced pancreatic cancer.

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Year:  2013        PMID: 24146260     DOI: 10.1007/s00280-013-2323-6

Source DB:  PubMed          Journal:  Cancer Chemother Pharmacol        ISSN: 0344-5704            Impact factor:   3.333


  10 in total

1.  Concurrent radiotherapy with S-1 plus cisplatin versus concurrent radiotherapy with cisplatin alone for the treatment of locally advanced cervical carcinoma: a pilot randomised controlled trial.

Authors:  Z Li; W Mao; N Lin; S Han
Journal:  Clin Transl Oncol       Date:  2015-08-25       Impact factor: 3.405

2.  Ischemic gastropathy after distal pancreatectomy with en bloc celiac axis resection for pancreatic body cancer.

Authors:  Ken-Ichi Okada; Manabu Kawai; Seiko Hirono; Motoki Miyazawa; Yuji Kitahata; Masaki Ueno; Shinya Hayami; Toshio Shimokawa; Hiroki Yamaue
Journal:  Langenbecks Arch Surg       Date:  2018-06-28       Impact factor: 3.445

3.  Gastrointestinal toxicities of 5-fluorouracil increase the proportion of regulatory T cells in intestinal tract: advantages of alternate-day S-1 administration.

Authors:  Taiki Kajiwara; Koh Miura; Shinobu Ohnuma; Miki Shimada; Toshihiro Komura; Masahide Toshima; Atsushi Kohyama; Katsuyoshi Kudoh; Sho Haneda; Hiroaki Musha; Takeshi Naitoh; Tetsuhiko Shirasaka; Michiaki Unno
Journal:  Int J Clin Oncol       Date:  2015-02-05       Impact factor: 3.402

4.  Randomized phase II study of daily and alternate-day administration of S-1 for adjuvant chemotherapy in completely-resected stage I non-small cell lung cancer: results of the Setouchi Lung Cancer Group Study 1301.

Authors:  Norihito Okumura; Junichi Soh; Hiroyuki Suzuki; Masao Nakata; Toshiya Fujiwara; Hiroshige Nakamura; Makoto Sonobe; Takuji Fujinaga; Kazuhiko Kataoka; Kenichi Gemba; Masafumi Kataoka; Katsuyuki Hotta; Hiroshige Yoshioka; Keitaro Matsuo; Junichi Sakamoto; Hiroshi Date; Shinichi Toyooka
Journal:  BMC Cancer       Date:  2021-05-06       Impact factor: 4.430

5.  Randomized phase II study of daily and alternate-day administration of S-1 for advanced gastric cancer (JFMC43-1003).

Authors:  Hiroaki Tanaka; Mitsuro Kanda; Satoshi Morita; Masataka Taguri; Kazuhiro Nishikawa; Mitsuo Shimada; Kazuya Muguruma; Keisuke Koeda; Masazumi Takahashi; Mikihito Nakamori; Hiroyuki Konno; Akihito Tsuji; Yoshinori Hosoya; Tetsuhiko Shirasaka; Susumu Yamamitsu; Michio Sowa; Masaki Kitajima; Masazumi Okajima; Michiya Kobayashi; Junichi Sakamoto; Shigetoyo Saji; Kosei Hirakawa
Journal:  Int J Clin Oncol       Date:  2017-06-30       Impact factor: 3.402

6.  Inhibition of Prostaglandin Reductase 2, a Putative Oncogene Overexpressed in Human Pancreatic Adenocarcinoma, Induces Oxidative Stress-Mediated Cell Death Involving xCT and CTH Gene Expressions through 15-Keto-PGE2.

Authors:  Emily Yun-Chia Chang; Yi-Cheng Chang; Chia-Tung Shun; Yu-Wen Tien; Shu-Huei Tsai; Siow-Wey Hee; Ing-Jung Chen; Lee-Ming Chuang
Journal:  PLoS One       Date:  2016-01-28       Impact factor: 3.240

7.  Randomized feasibility study of S-1 for adjuvant chemotherapy in completely resected Stage IA non-small-cell lung cancer: results of the Setouchi Lung Cancer Group Study 0701.

Authors:  Junichi Soh; Norihito Okumura; Masao Nakata; Hiroshige Nakamura; Minoru Fukuda; Masafumi Kataoka; Shinsuke Kajiwara; Yoshifumi Sano; Motoi Aoe; Kazuhiko Kataoka; Katsuyuki Hotta; Keitaro Matsuo; Shinichi Toyooka; Hiroshi Date
Journal:  Jpn J Clin Oncol       Date:  2016-05-20       Impact factor: 3.019

8.  Mesenteric approach during pancreaticoduodenectomy for pancreatic ductal adenocarcinoma.

Authors:  Seiko Hirono; Manabu Kawai; Ken-Ichi Okada; Motoki Miyazawa; Atsushi Shimizu; Yuji Kitahata; Masaki Ueno; Toshio Shimokawa; Akimasa Nakao; Hiroki Yamaue
Journal:  Ann Gastroenterol Surg       Date:  2017-06-07

9.  A Phase Ib study of ruxolitinib + gemcitabine ± nab-paclitaxel in patients with advanced solid tumors.

Authors:  Todd M Bauer; Manish R Patel; Andres Forero-Torres; Thomas J George; Albert Assad; Yining Du; Herbert Hurwitz
Journal:  Onco Targets Ther       Date:  2018-04-30       Impact factor: 4.147

Review 10.  Gemcitabine Compared With Gemcitabine and S-1 Combination Therapy in Advanced Pancreatic Cancer: A Systematic Review and Meta-Analysis.

Authors:  Doudou Li; Changhao Chen; Yu Zhou; Rufu Chen; Xinxiang Fan; Zhuofei Bi; Zhihua Li; Yimin Liu
Journal:  Medicine (Baltimore)       Date:  2015-09       Impact factor: 1.817

  10 in total

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