Randomized phase II study of S-1 dosing schedule for resected colorectal cancer

Chu Matsuda, Mamoru Uemura, Ken Nakata, Tatsushi Shingai, Junichi Nishimura, Taishi Hata, Masakazu Ikenaga, Ichiro Takemasa, Tsunekazu Mizushima, Takeshi Kato, Masataka Ikeda, Masayuki Ohue, Kohei Murata, Junichi Hasegawa, Taroh Satoh, Hirofumi Yamamoto, Mitsugu Sekimoto, Riichiro Nezu, Yuichiro Doki, Masaki Mori

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Postoperative adjuvant chemotherapy for patients with stage III Colorectal cancer (CRC) is now internationally accepted as standard care for improving patient outcomes. The Adjuvant Chemotherapy Trial of S-1 for Colorectal Cancer (ACTS-CC) confirmed the non-inferiority of S-1 to tegafur/urcail/leucovorin in terms of overall survival and disease-free survival in patients with stage III CRC after curative surgery. However, the 6-month completion rate of S-1 treatment was 76.5 % in the ACTS-CC. Therefore, treatment completion remains an unresolved problem. Methods/Design: A randomized phase II trial was designed to evaluate the efficacy and safety of oral daily administration and alternate-day administration of S-1 as adjuvant chemotherapy in curatively resected stage III CRC. Enrolled patients were assigned to either S-1 daily administration (Arm A) or alternate-day S-1 administration (Arm B). Assigned treatment will start within 8 weeks after surgery. In both arms, S-1 dosing (oral) will be based on body surface area (80 mg/day for body surface area < 1.25 m2, 100 mg/day for 1.25-1.5 m2, or 60 mg/day for > 1.5 m2). In Arm A, S-1 will be administered orally for 28 days, followed by a 14-day rest. Administration will be conducted for 24 weeks from the date of therapy start. In Arm B, S-1 will be administered orally on alternate days for 28 weeks from the date of the start of therapy. After treatment, all patients will be observed without additional therapy unless recurrent lesions or other cancer lesions occur. The primary endpoint is treatment completion rate. Secondary endpoints include 3-year disease-free survival, compliance, and adverse events. Discussion: Previously, S-1 alternate-day intake maintained the efficacy of chemotherapy while reducing adverse effects for patients with R0-resected stage II/III gastric cancer. Improvement of chemotherapy completion rate for patients with colorectal cancer will lead to an improved patient prognosis. Therefore, a randomized phase II trial has been designed to examine the efficacy of alternate-day versus current standard daily S-1 administration as adjuvant chemotherapy for R0-resected stage III colorectal cancer.

Original languageEnglish
Article number452
JournalBMC Cancer
Volume15
Issue number1
DOIs
Publication statusPublished - Jun 3 2015
Externally publishedYes

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Colorectal Neoplasms
Appointments and Schedules
Adjuvant Chemotherapy
Body Surface Area
Therapeutics
Disease-Free Survival
Tegafur
Drug Therapy
Leucovorin
Compliance
Stomach Neoplasms
Oral Administration
Patient Care
Safety
Survival
Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Genetics
  • Cancer Research

Cite this

Matsuda, C., Uemura, M., Nakata, K., Shingai, T., Nishimura, J., Hata, T., ... Mori, M. (2015). Randomized phase II study of S-1 dosing schedule for resected colorectal cancer. BMC Cancer, 15(1), [452]. https://doi.org/10.1186/s12885-015-1476-6

Randomized phase II study of S-1 dosing schedule for resected colorectal cancer. / Matsuda, Chu; Uemura, Mamoru; Nakata, Ken; Shingai, Tatsushi; Nishimura, Junichi; Hata, Taishi; Ikenaga, Masakazu; Takemasa, Ichiro; Mizushima, Tsunekazu; Kato, Takeshi; Ikeda, Masataka; Ohue, Masayuki; Murata, Kohei; Hasegawa, Junichi; Satoh, Taroh; Yamamoto, Hirofumi; Sekimoto, Mitsugu; Nezu, Riichiro; Doki, Yuichiro; Mori, Masaki.

In: BMC Cancer, Vol. 15, No. 1, 452, 03.06.2015.

Research output: Contribution to journalArticle

Matsuda, C, Uemura, M, Nakata, K, Shingai, T, Nishimura, J, Hata, T, Ikenaga, M, Takemasa, I, Mizushima, T, Kato, T, Ikeda, M, Ohue, M, Murata, K, Hasegawa, J, Satoh, T, Yamamoto, H, Sekimoto, M, Nezu, R, Doki, Y & Mori, M 2015, 'Randomized phase II study of S-1 dosing schedule for resected colorectal cancer', BMC Cancer, vol. 15, no. 1, 452. https://doi.org/10.1186/s12885-015-1476-6
Matsuda C, Uemura M, Nakata K, Shingai T, Nishimura J, Hata T et al. Randomized phase II study of S-1 dosing schedule for resected colorectal cancer. BMC Cancer. 2015 Jun 3;15(1). 452. https://doi.org/10.1186/s12885-015-1476-6
Matsuda, Chu ; Uemura, Mamoru ; Nakata, Ken ; Shingai, Tatsushi ; Nishimura, Junichi ; Hata, Taishi ; Ikenaga, Masakazu ; Takemasa, Ichiro ; Mizushima, Tsunekazu ; Kato, Takeshi ; Ikeda, Masataka ; Ohue, Masayuki ; Murata, Kohei ; Hasegawa, Junichi ; Satoh, Taroh ; Yamamoto, Hirofumi ; Sekimoto, Mitsugu ; Nezu, Riichiro ; Doki, Yuichiro ; Mori, Masaki. / Randomized phase II study of S-1 dosing schedule for resected colorectal cancer. In: BMC Cancer. 2015 ; Vol. 15, No. 1.
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AU - Matsuda, Chu

AU - Uemura, Mamoru

AU - Nakata, Ken

AU - Shingai, Tatsushi

AU - Nishimura, Junichi

AU - Hata, Taishi

AU - Ikenaga, Masakazu

AU - Takemasa, Ichiro

AU - Mizushima, Tsunekazu

AU - Kato, Takeshi

AU - Ikeda, Masataka

AU - Ohue, Masayuki

AU - Murata, Kohei

AU - Hasegawa, Junichi

AU - Satoh, Taroh

AU - Yamamoto, Hirofumi

AU - Sekimoto, Mitsugu

AU - Nezu, Riichiro

AU - Doki, Yuichiro

AU - Mori, Masaki

PY - 2015/6/3

Y1 - 2015/6/3

N2 - Background: Postoperative adjuvant chemotherapy for patients with stage III Colorectal cancer (CRC) is now internationally accepted as standard care for improving patient outcomes. The Adjuvant Chemotherapy Trial of S-1 for Colorectal Cancer (ACTS-CC) confirmed the non-inferiority of S-1 to tegafur/urcail/leucovorin in terms of overall survival and disease-free survival in patients with stage III CRC after curative surgery. However, the 6-month completion rate of S-1 treatment was 76.5 % in the ACTS-CC. Therefore, treatment completion remains an unresolved problem. Methods/Design: A randomized phase II trial was designed to evaluate the efficacy and safety of oral daily administration and alternate-day administration of S-1 as adjuvant chemotherapy in curatively resected stage III CRC. Enrolled patients were assigned to either S-1 daily administration (Arm A) or alternate-day S-1 administration (Arm B). Assigned treatment will start within 8 weeks after surgery. In both arms, S-1 dosing (oral) will be based on body surface area (80 mg/day for body surface area < 1.25 m2, 100 mg/day for 1.25-1.5 m2, or 60 mg/day for > 1.5 m2). In Arm A, S-1 will be administered orally for 28 days, followed by a 14-day rest. Administration will be conducted for 24 weeks from the date of therapy start. In Arm B, S-1 will be administered orally on alternate days for 28 weeks from the date of the start of therapy. After treatment, all patients will be observed without additional therapy unless recurrent lesions or other cancer lesions occur. The primary endpoint is treatment completion rate. Secondary endpoints include 3-year disease-free survival, compliance, and adverse events. Discussion: Previously, S-1 alternate-day intake maintained the efficacy of chemotherapy while reducing adverse effects for patients with R0-resected stage II/III gastric cancer. Improvement of chemotherapy completion rate for patients with colorectal cancer will lead to an improved patient prognosis. Therefore, a randomized phase II trial has been designed to examine the efficacy of alternate-day versus current standard daily S-1 administration as adjuvant chemotherapy for R0-resected stage III colorectal cancer.

AB - Background: Postoperative adjuvant chemotherapy for patients with stage III Colorectal cancer (CRC) is now internationally accepted as standard care for improving patient outcomes. The Adjuvant Chemotherapy Trial of S-1 for Colorectal Cancer (ACTS-CC) confirmed the non-inferiority of S-1 to tegafur/urcail/leucovorin in terms of overall survival and disease-free survival in patients with stage III CRC after curative surgery. However, the 6-month completion rate of S-1 treatment was 76.5 % in the ACTS-CC. Therefore, treatment completion remains an unresolved problem. Methods/Design: A randomized phase II trial was designed to evaluate the efficacy and safety of oral daily administration and alternate-day administration of S-1 as adjuvant chemotherapy in curatively resected stage III CRC. Enrolled patients were assigned to either S-1 daily administration (Arm A) or alternate-day S-1 administration (Arm B). Assigned treatment will start within 8 weeks after surgery. In both arms, S-1 dosing (oral) will be based on body surface area (80 mg/day for body surface area < 1.25 m2, 100 mg/day for 1.25-1.5 m2, or 60 mg/day for > 1.5 m2). In Arm A, S-1 will be administered orally for 28 days, followed by a 14-day rest. Administration will be conducted for 24 weeks from the date of therapy start. In Arm B, S-1 will be administered orally on alternate days for 28 weeks from the date of the start of therapy. After treatment, all patients will be observed without additional therapy unless recurrent lesions or other cancer lesions occur. The primary endpoint is treatment completion rate. Secondary endpoints include 3-year disease-free survival, compliance, and adverse events. Discussion: Previously, S-1 alternate-day intake maintained the efficacy of chemotherapy while reducing adverse effects for patients with R0-resected stage II/III gastric cancer. Improvement of chemotherapy completion rate for patients with colorectal cancer will lead to an improved patient prognosis. Therefore, a randomized phase II trial has been designed to examine the efficacy of alternate-day versus current standard daily S-1 administration as adjuvant chemotherapy for R0-resected stage III colorectal cancer.

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