Phase III study of cisplatin with or without S-1 in patients with stage IVB, recurrent, or persistent cervical cancer

Yoichi Aoki, Kazunori Ochiai, Soyi Lim, Daisuke Aoki, Shoji Kamiura, Hao Lin, Noriyuki Katsumata, Soon Do Cha, Jae-Hoon Kim, Byoung Gie Kim, Yasuyuki Hirashima, Keiichi Fujiwara, Young Tak Kim, Seok Mo Kim, Hyun Hoon Chung, Ting Chang Chang, Toshiharu Kamura, Ken Takizawa, Masahiro Takeuchi, Soon Beom Kang

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Abstract

Background: This open-label phase III trial evaluated efficacy and safety of S-1 plus cisplatin vs. cisplatin alone as first-line chemotherapy in patients with stage IVB, recurrent, or persistent cervical cancer. Methods: Patients were randomised (1:1) to S-1 plus cisplatin (study group) or cisplatin alone (control group). In each cycle, cisplatin 50 mg/m2 was administered on Day 1 in both groups. S-1 was administered orally at 80–120 mg daily on Days 1–14 of a 21-day cycle in the study group. The primary endpoint was overall survival (OS). Results: A total of 375 patients were enrolled, of whom 364 (188, study group; 176, control group) received treatment. Median OS was 21.9 and 19.5 months in the study and control groups, respectively (log-rank P = 0.125; hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.67–1.05). Median progression-free survival (PFS) was 7.3 and 4.9 months in the study and control groups, respectively (HR 0.62, 95% CI 0.48–0.80, P < 0.001). The adverse event (AE) rate increased in the study group despite the absence of any unexpected AEs. Conclusions: S-1 plus cisplatin did not show superiority over cisplatin alone in OS but significantly increased PFS in patients with stage IVB, recurrent, or persistent cervical cancer. Since the standard therapy has changed in the course of this study, further studies are warranted to confirm the clinical positioning of S-1 combined with cisplatin for this population.

Original languageEnglish
Pages (from-to)530-537
Number of pages8
JournalBritish journal of cancer
Volume119
Issue number5
DOIs
Publication statusPublished - 2018 Aug 28

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Uterine Cervical Neoplasms
Cisplatin
Control Groups
Disease-Free Survival
Survival
Confidence Intervals
Safety
Drug Therapy
Therapeutics
Population

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Aoki, Yoichi ; Ochiai, Kazunori ; Lim, Soyi ; Aoki, Daisuke ; Kamiura, Shoji ; Lin, Hao ; Katsumata, Noriyuki ; Cha, Soon Do ; Kim, Jae-Hoon ; Kim, Byoung Gie ; Hirashima, Yasuyuki ; Fujiwara, Keiichi ; Kim, Young Tak ; Kim, Seok Mo ; Chung, Hyun Hoon ; Chang, Ting Chang ; Kamura, Toshiharu ; Takizawa, Ken ; Takeuchi, Masahiro ; Kang, Soon Beom. / Phase III study of cisplatin with or without S-1 in patients with stage IVB, recurrent, or persistent cervical cancer. In: British journal of cancer. 2018 ; Vol. 119, No. 5. pp. 530-537.
@article{0083e1c65de549cd93ffc463227366bb,
title = "Phase III study of cisplatin with or without S-1 in patients with stage IVB, recurrent, or persistent cervical cancer",
abstract = "Background: This open-label phase III trial evaluated efficacy and safety of S-1 plus cisplatin vs. cisplatin alone as first-line chemotherapy in patients with stage IVB, recurrent, or persistent cervical cancer. Methods: Patients were randomised (1:1) to S-1 plus cisplatin (study group) or cisplatin alone (control group). In each cycle, cisplatin 50 mg/m2 was administered on Day 1 in both groups. S-1 was administered orally at 80–120 mg daily on Days 1–14 of a 21-day cycle in the study group. The primary endpoint was overall survival (OS). Results: A total of 375 patients were enrolled, of whom 364 (188, study group; 176, control group) received treatment. Median OS was 21.9 and 19.5 months in the study and control groups, respectively (log-rank P = 0.125; hazard ratio [HR] 0.84, 95{\%} confidence interval [CI] 0.67–1.05). Median progression-free survival (PFS) was 7.3 and 4.9 months in the study and control groups, respectively (HR 0.62, 95{\%} CI 0.48–0.80, P < 0.001). The adverse event (AE) rate increased in the study group despite the absence of any unexpected AEs. Conclusions: S-1 plus cisplatin did not show superiority over cisplatin alone in OS but significantly increased PFS in patients with stage IVB, recurrent, or persistent cervical cancer. Since the standard therapy has changed in the course of this study, further studies are warranted to confirm the clinical positioning of S-1 combined with cisplatin for this population.",
author = "Yoichi Aoki and Kazunori Ochiai and Soyi Lim and Daisuke Aoki and Shoji Kamiura and Hao Lin and Noriyuki Katsumata and Cha, {Soon Do} and Jae-Hoon Kim and Kim, {Byoung Gie} and Yasuyuki Hirashima and Keiichi Fujiwara and Kim, {Young Tak} and Kim, {Seok Mo} and Chung, {Hyun Hoon} and Chang, {Ting Chang} and Toshiharu Kamura and Ken Takizawa and Masahiro Takeuchi and Kang, {Soon Beom}",
year = "2018",
month = "8",
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doi = "10.1038/s41416-018-0206-7",
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Aoki, Y, Ochiai, K, Lim, S, Aoki, D, Kamiura, S, Lin, H, Katsumata, N, Cha, SD, Kim, J-H, Kim, BG, Hirashima, Y, Fujiwara, K, Kim, YT, Kim, SM, Chung, HH, Chang, TC, Kamura, T, Takizawa, K, Takeuchi, M & Kang, SB 2018, 'Phase III study of cisplatin with or without S-1 in patients with stage IVB, recurrent, or persistent cervical cancer', British journal of cancer, vol. 119, no. 5, pp. 530-537. https://doi.org/10.1038/s41416-018-0206-7

Phase III study of cisplatin with or without S-1 in patients with stage IVB, recurrent, or persistent cervical cancer. / Aoki, Yoichi; Ochiai, Kazunori; Lim, Soyi; Aoki, Daisuke; Kamiura, Shoji; Lin, Hao; Katsumata, Noriyuki; Cha, Soon Do; Kim, Jae-Hoon; Kim, Byoung Gie; Hirashima, Yasuyuki; Fujiwara, Keiichi; Kim, Young Tak; Kim, Seok Mo; Chung, Hyun Hoon; Chang, Ting Chang; Kamura, Toshiharu; Takizawa, Ken; Takeuchi, Masahiro; Kang, Soon Beom.

In: British journal of cancer, Vol. 119, No. 5, 28.08.2018, p. 530-537.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase III study of cisplatin with or without S-1 in patients with stage IVB, recurrent, or persistent cervical cancer

AU - Aoki, Yoichi

AU - Ochiai, Kazunori

AU - Lim, Soyi

AU - Aoki, Daisuke

AU - Kamiura, Shoji

AU - Lin, Hao

AU - Katsumata, Noriyuki

AU - Cha, Soon Do

AU - Kim, Jae-Hoon

AU - Kim, Byoung Gie

AU - Hirashima, Yasuyuki

AU - Fujiwara, Keiichi

AU - Kim, Young Tak

AU - Kim, Seok Mo

AU - Chung, Hyun Hoon

AU - Chang, Ting Chang

AU - Kamura, Toshiharu

AU - Takizawa, Ken

AU - Takeuchi, Masahiro

AU - Kang, Soon Beom

PY - 2018/8/28

Y1 - 2018/8/28

N2 - Background: This open-label phase III trial evaluated efficacy and safety of S-1 plus cisplatin vs. cisplatin alone as first-line chemotherapy in patients with stage IVB, recurrent, or persistent cervical cancer. Methods: Patients were randomised (1:1) to S-1 plus cisplatin (study group) or cisplatin alone (control group). In each cycle, cisplatin 50 mg/m2 was administered on Day 1 in both groups. S-1 was administered orally at 80–120 mg daily on Days 1–14 of a 21-day cycle in the study group. The primary endpoint was overall survival (OS). Results: A total of 375 patients were enrolled, of whom 364 (188, study group; 176, control group) received treatment. Median OS was 21.9 and 19.5 months in the study and control groups, respectively (log-rank P = 0.125; hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.67–1.05). Median progression-free survival (PFS) was 7.3 and 4.9 months in the study and control groups, respectively (HR 0.62, 95% CI 0.48–0.80, P < 0.001). The adverse event (AE) rate increased in the study group despite the absence of any unexpected AEs. Conclusions: S-1 plus cisplatin did not show superiority over cisplatin alone in OS but significantly increased PFS in patients with stage IVB, recurrent, or persistent cervical cancer. Since the standard therapy has changed in the course of this study, further studies are warranted to confirm the clinical positioning of S-1 combined with cisplatin for this population.

AB - Background: This open-label phase III trial evaluated efficacy and safety of S-1 plus cisplatin vs. cisplatin alone as first-line chemotherapy in patients with stage IVB, recurrent, or persistent cervical cancer. Methods: Patients were randomised (1:1) to S-1 plus cisplatin (study group) or cisplatin alone (control group). In each cycle, cisplatin 50 mg/m2 was administered on Day 1 in both groups. S-1 was administered orally at 80–120 mg daily on Days 1–14 of a 21-day cycle in the study group. The primary endpoint was overall survival (OS). Results: A total of 375 patients were enrolled, of whom 364 (188, study group; 176, control group) received treatment. Median OS was 21.9 and 19.5 months in the study and control groups, respectively (log-rank P = 0.125; hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.67–1.05). Median progression-free survival (PFS) was 7.3 and 4.9 months in the study and control groups, respectively (HR 0.62, 95% CI 0.48–0.80, P < 0.001). The adverse event (AE) rate increased in the study group despite the absence of any unexpected AEs. Conclusions: S-1 plus cisplatin did not show superiority over cisplatin alone in OS but significantly increased PFS in patients with stage IVB, recurrent, or persistent cervical cancer. Since the standard therapy has changed in the course of this study, further studies are warranted to confirm the clinical positioning of S-1 combined with cisplatin for this population.

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U2 - 10.1038/s41416-018-0206-7

DO - 10.1038/s41416-018-0206-7

M3 - Article

VL - 119

SP - 530

EP - 537

JO - British Journal of Cancer

JF - British Journal of Cancer

SN - 0007-0920

IS - 5

ER -