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Br J Cancer. 2018 Aug;119(5):530-537. doi: 10.1038/s41416-018-0206-7. Epub 2018 Aug 3.

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

Author information

1
Department of Obstetrics and Gynecology, Graduate School of Medical Science, University of the Ryukyus, 207 Uehara Nishihara-cho, Nakagami-gun, Okinawa, 903-0215, Japan.
2
Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 3-19-18, Nishishimbashi, Minato-ku, Tokyo, 105-8471, Japan. kochiai@jikei.ac.jp.
3
Department of Obstetrics and Gynecology, Gachon University Gil Medical Center, 1198 Guwol-dong, Namdong-gu, Incheon, 405-760, Korea.
4
Department of Obstetrics and Gynecology, Keio University School of Medicine, 35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan.
5
Department of Gynecology, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, Osaka, 541-8567, Japan.
6
Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, No. 123, Ta-Pei Road, Niao-Sung District, Kaohsiung, 83301, Taiwan.
7
Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
8
Department of Medical Oncology, Nippon Medical School Musashikosugi Hospital, 1-396, Kosugi-cho, Nakahara-ku, Kawasaki-shi, Kanagawa, 211-8533, Japan.
9
Department of Obstetrics and Gynecology, Keimyung University School of Medicine, 194 Dong San Dong, Daegu, 700-712, Korea.
10
Department of Obstetrics and Gynecology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.
11
Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Gangnam-gu, Seoul, 135-710, Korea.
12
Department of Gynecology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
13
Department of Gynecologic Oncology, Saitama Medical University International Medical Center, 1397-1, Yamane, Hidaka, Saitama, 350-1298, Japan.
14
Department of Obstetrics and Gynecology, Asan Medical Center, 388-1 Pungnap-2dong, Songpa-gu, Seoul, 138-736, Korea.
15
Department of Obstetrics and Gynecology, Chonnam National University Hwasun Hospital, 160 Ilsimri Hwasun-eup, Hwasun, Jeonnam, 519-809, Korea.
16
Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 50 Ilwon-Dong, Gangnam-gu, Seoul, 135-710, Korea.
17
Department of Obstetrics and Gynecology, Linkou Chang Gung Memorial Hospital and Chang Gung University Medical College, No.5, Fu-Shin Street, Kueishan County, Taoyuan, 33305, Taiwan.
18
Department of Obstetrics and Gynecology, Kurume University School of Medicine, Asahi-machi 67, Kurume, Fukuoka, 830-0011, Japan.
19
Department of Gynecology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-10-6, Ariake, Koto-ku, Tokyo, 135-8550, Japan.
20
Department of Clinical Medicine (Biostatistics), Kitasato University School of Pharmacy, Shirokane 5-9-1, Minato-ku, Tokyo, 108-8641, Japan.
21
Department of Obstetrics and Gynecology, Konkuk University School of Medicine, 120-1 Neungdong-ro, Gwangjin-gu, Seoul, 05080, Korea.

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.

PMID:
30072745
PMCID:
PMC6162273
DOI:
10.1038/s41416-018-0206-7
[Indexed for MEDLINE]
Free PMC Article

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