Oral adjuvant chemotherapy using uracil-tegafur (UFT) with leucovorin (LV) after resection of colorectal cancer liver metastases: Long-term survival results of the phase III UFT/LV study.-Reference-Cited by-同舟云学术

Oral adjuvant chemotherapy using uracil-tegafur (UFT) with leucovorin (LV) after resection of colorectal cancer liver metastases: Long-term survival results of the phase III UFT/LV study.

Published:2017-02-01 Issue:4_suppl Volume:35 Page:672-672
ISSN:0732-183X
Container-title:Journal of Clinical Oncology
language:en
Short-container-title:JCO

Author:

Hasegawa Kiyoshi¹,Saiura Akio²,Takayama Tadatoshi³,Miyagawa Shinichi⁴,Yamamoto Junji⁵,Bandai Yasutsugu⁶,Teruya Masanori⁷,Yoshimi Fuyo⁸,Kawasaki Seiji⁹,Koyama Hiroto¹⁰,Oba Masaru¹,Takahashi Michiro¹¹,Yamashita Suguru¹,Mizunuma Nobuyuki¹²,Matsuyama Yutaka¹³,Watanabe Toshiaki¹⁴,Makuuchi Masatoshi¹⁵,Kokudo Norihiro¹⁶,

Affiliation:

1. Hepato-Biliary-Pancreatic Surgery Division, Graduate School of Medicine, University of Tokyo, Tokyo, Japan;

2. Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan;

3. Nihon University School of Medicine, Department of Digestive Surgery, Tokyo, Japan;

4. First Department of Surgery, Shinshu University School of Medicine, Matsumoto, Japan;

5. Department of Surgery National Defense Medical College, Saitama, Japan;

6. Department of Surgery, JCHO Tokyo Yamate Medical Center, Tokyo, Japan;

7. Department of Surgery, Showa General Hospital, Tokyo, Japan;

8. Department of Surgery, Ibaraki Prefectural Central Hospital and Cancer Center, Ibaraki, Japan;

9. Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine, Tokyo, Japan;

10. Department of Surgery, Sempos Tokyo Takanawa Hospital, Tokyo, Japan;

11. Department of Gastrointestinal Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Ariake Hospital, Tokyo, Japan;

12. Department of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan;

13. Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan;

14. Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan;

15. University of Tokyo, Tokyo, Japan;

16. Hepato-Biliary-Pancreatic Surgery Division, Graduate School of Medicine, University of Tokyo, Tokyo, Japan

Abstract

672 Background: Surgical resection has been accepted as the standard therapy for colorectal cancer liver metastases (CRLM), however, high recurrence incidence even after curative resection remains a severe problem. The 1st analysis of the UFT/LV trial showed that oral UFT/LV for 6 months significantly prolonged relapse-free survival (RFS) after resection for CRLM (Kobayashi A et al. ASCO 2014, Hasegawa K et al. PlosOne 2016 E-pub). To further evaluate the impact of the UFT/LV therapy on overall survival (OS), we performed the 2nd analysis under longer follow-up period, as have been scheduled by the protocol. Methods: Patients undergoing curative resection of CRLM were randomly assigned to either UFT/LV or surgery alone (control) group. In the UFT/LV group, 5 cycles of adjuvant UFT/LV (UFT 300mg/m2 and LV 75 mg/day for 28 days followed by 7 days rest in one cycle) were administered. Results: Between 2004 and 2010, a total of 180 patients were enrolled to this trial, among whom 3 patients were ineligible for analysis. Median follow-up of the 2nd analysis was 6 years. The 5y-OS rate in the UFT/LV group was 65.3%, which was slightly better than the control group (62.2%) without statistical significance. The hazard ratio for death in the UFT/LV relative to the control was 0.86 (95% confidence interval: 0.54-1.38, P = 0.54). The OS curves of the 2 groups were identical within 4 years after resection, however, the OS curve of the UFT/LV group seemed to go higher than the control group. The 5y-RFS rate in the UFT/LV group was 36.2%, which was significantly better than that in the control group (32.3%), as have been shown by the 1st analysis. Conclusions: The results of the 2nd analysis suggested that oral UFT/LV adjuvant chemotherapy might be also useful to prolong OS, as have been confirmed for RFS. This regimen can be recommended as an alternative choice after hepatic resection for CRLM. Clinical trial information: C000000013.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Link

http://ascopubs.org/doi/pdfdirect/10.1200/JCO.2017.35.4_suppl.672

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