Phase II Trial of S-1 and Oxaliplatin Plus Cetuximab for Colorectal Cancer Patients with Initially Unresectable or Not Optimally Resectable Liver Metastases (KSCC1002).
BACKGROUND
The Kyushu Study Group of Clinical Cancer (KSCC) conducted phase II trials of KSCC1002 (UMIN000001308) concerning liver resectability after first-line treatment of initially unresectable or not optimally resectable colorectal liver metastases in a prospective, multicenter study.


METHODS
Patients with wild-type KRAS received 4-6 cycles of S-1 and oxaliplatin (SOX) plus cetuximab. Liver resectability was evaluated subsequently with the liver resection rate as the primary endpoint.


RESULTS
Of the 33 patients enrolled between March 2010 and July 2013, the median number of administration cycles was 4 (range 0-10). The overall response rate was 63.6 % (95 % confidence interval [CI] 45.1-79.6 %). Liver resection was possible in 16 of 33 (48.5 %) patients, and there were 13 R0 cases (39.4 %). We conducted a central review of liver resectability evaluated by five liver surgeons, and the resectability increased from 18.2 to 66.7 % after chemotherapy, based on imaging. The median overall survival for all 33 cases was 31.6 months (95 % CI 14.8-not reached). The median progression-free survival was 9.7 months (95 % CI 6.2-11.8).


CONCLUSIONS
SOX plus cetuximab is safe and effective for advanced colorectal cancer with limited liver metastasis, and may lead to high liver resectability.
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Fukuoka, Japan. okieiji@surg2.med.kyushu-u.ac.jp.
Eiji
E
Oki
Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
Yasunori
Y
Emi
Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Yuji
Y
Miyamoto
Department of Surgery, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
Akira
A
Kabashima
Department of Surgery, Steel Memorial Yawata Hospital, Kitakyushu, Japan.
Hidefumi
H
Higashi
Department of Surgery, Kurume University Medical Center, Kurume, Japan.
Yutaka
Y
Ogata
Department of Gastroenterological Surgery, Beppu Medical Center, Beppu, Japan.
Masahiko
M
Ikebe
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Fukuoka, Japan.
Hiroshi
H
Saeki
Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.
Shoji
S
Tokunaga
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Fukuoka, Japan.
Ken
K
Shirabe
Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Toru
T
Beppu
Department of Surgery, Kurume University Medical Center, Kurume, Japan.
Shinji
S
Uchida
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Mitsuhisa
M
Takatsuki
Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Masahiko
M
Sakoda
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Susumu
S
Eguchi
Department of Surgery, Kurume University School of Medicine, Kurume, Japan.
Yoshito
Y
Akagi
Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, Kobe, Japan.
Yoshihiro
Y
Kakeji
Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Hideo
H
Baba
Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Shoji
S
Natsugoe
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Fukuoka, Japan.
Yoshihiko
Y
Maehara
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068818:Cetuximab / Q000008:administration & dosage; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004338:Drug Combinations; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000008:administration & dosage; D011379:Prognosis; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage
D004338:Drug Combinations; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000068818:Cetuximab