A multi-institutional feasibility study of S-1/oxaliplatin plus bevacizumab in patients with advanced/metastatic colorectal cancer: the HiSCO-02 prospective phase II study.
OBJECTIVE
FOLFOX is a standard combination chemotherapy regimen for metastatic colorectal cancer (CRC). 5-Fluorouracil (5-FU) is infused continuously through a pump for 46 h; therefore, replacement of infused 5-FU with oral S-1 would be more convenient for patients. We investigated the efficacy and safety of S-1/oxaliplatin (SOX) plus bevacizumab regimen in a community setting.


METHODS
We conducted a phase II clinical study in Hiroshima, Japan. We enrolled individuals aged 20-80 years who had metastatic CRC, an Eastern Cooperative Oncology Group performance status of 0 or 1, assessable lesions, and not received previous chemotherapy. Eligible patients were administered SOX plus bevacizumab (S-1 80 mg/m2/day, day 1-14 orally; and oxaliplatin 130 mg/m2day 1 i.v., bevacizumab 7.5 mg/kg, day 1 i.v. q3w). The primary endpoint was response rate (RR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.


RESULTS
Between May 2011 and January 2014, 55 patients (mean age 64 years) were enrolled at 12 institutions. Median follow up duration was 20.2 months (range 1.3-47.1 months). RR was 47.1 % [95 % confidence interval (CI) 33.7-60.6 %]. Median PFS and OS was 9.2 months (95 % CI 7.6-10.8) and 22.5 months (95 % CI 19.4-25.9), respectively. Major adverse events (grade 3/4) were neutropenia (9.3 %), thrombocytopenia (5.6 %), anorexia (18.5 %), and sensory neuropathy (16.7 %).


CONCLUSIONS
These data suggested that SOX plus bevacizumab is effective and capable of being managed in metastatic CRC patients in our community clinical practice.
Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Manabu
M
Shimomura
Division of Clinical Oncology, Hiroshima Prefectural Hospital, 1-5-54, Ujina-Kanda, Minami-ku, Hiroshima, Japan.
Katsunori
K
Shinozaki
Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Takao
T
Hinoi
Department of Surgery, Hiroshima City Asa Hospital, Hiroshima, Japan.
Masanori
M
Yoshimitsu
Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.
Manabu
M
Kurayoshi
Department of Surgery, Onomichi General Hospital, Onomichi, Japan.
Daisuke
D
Sumitani
Department of Surgery, Chugoku Rosai Hospital, Kure, Japan.
Yasuyo
Y
Ishizaki
Department of Surgery, Hiroshima General Hospital of West Japan Railway Company, Hiroshima, Japan.
Takafumi
T
Oshiro
Department of Surgery, Yoshida General Hospital, Akitakata, Japan.
Shinya
S
Kodama
Department of Surgery, National Hospital Organization Kure Medical Center, Kure, Japan.
Yosuke
Y
Shimizu
Department of Surgery, Chuden Hospital, Hiroshima, Japan.
Michinori
M
Arita
Department of Surgery, National Hospital Organization Hiroshima-nishi Medical Center, Ohtake, Japan.
Masakazu
M
Tokunaga
Department of Surgery, Kure City Medical Association Hospital, Kure, Japan.
Makoto
M
Yoshida
Department of Epidemiology, Infectious Disease Control and Prevention, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Junko
J
Tanaka
Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Hideki
H
Ohdan
Chemotherapy; Metastatic colorectal cancer; Prospective phase II study; S-1