• Hiroaki Tanioka, Michitaka Honda, Chihiro Tanaka, Yoshitaka Morita, Keiichiro Ishibashi, Takeshi Kato, Chu Matsuda, Masato Kataoka, Hironaga Satake, Yoshinori Munemoto, Kenji Kobayashi, Masazumi Takahashi, Ken Nakata, Junichi Sakamoto, Koji Oba, and Hideyuki Mishima.
• Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan.
• Int. J. Clin. Oncol. 2019 Jul 1; 24 (7): 836-841.

BackgroundThe reintroduction of oxaliplatin as a third-or-later-line regimen has been a promising option for patients with metastatic colorectal cancer (mCRC) who previously received chemotherapy including oxaliplatin. In this single-arm phase II study, we evaluated the efficacy of biweekly SOX, which is the combination of oxaliplatin reintroduction and S-1, as a third-or-later-line treatment.MethodsPatients with mCRC who had previously received prior chemotherapy including oxaliplatin and irinotecan and were planned to receive the reintroduction of oxaliplatin were enrolled. Oxaliplatin (85 mg/m2) with/without bevacizumab (5 mg/kg) was given intravenously on day 1. Oral S-1 was administered on day 2-8 at a dose of 40-60 mg (calculated according to the body surface area) twice a day. Cycles were repeated every 2 weeks. The primary endpoint was the progression-free survival (PFS); our hypothesis was that the median PFS would be 3.5 months with a minimum threshold above 2.0 months. The secondary endpoints included the adverse events (AEs), response rate and overall survival (OS).ResultsA total of 41 patients from 12 institutes were enrolled. The median PFS and OS survival were 3.3 months (95% confidence interval [CI] 2.7-4.2) and 10.1 months (8.3-14.6), and response rate and disease control rate were 10.0% and 65.0%, respectively. Grade 3 AEs included thrombocytopenia (5.0%), anorexia (5.0%), pneumonia (5.0%) and fatigue (5.0%). There were no cases of grade 4 AEs or treatment-related death.ConclusionBiweekly SOX regimen with reintroduction of oxaliplatin could be exploitable as the third- and/or later-line treatments for patients with mCRC.

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