PMID- 30778794 OWN - NLM STAT- MEDLINE DCOM- 20190807 LR - 20200225 IS - 1437-7772 (Electronic) IS - 1341-9625 (Linking) VI - 24 IP - 7 DP - 2019 Jul TI - Biweekly S-1 plus oxaliplatin (SOX) reintroduction in previously treated metastatic colorectal cancer patients (ORION 2 study): a phase II study to evaluate the efficacy and safety. PG - 836-841 LID - 10.1007/s10147-019-01414-0 [doi] AB - BACKGROUND: The 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. METHODS: Patients 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/m(2)) 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). RESULTS: A 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. CONCLUSION: Biweekly SOX regimen with reintroduction of oxaliplatin could be exploitable as the third- and/or later-line treatments for patients with mCRC. FAU - Tanioka, Hiroaki AU - Tanioka H AD - Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan. FAU - Honda, Michitaka AU - Honda M AUID- ORCID: 0000-0003-3492-9881 AD - Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University, 1 Hikarigaoka, Fukushima, Fukushima, 960-1295, Japan. mhonda@fukushimamed.com. FAU - Tanaka, Chihiro AU - Tanaka C AD - Department of Surgery, Gifu Prefectual General Medical Center, Gifu, Japan. FAU - Morita, Yoshitaka AU - Morita Y AD - Department of Radiology, National Hospital Organization Kobe Medical Center, Kobe, Japan. FAU - Ishibashi, Keiichiro AU - Ishibashi K AD - Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan. FAU - Kato, Takeshi AU - Kato T AD - Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan. FAU - Matsuda, Chu AU - Matsuda C AD - Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan. FAU - Kataoka, Masato AU - Kataoka M AD - Department of Surgery, Naogoya Medical Center, Nagoya, Japan. FAU - Satake, Hironaga AU - Satake H AD - Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan. FAU - Munemoto, Yoshinori AU - Munemoto Y AD - Department of Surgery, Fukui Saiseikai Hospital, Fukui, Japan. FAU - Kobayashi, Kenji AU - Kobayashi K AD - Department of Surgery, Matsunami General Hospital, Gifu, Japan. FAU - Takahashi, Masazumi AU - Takahashi M AD - Department of Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan. FAU - Nakata, Ken AU - Nakata K AD - Department of Surgery, Sakai City Medical Center, Sakai, Japan. FAU - Sakamoto, Junichi AU - Sakamoto J AD - Tokai Central Hospital, Kagamigahara, Japan. FAU - Oba, Koji AU - Oba K AD - Department of Biostatistics, The University of Tokyo School of Public Health, Tokyo, Japan. FAU - Mishima, Hideyuki AU - Mishima H AD - Cancer Center, Aichi Medical University, Aichi, Japan. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20190218 PL - Japan TA - Int J Clin Oncol JT - International journal of clinical oncology JID - 9616295 RN - 0 (Drug Combinations) RN - 04ZR38536J (Oxaliplatin) RN - 150863-82-4 (S 1 (combination)) RN - 1548R74NSZ (Tegafur) RN - 2S9ZZM9Q9V (Bevacizumab) RN - 5VT6420TIG (Oxonic Acid) MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse effects MH - Bevacizumab/administration & dosage/adverse effects MH - Colorectal Neoplasms/*drug therapy/mortality/pathology/*secondary MH - Disease-Free Survival MH - Drug Administration Schedule MH - Drug Combinations MH - Female MH - Humans MH - Male MH - Middle Aged MH - Oxaliplatin/*administration & dosage/adverse effects MH - Oxonic Acid/*administration & dosage/adverse effects MH - Retreatment MH - Survival Rate MH - Tegafur/*administration & dosage/adverse effects OTO - NOTNLM OT - Biweekly SOX OT - Metastaic colorectal cancer OT - Oxaliplatin reintroduction EDAT- 2019/02/20 06:00 MHDA- 2019/08/08 06:00 CRDT- 2019/02/20 06:00 PHST- 2018/11/01 00:00 [received] PHST- 2019/02/06 00:00 [accepted] PHST- 2019/02/20 06:00 [pubmed] PHST- 2019/08/08 06:00 [medline] PHST- 2019/02/20 06:00 [entrez] AID - 10.1007/s10147-019-01414-0 [pii] AID - 10.1007/s10147-019-01414-0 [doi] PST - ppublish SO - Int J Clin Oncol. 2019 Jul;24(7):836-841. doi: 10.1007/s10147-019-01414-0. Epub 2019 Feb 18.