Phase II study with oxaliplatin and S-1 for patients with metastatic colorectal cancer

Abstract

These data indicate that the OS regimen is effective and well tolerated in patients with advanced colorectal cancer.

A Systemic Analysis of S-1 Regimens for Treatment of Patients with Colon Cancer

“…Via steps of screening the title and reading the abstract, 6 studies were identified (Van den Brande et al, 2003;Kim et al, 2009;Yokoyama et al, 2009;Zang et al, 2009;Mizushima et al, 2013;Zhu et al, 2011). These studies had been carried out in China, Japan, Korea and Belgium.…”

New Option for Metastatic Colorectal Cancer: Oxaliplatin and Novel Oral S-1 Combination Chemotherapy

“…Eligible patients met all of the following criteria: presence of unresectable, metastatic, histologically confirmed colorectal cancer; age from 18 to 70 years [11] or from 20 to 74 years [12]; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 [11] or 0-1 [12]; estimated life expectancy of more than 3 months; and adequate hematological, renal, and hepatic functions. The presence of a unidimensionally measurable lesion was also required for the phase II studies.…”

“…Stable disease (SD) was defined as insufficient shrinkage to qualify for partial response and insufficient increase to qualify for progressive disease. Tumor responses were evaluated every two cycles [11] or every month [12] by three-dimensional computed tomography and were determined by an independent response review committee. All partial and complete responses were confirmed not less than 4 weeks after the criteria for response were first met.…”

“…In phase II studies, S-1 as a single agent showed an overall response rate (ORR) of 19-40% with tolerable toxicities in the first-line treatment of metastatic colorectal cancer [8][9][10]. To explore the possibility of using S-1 to replace the continuous FU infusion of the FOLFOX regimen, Korean investigators carried out a phase II clinical trial [11] and Japanese investigators performed a phase I/II clinical trial [12] with a regimen of oxaliplatin plus S-1 (OS) for the first-line treatment of metastatic colorectal cancer, respectively.…”

“…Level 2 was determined to be the recommended dose (RD) for the phase II part of the study. In two Japanese and Korean phase II studies, oxaliplatin 130 mg/m 2 mixed with 250 mL of dextrose solution was administered intravenously over 2 h on day 1, and S-1 40 mg/m 2 [body surface area (BSA) < 1.25 m 2 , 40 mg; 1.25 ≤ BSA < 1.5, 50 mg; BSA ≥ 1.5, 60 mg] was administered orally, twice daily from day 1 to 14, followed by a 7-day rest period [11,12]. The treatment was repeated every 3 weeks until progression of the disease, the development of unacceptable toxicity, or consent withdrawal by the patient.…”