Clinical Trial of Oxaliplatin, 5-Fluorocuracil, and Leucovorin in Advanced Colorectal Cancer: 48 Cases

Lee, Seung Hyun; Ahn, Byung Kwon; Baek, Sung Uhn

Abstract

PURPOSE: Although 5-fluorouracil (5-FU) has been used as the basis of chemotherapy regimen for colorectal cancer for more than 40 years, 5-FU as single agent treatment has rarely achieved objective response rates higher than 15% in advanced colorectal cancers. The modulation of 5-FU with biologic modifiers has resulted in higher response rates, but survival advantages was not meaningful. Oxaliplatin is one of the newly developed drugs with proven activity against colorectal cancer. To evaluate the therapeutic efficacy and safety profile of oxaliplatin, we reviewed patients who received oxaliplatin chemotherapy.
METHODS
We reviewed 48 patients who received combination chemotherapy with oxaliplatin, 5-FU, and leucovorin (LV) from Jan. 2000 to Dec. 2001. The combination chemotherapy consisted of oxaliplatin (85 mg/m2 on day 1) as a 2~6 hour infusion followed by continuous infusion of 5-FU (1,500 mg/m2 on day 1, 2), concurrently with LV (45 mg on day 1, 2) as a 2 hour infusion. The combination chemotherapy interval was 2 weeks.
RESULTS
Of the 48 patients who received the combination chemotherapy with oxaliplatin, 5-FU, and LV, 25 cases were male, 23 cases were female. The median age was 51.4 years. The primary tumor sites were colon in 22 cases, and rectum in 26. According to TNM stage at diagnosis, 1 case was stage I, 5 cases were stage II, 21 cases were stage III, and 21 cases were stage IV. The metastatic sites were liver in 29 cases, lung in 10, pelvis in 7, peritoneum in 5, bone in 1, lymph node in 1, and spleen in 2. Previous chemotherapy were Mayo regimen in 43 patients, irrinotecan in 1 patient. Four patients had not received previous chemotherapy. Previously of the 48 patients, we could assess the chemotherapy response for 25 cases. Complete response was not observed. Partial response was 3 cases (12%), stable disease in 12 cases (48%), progressive disease in 10 cases (40%). From 227 cycles analyzed, the main toxicity was gastrointestinal one. Peripheral neuropathy was identifed in 5 cases.
CONCLUSIONS
We reviewed 48 patients with advanced colorectal cancer who received combination chemotherapy with oxaliplatin, 5-FU and LV. Of the 25 evaluable patients, the objective response rate was 12%. In our study, the combination chemotherapy with oxaliplatin, 5-FU, LV has not resulted in improved response rate, but overall toxicity was acceptable.