Cancer Res Treat.  2006 Dec;38(4):201-205.

Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Relapsed or Metastatic Colorectal Cancer as Second Line Therapy

• Lee DJ
• Oh HS
• Choi JH
• Lee YY
• Kim IS
• Ahn MJ

Abstract

PURPOSE
The purpose of the study was to assess the efficacy and safety of biweekly oxaliplatin in combination with leucovorin (LV)-modulated bolus plus infusion of 5-fluorouracil (5-FU) in patients with relapsed or metastatic colorectal cancer (CRC) as a second line therapy.
MATERIALS AND METHODS
Between November 2002 and October 2005, 26 patients with histologically confirmed relapsed or metastatic CRC were enrolled. All patients were previously treated with irinotecan-based combination chemotherapy. The chemotherapy regimen consisted of oxaliplatin 85 mg/m2 on day 1; LV 200 mg/m2 on days 1 and 2; and 5-FU 400 mg/m2 bolus IV with 600 mg/m2 with a 22-hour infusion on days 1 and 2 every 2 weeks.
RESULTS
The median age of the 26 patients was 50.5 years (range, 31~72). Their metastatic sites included: the liver (42.3%), peritoneum (26.9%), lung (23.1%) and ovary (7.7%). Twenty five patients were evaluated for their response. Four patients achieved partial responses and 15 patients had stable disease. The overall response rate was 16% (95% confidence interval; 1.7~30.3%). The median follow-up duration for the surviving patients was 7.4 months (range, 2.08~21.2). Median overall survival (OS) and 1-year OS rates were 16.7 months and 63.9%, respectively. The most common hematological toxicities were: NCI grade I/II leucopenia (49.3%), grade I/II neutropenia (41%) and grade I/II anemia (65.2%). The main non-hematological toxicities were: grade I/II peripheral neuropathy (16.1% and 21.5%, respectively) and nausea/ vomiting (23.6%/18.5%). There was no life-threatening toxicity.
CONCLUSION
The oxaliplatin, 5-FU and LV combination chemotherapy, scheduled as a biweekly protocol, was effective and well tolerated in the treatment of relapsed or metastatic colorectal cancer patients as second line chemotherapy.

Keyword

Oxaliplatin; 5-fluorouracil; Leucovorin; Colorectal neoplasms

MeSH Terms

Anemia
Colorectal Neoplasms*
Drug Therapy
Drug Therapy, Combination
Female
Fluorouracil*
Follow-Up Studies
Humans
Leucovorin*
Liver
Lung
Neutropenia
Ovary
Peripheral Nervous System Diseases
Peritoneum
Vomiting
Fluorouracil
Leucovorin

Figure

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  Fig. 1 Kaplan-Meier estimate of overall survival.

• 

  Fig. 2 Kaplan-Meier estimate of progression free survival.

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