Oxaliplatin, 5-Fluorouracil and Leucovorin in Relapsed or Metastatic Colorectal Cancer as a First-Line or a Second-Line Therapy
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- Category: Vol. 77, September 2009
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Oxaliplatin, 5-Fluorouracil and Leucovorin in Relapsed or Metastatic Colorectal Cancer as a First-Line or a Second-Line Therapy,HALA EL-SHENSHAWY, DOAA SHARAF ELDEEN, MAIY AL SHAHAT, SOUMAYA ETEBA and WAFAA EL-BESHBESHI
Abstract
Purpose: The purpose of this 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 first-line and as a second line therapy.
Materials and Methods: Between January 2004 and March 2007, 44 patients with histologically confirmed relapsed or metastatic CRC were enrolled. Only 42 patients were evaluable. Twenty-one patients were previously treated with irinotecan-based combination chemotherapy and twenty-one patients were chemotherapy-naïve. The chemotherapy regimen con-sisted of oxaliplatin 85mg/m2 on day 1; LV 200mg/m2 on days 1 & 2 and 5-FU 400mg/m2 bolus IV with 600mg/m2 with a 22-hour infusion on days 1 and 2 every 2 weeks.
Results: The median age of the 42 patients was 50.5 years (range, 31-69). Their metastatic sites included: the liver (48.6%), peritoneum (31.4%), lung (22.9%), ovary (5.7%) and bone (14.3%). All 42 patients were evaluated for response. Two patients achieved complete responses and 16 patients had partial responses. Stable disease was seen in 14 patients. The overall response rate was 42.9% (95% confidence interval; 8.5-62.5%). The median overall survival (OS), 1-year OS and 2-year OS rates were 18.6 months, 64.3% and 33.3%, respec-tively. The median progression free survival (PFS), 1-year and 2-years PFS were 8.1 months (range: 1.6-25.3 months), 28.1% and 12.5%. The overall response rate in patients receiving FOLFOX as first-line therapy was 52.3% versus 33.3% in patients receiving FOLFOX as second-line therapy (p=0.035). Only two patients achieved complete response (CR) in patients receiving FOLFOX as first-line therapy versus no CR in patients receiving FOLFOX as second-line therapy (p=0.015). The median overall survival in patients receiving FOLFOX as first-line therapy were 19.3 months (range: 5.1-32.3 months) versus 16.2 months (range: 3.5-29.2 months) in patients receiving FOLFOX as second-line therapy, (p=0.256). The median progression-free survival in patients receiving FOLFOX as first-line therapy were 8.4 months (range: 5-25.3 months), versus 6.2 months (range: 4.1-24.5 months), in patients receiving FOLFOX as second-line therapy, (p=0.021). The most common hematological toxicities were: NCI grade I/II leucopenia (46.1%), grade I/II neutropenia (42.6%) and grade I/II anemia (57%). The main non-hematological toxicities were: grade I/II peripheral neuropathy
(25.2% and 18.5%, respectively) and nausea/vomiting (24.9%/20.3%). 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 a second line therapy as well as a first-line therapy.