Abstract
BACKGROUND: Results of phase III clinical studies comparing efficacy of Xeloda vs. standard 5-FU/FA protocols as first line therapy of metastatic colorectal carcinoma (MCRC), have shown better efficacy of Xeloda, with less toxic adverse effects, apart from handfoot syndrome. METHODS: From January 2000 to May 2001 the study enrolled 54 patients with MCRC, 38 males and 16 females, aged 30-78 years. All patients had metastatic diseases. In 33 the primary tumor was in colon, in 21 in rectum. All patients received Xeloda 2500 mg/m2/day in two daily doses, during 14 days followed by 7 days of pause. Dose intensity was 88,79% +/- 9,2. For efficacy evaluation the WHO criteria and tumor markers CEA and CA 19-9 were used. RESULTS: Overall response rate was 47%, with 13% complete responses, 34% partial responses 38% stable disease and 15% disease progression. No significant difference was found between patients with regard to localization of primary tumor (colon or rectum). There was no significant difference in response rate when compared 27 patients with adverse events of capecitabine ('hand and foot' syndrome and diarrhea) and those without them. Response rate in a subgroup of 21 evaluable (out of 29) patients with initial signs of liver dysfunction was worse (p<0.005) in comparison with patients with normal liver function. Most frequent adverse events were 'hand and foot' syndrome (52%) and diarrhea (24%), or both (14%). Other adverse events, up to grade 2 toxicity, were sporadically reported; however, hematological toxicity was significantly more common in a subgroup of patients with compromised liver function (p<0.007). CONCLUSION: This study has shown that Xeloda is a good monotherapy choice, with high response rate as first line therapy of metastatic CRC. Adverse events do not influence response. Liver dysfunction is a poor prognostic parameter. Therapy with Xeloda is convenient and relatively safe in patients with liver dysfunction, where administration of other cytotoxic agents is not possible.
Highlights
S ince 1957, when fluoropyrimidine derivative 5-Fluorouracil (5-FU) was synthesized, up to nowadays, this chemotherapeutic agent has been widely used for treatment of patients with colorectal cancer
There was no statistically significant difference in therapeutic response between patients' localization of primary tumor in colon and those with tumor localized in rectum, nor with regard to the free interval from operation to appearance of metastases
There was no significant difference in therapeutic response in a subgroup of 27 patients with recorded adverse effects of capecitabine ('hand and foot' syndrome and diarrhea) (Figure 2)
Summary
S ince 1957, when fluoropyrimidine derivative 5-Fluorouracil (5-FU) was synthesized, up to nowadays, this chemotherapeutic agent has been widely used for treatment of patients with colorectal cancer. During last 45 years majority of investigational efforts has been directed towards increase of 5-FU efficacy. During 1960 and 1970, 5-FU was used mostly as monotherapy with response rate 8% to 85%, as reported in literature. Like nitrosourea derivatives and mitomycin C did not manage to increase efficacy when used in combination with 5-FU (MOF, BOF etc.) (1). In 1980, certain progress was achieved thanks to 5-FU biomodulation and 5-FU based therapeutic regimens. Continuous infusion enabled significant increase of response rate and modest improvement in overall survival (2). Numerous substances were used as 5-FU biomodulators with dif-. Results of phase III clinical studies comparing efficacy of Xeloda vs. standard 5-FU/FA protocols as first line therapy of metastatic colorectal carcinoma (MCRC), have shown better efficacy of Xeloda, with less toxic adverse effects, apart from hand-foot syndrome
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