Oxaliplatin added to simplified bimonthly low-dose leucovorin and 5-FU for pretreated advanced colorectal cancer is effective and not affected by different previous 5-FU regimens

Ruey Kuen Hsieh, Tsu Yi Chao, Wei Shon Chen, Tsai Shen Yang, Li Tzong Chen, Po Min Chen, Jin Hwang Liu

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

This phase II study examined bimonthly oxaliplatin (85 mg/m2) added to a continuous infusion of fluorouracil (3000 mg/m2 for 46 h following a 400 mg/m2 bolus), with leucovorin (LV) (150 mg/m 2) administrated in a simplified way to patients with metastatic colorectal cancers (CRC) refractory or resistant to 5-fluorouracil (5-FU). Sixty patients were registered. Of the 52 evaluable patients, 3 (5.8%) achieved a complete response (CR) and 18 (34.6%) achieved a partial response (PR). The overall response rate (CR+PR) was 40.4% (95% confidence interval [CI]: 26.6%-54.2%) for evaluable patients and 35% (95% CI: 22.6%-47.4%) by intention to treat. The median progression-free survival (PFS) was 5.2 months, and the median survival was 14.2 months. No significant differences were seen in response rates and PFS of patient groups pretreated either with high-dose 5-FU/LV by continuous infusion or with intravenous 5-FU/LV by a weekly bolus. From the 421 cycles analyzed, dose-limiting toxicities included cumulative sensory neuropathy and leukopenia, accounting for 11.6% and 10.0%, National Cancer Institute-Common Toxicity Criteria grade 3/4 toxicities per patient, respectively. Two (3.3%) patients experienced hepatic encephalopathy related to high-dose 5-FU. With necessary caution, this regimen was effective for 5-FU-pretreated CRC, regardless of ethnic differences, and it had the advantage of LV being administrated at a low dose in a simplified way.

Original languageEnglish
Pages (from-to)171-179
Number of pages9
JournalCancer Investigation
Volume22
Issue number2
DOIs
Publication statusPublished - 2004
Externally publishedYes

Fingerprint

oxaliplatin
Leucovorin
Fluorouracil
Colorectal Neoplasms
Disease-Free Survival
Confidence Intervals
Hepatic Encephalopathy
National Cancer Institute (U.S.)
Leukopenia

Keywords

  • 5-FU
  • Leucovorin
  • Metastatic colorectal cancer
  • Oxaliplatin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Oxaliplatin added to simplified bimonthly low-dose leucovorin and 5-FU for pretreated advanced colorectal cancer is effective and not affected by different previous 5-FU regimens. / Hsieh, Ruey Kuen; Chao, Tsu Yi; Chen, Wei Shon; Yang, Tsai Shen; Chen, Li Tzong; Chen, Po Min; Liu, Jin Hwang.

In: Cancer Investigation, Vol. 22, No. 2, 2004, p. 171-179.

Research output: Contribution to journalArticle

Hsieh, Ruey Kuen ; Chao, Tsu Yi ; Chen, Wei Shon ; Yang, Tsai Shen ; Chen, Li Tzong ; Chen, Po Min ; Liu, Jin Hwang. / Oxaliplatin added to simplified bimonthly low-dose leucovorin and 5-FU for pretreated advanced colorectal cancer is effective and not affected by different previous 5-FU regimens. In: Cancer Investigation. 2004 ; Vol. 22, No. 2. pp. 171-179.
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abstract = "This phase II study examined bimonthly oxaliplatin (85 mg/m2) added to a continuous infusion of fluorouracil (3000 mg/m2 for 46 h following a 400 mg/m2 bolus), with leucovorin (LV) (150 mg/m 2) administrated in a simplified way to patients with metastatic colorectal cancers (CRC) refractory or resistant to 5-fluorouracil (5-FU). Sixty patients were registered. Of the 52 evaluable patients, 3 (5.8{\%}) achieved a complete response (CR) and 18 (34.6{\%}) achieved a partial response (PR). The overall response rate (CR+PR) was 40.4{\%} (95{\%} confidence interval [CI]: 26.6{\%}-54.2{\%}) for evaluable patients and 35{\%} (95{\%} CI: 22.6{\%}-47.4{\%}) by intention to treat. The median progression-free survival (PFS) was 5.2 months, and the median survival was 14.2 months. No significant differences were seen in response rates and PFS of patient groups pretreated either with high-dose 5-FU/LV by continuous infusion or with intravenous 5-FU/LV by a weekly bolus. From the 421 cycles analyzed, dose-limiting toxicities included cumulative sensory neuropathy and leukopenia, accounting for 11.6{\%} and 10.0{\%}, National Cancer Institute-Common Toxicity Criteria grade 3/4 toxicities per patient, respectively. Two (3.3{\%}) patients experienced hepatic encephalopathy related to high-dose 5-FU. With necessary caution, this regimen was effective for 5-FU-pretreated CRC, regardless of ethnic differences, and it had the advantage of LV being administrated at a low dose in a simplified way.",
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AU - Chen, Wei Shon

AU - Yang, Tsai Shen

AU - Chen, Li Tzong

AU - Chen, Po Min

AU - Liu, Jin Hwang

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N2 - This phase II study examined bimonthly oxaliplatin (85 mg/m2) added to a continuous infusion of fluorouracil (3000 mg/m2 for 46 h following a 400 mg/m2 bolus), with leucovorin (LV) (150 mg/m 2) administrated in a simplified way to patients with metastatic colorectal cancers (CRC) refractory or resistant to 5-fluorouracil (5-FU). Sixty patients were registered. Of the 52 evaluable patients, 3 (5.8%) achieved a complete response (CR) and 18 (34.6%) achieved a partial response (PR). The overall response rate (CR+PR) was 40.4% (95% confidence interval [CI]: 26.6%-54.2%) for evaluable patients and 35% (95% CI: 22.6%-47.4%) by intention to treat. The median progression-free survival (PFS) was 5.2 months, and the median survival was 14.2 months. No significant differences were seen in response rates and PFS of patient groups pretreated either with high-dose 5-FU/LV by continuous infusion or with intravenous 5-FU/LV by a weekly bolus. From the 421 cycles analyzed, dose-limiting toxicities included cumulative sensory neuropathy and leukopenia, accounting for 11.6% and 10.0%, National Cancer Institute-Common Toxicity Criteria grade 3/4 toxicities per patient, respectively. Two (3.3%) patients experienced hepatic encephalopathy related to high-dose 5-FU. With necessary caution, this regimen was effective for 5-FU-pretreated CRC, regardless of ethnic differences, and it had the advantage of LV being administrated at a low dose in a simplified way.

AB - This phase II study examined bimonthly oxaliplatin (85 mg/m2) added to a continuous infusion of fluorouracil (3000 mg/m2 for 46 h following a 400 mg/m2 bolus), with leucovorin (LV) (150 mg/m 2) administrated in a simplified way to patients with metastatic colorectal cancers (CRC) refractory or resistant to 5-fluorouracil (5-FU). Sixty patients were registered. Of the 52 evaluable patients, 3 (5.8%) achieved a complete response (CR) and 18 (34.6%) achieved a partial response (PR). The overall response rate (CR+PR) was 40.4% (95% confidence interval [CI]: 26.6%-54.2%) for evaluable patients and 35% (95% CI: 22.6%-47.4%) by intention to treat. The median progression-free survival (PFS) was 5.2 months, and the median survival was 14.2 months. No significant differences were seen in response rates and PFS of patient groups pretreated either with high-dose 5-FU/LV by continuous infusion or with intravenous 5-FU/LV by a weekly bolus. From the 421 cycles analyzed, dose-limiting toxicities included cumulative sensory neuropathy and leukopenia, accounting for 11.6% and 10.0%, National Cancer Institute-Common Toxicity Criteria grade 3/4 toxicities per patient, respectively. Two (3.3%) patients experienced hepatic encephalopathy related to high-dose 5-FU. With necessary caution, this regimen was effective for 5-FU-pretreated CRC, regardless of ethnic differences, and it had the advantage of LV being administrated at a low dose in a simplified way.

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