Oxaliplatin as single agent in previously untreated colorectal carcinoma patients: A phase II multicentric study

E. Díaz-Rubio, J. Sastre, A. Zaniboni, R. Labianca, H. Cortés-Funes, F. De Braud, C. Boni, M. Benavides, G. Dallavalle, M. Homerin

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Abstract

Background: Oxaliplatin is a new cytotoxic agent from he diaminocychlohexane family with proven antitumor activity against colon cancer cell lines. Activity in patients with colorectal carcinoma previously treated with 5-fluorouracil has been studied in three single-agent phase II trials, showing a reproducible response rate of 10%. Here we report a phase II trial with oxaliplatin as a first-line chemotherapy for metastatic colorectal cancer. Patients and methods: Twenty-five patients were entered in the study. All of them had metastatic disease without previous chemotherapy, and at least one lesion had to be measurable by computed tomography (CT). Therapy consisted of a two-hour infusion of oxaliplatin at a dose of 130 mg/m2 every 21 days. Results: The overall response rate determined by investigators was 20% (95% CI, 6.8%-40.7%). Eight patients (32%) had stable disease. The median time to disease progression in responders was six months (range four to nine). The median progression-free survival was four months and median overall survival 14.5 months (95% CI, 10-20 months). The main toxic effects were peripheral neuropathy (92%) and laryngopharyngeal dysesthesia (75%). No severe grade 3-4 neurotoxicities (NCI-CTC) were found. Gastrointestinal and hematological toxicities were mild. Conclusions: Oxaliplatin is an active agent in first-line chemotherapy for advanced colorectal cancer. It was well tolerated, caused no topic deaths, had low hematotoxicity, well controlled gastrointestinal toxicity, and frequent but mild peripheral neurological symptoms. Therefore, it is of interest to associate oxaliplatin with other active compounds.

Original languageEnglish
Pages (from-to)105-108
Number of pages4
JournalAnnals of Oncology
Volume9
Issue number1
DOIs
Publication statusPublished - Jan 1998

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oxaliplatin
Colorectal Neoplasms
Drug Therapy
Paresthesia
Poisons
Cytotoxins
Peripheral Nervous System Diseases
Fluorouracil
Colonic Neoplasms
Disease-Free Survival
Disease Progression
Tomography
Research Personnel
Cell Line

Keywords

  • Advanced colorectal carcinoma
  • Oxaliplain
  • Phase II study

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Oxaliplatin as single agent in previously untreated colorectal carcinoma patients : A phase II multicentric study. / Díaz-Rubio, E.; Sastre, J.; Zaniboni, A.; Labianca, R.; Cortés-Funes, H.; De Braud, F.; Boni, C.; Benavides, M.; Dallavalle, G.; Homerin, M.

In: Annals of Oncology, Vol. 9, No. 1, 01.1998, p. 105-108.

Research output: Contribution to journalArticle

Díaz-Rubio, E, Sastre, J, Zaniboni, A, Labianca, R, Cortés-Funes, H, De Braud, F, Boni, C, Benavides, M, Dallavalle, G & Homerin, M 1998, 'Oxaliplatin as single agent in previously untreated colorectal carcinoma patients: A phase II multicentric study', Annals of Oncology, vol. 9, no. 1, pp. 105-108. https://doi.org/10.1023/A:1008200825886
Díaz-Rubio, E. ; Sastre, J. ; Zaniboni, A. ; Labianca, R. ; Cortés-Funes, H. ; De Braud, F. ; Boni, C. ; Benavides, M. ; Dallavalle, G. ; Homerin, M. / Oxaliplatin as single agent in previously untreated colorectal carcinoma patients : A phase II multicentric study. In: Annals of Oncology. 1998 ; Vol. 9, No. 1. pp. 105-108.
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AB - Background: Oxaliplatin is a new cytotoxic agent from he diaminocychlohexane family with proven antitumor activity against colon cancer cell lines. Activity in patients with colorectal carcinoma previously treated with 5-fluorouracil has been studied in three single-agent phase II trials, showing a reproducible response rate of 10%. Here we report a phase II trial with oxaliplatin as a first-line chemotherapy for metastatic colorectal cancer. Patients and methods: Twenty-five patients were entered in the study. All of them had metastatic disease without previous chemotherapy, and at least one lesion had to be measurable by computed tomography (CT). Therapy consisted of a two-hour infusion of oxaliplatin at a dose of 130 mg/m2 every 21 days. Results: The overall response rate determined by investigators was 20% (95% CI, 6.8%-40.7%). Eight patients (32%) had stable disease. The median time to disease progression in responders was six months (range four to nine). The median progression-free survival was four months and median overall survival 14.5 months (95% CI, 10-20 months). The main toxic effects were peripheral neuropathy (92%) and laryngopharyngeal dysesthesia (75%). No severe grade 3-4 neurotoxicities (NCI-CTC) were found. Gastrointestinal and hematological toxicities were mild. Conclusions: Oxaliplatin is an active agent in first-line chemotherapy for advanced colorectal cancer. It was well tolerated, caused no topic deaths, had low hematotoxicity, well controlled gastrointestinal toxicity, and frequent but mild peripheral neurological symptoms. Therefore, it is of interest to associate oxaliplatin with other active compounds.

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