Abstract
Objective
To investigate the efficiency and safety of the oxaliplatin, fluorouracil (5-FU) and leucovorin regimen (FOLFOX) in previously untreated patients with metastatic or recurrent colorectal cancer.
Methods
Previously untreated patients with metastatic or recurrent colorectal cancer received 100 mg/m2 of oxaliplatin intravenously (IV) over 2 h on day 1, and IV 400 mg/m2 of leucovorin over 2 h followed by a bolus of 400 mg/m2 of 5-FU. Then 2,600–3,000 mg/m2 of 5-FU was administered by continuous infusion over 46 h.
Results
An evaluated response rate was determined for 97 of 105 treated patients. The overall response rate was 35.1%, 9 patients (9.3%) had a complete response and 25 patients (25.8%) a partial response. Thirty-two patients (33.0%) developed stable disease and 32.0% of the patients progressed. The median time to progression (TTP) was 7.7 months and the median overall survival 20.5 months. One and 2-year survival rates were 68% and 32%. Toxic effects based on the National Cancer Institute-Common Toxicity Criteria (NCI-CTC), reaching grade 3/4 were: neutropenia 12.3%, anemia 11.3%, vomiting 4.1% and diarrhea 7.2%. Grade 3 neuropathy was 5.1%. The overall survival rate of patients who had received a radical resection was superior to the patients who had not received a operation, or had received a palliative resection (P=0.0658). The serum levels of CEA, ALP and LDH had no relationship with survival (P>0.05).
Conclusion
The FOLFOX regimen containing oxaliplatin, 5-FU plus leucovorin was an efficacious regimen with good tolerability in previously untreated metastatic or recurrent colorectal cancer patients.
Similar content being viewed by others
References
Gil-delgado MA, Khayat D, Taieb J. Cancer of the Colon and Rectum. In: Pollock RE, Doroshow JH, Khayat D et al (Eds). UICC manual of clinical oncology, 2004, 487–504.
Levi F, Misser JL, Brienza S, et al. A chronopharmacologic phase II clinical trial with 5 fluorouracil, flolinic acid, and oxaliplatin using an ambulatory multichannel programmable pump, high antitumor effectiveness against metastatic colorectal cancer. Cancer 1992; 69: 893–900.
Wan DS, Pan ZZ. Carcinoma of Large Intestine. In: Clinical Oncology. Science Publishing House, Beijing. 2005, 346–361.
Cohen AM, Minsky BD, Schilsky RL. Cancer of the Colon. In Devita VT Jr, Hellman S, Rosenberg SA (Eds). Principles and Practice of Oncology. Philadelphia, Lippincott-Raven. 1997, 1061–1125.
Piedbois P, Buyse M, Rustum Y, et al. Advanced Colorectal Cancer Meta-Analysis Project: Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: Evidence in terms of response rate. J Clin Oncol 1992; 10:896–903.
Lo Bello L, Pistone G, Restuccia S, et al. 5-fluorouracil alone versus 5-fluorouracil plus folinic acid in the treatment of colorectal carcinoma: Meta-analysis. Int J Clin Pharmacol Ther 2000; 38: 553–562.
de Granmont A, Figer A, Seymour M, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000; 18: 2938–2947.
Goldberg RM, Sargent DJ, Morton RF, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004; 22:23–30.
Colucci G, Gebbia V, Paoletti G, et al. Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell’Italia Meridionale. J Clin Oncol 2005; 23:4866–4875.
Tournigand C, Andre T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer. A randomized GERCOR study. J Clin Oncol 2004; 22:229–237.
Mathe G, Kidani Y, Segiguchi M, et al. Oxalato-platinum or L-OHP, a third generation platinum complex: An experimental and clinical appraisal and preliminary comparison with cis-platinum and carboplatinum. Biomed Pharmacother 1989; 43:237–250.
Sorbye H, Glimelius B, Berglund A, et al. Multicenter phase II study of Nordic fluorouracil and folinic acid bolus schedule combined with oxaliplatin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 2004; 22:31–38.
Kalofonos HP, Aravantinos G, Kosnidis P, et al. Irinotecan or oxaliplatin combined with leucovorin and 5-fluorouracil as first-line treatment in advanced colorectal cancer: a multicenter, randomized, phase II study. Ann Oncol 2005; 16:869–877.
Author information
Authors and Affiliations
Corresponding author
About this article
Cite this article
Han, B., Xu, R., Shi, Y. et al. Oxaliplatin, fluorouracil and leucovorin (FOLFOX) as first-line chemotherapy for metastatic or recurrent colorectal cancer patients. Chin. J. Clin. Oncol. 4, 397–400 (2007). https://doi.org/10.1007/s11805-007-0397-9
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/s11805-007-0397-9