Weekly oxaliplatin (OXA), 5-fluorouracil (FU) and leucovorin (LV) as first line treatment for advanced colorectal cancer (CRC) –A phase II study
Document Type
Article
Department
Haematology and Oncology, East Africa
Abstract
Background: OXA has previously shown high efficacy in metastatic colorectal cancer when combined with 5FU/LV, mainly as a FOLFOX schedule. This phase II clinical study was designed to evaluate the efficacy and toxicity of a different OXA-5FU/LV schedule, as first line treatment of advanced colorectal cancer.
Methods: Forty-five patients with advanced CRC (median age 69 years, range 50–80, 34 males, 11 females were included. Sites of metastases included liver 25 (55.6%), lymph nodes 14 (31.1%), pelvis 12 (26.7%), peritoneum 11 (24.4%), other 9 (20.0%). Eleven patients had received prior adjuvant chemotherapy, and two radiotherapy outside of the target lesions. The regimen consisted of 200 mg/m2 LV (2h i.v.), 450 mg/m2 5-FU (bolus), and 45 mg/m2 OXA (2h i.v.), weekly for 6 weeks as induction therapy and then weekly for 3 weeks with 1 week rest until progression or unacceptable toxicity.
Results: All patients were evaluable for response and toxicity. Grade 3–4 toxicities were: neurotoxicity (4%), diarrhea (4%), leucopenia (2%), nausea/vomiting (2%) and allergy (2%). Dose reductions were necessary in 14 of 45 patients (31.1%) and treatment was early interrupted in 3 of 45 patients (2 progressive disease and 1 death due to acute myocardial infarction). Complete response was observed in 4/45 (8.9%), partial response in 11/45 (24.4%) for a response rate of 33.3%. At a median follow-up of 19 months, 29 patients had relapsed (64.5%). Median time to progression was 13.4 months [95% CI: 10.6–18.2], and median survival 20.4 months [95% CI: 17.2–28.2].
Conclusions: This schedule is highly effective as first line treatment for advanced CRC. It is a feasible, well-tolerated regimen, with low incidence of G3–4 toxicities. Further evaluation is warranted. No significant financial relationships to disclose.
Publication (Name of Journal)
Journal of Clinical Oncology
DOI
https://doi.org/10.1200/jco.2004.22.90140.3712
Recommended Citation
Athanasiadis, A.,
Pissanidis, N.,
Saleh, M.,
Moshidis, A.,
Chatzichristou, A.,
Makrantonakis, N.,
Kamentsidis, P.,
Natsiopoulos, I.,
Christakis, C.
(2004). Weekly oxaliplatin (OXA), 5-fluorouracil (FU) and leucovorin (LV) as first line treatment for advanced colorectal cancer (CRC) –A phase II study. Journal of Clinical Oncology, 22(14).
Available at:
https://ecommons.aku.edu/eastafrica_fhs_mc_haematol_oncol/4
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This work is licensed under a Creative Commons Attribution 4.0 International License.
Comments
This work was published before the author joined Aga Khan University.