Z Gastroenterol 2005; 43 - 163
DOI: 10.1055/s-2005-869810

A prospective study of FOLFOX4 regimen's tolerance in the treatment of metastatic colorectal cancer

É Végh 1, Á Petrányi 1, K Tamas 1, Z Szűcs 1, G Bodoky 1
  • 1Department of Oncology, Szent Laszlo Hospital, Budapest, Hungary

Purpose: Oxaliplatin is an effective anticancer agent in the treatment of colorectal cancer (CRC), and its usage has become widespread also in Hungary in the last few years. Between February 2003 and January 2005. we evaluated the hematological, gastrointestinal, acute and chronic neurological and other type toxicities at our department, including the dose limiting toxicities of oxaliplatin plus de Gramont regimen.

Methods: We conducted a prospective analysis of 95 metastatic colorectal patients treated with FOLFOX4 regimen (OX 85mg/m2 d1, LV 200mg/m2, 5FU bolus 400mg/m2 and 22h 600mg/m2 d1–2, q2w) in metastatic setting and we evaluated the toxic event associated with this regimen. We determined toxicity using NCI-CTC toxicity grades. Results: Main results are presented here: neutropenia grade 1–2 and 3–4: 21% and 17%; thrombocytopenia grade 1–2 and 3–4: 13% vs. 3%,; nausea grade 1–2 and 3–4: 84%, 0%; vomiting grade 1–2 and 3–4: 43% vs. 1%; diarrhoea grade 1–2 and 3–4: 12% vs. 4%; mucositis grade 1–2 and 3–4: 3% vs. 1%, alopecia grade 1–2: 1%. We also evaluated the frequency of the acute and chronic peripherial sensory neuropathy: 80% of our patients experienced grade 1–2 acute peripherial sensory neuropathy (PSN) (no grade 3–4 acute sensory neuropathy was detected), and 46% of our patients developed chronic sensory neuropathy (2% has grade 3–4 severity, the other was grade 1–2 severity). 21% of our patient developed grade 1–2 fever and 3% grade 3–4 during or after the oxaliplatin infusion. 9% of our patient experienced grade 1–2 dyspnoe and/or chest pain. Intensity and incidence of fever and dyspnoe/chest pain increasing with higher cumulative dose, usually occurred after the 10th cycle. Conclusions: The FOLFOX4 regimen has only mild haematological and gastrointestinal side effects, nephrotoxicity did not occur. The frequent acute PSN that is triggered and/or aggravated by cold, was rapidly reversible. Chronic PSN limited the duration of oxaliplatin treatment only in 2% of our patients. We interrupted FOLFOX4 regimen because of a type of allergic-idiosyncratic reaction (fever, chill, dyspnoe and chest pain) in 6 patients, usually between 10–12th cycles.