Z Gastroenterol 2006; 44 - A152
DOI: 10.1055/s-2006-943518

Tolerability of FOLFOX4 adjuvant treatment – our experiences in the first year

E Vegh 1, Á Petrányi 1, Z Szucs 1, K Tamas 1, Z Arányi 1, G Bodoky 1
  • 1Szent Laszlo Hospital, Budapest, Hungary

Purpose: In Hungary, we have the opportunity to use oxaliplatin in the adjuvant treatment of stage III colorectal cancer (CRC) since autumn of 2004. This drug is a highly effective anticancer agent, but administering in adjuvant setting it is important to know its safety profile. In a 15-month period, between November 2004 and January 2006 we evaluated the gastrointestinal, haematological, neurological and other types of toxicity of the adjuvant FOLFOX4 (oxaliplatin + de Gramont) cytostatic treatment at our department.

Methods: We conducted a prospective analysis with inclusion of 38 patients having been operated due to stage III colorectal cancer. We evaluated toxicity according to the NCI Common Toxicity Criteria. We also assessed the dose limiting toxicity of this adjuvant treatment. Results: In accordance with the NCI-CTC, toxicity events occurred with the following frequencies: neutropenia grade 1–2 and 3–4: 50% and 29%; thrombocytopenia grade 1–2 and 3–4: 29% vs. 5%; nausea grade 1–2 and 3–4: 84% vs. 5%; vomiting grade 1–2 and 3–4: 52% vs. 8%; diarrhoea grade 1–2 and 3–4: 13% vs. 3%; mucositis grade 1–2 and 3–4: 3% vs. 0%; acute peripheral sensory neuropathy (PSN) grade 1–2 and 3–4 84% vs. 3%; allergic-idiosyncratic reactions (with fever, chill, dyspnoe and/or chest pain) grade 1–2 and 3–4 29% vs. 3%. Among the side effects influencing the quality of life, the PSN and the allergic-idiosyncratic reactions increasing after higher cumulative oxaliplatin doses (usually after the 10th cycle) are important, because these side effects can limite the duration of adjuvant FOLFOX4 treatment.

Conclusions: The FOLFOX4 regimen has proved to be a well tolerable adjuvant treatment. The haematological and gastrointestinal side effects were mild or moderate; we have not detected any nephrotoxicity and alopecia. Some of the allergic-idiosyncratic reactions could be prevented or decreased by extending the time of the administration of oxaliplatin from 2 hours to 6 hours or to 24 hours.