Objective: The study was designed to assess the skin and subcutaneous toxicity in patients with advancedcolorectal carcinoma treated with four different schedules of FOLFOX.
Methods: The patients with histologicallyconfirmed advanced colorectal carcinoma (CRC) were included in the study as per specified inclusion criteria.Toxicity was graded according to CTC v2.0. The frequency of grade 3 and 4 adverse effects were comparativelyassessed in each treatment arm.
Results: Very severe toxicity was attributed to the FOLFOX7 schedule. Thedifference between the incidence rate of grade 4 toxicity with all other grades for all parameters of skin andsubcutaneous toxicity was highly significant (p=0.00<0.001). Grade 4 hand and foot syndrome was reported onlyin the FOLFOX7 treatment arm. The most frequent adverse symptom of skin and subcutaneous toxicity reportedin the patients treated with modified schedule of FOLFOX was pruritus (grade 1). Frequency and onset of skinand subcutaneous toxic symptoms like alopecia (p=0.000), nail discoloration (p=0.021) and pruritis (p=0.000)was significantly different in each FOLFOX treatment arm. A few cases of oncholysis were also reported inthe FOLFOX7 treatment arm. Hand and foot syndrome was fast progressing in patients with grade 1 toxicity.
Conclusion: Higher frequency and severity of hand and foot syndrome and pruritus wasa found in the FOLFOX7treatment arm. Skin and subcutaneous toxicity was comparatively low in the FOLFOX6 treatment arm.