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The secondary objectives are to determine the effect of dose escalation on overall survival, progression free survival, quality of life and rate of grade 3-5 toxicities.
According to Bridwell criteria [14], interbody fusion rate of Grade I between both groups was nearly the same (MIS 85.7%, open 80%, P = 0.943).
The overall rate of grade 3 toxicity was 38%.
So, in schemes with only 5-fluorouracil, the rate of grade ¾ diarrhoea is about 20 25%; adding irinotecan, the rate of grade ¾ diarrhea is about 30 40%.
So, the rate of grade 4 neutropenia (1 patient, 2.2%) was lower than expected.
However, the rate of grade 3 4 neutropenia was 75% at the recommended dose.
The rate of grade 3/4 diarrhoea in this trial was 7.5%.
The rate of grade 3 and 4 radiation oesophagitis was 17%.
Literature has reported the prevalence or diagnosed rate of grade 1 hypertension in the population worldwide.
In the ARO trial [ 3], the rate of grade 3 toxicity was 0.3%.
The rate of grade 2 peripheral neuropathy in our study may be considered somewhat low.
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