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Erythema and swelling increased in frequency and intensity with subsequent immunizations, with most (79 100%) volunteers in all groups experiencing Grade 3 swelling after the third vaccination.
The primary toxicity was mucositis, with 29/30 patients experiencing grade 3 and 1/30 experiencing grade 4.
Mucositis was common with 50% of patients experiencing grade 2 symptoms and 25% experiencing grade 3 symptoms during at least one cycle of their treatment (Table 1).
Neurological toxicity was also common with 20 patients (33%) experiencing grade 2 and 13 patients (21%) experiencing grade 3 neurotoxicity during or post treatment.
28 Among the patients treated in VECTIS, 84% experienced ST overall, with 28% experiencing grade 1 and 57% experiencing grade ≥2 events.
More myelosuppression was observed compared with the phase I trial, with 12% of patients experiencing grade 4 thrombocytopenia and 15% experiencing grade 4 neutropenia.
Cutaneous toxicity was mild, with 41.9% of the patients experiencing grade 1 2 toxicity (Table 3).
Within the sTACE group, myelosuppression was very uncommon with only one patient experiencing grade 3 neutropenia.
All patients experiencing grade 3 4 neurotoxicity or significant cardiac toxicity were withdrawn from treatment.
Decitabine was again well tolerated, with 33.5% of patients experiencing grade 3 or 4 toxicity.
An additional three patients were enrolled at this dose level, with one experiencing grade 3 thrombocytopenia.
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