Kaolinite layers were exfoliated as single sheets and admixed with cellulose fibers, forming an advanced exfoliated kaolinite/cellulose fiber (EXK/CF) composite, which was characterized as a promising carrier for the oxaliplatin (OL) drug to induce safety as well as the therapeutic effect. The EXK/CF composite exhibited promising loading capacity and achieved an experimental value of 670 mg/g and an expected theoretical value of 704.4 mg/g. The loading behavior of OL using the EXK/CF composite followed the pseudo-first-order kinetic model and the Langmuir equilibrium model, achieving an adsorption energy of 7.7 kJ/mol. This suggested physisorption and homogeneous loading behavior of the OL molecules in a monolayer form. The release profile of OL from EXK/CF continued for about 100 h with maximum release percentages of 86.4 and 95.2% in the phosphate and acetate buffers, respectively. The determined diffusion exponent from the Korsmeyer–Peppas kinetic model suggested non-Fickian transport behavior of the OL molecules and releasing behavior controlled by erosion as well as diffusion mechanisms. Regarding the cytotoxic effect, the EXK/CF composite has a high safety impact on the normal colorectal cells (CCD-18Co) and higher toxic impacts on the colorectal cancer cell (HCT116) than the free oxaliplatin drug.

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A B S T R A C T PurposeThis open-label, randomized phase II trial assessed efficacy and tolerability of two low-dose regimens of subcutaneous (SC) decitabine in patients with low-or intermediate-1-risk myelodysplastic syndrome (MDS). Patients and MethodsPatients received decitabine 20 mg/m 2 SC per day for 3 consecutive days on days 1, 2, and 3 every 28 days (schedule A) or 20 mg/m 2 SC per day once every 7 days on days 1, 8, and 15 every 28 days (schedule B) for up to 1 year. Primary efficacy end point was overall improvement rate (OIR:. Secondary end points were HI, transfusion independence, cytogenetic response, overall survival (OS), and time to acute myeloid leukemia or death. ResultsEfficacy and safety populations were identical: schedule A, n ϭ 43; schedule B, n ϭ 22. Median time from MDS diagnosis to treatment was 3.6 months; 89% had de novo MDS. The trial was terminated early on achievement of protocol-defined OIR superiority of schedule A over schedule B; OIR was 23% for schedule A (seven CRs, three HIs) and 23% for schedule B (one mCR, one PR, three HIs). No differences were observed in secondary end points. Median OS was not reached; approximately 70% of patients were alive at 500 days. Patients in schedule A (67%) and schedule B (59%) were RBC/platelet independent on study. The most frequent drug-related adverse events overall were neutropenia (28% v 36%), anemia (23% v 18%), and thrombocytopenia (16% v 32%).