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Evaluation for effects on anticancer efficacy and patient’s QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer

ABSTRACT: Interventions: mFOLFOX6+Panitumumab therapy is performed until PD. And dosage of Panitumumab is adjusted according to skin toxicity measured by self-check sheet before each therapy. Oxaliplatin 85mg/m2 5FU 400mg/m2 bolus, 2400mg/m2 continuous drip Levofolinate 200mg/m2 Panitumumab 6mg/kg Primary outcome(s): Progression-free survival Study Design: Single arm Non-randomized

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2630399 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Purpose: The purpose of this study was 1) to predict the requisite vancomycin daily dose (D van ) used in the target patients suffering from both bacterial infection and hematological malignancies and 2) to construct a vancomycin-dose-graphical tool to assist clinicians to develop vancomycin dosing regimens and further 3) to establish a programming process for vancomycin dynamic dosage adjustment to help clinicians to adjust vancomycin dosing regimens according to physiological and pathogenic factors of the target patients. Methods: The D van model associated with microbial susceptibility, vancomycin pharmacokinetics, and dosing parameters was established, and the D van was estimated based on the established D van model and using Monte Carlo simulations. D van achieving 90% of probability of target attainment (PTA) for bacterial isolate or cumulative fractions of response (CFR) for the bacterial population at a ratio of daily area under the curve (AUC24) to the minimum inhibitory concentration (MIC) [i.e., AUC24/MIC] of 400-600 was considered sufficient to treat infection occurring in the target patients. On the basis of the predicted D van , the physiological states of patients, and the pathogenic variables of infection, a vancomycin-dose-graphical tool for the target patients and a programming process for vancomycin dynamic dosage adjustment were constructed. Results: This study predicted the requisite D van used in patients suffering from both bacterial infection and hematological malignancies and constructed a vancomycin-dose-graphical tool for the target patients, at different physiological states and pathogenic variables, to formulate vancomycin dosing regimens. Also, this study established and expounded the formulation process of vancomycin dosage dynamic adjustment according to fluctuant renal function of the target patients. Conclusion: With the tools, the required D van or vancomycin dosing regimens for the target patients, at different physiological states and pathogenic variables, can be readily known, whether or not vancomycin dynamic dosage adjustment is required.

Dataset Information

Evaluation for effects on anticancer efficacy and patient’s QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer

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