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1.
Ann Oncol ; 34(1): 48-60, 2023 01.
Article in English | MEDLINE | ID: mdl-36182023

ABSTRACT

In 2021, the Food and Drug Administration Oncology Center of Excellence announced Project Optimus focusing on dose optimization for oncology drugs. The Methodology for the Development of Innovative Cancer Therapies (MDICT) Taskforce met to review and discuss the optimization of dosage for oncology trials and to develop a practical guide for oncology phase I trials. Defining a single recommended phase II dose based on toxicity may define doses that are neither the most effective nor the best tolerated. MDICT recommendations address the need for robust non-clinical data which are needed to inform trial design, as well as an expert team including statisticians and pharmacologists. The protocol must be flexible and adaptive, with clear definition of all endpoints. Health authorities should be consulted early and regularly. Strategies such as randomization, intrapatient dose escalation, and real-world eligibility criteria are encouraged whereas serial tumor sampling is discouraged in the absence of a strong rationale and appropriately validated assay. Endpoints should include consideration of all longitudinal toxicity. The phase I dose escalation trial should define the recommended dose range for later testing in randomized phase II trials, rather than a single recommended phase II dose, and consider scenarios where different populations may require different dosages. The adoption of these recommendations will improve dosage selection in early clinical trials of new anticancer treatments and ultimately, outcomes for patients.


Subject(s)
Antineoplastic Agents , Neoplasms , Humans , Antineoplastic Agents/adverse effects , Clinical Trials, Phase I as Topic , Clinical Trials, Phase II as Topic , Dose-Response Relationship, Drug , Medical Oncology , Neoplasms/drug therapy , Randomized Controlled Trials as Topic , Research Design , Therapies, Investigational/methods
2.
Open Microbiol J ; 5: 107-13, 2011.
Article in English | MEDLINE | ID: mdl-22145012

ABSTRACT

Klebsiella pneumoniae liver abscess syndrome (KLAS) is an emerging invasive infection caused by highly virulent community-acquired strains of K. pneumoniae displaying hypermucoviscosity. The salient features of this syndrome include the presence of bacteremia, primary monomicrobial liver abscess, and metastatic complications. A previously healthy Argentinean man presented with fever and found to have liver abscess caused by K. pneumoniae with metastatic seeding of gastric wall. Cultures from blood and liver abscess grew hypermucoviscous K1 K. pneumoniae with sequence type (ST) 23 by multilocus sequence typing (MLST), positive for rmpA (regulator of mucoid phenotype A), wzy(KpK1) (capsular polymerase) and aerobactin genes. The hypermucoviscous phenotype of this K. pneumoniae isolate was readily identified by the "string test" (colonies formed a long string when touched with a loop). The patient responded favourably to percutaneous drainage of the abscess and antibiotics. This is the first documented report of KLAS described in Argentina, and may signal the emergence of this syndrome in South America.

3.
J Clin Microbiol ; 43(10): 5400-2, 2005 Oct.
Article in English | MEDLINE | ID: mdl-16208031

ABSTRACT

Salmonella enterica serotype Panama is capable of causing severe infection in children and is often transmitted via contaminated food. Here, we present the first documented case of serotype Panama infection that was acquired through the consumption of contaminated breast milk. The mother excreted the organism asymptomatically for at least 2 weeks.


Subject(s)
Breast Feeding , Meningitis, Bacterial/microbiology , Milk, Human/microbiology , Salmonella Infections/microbiology , Salmonella enterica/isolation & purification , Feces , Female , Humans , Infant, Newborn , Infectious Disease Transmission, Vertical , Salmonella Infections/transmission , Salmonella enterica/classification , Salmonella enterica/genetics , Salmonella enterica/pathogenicity , Serotyping
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