Relationship Between Response and Dose in Published, Contemporary Phase I Oncology Trials
نویسندگان
چکیده
منابع مشابه
Dose-Levels and First Signs of Efficacy in Contemporary Oncology Phase 1 Clinical Trials
PURPOSE Phase 1 trials play a crucial role in oncology by translating laboratory science into efficient therapies. Molecular targeted agents (MTA) differ from traditional cytotoxics in terms of both efficacy and toxicity profiles. Recent reports suggest that higher doses are not essential to produce the optimal anti-tumor effect. This study aimed to assess if MTA could achieve clinical benefit ...
متن کاملRE: Meta-analysis of the relationship between dose and benefit in phase I targeted agent trials.
Recently, Gupta et al. retrospectively evaluated phase I studies of molecularly targeted agents sponsored by the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP) (1). They observed a trend for increased response rate (≥61% maximum tolerated dose [MTD] vs ≤60% MTD; odds ratio [OR] = 1.56; P = .10) and statistically significantly improved overall survival (≥61% MTD vs <20%...
متن کاملMeta-analysis of the relationship between dose and benefit in phase I targeted agent trials.
BACKGROUND To date, the primary objective of phase I trials has been to safely select the maximum tolerated dose (MTD) of a drug or drug combination for utilization in subsequent trials. Although conventional cytotoxic chemotherapy is generally more effective at the MTD than molecularly targeted agents (MTAs), recent single-institution data suggest that molecularly targeted agent may not requir...
متن کاملDose-response relationship in phase I clinical trials: A European Drug Development Network (EDDN) collaboration study.
3084 Background: Alkylating agents have a strong dose effect relationship and this concept is used for development of novel cytotoxic (CTX) drugs. However, the need to reach MTD to obtain optimal benefit with molecularly targeted agents (MTA) is controversial. In this study we aimed to evaluate the relationship between dose and efficacy in a large cohort of phase I patients (pts) with refractor...
متن کاملBayesian designs of phase II oncology trials to select maximum effective dose assuming monotonic dose-response relationship
BACKGROUND For many molecularly targeted agents, the probability of response may be assumed to either increase or increase and then plateau in the tested dose range. Therefore, identifying the maximum effective dose, defined as the lowest dose that achieves a pre-specified target response and beyond which improvement in the response is unlikely, becomes increasingly important. Recently, a class...
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ژورنال
عنوان ژورنال: Journal of the National Comprehensive Cancer Network
سال: 2020
ISSN: 1540-1405,1540-1413
DOI: 10.6004/jnccn.2019.7375