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• W103694265 abstract "Phase II clinical trials have long been used to screen new cancer therapeutics for antitumor activity (efficacy) worthy of further evaluation. Traditionally, the primary end point used in these screening trials has been objective response rate (RR), with the desired rate being arbitrarily set by the researchers before initiation of the trial. For cytotoxic agents, especially in common tumor types, response has been a reasonably robust and validated surrogate of benefit. Phase II trials with response as an end point have a modest sample size (15-40 patients) and are completed rapidly allowing early decisions regarding future development of a given agent. More recently, a number of new agents have proven successful in pivotal phase III studies, despite a low or very modest RR demonstrated in early clinical trials. Researchers have postulated that these novel agents, as a class, may not induce significant regression of tumors, and that the use of RR as an end point for phase II studies will result in false negative results, and point out that not all available data is used in making the decision. Others have pointed out that even novel agents have proven unsuccessful in pivotal trials if objective responses are not demonstrated in early clinical trials. We review here the historical and current information regarding objective tumor response." @default.
• W103694265 created "2016-06-24" @default.
• W103694265 creator A5011285948 @default.
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• W103694265 date "2009-09-01" @default.
• W103694265 modified "2023-10-01" @default.
• W103694265 title "Tumor Shrinkage and Objective Response Rates" @default.
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• W103694265 doi "https://doi.org/10.1097/ppo.0b013e3181b9c506" @default.
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• W103694265 hasPublicationYear "2009" @default.
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