Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · May 2000
Randomized Controlled Trial Multicenter Study Clinical TrialPreliminary results of multicenter phase II trial of docetaxel (Taxotere) in combination with doxorubicin as first line chemotherapy in Indonesian patients with advanced or metastatic breast cancer.
Docetaxel and doxorubicin have produced a high degree of activity in previously untreated/treated patients with metastatic breast cancer (MBC). The efficacy of Taxotere (T) single agent as 2nd line chemotherapy is well established in large randomized phase III studies. ⋯ Taxotere--doxorubicin combination is very active in the first-line treatment of MBC, seems to be especially effective in patients with liver metastases, and is associated with a manageable toxicity profile.
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To facilitate the proper and quick evaluation of cancer chemotherapy, the issues of surrogate and true endpoints in clinical trials were reviewed. Surrogate endpoints are defined as response variables that can substitute for a true endpoint due to their close correlation with the true endpoint, and their occurrence earlier than true endpoint. The response rate in cancer chemotherapy has been used as a surrogate or true endpoint for the evaluation of treatments. However, recent studies revealed that response rates do not always correlate with survival time (time to failure), and better surrogate endpoints such as time to progression, median survival time, or various surrogate biomarkers are now under investigation.
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Gan To Kagaku Ryoho · May 2000
Review[Phase I clinical trial design of anticancer agents--a Fibonacci and a modified Fibonacci sequence].
A Phase I clinical trial of an anticancer agent is the first evaluation in humans, and it is an important step in drug development. From the ethical point of view, the goal is to escalate to the maximum tolerated dose quickly, yet safely, to minimize the likelihood of treating patients at doses that are too low or high. ⋯ The modified Fibonacci sequence has been generally adopted for dose escalation, although it includes some problems. It is necessary to recognize that the method used for Phase I clinical trials for anticancer agents remains unsatisfactory, and that it is also necessary to develop more ethical and scientific methods.