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One good example of considering gene expressions at the review for approval

One good example of considering gene expressions at the review for approval Taxol : Indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. retrospective subgroup analysis

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One good example of considering gene expressions at the review for approval

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  1. One good example of considering gene expressions at the review for approval • Taxol: Indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containingcombination chemotherapy. • retrospective subgroup analysis • ER/PR (-): !! ER/PR (+): ?? • ODAC: Retrospective analysis should not be used basis for approval. The indication should include all patients.

  2. 2. Characteristics of subgroups divided by the results of genetic analyses could be different ODAC: Because receptor-positive tumors tend to grow more slowly, longer follow-up would be needed. 3. Patients’ options Representative of patients (ODAC): “I think patients need the options. --- For those who can’t tolerate to tamoxifen, it would be a very important option to be able to have Taxol.”

  3. CLINICAL TRIAL The results is HYPOTHESIS retrospective gene/expression analyses subgroup analyses prospectively specified in the protocol Reevaluate the outcome Ethical Problems !? That Clinical Trial = Confirmatory Study Require Confirmatory Study CONCLUSION

  4. Study Design Is it possible to apply results of microarray method prospectively? How can we stratify? How can we perform statistical analyses? How can we estimate the number of patients to be enrolled? Sufficient data obtained from clinical trials should be required (e.g. survival, response to drugs,natural course, etc.) Genetical Information (by microarray, etc.)

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