Reviewer's comments, followed by Weisenthal's rebuttal:
4. Cost/benefit analysis: a clinician concurring with obtaining an assay directed assessment is faced with a number of questions difficult to answer. a)what is the likelihood that that the answer will prove helpful?, b)what is the cost of the procedure?, and c)is it worth the added morbidity required in some instances to obtain the sample? These questions are not unlike those raised by the authors of the overview. Their claim that too high a bar is placed against proponents of assay-directed decisions must be contested. Aren't the usual requirements of clinical trials that they address risk versus benefit questions, avoid reliance on anecdotal reports, and generate the appropriate studies to prove hypotheses? In this context, the case for assay-directed determinations to select the treatment of patients with ovarian case has not yet been made.
Weisenthal's rebuttal: To answer the above questions: (a) In every single study ever published, comprising more than 600 patients, i.e. non-anecdotal, patients treated with drugs active in the assays have a good prognosis, relative to the group as a whole, while patients treated with drugs inactive in the assays have a poor prognosis, relative to the group as a whole, and the differences have been highly significant. The value of this information, in any given individual situation, depends on the circumstances and clinical judgment, as in the case of any laboratory test. (b) The tests typically cost $1500 to $2500. (c) We've received 700 specimens of ovarian cancer in the past 10 years. In >95% of cases, the tissue or fluid was obtained during diagnostic or therapeutic procedures which would have been performed even had tissue/fluid for the assays not been required. Again, there is not a single laboratory or radiographic test in the history of cancer medicine which has been shown to improve the results of cancer treatment; all which has ever been shown before is that the tests are usefully accurate. This is also the time-honored standard required by the FDA in the case of test kits and devices.)
(Return to "The Article Reviewed" ONCOLOGY annonymous review):