30 years' worth of clinical trials have produced no important progress in the chemotherapy of advanced (Stage III, IV, and recurrent/refractory) ovarian cancer. Such trials have not benefitted ovarian cancer patients; they have produced no progress whatsoever in the treatment of ovarian cancer as a disease; they have not benefitted cancer research in general. These issues are discussed in detail elsewhere on this website.
We have produced an entire generation of investigators in clinical oncology who believe that the only valid form of clinical research is to perform "well-designed," prospective, randomized trials in which patients are randomized to receive one empiric drug combination versus another empiric drug combination. The problem is not with using the prospective, randomized trial as a research instrument. The problem comes from applying this (time and resource-consuming) instrument to address hypotheses of trivial importance (i.e. do most cancers prefer Pepsi Cola or Coca Cola?). As once stated by Dr. Martin Appel (in another context): "any experiment which has failed 1,000 consecutive times should be viewed with suspicion." Clinical research into the chemotherapy of advanced ovarian cancer has produced no progress dating back to the 1960s. To this date, no form of first-line chemotherapy has been proven superior to the single agent alkylators (including orally-administered agents) which were utilized in the 1960s. Government and academic clinical investigators have failed to support the individualization of chemotherapy through laboratory testing, in favor of attempts to identify "one size fits all treatments" through trial and error testing which has consumed tens of thousands of human lives. This entire effort has been a colossal failure and a colossal waste of human and financial resources.
As discussed elsewhere on this website, cell culture drug resistance testing (CCDRT, also known as "chemosensitivity testing," "drug resistance testing," and "drug response testing") has been shown to correlate strongly (and non-controversially) with patient response to chemotherapy and with long-term patient survival after treatment with chemotherapy. What has been missing until most recently are data to show that basing treatment decisions on the results of CCDRT improves clinical outcomes. This is simply because the investigators who control the clinical trials system have been entirely non-supportive of clinical trials to compare CCDRT-directed chemotherapy to "standard," one-size-fits all chemotherapy. Some day this will change. The failure of 30 years' worth of clinical trials research into "one size fits all" therapy will eventually force a consideration of new approaches. But it will be years before the results of such trials are available. To late for treatment decision which must be made today.
There is no proof beyond reasonable doubt for any approach to treating advanced ovarian cancer today. There is only the bias of clinical investigators as a group and as individuals. My own bias, based on the preponderance of evidence as outlined on this web site, is to make extensive use of cell culture drug resistance testing in treatment decisions. Return to main index page of Human Tumor Assay Journal.