With Ovarian Cancer, after 25 years of prospective, randomized clinical trials to identify the best treatments to give to the average patient, there has been absolutely no progress. A meta-analysis of all trials showed that there was no difference. During those 25 years, Taxol (Paclitaxel) came along. Two large clinical trials showed that Taxol/Platinum combinations were better than single platinum regimen. And Taxol became one of the most remunerative cancer drugs of all time. So Taxol/Platinum became “standard” therapy.

But then two more very large trials were done, showing that there was no advantage to giving Taxol/Platinum over single agent platinum (like Carboplatin). And Taxol/Platinum also wasn’t any better than another non-Taxol combination (not previously tested against Taxol/Platinum). But Taxol/Platinum remained “standard” therapy. Now that Taxol went off patent, some academic oncology groups have (as their major ovarian cancer project) clinical trials to show that Platinum/Docetaxel (a drug like Taxol, but still on patent) can now be the new “standard” therapy.

Patients are treated with Taxol/Carboplatin. If Taxol/Carboplatin doesn’t work, they’ll be crossed over to Docetaxel (Taxotere), a drug which is mostly (if not completely) cross resistant with Taxol, for which the cancer clinic will collect several thousand dollars from the large pharmaceutical company if and when they are treated with this drug.

All the while doing this, the American Society of Clinical Oncology is refusing to suggest clinical trials of “cell death endpoint” cell culture assays because, lacking something patentable or proprietary, all assay-testing laboratories can offer is free assays and not the millions of dollars that a pharmaceutical company can offer to push its Docetaxel (Taxotere) trials.

With Breast Cancer, this is what passes for a successful experiment in clinical oncology. Henderson, et al, entered 3,100 breast cancer patients in a prospective, randomized study to compare cyclophosphamide + doxorubicin alone versus cyclophosphamide + doxorubicin plus Taxol (in the adjuvant, pre-metastatic setting). The results were microscopically positive, at best, and cannot begin to justify the enormous financial and human resources expended (while making no effort at all to test and improve methods to individualize treatment).

But these results changed the face of the adjuvant chemotherapy of breast cancer.

Cyclophosphamide + Doxorubicin + Taxol became standard of care. Taxol recently went off patent. Now the thrust is to identify on-patent therapy which is microscopically better in clinical trials of one-size-fits-all treatment. Already, the community-based oncologists are migrating to Cyclophosphamide + Doxorubicin + Docetaxel (expensive/remunerative) so what was the purpose of doing that 3,100 patient prospective, randomized Henderson study?