[gdpawel]

Would it be safe to say that one of the reasons medical oncologists don’t like in vitro chemosensitivity tests is that it may be in direct competition with the randomized controlled clinical trial paradigm – a fiercely defended relic of our ignorance? Cell culture assays measure the “efficacy” of anti-cancer drugs. The randomized clinical trial measures the “efficacy” of anti-cancer drugs. And the new molecular testing rates the efficacy of population research vs rating the efficacy of drugs “actually” tested against an individual’s cancer cells.

The oncologist’s trade group, American Society of Clinical Oncologists (ASCO) says oncologists should make chemotherapy treatment recommendations on the basis of published reports of clinical trials and a patient’s health status and treatment preferences. All the rigorous clinical trials identified are the best treatments for the “average” patient (do cancer cells like Coke or Pepsi). But cancer is far more heterogeneous in response to various individual drugs than are bacterial infections. The tumors of different patients have different responses to chemotherapy.

The ASCO tech assessments say that chemotherapy sensitivity and resistance assays (CSRAs) should not be used outside the confines of a clinical trial setting. The same people who maintain that assay-directed therapy should not be used until proven in prospective randomized clinical trials, are the same people whose entire careers are utterly dependent upon mega-trials 100% funded by pharmaceutical companies (that, plus fees from speeches they give for these companies), are the same people who control the clinical trials system, the grant review study sections, and the journal editorial boards.

No wonder ASCO doesn’t recommend the use of CSRAs (no matter how good they are) to select chemotherapeutic agents for individual patients outside of the clinical trial setting. Besides the authors of these tech assessments trying to invent a brand new criterion for validating a laboratory test, they’d like to have these tests in clinical trials. Tens of thousands of scientists pushing a goal of finding the tiniest improvements in treatment rather than genuine breakthroughs that fosters redundant problems and rewards academic achievement and publication above all else.

Why is ASCO (and others) protecting the status of treatments which are only marginally and minimally and inconsistently effective? This prevents serendipitous and fortuitous discovery. Truly effective treatment don’t need prospective randomized trials. Even ASCO points out, because the number of available chemotherapeutic agents has increased enormously over the past few years, the emphasis on the rationale for these assays have never been stronger. As the number of possible treatment options supported by completed randomized clinical trials increases, the scientific literature becomes increasingly vague for guiding physicians.

With all these uncertainties, would it be wrong to make a clinical decision based on CSRAs? Should it be denied to patients who walk in the door asking for it? Patients who want this testing, after a thorough discussion about the peer-reviewed studies and experience that supports it, should not be hindered by restrictive ASCO policy. I never heard that ASCO had been knighted a regulatory agency.

Until the controlled, randomized trialist approach has delivered curative results with a high success rate, the choice of physicians and patients to integrate promising insights and methods like chemoresponse assays, remains an essential component of this kind of treatment technology.