Pharma's Cutting Edge

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Hype or Hope: Eliminating Suffering and Death from Cancer by 2010

I finally got around to reading the National Cancer Institute's Cancer Bulletin for July 19, 2005 written by NCI Director, Andrew von Eschenbach. Dr. Eschenbach devotes the entirety of the two-page bulletin to his reply to the recent question posed by Sen. Arlen Specter (R, PA): "What would it take to accelerate by 5 years the achievement of the 2015 goal of eliminating the suffering and death due to cancer?" For those of you who we're already skeptical of the aggressive 2015 goal that Eschenbach set two years agobelieving it was little more than aggrandizement for the purpose of ensuring continuous generous public support of NCI initiatives for the next decadewhat must you be thinking now? Never mind the question. I know exactly what you are thinking now; I am probably in agreement with you.

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Let's cut to the bottom line. If there is any chance to eliminate suffering and death due to cancer by 2010 (less than five years away, remember), it would have to mean eliminating suffering and death among those who either are already diagnosed with cancer and are receiving treatment (or watchful waiting) with approved or experimental therapies or those who have cancer lurking somewhere in the body and don't know it yet. This is because cancer takes years to become established through the processes of initiation, promotion and progression to malignancy. So strategies aimed at actually preventing cancer, by interrupting it's initiation or promotion, for instance, will not play a role by 2010. We're left with two possible interventions: (1) Diagnostics, to detect and treat cancer earlier, after malignant conversion but prior to widespread metastasis, when the disease associated with longer survival and (2) Agents that have already been approved to treat cancer or those that are in the latter stages of development.

I'm not going to focus on diagnostics, because, well, this IS a pharmaceuticals and biopharmaceuticals newlsetter/blog. But I will point out that diagnostics capable of reliably detecting some of the most deadly cancers before they are clinically apparent or dangerousEschenbach mentions ovarian and lungare still years away from routine clinical practice. Yes, progress is being made, and it's being made at a rapid pace, spurred on by NCI/FDA initiatives and industry incentives to be first to market. Just this past week, for instance, Mian et al published a promising study of a mass spec-based peptidomic assay that could distinguish early- from late-stage melanoma. In a thoughtful editorial accompanying the Mian study, Robbins et al point out the many technical difficulties that must be overcome before a new cancer diagnostic is ready for routine clinical use. Despite reliable predictions of melanoma stage using 205 serum samples, much further work is needed before Mian et al's assay could be used routinely. From Robbins et al: " The proof of the potential value of this exciting new approach will be in the ability of disparate groups to reproduce either the entire proteomic patterns generated in other labs or to show that the highly discriminatory peptides have the same amino acid sequences and, thereby, truly qualify as cancer biomarkers. Welook forward to new reports using this technology and validation studies to assure it's authenticity. At present, this promising new approach is not yet ready for patient classification or treatment choices." Similar sentiments might apply to every peptide-or protein-based novel diagnostic test in development.

Let's be wildly optimistic and assume that reliable, accurate diagnostics for detecting 80% of all deadly cancers become routinely available by 2010. That still might leave quite of bit of suffering and death among those unfortunate patients whose cancers had already grown and spread, not to mention those in the group that includes the 20% of cancers for which a diagnostic was not yet discovered or developed completely. The truth is that in order to eliminate death and suffering from cancer by 2010 via improvements in diagnostics, researchers in academia and industry would have to develop and receive approval to market cancer diagnostics for all deadly cancers well before those cancers had a chance to metastasize (to be on the safe side, completely reliable diagnostics would have to be readily available by 2008), and some form or non- or low-morbid therapy would have to be available to treat the clinically benign tumors discovered to assure long-term survival or cure. I would describe this scenario as unlikely impossible.

Which brings us to a discussion of cancer therapies. Newer treatments and supportive care have improved both overall and disease-free survival for cancer, including cancers that we're until recently nearly impossible to treat (e.g. advanced prostate cancer and non small-cell lung cancer). Although Eschenbach argues for more funds to eliminate suffering and death from cancer by 2015 or perhaps as early as 2010, for the sake of debate, let's establish our own goal of merely eliminating suffering from cancer and relegating the elimination of death from cancer to a goal for the next generation of medical bureaucrats to tackle. It's not as straightforward to measure elimination of suffering compared with death, but we can use surrogate measures of suffering such as time-to-disease progression (TTP) and progression-free survival (PFS). Let's assume for our goal of eliminating suffering from cancer by 2010 that all therapies in the latter stages of development (i.e. Phase 2b and later for drugs) or those already marketed are at least as effective in clinical practice as they we're in clinical trials at their most efficacious. How close are we to our goal?

Below is a table showing the best efficacy responsesfocusing only on prevention of sufferingfor selected therapies that have been tested in some of the deadliest, most debilitating cancers. Given their progress in development, these are the therapies that have a realistic chance of being used routinely to treat cancer by 2010. Not quite the elimination of suffering that we might have hoped for, huh? But it is progress. I do not show this to paint a bleak picture of forthcoming cancer therapies. Keep in mind when reviewing these data that nearly all of the studies from which they we're derived enrolled patients with advanced disease who had been treated previously with multiple therapies. Neverthless, these are real patients with real cancers, very similar to the real patients with real cancers who are today being diagnosed with early or mid-stage disease many of whom will, by 2010, require treatments for their progressive, advanced disease.

Will we completely eliminate suffering from cancer by 2010, even with major improvements in diagnostics and the best possible success of drugs now in late-stage development? The answer, I'm afraid, is no, we will not, because it is not possible. Will we come close to eliminating suffering from cancer? No, not by 2010. By 2015, effective drugs now in Phase 1 and late preclinical testing will have become available for routine clinical use. Perhaps these promising drugs, combined with advances in diagnostics and supportive care will come close to eliminating suffering by 2015. Perhaps. Let us hope for that, but let us also not be lured into ill-conceived policy decisions by hype.

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