I am leaving shortly for another tour of German and Swiss complementary cancer clinics. I hope to report on my findings when I get home in a few weeks. In the meantime, I wanted to share with you an excellent blog from H. Kenneth Schueler. Ken discusses an important article on a trial of pancreatic enzymes that was recently published in the Journal of Clinical Oncology.

"Why we need Integrative Cancer Care: A Necessary Remedy to the "them" against "us" schism between CAM (Complementary & Alternative Medicine) and Conventional Oncology"
by H. Kenneth Schueler (reprinted with permission).

OK, it's August 17th and I'm reading my latest issue of the Journal of Clinical Oncology, and there it is, an article I never expected to see published: "Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer."

My friend Ralph Moss, PhD, one of the keenest observers of alternative cancer treatments, has previously described the unfortunate political acrimony which haunted this clinical trial. See Dr. Moss's very insightful Newsletter of June 21,2008, "A Great Opportunity Lost" at:

http://www.cancerdecisions.com/content/view/122/2/lang,english/

This Phase III trial was to be the showcase study for Dr. Nicholas Gonzalez's regimen for pancreatic cancer which included "proteolytic (digestive) enzymes, nutritional supplements, detoxification (coffee enemas ), organic diet (70% raw or minimally cooked); skin brushing and cleansing; salt and soda baths, liver flush, clean sweep, etc." 32 patients chose Dr. Gonzalez's Enzyme regimen and were managed by him; 23 patients chose conventional chemotherapy and most of them were managed at Columbia University-19 of those 23 received Gemcitabine(Gemzar), Capecitabine (Xeloda) and Docetaxel (Taxotere).

Pancreatic cancer is considered one of the most lethal cancers with a survival of 4-6 months for metastatic disease and an overall 5-year survival < 4 percent. The results of the above trial were as follows: "Those who chose gemcitabine-based chemotherapy survived more than three times as long (14.0 months) vs 4.3 months median survival for those on the enzyme protocol. The chemo patients also had a better quality of life than those who chose proteolytic enzyme treatment."

The above trial results were not a surprise to me. It is almost impossible to put the brakes on an extremely aggressive metastatic cancer without employing chemotherapy to disrupt tumor cell division by targeting DNA within the nucleus. Molecularly targeted therapies can be invaluable in simultaneously inhibiting cell cycle signaling from growth factors (e.g. VEGF, EGFR, PDGFR,etc.), proteins, genes, signal transduction molecules, oncogene products ,etc. Examples of some targeted therapies include: Tarceva, Erbitux, Avastin, Sutent, Sorafenib, Vatalanib, etc. Surprisingly, Tarceva (inhibits EGFR) was recently approved (in combination with Gemzar ) for pancreatic cancer even though it only extended survival by two weeks: median survival 6.24 months v 5.91 months. (J Clin Oncol. 2007 May 20;25:1960-1966.)

It could be noted that the chemo patients were receiving hospital-based supportive care at Columbia (e.g., pain medication, noninvasive biliary stents, etc.) so their quality of life reports may have been superior to the enzyme patients treated at Dr. Gonzalez's office. But much more likely, it was the Gemcitabine which improved the symptoms in the Columbia Group. Several compelling studies have demonstrated that even though Gemcitabine did not produce objective responses (radiographically confirmed reductions in tumor size), there was a measureable "clinical benefit" defined as an improvement in pain, performance status or weight without a deterioration in any other factor-although the objective response rate for patients with measurable disease was only 11 percent, a clinical benefit was observed in 27 percent. ["A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer." (Ann Oncol. 1996;7:347-353.) "Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial." (J Clin Oncol. 1997;15:2403-2413.)

SO WHAT'S IMPORTANT ABOUT THIS COLUMBIA STUDY? It's this conclusion by the Columbia authors: "This report may be among the first controlled, clinical studies to compare allopathic treatment to an alternative medicine program for a survival end point." They go on to reference another study in which vitamin E and beta carotene are cited as having no effect in reducing the incidence of lung cancer among male smokers, and raise the possibility they may actually have harmful as well as beneficial effects (N Engl J Med. 1994;330:1029-1035). Bottom line message: Standard of Care conventional oncology trumps CAM! Not only was the trial poorly constructed and executed, but the above Conclusion demonstrates the same "Us Against Them" attitude which has so fragmented not just oncology but all of healthcare.

Several of my physician friends have told me two lessons they learned during medical school: never say anything publicly that is so far outside the box you could be labeled a "quack". Secondly, you will rarely get a research grant for a non-patentable drug-pharmaceutical companies have no interest in testing any drug they can't obtain exclusive rights to. So basically, that would have eliminated Ignaz Simmelweis's radical idea in 1847 of washing hands with chlorinated lime solutions before obstetrical deliveries to reduce the 10-35% infant mortality caused by Puerperal fever. It also would have prevented the bold discovery by Dr Barry J. Marshall and Dr J. Robin Warren of Australia of H. Pylori bacteria as the cause for duodenal and gastric ulcers and stomach cancer, and it's eventual treatment with antibiotics. When Marshall and Warren first presented their research 25 years ago, they were ridiculed by colleagues. But they were proven correct and in 2005 they jointly received the Nobel Prize.

Conventional Oncologists have regrettably dismissed many valuable alternative therapies as either confounding influences in their clinical trials of monotherapies or doublets[often funded by pharmaceutical companies], or as interfering with treatment [they lump together all botanicals, when only a few may have contraindications due to anti-oxidative effects with radiation or chemo, or competing for Cytochrome P-450 liver enzymes, or increasing coagulation times).

There is a growing consensus amongst Integrative Oncologists that for patients with metastatic cancer, the most effective approach to substantially increase survival is a cocktail regimen incorporating a group of therapeutic agents which simultaneously and synergistically target multiple tumor cell mechanisms...

The remainder of this commentary can be found at Ken Schueler's Facebook page: http://www.facebook.com/note.php?note_id=127421113030&comments=

My sincere thanks to Ken Scheuler for allowing me to reprint his commentary.

--Ralph W. Moss, Ph.D.

To check out my latest Current Topic report, 'German New Medicine®'-Hope or Hoax, click here.