THE MOSS REPORTS Newsletter (06/27/04)

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28 Jun 2004 02:40:32 -0000

" Cancer Decisions "

 

 

THE MOSS REPORTS Newsletter (06/27/04)

 

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Ralph W. Moss, Ph.D. Weekly CancerDecisions.com

Newsletter #138 06/27/04

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THE MOSS REPORTS

 

 

" The great tragedy of Science, " wrote the celebrated nineteenth century British

biologist Thomas Huxley, " is the slaying of a beautiful hypothesis by an ugly

fact. "

 

The hypothesis underpinning so-called targeted cancer treatments is indeed

beautiful. These treatments are designed to interfere on a molecular level with

the specific metabolic processes within cancer cells that enable tumors to grow

and multiply with such devastating speed. Better yet, these treatments are

designed to be selective, targeting only cancer cells and leaving normal cells

largely unharmed.

 

However, the ugly fact is that these treatments are no magic wand. Used on their

own they make little or no impact on the disease. Their effect is typically only

felt when they are used in combination with chemotherapy, and even then the

difference they make is extremely modest.

 

Yet to judge by the mounting media excitement concerning targeted cancer

treatments, a cure for this dread disease is almost within our grasp.

 

How are cancer patients to assess the real worth of treatments that are

announced with such triumphalism in the media, yet which, in the real world of

cancer therapy, are actually making only the most modest of differences, if any?

 

For the past thirty years I have been studying and closely monitoring

developments within the field of cancer treatment, sorting fact from fiction,

and helping cancer patients and their families to understand and weigh the

usefulness of the treatments they have been offered.

 

The Moss Reports represent a comprehensive library of cancer guides. In them, my

years of experience in researching cancer treatments have been distilled into a

careful assessment of the worth and effectiveness of the conventional and

alternative treatments of over two hundred different kinds of cancer.

 

If you or someone you love has received a diagnosis of cancer, a Moss Report can

provide you with the key to understanding the best that conventional and

alternative medicine have to offer. You can order a Moss Report on your specific

cancer type by calling Diane at 1-800-980-1234 (814-238-3367 from outside the

US), or by visiting our website: http://www.cancerdecisions.com

 

We look forward to helping you.

 

 

 

 

TARCEVA TOUTED FOR LUNG CANCER

 

 

 

At its clinical trials web page, the National Cancer Institute announces the

results of a Phase III trial with the celebratory headline: " Erlotinib

(Tarceva®) extends survival in advanced lung cancer. "

 

The study's principal investigator, Dr. Frances Shepherd of the University of

Toronto, asserts that patients with advanced non-small cell lung cancer " now

have an option to improve survival with minimal toxicity. "

 

" This is a landmark study since it is the first to document a survival

advantage, " Dr. Shepherd says. The results are particularly compelling, she

adds, because " until now there has been no treatment option for these patients. "

 

News of this triumphant announcement quickly echoed around the world. But what

does the data from this study really show?

 

Median survival in the Tarceva-treated patients was 6.7 months compared with 4.7

months for patients in the placebo group; i.e., the actual gain in survival was

two months. The time to pain progression was 2.79 months in the Tarceva-treated

group vs. 1.91 months in the placebo group, a gain of about three weeks. And

progression-free survival, which some consider the most important measure of a

drug's benefit, averaged 2.23 months in the Tarceva-treated group vs. 1.84

months in the placebo group, amounting to a gain of just 12 days.

 

In essence, the results of this study translate into this: patients who take

Tarceva will discover, on average, that their tumors have progressed two weeks

later than the tumors of patients who do not take this drug. Tarceva-takers will

then suffer a somewhat slower decline and will die two months later than

patients who don't take the drug.

 

The media, grasping at any positive news about cancer, was predictably

enthusiastic about Tarceva's performance after these clinical trial results were

announced at the American Society for Clinical Oncology's annual meeting in June

(Abstract #7022).

 

I located 140 news articles about this ASCO paper. Here are some typical

headlines:

 

· Drug improves survival in lung cancer patients (USA Today, June 5, 2004)

· Cancer drug prolongs survival (Newsday, NY, June 5, 2004)

· Trials show chemotherapy helping after lung surgery (New York Times, NY - June

5, 2004)

· New 'smart bomb' cancer drugs show promise (Palm Beach Post, FL, June 5, 2004)

· Treatments boost lung cancer survival (MSNBC, June 5, 2004)

· 'Targeted therapies' tackle cancers (Pioneer Press, MN, June 6, 2004

· Cancer drug prolongs life in study (Los Angeles Times, June 6, 2004)

 

Over 400 websites now refer to Tarceva as ‘a breakthrough drug'. But not

everyone agrees. Marianna Koczywas, MD, a medical oncologist at City of Hope

National Medical Center in Duarte, California, told a reporter from the Medscape

website that the Tarceva results were simply not compelling. While a two-month

increase in survival is statistically significant, she said, it is still a small

benefit and she is not convinced that it will have any impact on clinical

management. " The improvement in quality of life is more compelling, " she

conceded, although, as the clinical trial showed, pain relief only amounted to

three weeks of benefit (Peck 2004). In other words, Tarceva is clearly not a

cure. Nor is it without side effects of its own, the most common of which are

extensive skin rash and diarrhea.

 

 

Economic Dimensions

 

 

Dr. Koczywas added that the current study may speed approval of the drug (Peck

2004). That is what investors are betting on, as Wall Street went wild over the

news. In the wake of what TheStreet.com called " a triumphant clinical

announcement, " the shares of OSI Pharmaceuticals soared. The value of shares in

OSI's Tarceva partners, Genentech and Swiss drugmaker Roche, also skyrocketed.

According to TheStreet.com, for Genentech, " Tarceva's success is like hitting

the cancer-drug lottery jackpot twice. " Last year, in a similar scenario,

Genentech also " hit it big with positive results from its Avastin colon cancer

study " (Feuerstein 2004).

 

Click on or go the link below for my 2003 article on Avastin:

http://www.cancerdecisions.com/062903_page.html

 

If the FDA grants Tarceva a priority review, as now seems likely, it could be on

the market in the first quarter of 2005. How much will that be worth to OSI and

its shareholders? There are at least 100,000 non-small cell lung cancer (NSCLC)

patients in the US alone who might use the product. Banc [sic] of America

Securities biotech analyst Mike King puts a $30,000 per patient price tag on the

drug. If patients survive about six months, as anticipated, then Tarceva could

have annual sales of around $1.5 billion. But Tarceva will have to compete with

AstraZeneca's relatively new lung cancer drug, Iressa. Other estimates put the

drug's sales potential at a more modest $500 million to $700 million per year.

 

 

Targeted Drugs

 

 

Everyone in authority is now touting targeted drugs such as Tarceva, Iressa and

Avastin as the great hope in cancer, the culmination of decades of hard work and

inspiration. But the clinical track record so far has not lived up to the hype.

I realize that Tarceva is being tried in very ill patients with advanced or

treatment-resistant cancers, and that it might produce better results in earlier

stages of the disease, especially when used as an adjuvant after conventional

chemotherapy. But even so, the results do not look very promising to me. The

results with Tarceva are similar to those with other targeted drugs—a few months

increased survival, at best. We continue to hear claims that these agents are

revolutionizing cancer care. But if a few months' extra survival is the best

they can do, even when used in conjunction with powerful and intensive

chemotherapy, I simply don't see what all the shouting is about.

 

 

Comparison to Melatonin

 

 

I must admit to a considerable degree of frustration as I contemplate the

overheated and uncritical publicity about Tarceva. I cannot help wondering how

well this drug would do if it were put up against some well-known complementary

and alternative (CAM) treatments. To take just one example out of many, Paolo

Lissoni, MD, and his colleagues at the New St. Gerardo Hospital of Monza, Italy

(north of Milan) have repeatedly shown in clinical trials that the hormone

melatonin, when added to chemotherapy, significantly increases survival and has

other benefits in terms of quality of life. In one study of non-small cell lung

cancer, the tumor response rate was nearly double in patients who received added

melatonin (11 out of 34) as compared to those who didn't (6 out of 35). The

percentage of one-year survival was significantly higher in patients treated

with melatonin plus chemotherapy than in those who received chemotherapy alone

(15 out of 34 vs. 7 out of 36) (Lissoni 1992).

 

Dr. Lissoni has published literally dozens of PubMed-listed articles on the

topic of melatonin and cancer, and has presented his findings at ASCO in past

years. I cite nine randomized clinical trial articles in the references below.

When I visited Dr. Lissoni in Monza last November I found a brilliant man who

was all but worn out by his decades-long struggle to gain acceptance for this

simple and well-documented therapy.

 

Click on or go to the link below for an abstract of my recent medical journal

article on Dr. Lissoni and other Italian CAM therapies:

http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abs\

tract & list_uids=15165505

 

So what is the difference between Tarceva and melatonin?

 

For one thing, patients seem to do better with added melatonin than they do with

Tarceva. Melatonin also has a very low toxicity profile. Melatonin is a

naturally-occurring compound that has long been in the public domain. As an

adjuvant cancer treatment it is usually taken in a relatively high doses of 20

milligrams per day. (NOTE: Do not attempt this treatment except under the care

of a qualified physician.) Furthermore, it is a great deal cheaper than Tarceva.

The cost of 20 milligrams of melatonin averages approximately 40 cents per day.

Over a six month period a patient would spend a total of $75 on this supplement.

By contrast, the cost of Tarceva given over the same period would be around

$30,000. Thus, melatonin could theoretically save US $29,925 in medical costs

over a six-month period.

 

Tarceva praised to the skies; melatonin all but ignored. Call me cynical, but I

believe that the media, Wall Street and a few celebrated professors have gone

wild over Tarceva not so much because of its therapeutic value but because of

its positive impact on the stock market's bottom line.

 

 

 

--Ralph W. Moss, PhD

 

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REFERENCES:

 

Feuerstein, Adam. Successful Tarceva study sends shares skyward TheStreet.com.

April 26, 2004. Accessed June 9, 2004 from:

http://www.thestreet.com/tech/adamfeuerstein/10156368.html

 

Ghielmini M, Pagani O, de Jong J, Pampallona S, Conti A, Maestroni G, Sessa C,

Cavalli F. Double-blind randomized study on the myeloprotective effect of

melatonin in combination with carboplatin and etoposide in advanced lung cancer.

Br J Cancer. 1999 Jun;80(7):1058-61.

 

Lissoni P, Chilelli M, Villa S, Cerizza L, Tancini G. Five year survival in

metastatic non-small cell lung cancer patients treated with chemotherapy alone

or chemotherapy and melatonin: a randomized trial. J Pineal Res. 2003

Aug;35(1):12-5.

 

Lissoni P, Malugani F, Bukovec R, Bordin V, Perego M, Mengo S, Ardizzoia A,

Tancini G. Reduction of cisplatin-induced anemia by the pineal indole

5-methoxytryptamine in metastatic lung cancer patients. Neuroendocrinol Lett.

2003 Feb-Apr;24(1-2):83-5.

 

Lissoni P, Barni S, Mandala M, Ardizzoia A, Paolorossi F, Vaghi M, Longarini R,

Malugani F, Tancini G. Decreased toxicity and increased efficacy of cancer

chemotherapy using the pineal hormone melatonin in metastatic solid tumour

patients with poor clinical status. Eur J Cancer. 1999 Nov;35(12):1688-92.

 

Lissoni P, Paolorossi F, Ardizzoia A, Barni S, Chilelli M, Mancuso M, Tancini G,

Conti A, Maestroni GJ. A randomized study of chemotherapy with cisplatin plus

etoposide versus chemoendocrine therapy with cisplatin, etoposide and the pineal

hormone melatonin as a first-line treatment of advanced non-small cell lung

cancer patients in a poor clinical state. J Pineal Res. 1997 Aug;23(1):15-9.

 

Lissoni P, Tancini G, Barni S, Paolorossi F, Ardizzoia A, Conti A, Maestroni G.

Treatment of cancer chemotherapy-induced toxicity with the pineal hormone

melatonin. Support Care Cancer. 1997 Mar;5(2):126-9.

 

Lissoni P, Meregalli S, Fossati V, Paolorossi F, Barni S, Tancini G, Frigerio F.

A randomized study of immunotherapy with low-dose subcutaneous interleukin-2

plus melatonin vs chemotherapy with cisplatin and etoposide as first-line

therapy for advanced non-small cell lung cancer. Tumori. 1994 Dec

31;80(6):464-7.

 

Lissoni P, Barni S, Tancini G, Ardizzoia A, Ricci G, Aldeghi R, Brivio F, Tisi

E, Rovelli F, Rescaldani R, et al. A randomised study with subcutaneous low-dose

interleukin 2 alone vs interleukin 2 plus the pineal neurohormone melatonin in

advanced solid neoplasms other than renal cancer and melanoma. Br J Cancer. 1994

Jan;69(1):196-9.

 

Lissoni P, Barni S, Ardizzoia A, Paolorossi F, Crispino S, Tancini G, Tisi E,

Archili C, De Toma D, Pipino G, et al.Randomized study with the pineal hormone

melatonin versus supportive care alone in advanced nonsmall cell lung cancer

resistant to a first-line chemotherapy containing cisplatin. Oncology.

1992;49(5):336-9.

 

Peck, Peggy. Adjuvant chemotherapy associated with survival benefit for

early-stage NSCLC. June 7, 2004. Accessed June 9, 2004 from:

http://www.medscape.com/viewarticle/480292

 

Shepherd, FA, et al. A randomized placebo-controlled trial of erlotinib in

patients with advanced non-small cell lung cancer (NSCLC) following failure of

1st line or 2nd line chemotherapy. A National Cancer Institute of Canada

Clinical Trials Group (NCIC CTG) trial. Meeting: 2004 ASCO Annual Meeting

Abstract No: 7022

 

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IMPORTANT DISCLAIMER

 

The news and other items in this newsletter are intended for informational

purposes only. Nothing in this newsletter is intended to be a substitute for

professional medical advice.

 

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