SHARE...

The Efficacy of Chemotherapy for Cancer

In my previous article (Natural Health, December 1995/January 1996) I focused mainly on the efficacy of surgery. In this article I try to answer several questions related to chemotherapy:

What is the rationale for the use of chemotherapy?
What is the scientific evidence for its efficacy?
How much harm does it do?
What are the opinions of practicing oncologists about its efficacy?
Chemotherapy – a rationale

Compared to surgery and radiotherapy, chemotherapy has a different effect. It is intended to eradicate rapidly proliferating cells. But it also destroys a lot of quickly proliferating healthy cells. Additionally, it is toxic and harms the immune system (see below). Chemotherapy is a systemic therapy, as opposed to surgery and radiotherapy. Chemotherapy is the most likely of the conventional treatments to be effective if only its toxicity could be reduced if, as most alternative practitioners assert, cancer is a systemic disease.

What is the scientific evidence for its efficacy?

A randomized trial showing that the group receiving chemotherapy had a significantly higher survival rate when compared to an untreated group is required to demonstrate the effectiveness of a cancer treatment like chemotherapy. This has never been accomplished. Unfortunately, studies showing tumor shrinkage or comparisons of the long-term survival rates of unmatched groups are the primary sources of claims about the effectiveness of chemotherapy.

Tumor response studies operate under the presumption that the tumor is the disease, for example. If this assumption is incorrect and the tumor is merely a symptom of a systemic illness, the symptom can be eliminated, destroyed, or reduced without having any impact on the disease’s progression. Treatment cannot be deemed effective unless tumor shrinkage is accompanied by evidence of increased survival. Rarely do tumor response trials yield such evidence of improved survival1. However, tumor decrease can lessen discomfort.

Tumor response studies operate under the presumption that the tumor is the disease, for example. If this assumption is incorrect and the tumor is merely a symptom of a systemic illness, the symptom can be eliminated, destroyed, or reduced without having any impact on the disease’s progression. Treatment cannot be deemed effective until tumor shrinking is accompanied by evidence of increased survival. Rarely do tumor response trials yield such evidence of improved survival1. However, tumor decrease can lessen discomfort. 2. A portion of this increase is only noticeable because it results from earlier diagnosis, which extends the starting point for survival, and the rising prevalence of less fatal forms. However, it is unlikely that these factors account for more than a third of this improvement. While advancements in diagnostic techniques and an increase in less-fatal forms are unlikely to have developed in this way over the past thirty years, the percentage of survival has continued to rise steadily during that time.

The evidence for other types of leukemia is dubious. An analysis of 3-year survival rates between the 1950s and 1960s revealed higher percentages of 3-year survival for all types of leukemia during this time, but overall survival rates did not change. 3. As opposed to the case of ALL mentioned above, all of this increase can be attributed to the benefits of earlier diagnosis, which increases the starting point for survival, and the shifting proportion of the more lethal forms in the overall cases.

For some lymphomas, the survival rate has improved less dramatically1. But once more, a large portion of this increase can be attributed to subpar methodology.

“For most adult cancers, and particularly for epithelial cancers, there has been so little progress that it is difficult to distinguish any real improvement in survival rates from artifacts due to improvements in diagnosis and cancer registration,” says a renowned epidemiologist. 4“..(Tamoxifen for breast cancer, oestrogens for prostatic cancer, cytotoxic chemotherapy for small cell lung cancer and ovarian cancer, adjuvant therapy for resected breast cancer, and perhaps colorectal cancer all result in marginally longer survival times.)

“However, the effectiveness of the majority of other treatments is unknown, and a small percentage of patients will undoubtedly die from the short- or long-term side effects of cytotoxic therapy. 4.”

“Although there have been significant improvements in minimizing tissue damage from radiotherapy, avoiding disfigurement from radical surgery, and managing chemotherapeutic toxicity, it is unclear whether the elimination of all cytotoxic therapy would significantly reduce the number of cancer deaths each year for the majority of adult epithelial cancers..”….

“….The oncologist is forced to weigh the cost, inconvenience, and toxicity of treatment against its unknowable clinical benefit in the numerous cases where it is still unknown whether a given course of action will prolong remission or survival. It comes as no surprise that many clinicians react by forming a set of strongly held but unsupported beliefs about the benefits of specific regimens. For example, advanced non-metastatic laryngeal cancer is typically treated primarily with surgery in some treatment facilities and radiotherapy in others. More so than objective proof of long-term efficacy, the peculiarities and outpatient arrangements of the specific treatment center determine whether chemotherapy is administered as well as what form it will take. Similar examples can be drawn from the majority of cancer therapeutic fields. 4.”

Similarly claims that chemotherapy have produced increased percentage 5-year survival for other cancers, such as cancer of the large bowel1, could be attributed to poor methodology because none of these cancers exhibited a divergence between incidence and mortality rate curves over time 5.

Ulrich Abel reviewed the evidence for the efficacy of chemotherapy for invasive epithelial cancer 6, the cancer types that chemotherapy is most frequently used to treat. He came to the conclusion that randomised trials had provided some evidence that chemotherapy only improved survival for small-cell lung cancer. Even so, the increase in survival was only quantified in weeks or months.

Adjuvant chemotherapy for breast cancer

There is a common belief that adjuvant chemotherapy increases survival for women with advanced breast cancer. For instance, Professor Allan Langlands wrote in a letter to the Sydney Morning Herald on November 22, 1996, that a meta-analysis of more than 100 trials of adjuvant systemic therapy in thousands of women with breast cancer had confirmed a mortality risk reduction of more than 20% over the following ten years. The outcomes of 133 randomised trials involving 75,000 women were presumably the ones he was referring to when they were reported in the Lancet in 1992.

In these trials, 11,041 women were randomly assigned to long-term polychemotherapy or no chemotherapy. The most effective chemotherapy was this one. These women appeared to have a 6.3% survival advantage when examined ten years after their enrollment in a randomised controlled trial (51.3% vs. 45.0%). The advantage for node-negative women was only 4% (67.2% vs. 63.2%). It was less than 7% for node-positive women (46.6% vs. 39.8%). Two researchers from Manitoba stated in the Lancet that “no overall survival advantage has been seen so far” as a result of this slight difference.

The original trials must be examined to determine whether they were methodologically sound before these numbers can be trusted. They most likely contain findings from numerous trials that have since been discovered to be flawed. Numerous instances of fraud and subpar methodology can be found throughout the history of randomised trials of adjuvant therapy for breast cancer.

Later analyses in Italy, where the cyclophosphamide, metho-trexate, and fluorouracil (CMF) combination chemotherapy had the first positive survival effect, revealed that many patients had been disqualified because they were unable to complete the rather taxing therapy. As a result, the healthier treated women were compared randomly to all the controls, invalidating the trial’s findings.

Under the direction of the National Institutes of Health, randomised chemotherapy studies officially began in the United States in 1957. (NIH). This project eventually evolved into the Bernard Fisher-led National Surgical Adjuvant Project for Breast and Bowel Cancer (NSABP). Because Fisher had neglected to inform the National Cancer Institute (NCI) of the enrollment of inappropriate patients, a fact that had been known for three years, he was fired from the program in 1994. Then, inconsistencies were found in data from 12 additional treatment facilities. Exclusions that would have had an impact on the outcomes were also used in some of the early NSABP trials, such the Italian experiment.

The outcomes of the Italian and NSABP Trials are included in the results Professor Langlands is referring to.

One of the cornerstones of chemotherapy is the use of cytotoxic medications as an adjuvant treatment for breast cancer, and for more than 40 years, the NSABP was the program’s mainstay. The statistical quality control in the NSABP experiments was “grossly inadequate,” according to Irwin D. Bross’ 1994 article in the New England Journal of Medicine. Therefore, any conclusions lack scientific validity whether some fraudulent cases are eliminated post hoc or not.”7.

Ulrich Abel makes the following points about claims of efficacy in adjuvant breast cancer therapy 6:

There is only strong and reliable evidence that adjuvant systemic chemotherapy improves survival for patients with breast cancer, and more specifically for those with no more than three positive nodes;
Positive outcomes for patients who are unquestionably postmenopausal don’t appear to have been published yet;
It seems strange that the positive effects are limited to this small group;
Therefore, it is likely that the effect is caused by treatment-related suppression of ovarian function rather than direct cytotoxic effects on the tumor.

Chemotherapy for invasive cervical cancer

Chemotherapy is said to aid in the treatment of invasive cervical cancer, according to recent claims. According to a news story in the Sydney Morning Herald on February 24, 1999, the US National Cancer Institute is actually claiming a breakthrough in the treatment of late-stage invasive cervical cancer. They assert that this represents the first significant advancement in this cancer’s treatment in more than 40 years. (Many years ago, the effectiveness of surgery was asserted. This assertion has since been retracted.) Contrary to the claims made for surgery, this new evidence is based on the findings of randomised trials, therefore it merits deeper examination. Following hysterectomy, adding chemotherapy in the form of cisplatin at the same time as radiotherapy increased the percentage of 3-year survival by about 10-12%, according to data from 5 randomised trials.

As a result, the survival rate for women with cancer in stages IIB, III, and IVA rose from 63% to 75%. Survival rose from 77% to 87% for women with earlier-stage invasive cancer, Stages IA2, IB, and IIA. It implies that chemotherapy and radiotherapy work better together than they do alone and that chemotherapy may prevent cancer cells from healing radiation-induced damage.

Unfortunately, there have never been studies comparing these sorts of treatment to no treatment, so it is also plausible that the proportion of survivorship is moving closer to what it would be in the absence of treatment. Since radiotherapy has been shown to increase mortality in many cancer types, it is possible that the identical outcome could have been obtained by omitting radiotherapy entirely.

There is no reason to change my initial prediction that fewer than 6% of cancer cases would benefit from chemotherapy after taking these discoveries into account.

Chemotherapy for neuroblastomas in children.

The topic of whether chemotherapy works against this kind of tumor is brought up by a recent instance in which a court ordered chemotherapy against the parents’ desires for a kid who had a neuroblastoma. Tumors called neuroblastomas can develop anywhere along the sympathetic nervous system, including the adrenal gland, the chest, and the pelvis. Cyclophosphamide, high-dose cisplatin, vincristine, and other medication combinations are said to have a response rate of 59%1. According to reports, 15% of high-risk patients survive, “despite many therapy approaches.”1. This disparity between response rate and survival rate serves as an excellent illustration of the falsity of most claims regarding chemotherapy’s efficacy. This dismal survival rate is complicated by the fact that neuroblastomas may spontaneously regress.

How much harm does chemotherapy do?

There are three main areas of harm:

Weakening the body’s natural defences
increasing mortality
decreasing the quality of life

Weakening the immune system

It has been discovered that chemotherapy 96%8 decreases the function of natural killer cells. Chemotherapy may worsen the situation by encouraging the growth of additional tumors already existing to progress more quickly if tumors are already present elsewhere in the body and the immune system aids in controlling tumor growth. However, conventional immunotherapy provides scant solid evidence that the immune system plays a significant regulating role. In reality, a recent editorial on an immunotherapy meeting in Canberra in September 1998 reports that it may only be a significant factor in tumors with viral origin. 9.

However, Immuno-Augmentative Therapy, as used at the IAT Clinic in the Bahamas, appears to result in between 15% and 18% 5-year survival among patients with late-stage disease. 10. Similar to this, patients with late-stage cancer who received the Issels Wholebody Therapy had a 16.6% 5-year survival rate. 11. (The expected 5-year survival rate for patients with advanced cancer treated with conventional therapies is less than 2%.) It seems that orthodox immunotherapy and alternative immune-boosting techniques must be completely different since these two therapies are based on boosting the immune system using natural methods.

Increasing mortality

Analysis of non-cancer deaths among cancer patients reveals that conventional therapies frequently have a negative net impact, which helps to explain some claims of apparently effective treatments. (For instance, the treatment for cancer can harm the heart and result in heart failure-related deaths. Less cancer-related deaths result from this.) As there is little proof that surgery harms patients beyond temporarily suppressing their immune systems, 8, It would seem that radiotherapy and chemotherapy cause the majority of the damage.

Non-cancer deaths made up 21% of all deaths, according to analysis of data from 1.2 million cancer cases in the US SEER (Surveillance Evaluation & End Results) database. These fatalities exceeded the rate anticipated for patients of this type. All cancer types showed this excess, with a 37% overall figure. From 9% for breast cancer to 173% for lung cancer, the excess was found. 12. This excess increased by nearly 5 times over the year after diagnosis, ranging from around 50% for breast cancer to about 800% for lung cancer. The harm brought on by cancer treatment was cited by the authors as the reason of this effect (presumably mainly radiotherapy and chemotherapy).

Decreasing the quality of life

The data is overwhelming that chemotherapy frequently causes a severe reduction in quality of life. The only question is whether the very thinly veiled gain in survival justifies the quality of life decline.

What are the opinions of practising oncologists about the efficacy of chemotherapy?

The following are snippets taken from the Burzynski Research Institute’s website. 13:

In his article “Chemotherapy: Snake-Oil Remedy?,” published in the Los Angeles Times on January 9, 1987, Dr. Martin F. Shapiro noted that “some oncologists tell their patients of the paucity of proof that treatments work… Scientific studies that suggest overly optimistic views of chemotherapy may deceive others. When provided a financial incentive, other people respond. For doctors, operating successful chemotherapy practices is a far more lucrative venture than providing solace and peace to patients with terminal illnesses and their families.

By no means is Dr. Shapiro alone. Alan C. Nixon, PhD, former president of the American Chemical Society, remarked, “As a chemist trained to analyze data, it is inconceivable to me that physicians can disregard the strong evidence that chemotherapy produces much, much more harm than good.”

118 physicians who treated non-small-cell lung cancer in 1986 were surveyed by researchers at the McGill Cancer Center. More than 3/4 of them engaged in patient recruitment and dangerous substance-based lung cancer treatment trials. They were asked which of six active trials they would select if they developed cancer. 64 of the 79 respondents who responded claimed they wouldn’t consent to take part in a trial using the common chemotherapy drug cisplatin. 58 people rejected the trials as being unacceptable in general. their reasoning? The ineffectiveness and unreasonably high level of toxicity of chemotherapy 14. ”

As the doctors became more experienced with the treatment, it became less likely that they would accept it for themselves.

Similar findings were obtained from two additional studies that were published in 1987.15,16.

In 1988, a study of how experienced doctors would want to be treated for genito-urinary cancer revealed a similar situation. 17.

One author noted that the “risk” of receiving cytotoxic therapy was three times higher in the terminal stage than it was in the other patients when it came to the treatment of 252 advanced breast cancer patients. 18. This does not indicate the employment of a therapy that is specifically targeted toward patients’ wellbeing, as Abel points out. 6.

German biostatistician Dr. Ulrich Abel himself looked into doctors’ decisions regarding cancer therapy in March 1989. He sent out a survey to oncologists and research centers all over the world to see how they felt about using chemotherapy in advanced cancer, and he received 150 responses. According to him, “many oncologists’ personal beliefs seem to be in stark contrast to messaging intended for the general public”1,6.

And some other opinions:

“…Even the established oncology community has realized that chemotherapy does not effectively treat cancer. The latest cover story of Scientific American was titled “The War on Cancer – It’s Being Lost.” Famous epidemiologist John C. Bailar III, MD, PhD, Chairman of the Department of Epidemiology and Biostatistics at McGill University, mentioned the steadily rising number of cancer fatalities despite the increased use of lethal chemotherapy in it. He came to the conclusion that if scientists want to ever make headway against this relentless killer, they need to investigate in other avenues.. “13

Bailar’s perspective had not altered in a 1997 evaluation of the circumstances. 19.

A scathing critique by Harvard University’s John Cairns, a microbiology professor, appeared in Scientific American in 1985. It is impossible to identify any abrupt changes in the death rates for any of the major malignancies that could be attributed to chemotherapy, with the exception of a few uncommon cancers. Chemotherapy has not yet been proven to be able to cure any of the common malignancies.13

Why is chemotherapy used so frequently if it is so ineffective? Well, for starters, pharmaceutical corporations offer huge financial incentives. Chemotherapy cost $3.53 billion in 1990. That amount has more than doubled to $7.51 billion by 1994. Along with this constant rise in chemotherapy use, cancer fatalities also rose relentlessly..13

Oncologist Albert Braverman MD wrote in 1991 that “no disseminated neoplasm (cancer) incurable in 1975 is curable today…Many medical oncologists recommend chemotherapy for virtually any tumor, with a hopefulness undiscouraged by almost invariable failure.”13

The fundamental issue with chemotherapy is that treatment is frequently more harmful than beneficial, despite the fact that most qualified medical professionals will readily admit it in private. When asked what he or she can do for a patient’s cancer, an oncologist finds it difficult to respond, “Chemotherapy is unlikely to assist you!”

REFERENCES

Questioning Chemotherapy by R.W. Moss, Equinox Press, 1995, New York
Childhood leukemia: The facts, Lilleyman, JS, OUP, Oxford, 1994.
Science 1977; 195: 847-851. Enstrom, JE, and Austin, DF. Interpreting cancer survival rates.
Cancer treatment trials: historical failures, present advancement, and prospects. Peto, J., and Easton, D. 513-533. Cancer Surv 1989; 8.
The effectiveness of surgical cancer treatment is discussed by DJ Benjamin in Medical Hypotheses 40 (2) (1993): 129–138.
A critical review of advanced epithelial cancer chemotherapy by U. Abel 1992; 46: 439–452. In Biomedicine & Pharmacotherapy.
NEJM 1994; 331: 809; Bross, ID.
Natural immunity in breast cancer patients during neoadjuvant chemotherapy and following surgery. Beitsch, P et al. Surgical Oncology 3(4): 211-219 (1994).
Editorial by Goodnow, C.C. MJA 1998; 169: 570.
Options, The Alternative Cancer Therapy Book, R. Walters, Avery Publishing, 1993, New York
Immunotherapy in Progressive Metastatic Cancer: A 15-Year Follow-Up, J. Issels. August 1970 issue of Clinical Trials Journal, pp. 357–365, with an editorial on pp. 355–356
Non-cancer deaths in White Adult Cancer Patients, Barry W. Brown et al. JNCI 1993; 85 (12): 979-987.
Do we require a fresh strategy for combating cancer? Home page for the Burzynski Research Institute, available at www.cancermed.com/chemo.htm.
The use of expert surrogates to assess clinical trials in non-small cell lung cancer, McKillop, W.J., et al. Br J Cancer, 54, 661-667, 1986.
Advanced non-small-cell lung cancer: Should it be treated or not? J Clin Oncol, 5: 1711–1712 (1987)..
Anonym. Part I. Doubt about the use of chemical weapons. Ein gnadenloses Zuviel an Therapie. 1987; 26, 128–47; Der Spiegel.
Tannock, IF; Moore, MJ. How experienced doctors would like to be cared for if they were diagnosed with genito-urinary cancer. Abstract number 455 1988; 7: 118 in Proc. Amer. Soc. Clin. Oncol.
Treatment of the terminal stages of breast cancer, BMJ (Jan. 7, 1989); 298(6665):13–14. Holli, K., and Hakama, M.
Cancer Undefeated. NEJM 1997; 336 (22): 1569–1574. Bailar JC, Gornik HL.