Two Cancer Therapies Compared : Medicine: The study found that both the conventional treatment with toxic chemicals and the unorthodox approach were equally ineffectual in extending the lives of terminal patients.
An unusual attempt to compare the effectiveness of a popular but unorthodox cancer treatment to that of conventional chemotherapy has found that both were equally ineffectual in extending the lives of men and women with terminal cancer.
The study, published today in the New England Journal of Medicine, found no difference in the length of survival between patients treated at the University of Pennsylvania Cancer Center and patients at an alternative-treatment clinic in San Diego.
The researchers did, however, find that the conventionally treated patients reported a higher “quality of life” than patients at the Livingston-Wheeler Clinic--despite many claims made for alternative therapies and despite the toxicity of chemotherapy.
“It’s telling the many thousands of patients in this country who seek unproven care every year primarily because they feel it’s going to cure them and improve their quality of life . . . that that’s not true,” said Barrie Cassileth, the lead author of the paper.
“But it’s also telling conventional medicine . . . that we may not be doing patients any major favors by continuing to treat them with toxic regimens when we know they can’t be cured,” said Cassileth, who is on the faculty of the University of Pennsylvania.
The study is one of few to have attempted to apply scientific scrutiny to the alternative cancer treatment industry--a business believed to have grown to $10 billion a year on unproven promises and the hope of patients disenchanted with established medicine.
But experts in the field disagreed in their assessment of whether the findings said more about unconventional or conventional therapies. Some faulted the study’s methodology as being insufficiently rigorous because, among other things, the patients were not assigned randomly to the different therapies.
“I am a little anxious about this type of method,” said Dr. Charles Moertel, a prominent cancer specialist and professor of oncology at the Mayo Clinic. “I fear it would make (such research) vulnerable to criticism from outside orthodox ranks.”
In the study, patients at the University of Pennsylvania and in the San Diego clinic were matched by diagnosis, sex, age and race. The researchers then followed them, interviewing them every two months by telephone about their physical and mental state and quality of life.
The patients had a variety of cancers ranging from inoperable colon or rectal cancer to metastatic lung cancer. No standard treatment has been shown to be effective more than 20% of the time in such cases, cancer specialists pointed out.
Those patients on conventional treatment mostly received standard chemotherapeutic drugs. The Livingston-Wheeler Clinic, now known as the Livingston Clinic Foundation, was treating patients with a so-called immune-enhancing vaccine, vegetarian diets and coffee enemas.
The average length of survival in both groups was 15 months after diagnosis or date of recurrent or metastatic disease. Just four patients survived more than 36 months; the longest-term survivor, alive after 45 months, was on the unconventional treatment.
But the conventionally treated patients reported a better quality of life than the others--a condition the researchers measured through questions about physical and psychological state, sociability, nausea and the effect of the disease on family members.
According to Cassileth, that last finding was surprising in light of the nausea and other discomfort associated with chemotherapy. She attributed the finding to the toxicity of unconventional treatment and to a greater discrepancy for the San Diego clinic patients between “their level of hope and reality.”
“The letdown must have been massive for the Livingston-Wheeler patients,” said Cassileth, a specialist in so-called psycho-social oncology, who recently left the full-time faculty of the University of Pennsylvania School of Medicine to join the adjunct faculty and to start a consulting firm.
In a statement released Wednesday, Livingston officials said “quality of life . . . is notoriously difficult to measure.” They said the patients’ willingness to stay in the program suggested “that quality of life differences were not significant enough to cause them to change.”
Dr. Mace Rothenberg, a special assistant to the director of the National Cancer Institute, the federal cancer research agency, contended that the study should be seen as an indictment of unconventional, not conventional, treatments.
Rothenberg said oncologists generally give patients “an honest assessment” of their odds and of the slim chance that chemotherapy will help in advanced cases, but the success of the alternative treatment industry is based on claims that they work.
“The value here was showing that the people in the unconventional (group) didn’t do better than the people in the conventional (group) where we know the treatment is crummy,” he said.
In the paper, the researchers acknowledged “a number of methodologic flaws.” In particular, the patients were not randomly assigned to one or the other treatment. Instead, they “self-selected,” raising the possibility of some hidden differences between the groups.
Because the study was limited to patients with advanced cancers, it was impossible to evaluate the different treatments’ value in less-sick patients, “in whom treatment has more opportunity to succeed,” the researchers said.
“The methodology is so suspect that certainly we would not accept this as scientific evidence either pro or con any type of orthodox therapy,” said Moertel, whose own studies have refuted claims that Laetrile and Vitamin C were effective against advanced cancer.
