Ralph W. Moss, Ph.D. Weekly CancerDecisions.com
Newsletter #36 05/14/02
Good, Better and Best?
Last week, the medical journal The Lancet
published the results of a clinical trial that
compared three chemotherapy treatments for
metastatic (stage IV) colon and rectal cancer.
journal's editors characterized these three forms
of chemotherapy as "Good, Better, Best," and
stated that "many efficacious chemotherapy
regimens are available for the treatment of
colorectal cancer." To put it mildly, I think this
is an exaggeration of the benefit of chemotherapy
for advanced cancer of the colon and rectum.
According to the data, the average survival of
patients in this study ranged from 266 days for
the "good" therapy to 302 days for the "best"
therapy. Taken as a whole, the average survival
was around 10 months. However, this only tells
part of the story.
The so-called "good" treatment (a new drug called
raltitrexed) turned out to be no more effective,
but quite a bit more toxic, than the "better" and
"best" regimens. Many patients taking raltitrexed
developed severe diarrhea, nausea, and vomiting,
as well as rampant destruction of their bone
marrow. Raltitrexed was so toxic that eighteen
patients (about 6 percent) died from its adverse
The other two treatments, which had about equal
effects on survival, were based on the drug 5-FU.
The de Gramont regimen consisted of folinic acid
plus a single big dose of 5-FU followed by an
infusion of 5-FU. The Lokich regimen consisted of
a protracted infusion of 5-FU. The authors of the
study called the Lokich continuous infusion of
5-FU "an excellent alternative regimen," although
it brought toxic effects of its own, such as more
infections and blood clots.
The purpose of giving 5-FU is said to be
"palliation." This is defined by the authors as
the "improvement, control, and prevention of
symptoms." But palliation of symptoms is only one
aspect of quality of life for cancer patients.
Does 5-FU, as a palliative therapy, really
contribute to an improved quality of life or
greater sense of well-being? Many patients had to
stop treatment prematurely because of its
toxicity. And while about half the patients
reported a decrease in symptoms such as fatigue,
pain, insomnia and appetite loss, nearly 75
percent reported moderate or severe toxic effects,
including an increase in nausea and vomiting,
constipation, diarrhea, dry and sore mouth, eating
problems, and pain in the hands and feet.
In a previous analysis of 13 trials of palliative
chemotherapy for advanced colorectal cancer, the
average (median) survival was 11.7 months with
chemotherapy compared to 8.0 months without. Thus,
chemotherapy extended survival by 3.7 months. An
unresolved issue is that these studies compared
patients who received active treatment with those
who simply got supportive care. "Supportive care"
sounds humane, but in actuality these patients
were told that they would be offered no further
anticancer treatments. Those in the chemotherapy
group at least received hope in the form of active
Could this make a difference in survival? I
believe so. "People's perceptions of their
treatment play an important role in healing,"
according to Professor Daniel E. Moerman of the
University of Michigan-Dearborn. Any treatment
works better when both physician and patient
believe in it. To deprive patients of all hope
could certainly act as a "nocebo" (a negative
placebo) and have damaging effects on psychosocial
well-being. As an Oslo study has shown,
psychosocial well-being is an important predictor
of survival for some cancer patients.
It is true that some new drugs, such as CPT-11,
have been introduced to treat advanced colorectal
cancer. But 5-FU is still the standby. I find it
dismaying that a drug that was already old hat
when the "War on Cancer" was launched in 1971 is
still the best that the oncology community can
come up with.
Isn't it time that they broke out of
the chemotherapy model and looked at more
promising treatments in the realm of complementary
and alternative medicine?
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