An astonishing article appeared in the Journal of the
National Cancer Institute (June 18, 1997). It is a so-called "news"
article entitled "Chemotherapy Benefits Nearly All Early Breast Cancer
Patients." According to the article, "two major trials have demonstrated
that chemotherapy plus tamoxifen outperforms tamoxifen alone in nearly all
groups of early stage breast cancer patients." Because of this, the
article enthuses, "clinical practice is likely to change in more ways
than one."
The patients, who were all part of the NSABBP program, had cancers that
had not spread to the lymph nodes and whose tumors had estrogen receptors.
The NSABBP is the program that was so plagued by fraudulent data a few years
ago.
"Up to now," the article reports, "the standard approach
for node-negative, ER-positive patients has been post-surgical tamoxifen
alone."
THREE GROUPS
In the current so-called B-20 trial, patients were assigned to one of
three groups: either those receiving tamoxifen, or those receiving tamoxifen
PLUS one of two chemotherapy regimens: either methotrexate and 5-fluorouracil
(5-FU) followed by leucovorin, or cyclophosphamide, methotrexate and 5-FU
(known as CMF).
The results in all three groups were very close. "About 90 percent
of patients taking [either] chemotherapy plus tamoxifen were disease-free
at 5 years compared with 85 percent of those taking just tamoxifen alone."
So there was just a five percent difference between the two groups. But
notice that this was "disease-free survival." It refers to the
time to recurrence and is not the same as "actual survival. Actual
survival, according to the article, was "also better." But the
numbers are not given for improvement in actual survival: it is a fair assumption
that this is less than the 5 percent advantage in disease-free survival.
And so, on account of a less-than-five-percent advantage, all women with
this type of breast cancer are now to be given chemotherapy. As if there
were no drawbacks to chemo, in terms of both short and long term toxicity,
not just hair loss, nausea, etc. but damage to the immune system and even
the potential of death from some forms of treatment. There is also the considerable
expense involved, an item that is of considerable interest to the pharmaceutical
companies promoting the use of such drugs.
I thought it was interesting that the JNCI article does not state whether
the advantage in either disease-free or actual survival was statistically
significant. Nor is it clear what happens to women after the five year period.
Nor does the article state what the actual survival rate is in women who
do not receive tamoxifen, since there was simply no "no-treatment control
arm" included in this study. It is therefore hard to assess the actual
impact of treatment for this condition.
Perhaps chemotherapy is a proper treatment for some women in this category.
I would urge patients to be very suspicious of any high-pressure tactics
used to force them to take toxic drugs without due consideration given of
all their options.
