Men whose metastatic prostate cancer is maintained in remission by complete
hormonal therapy (CHT) with flutamide (Eulexin) and a luteinizing-hormone-releasing
hormone (LHRH) agonist have a health-related quality of life (QOL) equal
to that of a matched population of men in the general population, according
to a study published in the February issue of Urology (49:207-217,
"The goals of treating metastatic prostate cancer are to increase
longevity and maintain a high quality of life. Now we have evidence that
treatment with Eulexin and an LHRH agonist can accomplish both of these
goals," said Peter C. Albertsen, md, of the Division of Urology at
the University of Connecticut Health Science Center, Farmington, lead author
of the report.
The American Cancer Society (ACS) estimates that 334,500 men will be
diagnosed with prostate cancer in 1997. Prostate cancer is the second leading
cause of cancer death in American men and will claim some 41,800 lives
this year. According to the ACS, some 42% of prostate cancer cases are
diagnosed in either locally advanced or metastatic stages. In addition,
many patients initially treated for early-stage prostate cancer later experience
a recurrence, with metastatic disease.
Control of metastatic prostate cancer is based on depriving the tumor
of the growth-promoting effects of androgens, of which the principal one
is testosterone. Flutamide, an antiandrogen, acts by directly blocking
the effects of these hormones. Complete hormonal therapy combines flutamide
with an LHRH agonist to inhibit cancer growth by maximizing androgen blockade.
Studies Show Benefits of Complete Hormonal Blockade
Although, at present, metastatic prostate cancer cannot be cured, several
major studies have shown the value of CHT. One was a large National Cancer
Institute study comparing complete hormonal blockade with an LHRH analog
plus flutamide vs the LHRH analog alone in more than 600 patients with
stage D2 prostate cancer (N Engl J Med 321:419-424, 1989). Median
overall survival was significantly longer in patients receiving CHT with
flutamide than in those given only the LHRH agonist (34.9 vs 27.9 months);
also, progression-free survival was prolonged by 2.6 months (19%) in the
patients given the combination therapy (Eulexin product information, Schering
Corporation, Kenilworth, New Jersey, June 1996).
In this study, side effects of the LHRH agonist included hot flashes,
loss of sex drive, impotence, breast enlargement. and nausea. The only
additional side effect reported by patients in the CHT group was diarrhea
(12%, vs 4% in those given the LHRH agonist alone). Hepatic injury occurred
in fewer than 1.0% of patients receiving combined hormonal blockade.
New Study Measures More QOL Factors
Dr. Albertsen and his colleagues evaluated the health-related QOL (HRQL)
of 60 patients with metastatic (stage D2) prostate cancer in remission
and 53 patients whose stage D2 disease was progressing. All patients were
given an LHRH agonist and flutamide. In addition, the investigators compared
the QOL of the cancer patients in remission with that of men in the general
US population matched for age and sociodemographic criteria.
Previous QOL studies have been limited to such measurements as pain
scares and performance status. The new study was the first to measure the
impact on QOL of such disease- or treatment-related effects as diarrhea,
constipation, nausea, vomiting, weight gain or loss, urinary symptoms,
sexual function, and hot flashes and such equally important QOL indicators
as social interactions, mental health, vitality, and sexual satisfaction.
In this study of 113 patients, there were no HRQL differences between
the cancer patients in remission and men in the general population. Not
surprisingly, however, the men whose prostate cancer was progressing had
a significantly lower QOL in several areas--bodily pain, vitality, social
interactions, and mental health--than did those who were in remission.
In fact, the investigators' analysis showed that the reduction in HRQL
of prostate cancer patients in general is entirely attributable to the
lower QOL among those with progressive disease.
"Before making treatment decisions, cancer patients and health
care payers alike are increasingly demanding evidence that treatments have
a positive impact on their quality of life as well as their survival,"
Dr. Albertsen said. "We now know that when patients respond, CHT with
Eulexin provides meaningful benefits on both counts."
Since 1989, flutamide has been marketed in the United States by Schering
Corporation as part of CHT for the treatment of advanced (stage D2) prostate
cancer. In June 1996, flutamide received marketing clearance for use, in
combination with an LHRH agonist, as neoadjuvant therapy in conjunction
with radiation therapy for locally confined (stage B2-C) prostate cancer.