Complete Hormonal Therapy Maintains Normal QOL in Men with Metastatic Prostate Cancer

May 1, 1997

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

Men whose metastatic prostate cancer is maintained in remission by completehormonal therapy (CHT) with flutamide (Eulexin) and a luteinizing-hormone-releasinghormone (LHRH) agonist have a health-related quality of life (QOL) equalto that of a matched population of men in the general population, accordingto a study published in the February issue of Urology (49:207-217,1997).

"The goals of treating metastatic prostate cancer are to increaselongevity and maintain a high quality of life. Now we have evidence thattreatment with Eulexin and an LHRH agonist can accomplish both of thesegoals," said Peter C. Albertsen, md, of the Division of Urology atthe University of Connecticut Health Science Center, Farmington, lead authorof the report.

The American Cancer Society (ACS) estimates that 334,500 men will bediagnosed with prostate cancer in 1997. Prostate cancer is the second leadingcause of cancer death in American men and will claim some 41,800 livesthis year. According to the ACS, some 42% of prostate cancer cases arediagnosed in either locally advanced or metastatic stages. In addition,many patients initially treated for early-stage prostate cancer later experiencea recurrence, with metastatic disease.

Control of metastatic prostate cancer is based on depriving the tumorof the growth-promoting effects of androgens, of which the principal oneis testosterone. Flutamide, an antiandrogen, acts by directly blockingthe effects of these hormones. Complete hormonal therapy combines flutamidewith 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, severalmajor studies have shown the value of CHT. One was a large National CancerInstitute study comparing complete hormonal blockade with an LHRH analogplus flutamide vs the LHRH analog alone in more than 600 patients withstage D2 prostate cancer (N Engl J Med 321:419-424, 1989). Medianoverall survival was significantly longer in patients receiving CHT withflutamide 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 thepatients given the combination therapy (Eulexin product information, ScheringCorporation, 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 onlyadditional side effect reported by patients in the CHT group was diarrhea(12%, vs 4% in those given the LHRH agonist alone). Hepatic injury occurredin 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 remissionand 53 patients whose stage D2 disease was progressing. All patients weregiven an LHRH agonist and flutamide. In addition, the investigators comparedthe QOL of the cancer patients in remission with that of men in the generalUS population matched for age and sociodemographic criteria.

Previous QOL studies have been limited to such measurements as painscares and performance status. The new study was the first to measure theimpact 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 indicatorsas social interactions, mental health, vitality, and sexual satisfaction.

In this study of 113 patients, there were no HRQL differences betweenthe cancer patients in remission and men in the general population. Notsurprisingly, however, the men whose prostate cancer was progressing hada significantly lower QOL in several areas--bodily pain, vitality, socialinteractions, and mental health--than did those who were in remission.In fact, the investigators' analysis showed that the reduction in HRQLof prostate cancer patients in general is entirely attributable to thelower QOL among those with progressive disease.

"Before making treatment decisions, cancer patients and healthcare payers alike are increasingly demanding evidence that treatments havea positive impact on their quality of life as well as their survival,"Dr. Albertsen said. "We now know that when patients respond, CHT withEulexin provides meaningful benefits on both counts."

Since 1989, flutamide has been marketed in the United States by ScheringCorporation as part of CHT for the treatment of advanced (stage D2) prostatecancer. In June 1996, flutamide received marketing clearance for use, incombination with an LHRH agonist, as neoadjuvant therapy in conjunctionwith radiation therapy for locally confined (stage B2-C) prostate cancer.