What Is Proper Cancer Care in the Era of Managed Care?

The excellent article by Monaco and Goldschmidt summarizes potentialpitfalls that must be confronted and avoided as we balance the cost andallocation of health-care resources with the state-of-the-art cancer carethat we as a society have come to expect. As a clinician and researcherwho is devoting most of my professional efforts to prostate cancer, I wouldlike to put Monaco and Goldschmidt's article in the context of the mostcommon cancer now affecting American men.[1] Although these are my personalopinions, they are based on a number of recent practice guidelines, aswill be noted.

Early Diagnosis of Prostate Cancer

I believe that managed-care organizations should provide services forthe early diagnosis of prostate cancer. The American Urological Association(AUA), American College of Radiology, and American Cancer Society all recommendan annual prostate-specific antigen (PSA) blood test and digital rectalexamination (DRE) for men starting at age 50.[2,3] For men with a familyhistory and African-American males, who are at higher risk, testing shouldstart at age 40.[4]

Because no study has yet proven that these early detection strategiesimprove prostate cancer-specific mortality,[5] some managed-care organizationshave refused to pay for PSA testing when used for screening. With studiesnow showing that cancers detected by screening are more often organ-confined[6]and that the prostate cancer death rate has decreased in the PSA era (1991to 1995),[7] in my opinion there are fewer arguments for refusing coverage.Furthermore, studies by our group[8,9] and others[10] show a tumor size,stage, and survival disparity for African-American men. Thus, even if managed-careorganizations feel justified in rejecting coverage for detection servicesfor the majority of men, I feel that they should cover testing for high-riskgroups.

Managed-care systems also should be encouraged to further our knowledgein this area. Through their systems, they could prospectively assess thecosts and benefits of screening and study various fine-tuning strategiesfor PSA testing, such as age- and race-specific reference ranges,[4] thevalue of longitudinal testing,[11] and new free/complexed PSA assays.[12]

Treatment of End-Stage Prostate Cancer

Both the AUA[13] and the National Comprehensive Cancer Network (NCCN)[14]have published guidelines for the management of prostate cancer. Theseguidelines are obviously works-in-progress, as new research data will serveto modify the recommendations over time. At present, all authorities seemto agree that radical prostatectomy and external-beam radiation therapyare the accepted treatment options for carefully selected men with localizedprostate cancer and a life expectancy of 10 years or more. In addition,expectant or watchful-waiting is an accepted option for men with low-grade,low-stage tumors who have a limited anticipated life expectancy due toother diseases.

Treatment options for localized disease that are more controversialinclude prostate seed radiation (brachytherapy) and cryotherapy (percutaneousfreezing of the prostate).[15] Because 15 years may be needed to assessreliable prostate cancer outcomes data with the new treatments, practitionersare faced with a dilemma with respect to these options. While the newermodalities may provide potentially curative treatment with less expenseand lower morbidity, studies on their long-term efficacy are not yet available.

Although patient advocacy groups and many providers have been enthusiasticsupporters of the newer therapies, many managed-care organizations haverefused coverage because they consider these treatments unproven and thereforeexperimental or investigational. While the AUA guidelines suggest thatbrachytherapy may be considered a standard option for localized disease,[13]the NCCN guidelines still consider it investigational.[14] Regarding cryotherapy,the NCCN deems it experimental and the AUA recently (August 1996) revisedits policy statement as follows:

Cryosurgical treatment of the prostate is one of the methods of managementof adenocarcinoma of the prostate. The long-term curative efficacy of thistreatment modality has not been established. When used, appropriate disclosureof facts regarding all other treatments for prostate cancer should be madeto the patient.

I am keeping an open mind about these newer treatments for localizedprostate cancer. For the patient's sake, I hope that they are effectiveover the long term, and I include these treatments when I counsel my patientsabout their options. On the other hand, I can honestly empathize with themanaged-care organizations that refuse to cover these procedures becauseof sparse long-term outcomes data. Certainly, as part of a well-designedinstitutional review board clinical trial to further test these therapies,managed-care coverage has an opportunity to advance our knowledge of localizedprostate cancer.

Management of Advanced Prostate Cancer

Advanced prostate cancer includes locally advanced disease (traditionalstage C or T3) and metastatic disease (traditional D1 or any T, N1, M0[lymph node metastases] and D2 or any T, any N, M1 [distant metastases]).The mainstay of treatment for advanced disease has been and continues tobe hormonal therapy, or treatment to lower testicular and/or adrenal androgens.Also, a short course of hormonal medications given prior to definitivelocal radiation for stage C prostate cancer, called neoadjuvant hormonaltherapy, has been proven effective in intermediate (5-year) follow-up andis becoming a more standard treatment.[16]

Hormonal therapy for metastatic disease is standard, but the methodof hormonal therapy may become more controversial under managed care. Twooptions are available for hormonal therapy: orchiectomy (castration) orinjections of luteinizing hormone-releasing hormone (LHRH) agents. Of thetwo options, orchiectomy is generally the least expensive. Despite thehigher cost of monthly or quarterly injections of LHRH agents, most patients,when given a choice, would rather take injections than have their testiclesremoved.

In their quest to cut costs, I hope that managed-care organizationsdo not mandate that prostate cancer survivors undergo orchiectomy. On theother hand, the cost to society of these expensive medications is not trivial.Intermittent hormonal therapy is a new approach that appears promising,which mandates the reversible LHRH agents. This may make the argument betweenorchiectomy and LHRH agents less relevant.

In addition to testicular androgen suppression, adrenal androgen suppressionusing oral antiandrogens has been a common practice over the last decade.[17]Some, but not all, randomized trials have shown a survival benefit of antiandrogentherapy, and meta-analysis has shown a modest benefit.[18] Although notas expensive as LHRH injections, antiandrogens do add cost to a managed-carebudget. My hope is that antiandrogens and LHRH agents continue to be coveredby managed care and that patients and doctors be allowed to choose thesetreatments if they so desire.

Treatment of Hormone-Refractory Prostate Cancer

Hormone-refractory prostate cancer is frustrating for both patientsand providers. We have no "magic bullets," and the final stageof disease may be painful and depressing if not managed properly. Managedcare must continue to provide good palliative care for bone pain and late-stagemorbidity. Most important, this is the stage for which clinical trialstesting new treatments are urgently needed. Managed-care organizationsshould be encouraged to support such trials, as well as trials of futureinnovative therapies.

References:

1. Parker SL, Tong T, Bolden S, et al: Cancer statistics, 1996. CA CancerJ Clin 46(1):5-27, 1996.

2. Mettlin C, Jones G, Averett H, et al: Defining and updating the AmericanCancer Society guidelines for the cancer-related checkup: Prostate andendometrial cancers. CA Cancer J Clin 43:42-46, 1993.

3. American Urological Association: Early detection of prostate cancerand use of transrectal ultrasound, in AUA (ed): American Urological Association1992 Policy Statement Book, pp 4.20. Baltimore, Maryland, American UrologicalAssociation, 1992.

4. Morgan TO, Jacobson SJ, McCarthy WF, et al: Age-specific referenceranges for prostate-specific antigen in black men. N Engl J Med 335:304-310,1996.

5. Woolf SH: Screening for prostate cancer with prostate-specific antigen:An examination of the evidence. N Engl J Med 333:1401-1405, 1995.

6. Catalona WJ, Smith DS, Ratliff TL, et al: Detection of organ-confinedprostate cancer is increased through prostate-specific antigen-based screening.JAMA 270(8):948-954, 1993.

7. Hoeksema MJ, Law C: Cancer mortality rates fall: A turning pointfor the Nation. J Natl Cancer Inst 88:1706-1707, 1996.

8. Moul JW, Sesterhenn IA, Connelly RR, et al: Prostate-specific antigenvalues at the time of prostate cancer diagnosis are higher in African-Americanmen. JAMA 274:1277-1281, 1995.

9. Moul JW, Douglas TH, McCarthy WF, et al: Black race is an adverseprognostic marker for prostate cancer recurrence following radical prostatectomyin an equal-access health care system. J Urol 155:1667-1673, 1996.

10. Morton RA: Racial differences in adenocarcinoma of the prostatein North American men. Urology 44:637-645, 1994.

11. Carter HB, Pearson JD, Metter EJ, et al: Longitudinal evaluationof prostate-specific antigen levels in men with and without prostate disease.JAMA 267:2215-2220, 1992.

12. Catalona WJ, Smith DS, Wolfert RL, et al: Evaluation of percentageof free serum prostate-specific antigen to improve specificity of prostatecancer screening. JAMA 274:1214-1220, 1995.

13. Middleton RG, Thompson IM, Austenfeld MS, et al: Prostate cancerclinical guidelines panel summary report on the management of clinicallylocalized prostate cancer. J Urol 154:2144-2148, 1995.

14. Baker LH, Hanks G, Gershenson D, et al: NCCN prostate cancer practiceguidelines. Oncology 10(11; suppl):265-288, 1996.

15. Onik GM, Cohen J, Miller R, et al: Transrectal ultrasound-guidedpercutaneous radical cryosurgical ablation of the prostate. Cancer 72(4):1291-1299,1993.

16. Pilepich MV, Krall JM, Al-Sarraf M, et al: Androgen deprivationwith radiation therapy compared with radiation therapy alone for locallyadvanced prostatic carcinoma: A randomized comparative trial of the RadiationTherapy Oncology Group. Urology 45:616-623, 1995.

17. Crawford DA, Eisenberger MA, McLeod DG, et al: A controlled trialof leuprolide with and without flutamide in prostate cancer. N Engl J Med321:419-424, 1989.

18. Prostate Cancer Trialists' Collaborative Group: Maximum androgenblockade in advanced prostate cancer: An overview of 22 randomised trialswith 3283 deaths in 5710 patients. Lancet 346:265-269, 1995.