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Beyond the Abstract - Treatment options for localized prostate cancer, by Ravinder Mohan, MD, PhD

BERKELEY, CA (UroToday.com) -

 Enhancing feasibility of national guidelines to help in treatment choice for localized prostate cancer: A new, patient-centered, and practical approach

President Obama has declared September Prostate Cancer Awareness Month. Prostate cancer is not only the most common non-skin cancer diagnosed in American men, it is also the second leading cause of cancer death. Doubts about the benefits of screening for this cancer are a major barrier to its control. Awareness among patients and primary care physicians that it can be relatively easy to stratify the level of risk in newly detected cancer may help in increasing screening rates. With this aim, we have recently published a review article and accompanying patient education handout on "Treatment Options in Localized Prostate Cancer" in the August 15th, 2011 issue of the American Family Physician - which is the most widely read journal in primary care.1 The article offers a decision-making roadmap that can be individualized for newly-diagnosed patients and is based on a combination of national guidelines with findings from our recently published research.

Helping patients choose treatment or surveillance for newly diagnosed localized prostate cancer might be the most helpful intervention in the control of prostate cancer. This is because over 90% of prostate cancer patients are diagnosed with localized prostate cancer,2 and in 50% to 75% of these patients, the cancer will not lead to death.3,4 Unnecessary treatment in these patients leads to erectile dysfunction in two-thirds of patients and urinary incontinence in a third of patients, and at two years post treatment over half of surgery patients still have complete impotence and over a third have urinary leakage.5 Existing decision aids present pros and cons of treatment options but their usefulness is limited because they do not individualize decision-making. As a result, many physicians and patients remain reluctant to get screening because treatment of indolent cancers will potentially be hazardous to health-related quality of life (HRQOL).

To understand why patients choose over-treatment or under-treatment, we surveyed 184 patients at a private urology office before they were treated. They had already met with their urologists after a positive biopsy and had already chosen a course of treatment or were planning on active surveillance. Over 60% patients were college educated and had an annual income of over $50,000 and over 90% of patients had at least a ninth grade level of health-literacy. We used a questionnaire that we have developed to measure the core knowledge, understanding, and judgment of treatment options among newly-diagnosed patients; over half the patients in our survey answered over half the questions incorrectly.6 Most of our erring patients had grossly over-estimated the survival benefit through choosing treatment, and had chosen over-treatment, i.e., even if the guideline had recommended active surveillance as an equivalent choice, they had chosen treatment and had accepted the potential detrimental effects of treatment.7

Treatment choice is exceedingly difficult for even the most intelligent person, but 70% to 90% of patients choose a treatment in their first visit to the urologist after a positive biopsy.8 In this visit patients are not only confronted with a new diagnosis of cancer but also the immediate decision that they must make about whether they want surgery or radiotherapy. They have to choose from treatments with marginally different health-related quality of life (HRQOL) outcomes and without clear numerical probabilities of the frequency, severity, and duration of treatment-related sexual, urinary, and bowel dysfunction. Reported treatment outcomes vary widely and depend not only on the treatment procedure or the operator but also on the level of pretreatment dysfunction and its treatment, and the scale by which dysfunction was measured. Additionally, specialists are biased towards their own specialty even for the same hypothetical patient.9 Finding the HRQOL outcome that can best match the patient’s preference can also eclipse the bigger question of whether any treatment will enhance survival. If the patient is younger, patients, families and friends, and their physicians do not want to consider the option of active surveillance regardless of the grade of cancer or the risk of death due to prostate cancer. Many families have anecdotal knowledge of patients who died and had prostate cancer, and prostate cancer is a common cause of cancer death. Active surveillance is recommended only for patients whose life expectancy is less than 10 years, and many of the currently diagnosed patients have a 20 year or longer life expectancy. This is increasingly the case because of almost annual PSA screening from age 50 (and from age 40 in higher risk patients such as African Americans).

Individualized treatment choice based on the best available evidence can be found if physicians and patients follow recommendations of national guidelines that are updated annually. In complex clinical decisions, guidelines can be very helpful because unlike the opinion of a single expert, guidelines are written by a multi-disciplinary team which has the resources and time to balance the vast amount of conflicting outcomes data. Guidelines by the National Comprehensive Cancer Network (NCCN)10 offer a clear roadmap for the newly-diagnosed patient, and their recommendations are rated as the most evidenced-based.11 However, guidelines do not seem to get used in clinical practice.. We searched in PubMed with the words "prostate cancer" and "guidelines" or "NCCN" and could not find references that showed the use of any guidelines in decision-making. Guidelines require factoring of the PSA level and the cancer stage and grade, which are readily available, but they also require the pivotal factoring of the patient's health-adjusted life expectancy (HALE) which is difficult to estimate for both primary care physicians and specialists.12,13

HALE is the most powerful predictor of survival in these patients with or without treatment.14 Urology nomograms can predict the risk of cancer recurrence after different treatments but without factoring the patient's HALE they cannot also predict the survival benefit of competing treatments. Urologists have reported models that can predict survival in LPC patients,15 but these models do not estimate baseline HALE independent of the newly-diagnosed cancer. Patients need such an estimate to understand the differences in their survival with and without treatment. This information is also required to be able to use the guidelines. Because of wide heterogeneity in health, age per se cannot be used to estimate HALE. Calculation of co-morbidity scores in combination with use of life tables in estimation of HALE is also difficult given the limited time of an office visit. Even in the research setting, no formula is available to estimate long-term (10 years or longer) HALE in ambulatory patients. The method of Declining Exponential Approximation of Life Expectancy (DEALE)16 has been suggested, but it requires factoring of disease-specific mortalities of co-morbid diseases which are difficult to evaluate in individual patients given variable severity of diseases. A prognostic index incorporating age, sex, smoking status, six comorbid conditions, and four functional variables could stratify community dwelling older adults according to their 4-year mortality, but in a Dutch population the discriminant value of this index was similar to that of age and sex alone. 17

To address this barrier in the use of guidelines, we have recently published a new method by which HALE can be estimated easily and quickly. Our method uses a 12-item patient self-administered questionnaire to obtain a modified Charlson Co-morbidity score; this questionnaire was used by the Prostate Cancer Outcomes study.18 This co-morbidity score is used to place patients in health quartiles, or in below average (lowest quartile), average (middle two quartiles) and above average (highest quartile) health; and these quartiles are used to find HALE because life expectancy estimates Life tables are available in these categories.19

Our publication in the American Family Physician1 includes a simplified version of the NCCN guidelines in which our method of estimating HALE has been incorporated. It also includes a table with numerical frequencies of side-effects of different treatments as summarized recently by the AHRQ,5 and a sample Canadian protocol for Active Surveillance. With the help of these tools, patients can find the treatment recommended by evidence-based guidelines for their individual clinical situation; from this point, patients can choose either the recommended treatment or an alternative treatment based on their preferences of side-effect profiles of treatments. Similarly, if the guideline recommends two options as equivalent, patients can choose based on side-effect profiles of treatments. Because this approach can make decision-making more straight-forward for newly-diagnosed patients, we hope that patients and physicians will choose PSA screening with less hesitation.

For reassurance that patients are making an informed treatment choice, in our article in the American Family Physician we have also included the 18-item patient self-administered questionnaire that we had used in our survey to assess patients' core Knowledge, Understanding, and Judgment (KUJ) about pros and cons of different treatment options.20 Additionally, a one-page patient education handout in the same journal issue offers a summary of the core issues discussed above.21

 

References:

  1. Mohan R, Schellhammer PF. Treatment options for localized prostate cancer. Am Fam Physician. 2011 Aug 15;84(4):413-20.
  2. National Cancer Institute. Cancer advances in focus: prostate cancer. http://www.cancer.gov/cancertopics/factsheet/cancer-advances-in-focus/FS12_7.pdf. Accessed July 9, 2011.
  3. Cooperberg MR, Broering JM, Kantoff PW, Carroll PR. Con¬temporary trends in low risk prostate cancer: risk assess¬ment and treatment. J Urol. 2007;178(3 pt 2):S14-S19.
  4. Parker C, Muston D, Melia J, Moss S, Dearnaley D. A model of the natural history of screen-detected pros¬tate cancer, and the effect of radical treatment on over¬all survival. Br J Cancer. 2006;94(10):1361-1368.
  5. Agency for Healthcare Research and Quality. Treating prostate cancer. A guide for men with localized prostate cancer. http://www.effectivehealthcare.ahrq.gov/ehc/products/9/98/ProstateCancerConsumer.pdf. Accessed June 4, 2010.
  6. Beydoun HA, Mohan R, Beydoun MA, Davis J, Lance R, Schellhammer P. Development of a scale to assess patient misperceptions about treatment choices for localized prostate cancer. BJU Int. 2010;106(3):334-341.
  7. Mohan R, Beydoun H, Barnes-Ely ML, et al. Patients’ survival expectations before localized prostate cancer treatment by treatment status. J Am Board Fam Med. 2009;22(3):247-256.
  8. Cohen H, Britten N. Who decides about prostate can¬cer treatment? A qualitative study. Fam Pract. 2003;20(6):724-729.
  9. Fowler FJ Jr, McNaughton Collins M, Albertsen PC, Zietman A, Elliott DB, Barry MJ. Comparison of recom¬mendations by urologists and radiation oncologists for treatment of clinically localized prostate cancer. JAMA. 2000;283(24):3217-3222.
  10. National Comprehensive Cancer Network. Prostate cancer.2010 Practice guidelines in oncology v.2. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp (registration required). Accessed June 4, 2010.
  11. Dahm P, Kunz R, Schünemann H: Evidence-based clinical practice guidelines for prostate cancer: the need for a unified approach. Curr Opin Urol.17:200-7, 2007
  12. Kistler CE, Lewis CL, Amick HR. Older adults' beliefs about physician-estimated life expectancy: a cross-sectional survey. BMC Fam Pract. 7: 9, 2006
  13. Wilson JRM, Clarke MG, Ewings P, Graham JD, MacDonagh R. The assessment of patient life expectancy: how accurate are urologists and oncologists? BJU International. 95:794-79, 2005
  14. Post PN, Hansen BE, Kil PJ, Janssen-Heijnen ML, Coe¬bergh JW. The independent prognostic value of comor¬bidity among men aged < 75 years with localized prostate cancer: a population-based study. BJU Int. 2001;87(9):821-826.
  15. Walz J, Gallina A, Saad F, et al. A nomogram predicting 10-year life expectancy in candidates for radical prostatectomy or radiotherapy for prostate cancer. J Clin Oncol 25:3576-81, 2007.
  16. Welch GH, Albertsen PC, Nease RF et al. Estimating treatment benefit for the elderly: the effect of competing risk. Ann Intern Med 124:577-584, 1996
  17. de Craen AJM, Westendorp RGJ. Prognostic Index for 4-Year Mortality in Older Adults. JAMA. 2006;296(6):648
  18. Hoffman RM, Stone SM, Espey D, et al: Differences between men with screening-detected versus clinically diagnosed prostate cancers in the USA. BMC Cancer 5:27, 2005. Accessible at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC555747/pdf/1471-2407-5-27.pdf. Accessed on September 15th, 2011.
  19. Mohan R, Beydoun H, Davis J, Lance R, Schellhammer P. Feasibility of using guidelines to choose treatment for prostate cancer. Can J Urol. 2010;17(1):4975-4984.
  20. Beydoun HA, Mohan R, Beydoun MA, Davis J, Lance R, Schellhammer P. Development of a scale to assess patient misperceptions about treatment choices for localized prostate cancer. BJU Int. 2010;106(3):334-341.
  21. Mohan R, Schellhammer P. Information from your Family Doctor. Prostate cancer: who should be treated? Accessible at: http://www.aafp.org/afp/2011/0815/p424.html. Accessed on September 15th, 2011.

 

Written by:
Ravinder Mohan, MD, PhD as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.

 

Associate Professor, Department of Family and Community Medicine
Eastern Virginia Medical School
825 Fairfax Avenue
Norfolk, VA 23507
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