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Patients’ Survival Expectations before Localized Prostate Cancer Treatment by Treatment Status

the Department of Family and Community Medicine (RM, LL), Eastern Virginia Medical School, Norfolk
the Graduate Program in Public Health (HB), Eastern Virginia Medical School, Norfolk
the Department of Pediatrics (MLB), Eastern Virginia Medical School, Norfolk
the Department of Urology (RL, PS), Eastern Virginia Medical School, Norfolk
the Department of Urology, MD Anderson Cancer Center, Houston, TX (JWD)

Correspondence: Corresponding author: Ravinder Mohan, MD, PhD, Associate Professor, Department of Family and Community Medicine, Eastern Virginia Medical School, 825 Fairfax Avenue, Norfolk, VA 23507 (E-mail: mohanr{at}evms.edu)

	Abstract

Top Notes Abstract Methods Results Discussion Conclusion References

 
Background: Cancer-specific mortality is projected to be only 1% in 15 years in approximately 75% of patients with screen-detected localized prostate cancer (LPC). Nearly 94% of patients choose treatment even though treatment damages health-related quality of life. No data are available regarding what survival benefit patients expected from treatment.

Objectives: A self-administered mailed survey was sent to 184 men with newly diagnosed LPC to query patients about expected survival with treatment versus observation.

Results: More than 90% of patients had at least a high school education and a ninth-grade health literacy. In addition, 68% patients had income of $50,000. Mean cancer grade was 6.6. Twenty-three patients chose observation and 161 patients chose surgery or radiotherapy. Mean comorbidity adjusted life expectancy (CALE) without the cancer was 22.9 years. Without cancer treatment, 15.2% of patients expected to live <5 years, 48.8% 5 to 10 years, 33.5% 11 to 19 years, and 2.4% 20 years. With treatment, survival expectations were <5 years in 0.6%, 5 to 10 years in 6.5%, 11 to 19 years in 30.0%, and 20 years in 62.9% of patients. Age, prostate-specific antigen level, CALE, anxiety, depression, and social support were factors that predicted differences between CALE and patient survival expectations with and without treatment.

Conclusion: LPC patients grossly underestimated their life expectancy without treatment and grossly overestimated the survival benefit of treatment.

To our knowledge, no studies of patient-physician communication have examined patients’ anticipated survival benefit of treatment. Without data from randomized trials in screen-detected patients, it is difficult to counsel patients regarding their survival with and without treatment. Even with the use of multifactorial models, accuracy of predicted survival is 75% or lower.¹² Physicians are also poor at estimating baseline comorbidity adjusted life expectancy (CALE), which is critical in making an informed decision.¹³ Thus, patients may accept a treatment recommendation not knowing what their baseline CALE is, how much the newly diagnosed cancer could reduce it, or how effectively treatment could minimize that reduction. Current overtreatment of LPC might be because patients do not understand the pros and cons of treatment.

In this study we surveyed newly diagnosed patients about their anticipation of survival with and without treatment. By estimating their baseline CALE without considering the newly diagnosed cancer, we calculated their perceived decrease in longevity with observation (PDLO), and their perceived increase in longevity with treatment (PILT) for the cancer.

	Methods

Top Notes Abstract Methods Results Discussion Conclusion References

 
We surveyed patients who had been newly diagnosed with LPC (stages T1a to T2c) in the preceding 6 months, had met with their urologist after the diagnosis, were scheduled to receive treatment or observation, and had not yet been treated with surgery or radiation. Patients with dementia, or those who could not read, write, or understand English, were excluded. All patients were recruited from a large, private urology practice in Norfolk, Virginia. Staff at this practice systematically contacted patients newly diagnosed with LPC between March 2005 and November 2007 regarding their interest in participation in a self-administered mailed survey. Two concomitant pretreatment self-administered surveys were used. The first survey asked patients about expectations of survival with and without treatment, comorbid diseases, mood, social support, satisfaction with life, health, and education by physicians about treatment options. A list of health-related words in a closed envelope was mailed with the survey. Patients were requested to open the envelope and read these words on the telephone to a research assistant. This was done to estimate patient health literacy by using a brief version of the Rapid Estimation of Health Literacy in Medicine scale.¹⁴ Patients were given a $10 stipend for completing this survey. A second pretreatment survey was a part of a longitudinal follow-up by urologists to evaluate generic HRQOL, prostate cancer related symptoms, and fear of cancer recurrence. The study methods were reviewed and approved by an Institutional Review Board.

Measures
The Charlson Comorbidity Index (CCI) is a validated measure of comorbidity. We used a patient self-reported CCI scale that asked about the presence and severity of 12 chronic conditions; the Prostate Cancer Outcomes Study used this CCI version.¹⁵ Score categories are 0, 1, 2, and 3 or more diseases.

The NCCN practice guidelines had recommended, for the first time in 2007,⁸ that the health-adjusted life expectancy of LPC patients can be estimated by weighting age-based life expectancy by 1.5 for patients in the highest health quartile, using no weighting for patients in the middle 2 health quartiles, and weighting by 0.5 for patients in the lowest health quartile. We used comorbidity scores as surrogate markers of health status because comorbidity is the main determinant of life expectancy in older patients,¹⁶ and the most important prognostic factor for patients with LPC who are <75 years old is the comorbidity score.¹⁷ We categorized patients into health quartiles by using their CCI score (0 disease score = highest health quartile; 1 or 2 disease score = middle 2 health quartiles; 3 disease score = lowest health quartile). Our basis of equating a 1 or 2 disease score with the middle 2 health quartiles was that almost half (49%) of the 3173 patients newly diagnosed with LPC in a Prostate Cancer Outcomes Study¹⁵ had a disease score of 1 or 2, and almost half (55.5%) of our patients had a disease score of 1 or 2. Both studies used the same version and scoring of the CCI. Patients were placed in 4 CALE categories: <5 years, 5 to 10 years, 10 to 20 years, and >20 years. These 4 categories were scored, respectively, from 1 to 4.

Patients were asked the following 2 questions: "How long do you expect you will live without any treatment for prostate cancer?" (Q1) and "How long do you expect you will live after treatment for prostate cancer?" (Q2). The possible responses to both questions were grouped into 4 categories (similar to the CALE categories): <5 years, 5 to 10 years, 10 to 20 years, and >20 years. These 4 categories were also scored from 1 to 4, respectively.

Based on Q1, Q2, and CALE scores, we calculated the patient's PDLO (which is CALE category score minus Q1 category score) and the patient's PILT (which is Q2 category score minus Q1 category score). A PDLO of 10 years is at least a 2-category difference between the CALE category and the Q1 category; this is only possible if the CALE was >20 years and the Q1 response was 5 to 10 years or if the CALE was 10 to 20 years and the Q1 response was <5 years. Similarly, a PILT of 10 years indicates that the response to Q2 was 10 years or more than the response to Q1. We conducted ordinal logistic regression analyses to identify the main sociodemographic, health, and cancer characteristics that could predict PDLO and PILT of 10 years.

The following validated self-administered scales were used. (1) The Short-Form 36 (SF-36, version 2) measures generic HRQOL; we calculated physical component summary and mental component summary scores from SF-36 data.¹⁸ (2) The Prostate Cancer Index measures urinary, sexual, and bowel symptoms and how much they bother the patient.¹⁹ (3) The Duke Activity Status Index²⁰ measures functional capacity in metabolic equivalents; this scale asks patients whether they could perform 12 activities which have different levels of exertion. (4) The Hospital Anxiety and Depression Scale measures the presence and severity of anxiety and depression.²¹ (5) The Fear of Cancer Recurrence Scale measures the fear of possible cancer recurrence.²² (6) The Medical Outcomes Study Social Support Survey measures social support in an overall score that includes multidimensional subscores.²³ (7) The Delighted-Terrible Seven Faces Scale²⁴ was used to measure patient satisfaction with life, health, and with education given by physicians about treatment options for LPC. (8) The Rapid Estimation of Health Literacy in Medicine scale, discussed earlier, measures health literacy; this was the only scale administered by telephone.¹⁴

Statistical Analyses
Frequencies and relative frequencies were used to describe categorical variables. Continuous variables were described using the mean, median, and SD. ² tests, Fisher's exact test,and independent sample t tests were used to examine bivariate associations. Unadjusted and adjusted odds ratios (ORs) and their 95% CIs were estimated using ordinal logistic regression analysis. Sociodemographic and health factors that were found to be associated with PDLO and PILT in the bivariate analysis at an level of 0.20 were kept in the multivariate models. All analyses were performed using SAS software (version 9.1, SAS Institute, Inc., Cary, NC).

	Results

Top Notes Abstract Methods Results Discussion Conclusion References

 
Surveys were mailed to 430 patients newly diagnosed with LPC, but 69 patients had already started treatment by the time the patients received the surveys, 3 patients never received the surveys, and 2 patients were found to be ineligible to participate because their cancer was not localized to the prostate. Of the 356 remaining patients, 104 patients did not return the survey because they were "not interested" in participating and 68 patients who did not return the surveys did not give a reason for not participating or could not be contacted. One hundred eighty-four of 356 patients (survey response rate of 52%) completed and returned the first pretreatment survey; 23 of these 184 patients (12.5%) patients chose observation.

Table 1 shows a demographic comparison of patients who chose treatment or observation. Mean patient age was 61.5 years, and most patients reported college education and a family income of >$50,000. Table 2 shows a comparison of patients who chose treatment or observation by cancer grade, PSA, life expectancy by age, and comorbidity scores. Mean Gleason grade was 6.6. Table 2 also includes a comparison of these patient groups by SF-36 scores (Physical Component and Mental Component Scores), as well as the urinary, sexual, and bowel function scores of the 144 of 184 patients who had also returned the second pretreatment survey. Table 3 shows a comparison of patients who chose treatment or observation by CALE, anxiety and depression, function capacity, social support, and satisfaction. Mean CALE was 22.9 years.

View this table: [in this window] [in a new window]   Table 1. Comparison of Sociodemographic Characteristics of Patients with Localized Prostate Cancer who Chose Treatment* and Observation

	Discussion

Top Notes Abstract Methods Results Discussion Conclusion References

What should these patients really be expecting? Nearly 86% of all patients diagnosed through PSA screening are not expected to die because of prostate cancer.²⁸ The Connecticut Tumor Registry found that almost 20% of patients with Gleason grade 6 who chose observation died as a result of LPC during a period of 20 years.²⁹ However, all the Registry's patients had been clinically diagnosed; in contrast, patients diagnosed with screen-detected LPC are expected to have a longer survival because of a gain in lead time. Patients in another commonly cited natural history study³⁰ were also not diagnosed by PSA screening. A review³¹ found that only one randomized, high-quality trial³² could find a survival benefit of treatment, but in this trial 95% of patients had cancer that was clinically palpable (and not detected by PSA screening), putting this cohort in an intermediate- to high-risk category. A study of 44,630 men found a survival benefit of treatment,³³ but only 2.1% of the patient sample had died of prostate cancer. If adjusted for lead time provided by screening and also for the impairment of HRQOL that follows treatment, treatment was projected to enhance quality-adjusted survival by only 0.5 year.³⁴

Overtreatment would be expected if patients believe that treatment will lead to a much longer survival. Many studies have found that nearly every patient initially wants eradication of the cancer.⁹ In qualitative studies, some patients accepted side effects for any gain in survival but they were convinced that treatment would improve survival.⁹ Assuming that tumors would grow exponentially, urologists at the Mayo Clinic were also of the opinion that only 0.3% and 14.5% of screen-detected LPCs were "clinically insignificant."³⁵ Patient anxiety caused by the new diagnosis of cancer and the consensus advice of specialists that LPC patients with a CALE of >10 years should choose treatment or be offered treatment⁶ will lead to high treatment rates. In 70% to 90% of patients, a treatment plan is usually made in a single visit to the urologist after a positive biopsy.³⁶

The mean Gleason grade of our patients was 6.6, and in 87% of patients the mean PSA was <10, both of which are low-risk categories but for which national guidelines recommend either observation or treatment.⁸ Only 12.5% of patients in our study chose observation. Specialists frequently recommend treatment even in low-risk patients because over 10 to 15 years the cancer may progress.²⁹ To manage this risk, a strategy of active surveillance with deferred initial treatment²⁸ is being increasingly recommended for patients at lower risk, ie, with cancers of Gleason grade <7, cancer stages T1c to T2a, and PSA <10. Almost half of patients with screen-detected cancer possess such characteristics.²⁷ In conjunction with specialists, primary care physicians (PCPs) can follow patients who choose this strategy. PCPs may also offer more balanced advice because they might be more knowledgeable about the patient's preferences, comorbidities, and baseline CALE.³⁷ Patients with LPC may also want to review educational materials with their PCP. The American Cancer Society website was recommended because its content, accuracy, balance, and readability was rated the highest among 44 patient education materials about LPC.³⁸

Overtreatment can also be reduced with decreased screening, and several studies have shown that fewer patients want PSA screening if they are counseled before screening.³⁹ Enthusiasm for routine screening is high among specialists who treat LPC. In a random nationwide survey, 43% of 559 radiation oncologists recommended routine PSA screening in average-risk patients older than 80.⁶ Primary care physicians who frequently order PSA testing without much discussion about risks and benefits of testing cited reasons of lack of time, competing demands, limited patient health literacy, and fear of liability.⁴⁰ Prescreening counseling is difficult because it is unclear what and how much discussion should occur. As yet, we cannot say that screening or treatment can improve survival. The deleterious effects of treatment on urinary, bowel, and sexual dysfunction are better known; however, their frequencies and severities after different treatment techniques have been reported in more than 800 publications,⁴¹ vary greatly, and are difficult to balance. We can also share with patients that there is a small risk of immediate morbidity and mortality associated with prostate biopsy and cancer treatment; that a new anxiety results from a positive PSA test, whether or not it is followed by a negative biopsy; and that we cannot compare the risk of death caused by comorbid diseases with that of death caused by cancer without knowing the grade and stage of the cancer. However, patients must also know that, even if diagnosed with cancer, no randomized controlled trial has shown that treatment can or cannot improve survival in patients with screen-detected cancer. Interestingly, a study found that more African American patients wanted PSA screening after the use of a decision aid,³⁹ presumably because of the appreciation of the higher risk in African American patients.

In our patients, age, CALE, depression, and anxiety were the most important predictors of PDLO or PILT. Though PSA level also influenced PDLO, PILT was related to social support. PDLO and PILT were not related to other factors such as race; income; education; health literacy; physical and mental summary SF-36 scores; urinary, bowel, and sexual symptoms; choice of treatment or observation; fear of cancer recurrence; functional capacity; and satisfaction with life, health, or with education by physicians in cancer treatment options. Although the association of PDLO and PILT with continuous depression scores was statistically significant, the importance of this finding is unclear given that 96.6% patients had a depression score of <7, which indicates no depression.

Our findings may be difficult to generalize because our study sample was small. However, the differences we found between CALE and patient expectations of survival with and without treatment were large. Also, the mean age²⁶ and mean cancer grade²⁷ of patients newly diagnosed with LPC in large series and in our patients were similar. Our patients were treated by urologists in a private practice and more than 80% of urologists in the United States are in private practice.⁴² Our method of equating CCI scores with NCCN recommended health quartiles to estimate CALE is new and has not been previously validated. We used this method because we could not find any other validated method to estimate long-term health-adjusted life expectancy in individual ambulatory patients. Finally, we lost accuracy in the estimation of PDLO and PILT by asking patients to predict their survival in ordinal intervals rather than in a discrete number of years. We used ordinal intervals because it might be easier for patients to predict their survival this way, and the intervals allowed an estimation of PDLO and PILT of more than or less than 10 years.

	Conclusion

Top Notes Abstract Methods Results Discussion Conclusion References

 
In patients with newly diagnosed LPC, in whom the mean cancer grade was <7 and in whom education, income, and health literacy was intermediate to high, almost 38% of our patients had expectations of a reduction in survival of 10 years if they chose observation, and 48.8% patients expected an improvement in survival of 10 years through choosing treatment. These expectations are highly unrealistic because no study has shown that the cancer or its treatment can affect survival by even 1 year, especially in screen-detected patients with a cancer Gleason grade of <7.

	Acknowledgments

 
We thank Mr. Brian Main, Department of Urology, Eastern Virginia Medical School, for help with data entry and analysis.

	Notes

Top Notes Abstract Methods Results Discussion Conclusion References

 
This article was externally peer reviewed.

Funding: Norfolk Foundation and the US Health Resources Service Administration Department of Health and Human Services, grant no. 2002737.

Conflict of interest: none declared.

Received for publication September 17, 2008. Revision received January 29, 2009. Accepted for publication February 2, 2009.

	References

Top Notes Abstract Methods Results Discussion Conclusion References

 

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This Article Abstract Full Text (PDF) Rapid Responses: Submit a response Alert me when this article is cited Alert me when Rapid Responses are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Mohan, R. Articles by Schellhammer, P. Search for Related Content PubMed PubMed Citation Articles by Mohan, R. Articles by Schellhammer, P. Social Bookmarking                      What's this?