**6. Discussion**

274 Topics in Cancer Survivorship

<5 1 (0.5) 26 (15.2) 1 (0.6)

5–10 4 (2.2) 83 (48.8) 11 (6.5) 11–19 67 (36.4) 57 (33.5) 51 (30.0) >=20 112 (60.9) 4 (2.4) 107 (62.9)

CALE, co-morbidity adjusted life expectancy; Q1, How long do you expect you will live without any treatment for prostate cancer?; Q2, How long do you expect you will live after the treatment of your

Table 4. Distribution of Men with Localized Prostate Cancer by Calculated Co-morbidity

Tables 5 and 6 present ordinal logistic regression models for PDLO and PILT. Age, CALE, depression, and anxiety scores predicted both PDLO and PILT. Furthermore, PSA level

Unadjusted Effects

Age 25 62 83 1.08 (1.04–1.13) 1.01 (0.92–1.10)

PSA level 25 62 82 0.94 (0.88–1.00) 0.93 (0.86–1.00)

CALE 25 62 83 0.92 (0.88–0.96) 0.93 (0.84–1.02)

Anxiety score 25 62 83 0.88 (0.81–0.96) 0.96 (0.85–1.08)

Depression score 25 58 82 0.79 (0.67–0.93) 0.85 (0.69–1.04)

\*A (PDLO) =<0 (reference group) indicates that CALE and self-reported survival expectation without

†A (PDLO) = 1 suggests that CALE exceeds self-reported survival expectation without treatment by one

‡A (PDLO) >=2 suggests that CALE exceeds self-reported survival expectation without treatment by at

PDLO, perceived decrease in longevity with observation (categorized); PSA, prostate-specic antigen;

Table 5. Ordinal Logistic Regression Modeling for Perceived Decrease in Longevity with

about 10 years). All covariates in the ordinal logistic regression model are dened as continuous

=<0\* PDLO = 1† PDLO

PDLO 95% CI)

=>2‡ OR (95% CI)

Baseline CALE Score Q1 Q2

(n = 184) (n = 170) (n = 170)

Adjusted Effects (OR

Expected Survival

Data provided as n (%).

choice for prostate cancer?

Adjusted Life Expectancy

predicted PDLO, whereas social support predicted PILT.

treatment are within the same range or CALE is less.

CALE, comorbidity adjusted life expectancy; OR, odds ratio.

Observation (PDLO) among Men with Localized Prostate Cancer

response category.

variables.

least 2 response categories (ie.,

(years)

Prostate cancer is the most common solid cancer in men. Younger patients make up a fast growing population that is being screen-detected and treated for low-risk LPC.25 To our knowledge, this is the first study to report the perceptions of newly diagnosed patients about how the cancer or its treatment could affect their survival. The mean age of our patients (61.5 years) was similar to the range of 58 to 64 years of US patients currently undergoing radical prostatectomy.26 The mean Gleason grade was 6.6 in our patients, similar to other series in which almost half of screen-detected cancers were "insignificant."27 By choosing treatment, these low-risk patients had accepted the treatment side effects in exchange for longer anticipated survival. Our questions were designed to find how much longer these patients expected to live by choosing treatment. These expectations were evaluated after the patients had discussed their treatment options with their urologists. Despite their mean baseline CALE of 22.9 years, without treatment, 26 of 170 patients expected to live <5 years and only 4 expected to live >20 years; with treatment, only 1 expected to live <5 years and 107 patients expected to live >20 years.

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 or higher 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

Patients' Survival Expectations Before Localized Prostate Cancer Treatment by Treatment Status 277

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

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. We

We had also studied whether our patients had adequate Knowledge, Understanding and Judgment (KUJ) of their treatment options by using a KUJ 18-item questionnaire that we have developed; we found that although the vast majority of our patients were educated, had good health literacy and had higher income, over half of the patients incorrectly answered over half of the questions on the KUJ scale. These findings have been published separately.44 Additionally, we had studied whether our patients had chosen treatment or observation in accordance with current NCCN guidelines and we had found that a majority had chosen over-treatment, i.e., they had chosen treatment even though for their clinical situation the NCCN had recommended observation as an equal alternative. These findings were published recently, 45 and had demonstrated that with the use of our method to estimate CALE it becomes feasible to use NCCN guidelines in decision-making in individual patients. Based on our research and NCCN guidelines, in August 2011 we have published a comprehensive and easy-to-understand approach in the journal *American Family Physician* (AFP)46 which can be used by newly-diagnosed patients and their physicians in quickly reaching an evidence-based and guideline-driven treatment choice. Decisionmaking is very hard especially for low-risk patients, traditionally primary care physicians are not involved in this process, and over 70% to 80% patients choose a treatment or observation in the first visit to the urologist after a positive biopsy. Although newer guidelines now recommend against PSA screening,47 this recommendation carries the risk of increasing mortality due to prostate cancer and prostate cancer is already the second most

had a depression score of <7, which indicates no depression.

have also published these findings earlier. 43

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, co-morbidities, 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 co-morbid 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

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

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, co-morbidities, 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

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 co-morbid 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

projected to enhance quality-adjusted survival by only 0.5 year. 34

the highest among 44 patient education materials about LPC.38

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. We have also published these findings earlier. 43

We had also studied whether our patients had adequate Knowledge, Understanding and Judgment (KUJ) of their treatment options by using a KUJ 18-item questionnaire that we have developed; we found that although the vast majority of our patients were educated, had good health literacy and had higher income, over half of the patients incorrectly answered over half of the questions on the KUJ scale. These findings have been published separately.44 Additionally, we had studied whether our patients had chosen treatment or observation in accordance with current NCCN guidelines and we had found that a majority had chosen over-treatment, i.e., they had chosen treatment even though for their clinical situation the NCCN had recommended observation as an equal alternative. These findings were published recently, 45 and had demonstrated that with the use of our method to estimate CALE it becomes feasible to use NCCN guidelines in decision-making in individual patients. Based on our research and NCCN guidelines, in August 2011 we have published a comprehensive and easy-to-understand approach in the journal *American Family Physician* (AFP)46 which can be used by newly-diagnosed patients and their physicians in quickly reaching an evidence-based and guideline-driven treatment choice. Decisionmaking is very hard especially for low-risk patients, traditionally primary care physicians are not involved in this process, and over 70% to 80% patients choose a treatment or observation in the first visit to the urologist after a positive biopsy. Although newer guidelines now recommend against PSA screening,47 this recommendation carries the risk of increasing mortality due to prostate cancer and prostate cancer is already the second most

Patients' Survival Expectations Before Localized Prostate Cancer Treatment by Treatment Status 279

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#### **7. Conclusion**

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 or more years if they chose observation, and 48.8% patients expected an improvement in survival of 10 or more 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.

#### **8. Acknowledgements**

This article has been reproduced by permission of the American Board of Family Medicine. We thank Mr. Brian Main, Department of Urology, Eastern Virginia Medical School, for help with data entry and analysis.

#### **9. References**


common cause of cancer death in American men. The algorithm and tools provided in our publication in AFP can empower primary care physicians in counseling newly-diagnosed patients and reduce the risk of over-treatment by convincing low-risk patients to choose active surveillance. With this safeguard, patients and physicians can choose screening for

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 or more years if they chose observation, and 48.8% patients expected an improvement in survival of 10 or more 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

This article has been reproduced by permission of the American Board of Family Medicine. We thank Mr. Brian Main, Department of Urology, Eastern Virginia Medical School, for help

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