- Email: [email protected]
POTENTIALLY AVOIDED SURGERIES IN MEN WITH LOCALIZED, LOW-RISK PROSTATE CANCER UNDERGOING ACTIVE SURVEILLANCE: A MODEL-BASED ANALYSIS
THE JOURNAL OF UROLOGY®
Vol. 181, No. 4, Supplement, Sunday, April 26, 2009
541 POTENTIALLY AVOIDED SURGERIES IN MEN WITH LOCALIZED, LOW-RISK PROSTATE CANCER UNDERGOING ACTIVE SURVEILLANCE: A MODEL-BASED ANALYSIS Bin Zhang, Joseph Menzin*, Waltham, MA; David W Lee, Waukesha, WI; Mark Friedman, Jonathan R Korn, Waltham, MA; John Kurhanewicz, San Francisco, CA; Robert Dann, Waukesha, WI INTRODUCTION AND OBJECTIVE: Active surveillance (AS) is emerging as an alternative to immediate treatment for patients with clinically localized, low-risk prostate cancer. Benefits from AS (avoidance of costs and risks of complications and mortality associated with treatment) must be balanced against potential harms (reduced life expectancy from metastatic progression, and worries of living with cancer). This study estimated the number of immediate surgeries avoidable by patients undergoing AS without any sacrifice of life expectancy. METHODS: We developed a Markov model comparing patients with clinically localized, low-risk prostate cancer (T 1-2b N0 M0, PSA <=10 ng/mL, Gleason sum <=6) undergoing AS with those receiving immediate surgery. We modeled patients’ annual progression through 4 health states (no clinical progression; clinical progression; metastatic cancer; dead), and surgery prompted by disease progression or patient choice in those with non-metastatic disease. Published literature, SEER*Stat and US life tables provided inputs. We derived the metastatic disease progression rates to equalize life expectancy under the two strategies (AS vs. immediate surgery), and then estimated the corresponding number of surgeries avoided by patients following AS starting at ages 65, 70 or 75. RESULTS: Simulated life expectancies under AS and immediate surgery were equal when annual rates of progression to metastatic cancer for the AS group were 1.6%, 2.1%, and 2.7% at ages 65, 70, and 75, respectively. With equalized life expectancies, the corresponding proportions of patients undergoing AS who would avoid surgery were 54.4%, 61.4%, and 68.6%. When life expectancy is quality-adjusted, 2-3% more patients in each age group could avoid surgery under AS. These results vary by the annual clinical progression rate and by the proportion of patients electing surgery without evidence of clinical progression. Based on the number of incident cases of localized, low-risk prostate cancer among US men aged 65-75, AS could avoid approximately 8,500-9,000 surgeries annually. CONCLUSIONS: Our simulations show that active surveillance has the potential to substantially reduce the number of patients with localized, low-risk prostate cancer who receive immediate surgery. Source of Funding: GE Healthcare
542 DECISION AIDS IMPROVE NEWLY DIAGNOSED PROSTATE CANCER PATIENTS UNDERSTANDING OF THE RATIONALE FOR ACTIVE SURVEILLANCE John D Seigne*, Telisa Stewart, Kate Clay, Stephen Kearing, Shaun Wason, John Heaney, Lebanon, NH INTRODUCTION AND OBJECTIVE: Engaging patients in high quality decision making regarding prostate cancer screening and treatment choice for early stage disease is challenging. Decision aids (DA) have been shown to be an effective tool in improving patient decision making where treatment choice is complex. In the United States it is clear that radical therapy is over utilized and that increasing the appropriate use of active surveillance has the potential for maintaining quality of life for patients with low risk prostate cancer. We examined the ability of an audiovisual Decision Aid to improve the understanding of the rationale for active surveillance in patients with newly diagnosed clinically localized prostate cancer. METHODS: From September 2007 - February 2008, a prospective cohort of 228 patients with newly diagnosed early stage prostate cancer were mailed a cover letter, informational pamphlets, and a video DA which includes facts about prostate cancer, treatment options, and testimony from patients prior to their consultation. Participants then
193
complete a questionnaire that captures prostate cancer knowledge, clinical and decision making data prior to the counseling visit. RESULTS: Of the 228 patients, 219 received the information package and completed the questionnaire prior to their appointment. 141(64%) patients watched the DA. 90 patients (41%) were newly diagnosed at our center while the remainder were diagnosed and initially counseled elsewhere and were coming for a second opinion. In general the patients’ knowledge about prostate cancer was good with ~90% answering correctly. Watching the DA did improve knowledge to >97% answering correctly (P<0.05). However, baseline understanding of the risk and rationale for active surveillance was low with only 50% of patients who did not watch the DA answering correctly compared to >70% of those watching the DA (P<0.01). A worrisome finding was that patients, who had been previously counseled elsewhere and did not watch the DA, knowledge of the rationale for active surveillance was no better than those who had never been counseled. CONCLUSIONS: Patients with early stage prostate cancer’s knowledge of the rationale for active surveillance is poor even following an initial consultation with a urologist. The use of an evidence based DA significantly improves patients knowledge regarding active surveillance Source of Funding: Foundation for Informed Medical Decision Making
543 SURVEILLANCE AND TREATMENT EXPENDITURES OF STAGE I TESTIS CANCER Hua-yin Yu*, Los Angeles, CA; Rodger A Madison, Santa Monica, CA; Christopher S Saigal, Los Angeles, CA; the Urologic Diseases in America Project INTRODUCTION AND OBJECTIVE: The economic impact of treatment choice for men with stage I testis cancer has primarily been examined via modeling at referral centers. Actual expenditures in the community are unknown. We evaluated expenditures for surveillance, retroperitoneal lymph node dissection (RPLND) and radiation therapy (XRT) in a population of privately insured men. METHODS: Using a claims database, we identified men who had radical orchiectomy for testis cancer from 2002 to 2007. Stage I men were identified as having primary RPLND or XRT if they occurred within 4 months of orchiectomy and were not preceded by chemotherapy. Surveillance patients were defined as men without RPLND, XRT, or chemotherapy within 4 months of orchiectomy. We identified claims related to testis cancer and calculated annual expenditures per patient, including treatment, follow up, and treatment for recurrences. We compared follow up test expenditures to expenditures predicted using National Comprehensive Cancer Network guidelines. RESULTS: 279, 72, and 388 patients had surveillance, RPLND and XRT, respectively, with mean follow up of 30, 30, and 28 mo. Cumulative 5-year expenditures were greatest for RPLND and lowest for XRT. Most expenditures were incurred during year 1. Physician and hospital services comprised the majority of expenditures. Overall expenditures in years 2-5 were highest among men on surveillance. Follow up test expenditures were lower among surveillance patients and higher among RPLND and XRT patients than projected. CONCLUSIONS: Long-term expenditures for stage I testis cancer are lowest after XRT. Expenditures for surveillance are between XRT and RPLND, even though no active treatment occurs at the initiation of this strategy. Follow up testing in these patients do not account for the bulk of expenditures. This suggests that surveillance patients are incurring more expenses related to physician and hospital services, including treatment for recurrences. These data also emphasize that actual expenditures for this disease may vary from projected models due to high rates of non-compliance with follow up protocols.
Vol. 181, No. 4, Supplement, Sunday, April 26, 2009
541 POTENTIALLY AVOIDED SURGERIES IN MEN WITH LOCALIZED, LOW-RISK PROSTATE CANCER UNDERGOING ACTIVE SURVEILLANCE: A MODEL-BASED ANALYSIS Bin Zhang, Joseph Menzin*, Waltham, MA; David W Lee, Waukesha, WI; Mark Friedman, Jonathan R Korn, Waltham, MA; John Kurhanewicz, San Francisco, CA; Robert Dann, Waukesha, WI INTRODUCTION AND OBJECTIVE: Active surveillance (AS) is emerging as an alternative to immediate treatment for patients with clinically localized, low-risk prostate cancer. Benefits from AS (avoidance of costs and risks of complications and mortality associated with treatment) must be balanced against potential harms (reduced life expectancy from metastatic progression, and worries of living with cancer). This study estimated the number of immediate surgeries avoidable by patients undergoing AS without any sacrifice of life expectancy. METHODS: We developed a Markov model comparing patients with clinically localized, low-risk prostate cancer (T 1-2b N0 M0, PSA <=10 ng/mL, Gleason sum <=6) undergoing AS with those receiving immediate surgery. We modeled patients’ annual progression through 4 health states (no clinical progression; clinical progression; metastatic cancer; dead), and surgery prompted by disease progression or patient choice in those with non-metastatic disease. Published literature, SEER*Stat and US life tables provided inputs. We derived the metastatic disease progression rates to equalize life expectancy under the two strategies (AS vs. immediate surgery), and then estimated the corresponding number of surgeries avoided by patients following AS starting at ages 65, 70 or 75. RESULTS: Simulated life expectancies under AS and immediate surgery were equal when annual rates of progression to metastatic cancer for the AS group were 1.6%, 2.1%, and 2.7% at ages 65, 70, and 75, respectively. With equalized life expectancies, the corresponding proportions of patients undergoing AS who would avoid surgery were 54.4%, 61.4%, and 68.6%. When life expectancy is quality-adjusted, 2-3% more patients in each age group could avoid surgery under AS. These results vary by the annual clinical progression rate and by the proportion of patients electing surgery without evidence of clinical progression. Based on the number of incident cases of localized, low-risk prostate cancer among US men aged 65-75, AS could avoid approximately 8,500-9,000 surgeries annually. CONCLUSIONS: Our simulations show that active surveillance has the potential to substantially reduce the number of patients with localized, low-risk prostate cancer who receive immediate surgery. Source of Funding: GE Healthcare
542 DECISION AIDS IMPROVE NEWLY DIAGNOSED PROSTATE CANCER PATIENTS UNDERSTANDING OF THE RATIONALE FOR ACTIVE SURVEILLANCE John D Seigne*, Telisa Stewart, Kate Clay, Stephen Kearing, Shaun Wason, John Heaney, Lebanon, NH INTRODUCTION AND OBJECTIVE: Engaging patients in high quality decision making regarding prostate cancer screening and treatment choice for early stage disease is challenging. Decision aids (DA) have been shown to be an effective tool in improving patient decision making where treatment choice is complex. In the United States it is clear that radical therapy is over utilized and that increasing the appropriate use of active surveillance has the potential for maintaining quality of life for patients with low risk prostate cancer. We examined the ability of an audiovisual Decision Aid to improve the understanding of the rationale for active surveillance in patients with newly diagnosed clinically localized prostate cancer. METHODS: From September 2007 - February 2008, a prospective cohort of 228 patients with newly diagnosed early stage prostate cancer were mailed a cover letter, informational pamphlets, and a video DA which includes facts about prostate cancer, treatment options, and testimony from patients prior to their consultation. Participants then
193
complete a questionnaire that captures prostate cancer knowledge, clinical and decision making data prior to the counseling visit. RESULTS: Of the 228 patients, 219 received the information package and completed the questionnaire prior to their appointment. 141(64%) patients watched the DA. 90 patients (41%) were newly diagnosed at our center while the remainder were diagnosed and initially counseled elsewhere and were coming for a second opinion. In general the patients’ knowledge about prostate cancer was good with ~90% answering correctly. Watching the DA did improve knowledge to >97% answering correctly (P<0.05). However, baseline understanding of the risk and rationale for active surveillance was low with only 50% of patients who did not watch the DA answering correctly compared to >70% of those watching the DA (P<0.01). A worrisome finding was that patients, who had been previously counseled elsewhere and did not watch the DA, knowledge of the rationale for active surveillance was no better than those who had never been counseled. CONCLUSIONS: Patients with early stage prostate cancer’s knowledge of the rationale for active surveillance is poor even following an initial consultation with a urologist. The use of an evidence based DA significantly improves patients knowledge regarding active surveillance Source of Funding: Foundation for Informed Medical Decision Making
543 SURVEILLANCE AND TREATMENT EXPENDITURES OF STAGE I TESTIS CANCER Hua-yin Yu*, Los Angeles, CA; Rodger A Madison, Santa Monica, CA; Christopher S Saigal, Los Angeles, CA; the Urologic Diseases in America Project INTRODUCTION AND OBJECTIVE: The economic impact of treatment choice for men with stage I testis cancer has primarily been examined via modeling at referral centers. Actual expenditures in the community are unknown. We evaluated expenditures for surveillance, retroperitoneal lymph node dissection (RPLND) and radiation therapy (XRT) in a population of privately insured men. METHODS: Using a claims database, we identified men who had radical orchiectomy for testis cancer from 2002 to 2007. Stage I men were identified as having primary RPLND or XRT if they occurred within 4 months of orchiectomy and were not preceded by chemotherapy. Surveillance patients were defined as men without RPLND, XRT, or chemotherapy within 4 months of orchiectomy. We identified claims related to testis cancer and calculated annual expenditures per patient, including treatment, follow up, and treatment for recurrences. We compared follow up test expenditures to expenditures predicted using National Comprehensive Cancer Network guidelines. RESULTS: 279, 72, and 388 patients had surveillance, RPLND and XRT, respectively, with mean follow up of 30, 30, and 28 mo. Cumulative 5-year expenditures were greatest for RPLND and lowest for XRT. Most expenditures were incurred during year 1. Physician and hospital services comprised the majority of expenditures. Overall expenditures in years 2-5 were highest among men on surveillance. Follow up test expenditures were lower among surveillance patients and higher among RPLND and XRT patients than projected. CONCLUSIONS: Long-term expenditures for stage I testis cancer are lowest after XRT. Expenditures for surveillance are between XRT and RPLND, even though no active treatment occurs at the initiation of this strategy. Follow up testing in these patients do not account for the bulk of expenditures. This suggests that surveillance patients are incurring more expenses related to physician and hospital services, including treatment for recurrences. These data also emphasize that actual expenditures for this disease may vary from projected models due to high rates of non-compliance with follow up protocols.