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IMPACT OF TREATMENT ON THE LONG TERM-SURVIVAL OF PATIENTS WITH LOCALISED PROSTATE CANCER
1033
1034
INDIVIDUAL PROGNOSTIC SIGNIFICANCE OF THE 19 SINGLE CONDITIONS CONTRIBUTING TO THE CHARLSON COMORBIDITY SCORE IN PATIENTS UNDERGOING RADICAL PROSTATECTOMY
IMPACT OF TREATMENT ON THE LONG TERM-SURVIVAL OF PATIENTS WITH LOCALISED PROSTATE CANCER
Froehner M.1, Koch R.2, Litz R.J.3, Oehlschlaeger S.1, Hakenberg O.W.1, Wirth M.P.1
Bouchardy C.2
1
Technical University of Dresden, Urology, Dresden, Germany, 2Technical University of Dresden, Biometry, Dresden, Germany, 3Technical University of Dresden, Anesthesiology, Dresden, Germany
1
INTRODUCTION & OBJECTIVES: In patients with prostate cancer, the Charlson score is the most commonly used comorbidity measure. We present herein an update of an earlier study [J Urol 171:697, 2004] based on an almost three times larger sample with extended follow-up investigating the individual prognostic value of the nineteen single conditions contributing to this score in the radical prostatectomy setting.
INTRODUCTION & OBJECTIVES: There are several treatment options for localised
MATERIAL & METHODS: 1302 consecutive patients who underwent radical prostatectomy were included into this study. The mean follow-up was 5.5 years, 82 patients were followed for more than 10 years. The Charlson score and the single conditions contributing to this score were recorded in all patients. Mortality (classified as overall, comorbid, prostate cancerspecific, second cancer-specific) was the study endpoint. Mantel-Haenszel hazard ratios (HRs) were estimated. Comparisons were made using the log rank test. RESULTS: Five conditions were associated with significantly increased overall mortality: congestive heart failure, peripheral vascular disease, hemiplegia, moderate or severe renal disease, metastatic solid tumour. Concerning comorbid mortality, the following five conditions reached the significance level: congestive heart failure, peripheral vascular disease, hemiplegia, moderate or severe renal disease, diabetes with end organ damage. A Charlson score of 2 or more reached statistic significance, compared with a Charlson score of 0 concerning comorbid (HR 8.1, p<0.0001) and overall (HR 2.6, p=0.0013) mortality. Congestive heart failure alone as the most contributory single condition produced similar HRs and p values (concerning comorbid mortality: HR 5.6, p=0.0001, concerning overall mortality: HR 2.9, p=0.0004), compared with the whole Charlson score. CONCLUSIONS: The Charlson score added little prognostic information to its most important single condition, congestive heart failure. This result may be explained by the selection-related elimination of high-risk patients leading to significantly increased mortality in some categories based on only few events without meaningful contribution to the validity of the whole score.
Schmidlin F.1, Fioretta G.2, Verkooijen H.M.2, Zanetti R.2, Rapiti E.2, James D.3, Miralbell R.4,
Department of Urology, Geneva University Hospitals, Geneva, Switzerland, 2Geneva Cancer
Registry, Imsp, Geneva, Switzerland, 3Association Prosca, -, Geneva, Switzerland, 4Department of Radiation Therapy, Geneva Unversity Hospitals, Geneva, Switzerland
prostate cancer. Most of these treatments are not evaluated in randomised trials. Therefore, the choice of treatment is challenging for patients and their physicians. In this population-based study, we evaluate the effect of treatment choice on mortality from prostate cancer. MATERIAL & METHODS: Using data from the Geneva Cancer Registry, we identified all 946 patients diagnosed with localised prostate cancer between 1989 and 1998. Available information included patient and tumour characteristics, treatment given during the first 6 months, vital status, and date and cause of death. We evaluated the effect of treatment on mortality from prostate cancer by Cox proportional hazard analysis accounting for all other factors linked to prognosis (age, sector of care, period, and way of discovery, lymph node status, clinical or pathological T stage, Gleason score/differentiation, and PSA value). RESULTS: The risk to die of prostate cancer at 5 five years was similar for operated patient (n=293, Hazard ratio: 1.0 reference), irradiated patient (n=186, HR: 1.1, 95%CI: 0.5-2.6) and patient managed with “watchful waiting” attitude (n=340, HR: 1.4, 95%CI: 0.7-2.7) and higher for those with hormonotherapy (n=56, HR: 2.4, 95%CI: 1.1-5.4) or miscellaneous treatments (n=71, HR: 4.0, 95% 1.9-8.2). However, after 10 years irradiated patients had an increased risk to die of prostate cancer compared to operated patients (HR: 1.9, 95%CI: 1.13.4). We observed important mortality differences between patient operated with negative surgical margins (n=205, HR: 1.0 reference) and patient with positive surgical margins (n=58, HR: 3.7, 95%CI: 1.5-9.1) or not specified margin status (n=30, HR: 6.1 95% CI: 2.1-18.0). CONCLUSIONS: Treatment choice influences the long term prognosis of prostate cancer with lower 10 years cancer mortality among operated patient. These results should be discussed in the context of quality of life not considered in this study. Also, tumour free surgical margin is an important prognosis factor.
1035
1036
PRELIMINARY RESULTS FROM A 12-MONTH FOLLOW-UP STUDY OF PATIENTS RECEIVING DIFFERENT TYPES OF TREATMENT FOR PROSTATE CANCER IN CONDITIONS OF USUAL CLINICAL PRACTICE
PROSTATE CANCER TREATMENT COSTS: WHAT INFLUENCES THEM?
Rodriguez - Miñón J.L.1, Cuesta J.M.2, Rodríguez - Molina J.3, Cavada E.4, Ibarz R.5, Casimiro C.6 1
Fundación Jiménez Diaz, Urology, Madrid, Spain, 2Hospital Fundación Calahorra, Urology, Calahorra, Spain, 3Hospital Clínico San Carlos, Urology, Madrid, Spain, 4Abbott Laboratories S.A., Medical Marketing, Madrid, Spain, 53d Health Research, Outcomes Research, Barcelona, Spain, 6Abbott Laboratories S.A, Medical Department, Madrid, Spain
INTRODUCTION & OBJECTIVES: To study the evolution of prostate-specific antigen (PSA) levels, biochemical progression (BP), adverse effects (AE), Health Related Quality of Life (HRQoL), and survival over 12 months in patients receiving different treatment for prostate cancer (PC) in conditions of usual clinical practice. MATERIAL & METHODS: Longitudinal, prospective, multicentre study in patients with PC. Patients were classified in 6 treatment groups: surgery, radiotherapy, chemotherapy, hormone therapy, combination therapy and other treatments. Biochemical markers were measured at 0, 6 and 12 months, PSA levels at 0 and 12 months, and AE at the 6 and 12 month visits. The number of patients who died during the study period, together with the cause of death (PC-related or otherwise) was recorded. HRQOL was measured with the SF-36 and UCLA Prostate Cancer Index (UCLA-PCI). RESULTS: 1483 patients were included. Mean age was 74.4 years (20-103; SD: 8.6). Data of BP at 6 and 12 months, PSA reduction at 12 months, survival rates, and HRQoL are shown in Table. A total of 499 and 420 AE were recorded at visit 2 and 3. The most frequent AE were hot flushes and sweating (17.2% and 15.4% of AE at visit 2and 3). Only 22 patients (1.48%) of the total sample died during follow-up, 11 due to prostate-related causes (0.74%) and 11 due to other causes. In the group of those who died, mean time from histological diagnosis of PC to death was 10.4 months (2–19; SD: 3.7). % patients who showed biochemical progression Treatment Group
% patients with a reduction in PSA
% patients who died
N (%) at 6 months
at 12 months
at 12 months
at 12 months
SF-36 At baseline At 12 months
UCLA-PCI At baseline At 12 months
PCS
MCS
UF
BF
SF
146 (10)
4.5
4.5
4.7
0
-
-
-
-
46 (26) 21 (21)
Radiotherapy
57 (3.9)
4.5
12.1
3.1
4.1
-
-
-
-
-
Chemotherapy
24 (1.6)
13.6
7.1
0
4.1
-
-
-
-
24 (22) 4 (10)
1028 (70.2)
2.3
Combination treatment
199 (13.6)
4
Other types
10 (0.7)
22.2
62.5
Total sample
1483
3.2
8.4
8.5 7.3
5.4 7.3 0
1.0 0.5
Krankenhaus Muenchen Harlaching, Department of Urology, Munich, Germany INTRODUCTION & OBJECTIVES: At least 8 different therapy modalities for the treatment of prostate cancer are widely spread over Europe and used according to the preference of each user. More and more cost calculations by administrative systems are influencing the decision for one or the other therapy. We want to show significant influence of often unmentioned factors on the cost profile of a therapy. Primary important medical and oncological factors as efficacy, side effects related costs are not included in this analysis. MATERIAL & METHODS: Critical analysis of the influence of often ignored cost inducing factors, as “indication range” resulting in therapies/year, necessity of “treatment in sterile OR”, “learning curve” induced additional costs, “treatment time” and “number of treatment connected staff ”, “sterilisation costs”, “special pre- or postoperative planning’s”, “treatment controls or intensive care”, and the ability of “out patient” treatment are shown for each therapy. RESULTS:
current PCa Treatments
% Pca as first Tx
Open surgery Lap surgery
learning curve Tx
Tx in OR
Tx time (min)
staff for Tx doc/ nurse/ anesthesist
hours manpower (h)
special pre/post procedures
steri-/ legalisation costs
mobile service/ outpatient
Costs/ Tx RPE =100%
45
50
Yes
180
2/3/1
18
post OR
Yes / No
No
100
45
200
Yes
240
2/3/1
24
post OR
Yes / No
No
150
Robot surgery
45
100
Yes
240
2/3/1
24
post OR
Yes / No
No
200
Cryo surgery
40
100
Yes
180
2/3/1
18
plan
No / No
Yes / No
150
Brachy LDR
30
100
Yes
180
3/2/1
18
plan/contr
No / Yes
Yes / Yes
200
Brachy HDR
20
50
Yes
240
3/3/1
28
plan/contr
No / Yes
No
200
Ext. radiation
30
50
No
300
2/1/0
15
plan
No / Yes
No / Yes
150
TURP+ Ablatherm
65
10
No
180
1/1/1
9
No
Yes / No
Yes / Yes
50
HRQoL*
Surgical
Hormone therapy
Thueroff S., Chaussy C.
43 (9) 44 (8)
-
-
-
81 (20) 86 (15)
-
-
85 (16) 80 (19)
23 (23) 8 (14) 36 (24) 12 (16)
0
-
-
-
-
-
22 (1.5)
-
-
82 (20) 86 (17)
-
27 (25) 10 (16)
*Only values with a statistically significant difference (p<0.05) from baseline are shown. In red those that showed an improvement. CONCLUSIONS: In this large sample of PC patients, rates of BP were relatively low after 6 and 12 months of treatment, PSA levels remained largely unchanged, and prostate-related mortality was generally low. There were few appreciable differences on these parameters between treatment groups.
CONCLUSIONS: This analysis shows topics, not to be forgotten, before in- / excluding prostate cancer treatments into the set up of a urological department. The “hidden costs” behind a therapy (disposables, service contracts, learning curve, training in use of ionizing material, number of staff needed, OR time, room availability, pre- and postoperative - not avoidable - preparations or controls should be known, calculated and taken in account.
Eur Urol Suppl 2006;5(2):281
1034
INDIVIDUAL PROGNOSTIC SIGNIFICANCE OF THE 19 SINGLE CONDITIONS CONTRIBUTING TO THE CHARLSON COMORBIDITY SCORE IN PATIENTS UNDERGOING RADICAL PROSTATECTOMY
IMPACT OF TREATMENT ON THE LONG TERM-SURVIVAL OF PATIENTS WITH LOCALISED PROSTATE CANCER
Froehner M.1, Koch R.2, Litz R.J.3, Oehlschlaeger S.1, Hakenberg O.W.1, Wirth M.P.1
Bouchardy C.2
1
Technical University of Dresden, Urology, Dresden, Germany, 2Technical University of Dresden, Biometry, Dresden, Germany, 3Technical University of Dresden, Anesthesiology, Dresden, Germany
1
INTRODUCTION & OBJECTIVES: In patients with prostate cancer, the Charlson score is the most commonly used comorbidity measure. We present herein an update of an earlier study [J Urol 171:697, 2004] based on an almost three times larger sample with extended follow-up investigating the individual prognostic value of the nineteen single conditions contributing to this score in the radical prostatectomy setting.
INTRODUCTION & OBJECTIVES: There are several treatment options for localised
MATERIAL & METHODS: 1302 consecutive patients who underwent radical prostatectomy were included into this study. The mean follow-up was 5.5 years, 82 patients were followed for more than 10 years. The Charlson score and the single conditions contributing to this score were recorded in all patients. Mortality (classified as overall, comorbid, prostate cancerspecific, second cancer-specific) was the study endpoint. Mantel-Haenszel hazard ratios (HRs) were estimated. Comparisons were made using the log rank test. RESULTS: Five conditions were associated with significantly increased overall mortality: congestive heart failure, peripheral vascular disease, hemiplegia, moderate or severe renal disease, metastatic solid tumour. Concerning comorbid mortality, the following five conditions reached the significance level: congestive heart failure, peripheral vascular disease, hemiplegia, moderate or severe renal disease, diabetes with end organ damage. A Charlson score of 2 or more reached statistic significance, compared with a Charlson score of 0 concerning comorbid (HR 8.1, p<0.0001) and overall (HR 2.6, p=0.0013) mortality. Congestive heart failure alone as the most contributory single condition produced similar HRs and p values (concerning comorbid mortality: HR 5.6, p=0.0001, concerning overall mortality: HR 2.9, p=0.0004), compared with the whole Charlson score. CONCLUSIONS: The Charlson score added little prognostic information to its most important single condition, congestive heart failure. This result may be explained by the selection-related elimination of high-risk patients leading to significantly increased mortality in some categories based on only few events without meaningful contribution to the validity of the whole score.
Schmidlin F.1, Fioretta G.2, Verkooijen H.M.2, Zanetti R.2, Rapiti E.2, James D.3, Miralbell R.4,
Department of Urology, Geneva University Hospitals, Geneva, Switzerland, 2Geneva Cancer
Registry, Imsp, Geneva, Switzerland, 3Association Prosca, -, Geneva, Switzerland, 4Department of Radiation Therapy, Geneva Unversity Hospitals, Geneva, Switzerland
prostate cancer. Most of these treatments are not evaluated in randomised trials. Therefore, the choice of treatment is challenging for patients and their physicians. In this population-based study, we evaluate the effect of treatment choice on mortality from prostate cancer. MATERIAL & METHODS: Using data from the Geneva Cancer Registry, we identified all 946 patients diagnosed with localised prostate cancer between 1989 and 1998. Available information included patient and tumour characteristics, treatment given during the first 6 months, vital status, and date and cause of death. We evaluated the effect of treatment on mortality from prostate cancer by Cox proportional hazard analysis accounting for all other factors linked to prognosis (age, sector of care, period, and way of discovery, lymph node status, clinical or pathological T stage, Gleason score/differentiation, and PSA value). RESULTS: The risk to die of prostate cancer at 5 five years was similar for operated patient (n=293, Hazard ratio: 1.0 reference), irradiated patient (n=186, HR: 1.1, 95%CI: 0.5-2.6) and patient managed with “watchful waiting” attitude (n=340, HR: 1.4, 95%CI: 0.7-2.7) and higher for those with hormonotherapy (n=56, HR: 2.4, 95%CI: 1.1-5.4) or miscellaneous treatments (n=71, HR: 4.0, 95% 1.9-8.2). However, after 10 years irradiated patients had an increased risk to die of prostate cancer compared to operated patients (HR: 1.9, 95%CI: 1.13.4). We observed important mortality differences between patient operated with negative surgical margins (n=205, HR: 1.0 reference) and patient with positive surgical margins (n=58, HR: 3.7, 95%CI: 1.5-9.1) or not specified margin status (n=30, HR: 6.1 95% CI: 2.1-18.0). CONCLUSIONS: Treatment choice influences the long term prognosis of prostate cancer with lower 10 years cancer mortality among operated patient. These results should be discussed in the context of quality of life not considered in this study. Also, tumour free surgical margin is an important prognosis factor.
1035
1036
PRELIMINARY RESULTS FROM A 12-MONTH FOLLOW-UP STUDY OF PATIENTS RECEIVING DIFFERENT TYPES OF TREATMENT FOR PROSTATE CANCER IN CONDITIONS OF USUAL CLINICAL PRACTICE
PROSTATE CANCER TREATMENT COSTS: WHAT INFLUENCES THEM?
Rodriguez - Miñón J.L.1, Cuesta J.M.2, Rodríguez - Molina J.3, Cavada E.4, Ibarz R.5, Casimiro C.6 1
Fundación Jiménez Diaz, Urology, Madrid, Spain, 2Hospital Fundación Calahorra, Urology, Calahorra, Spain, 3Hospital Clínico San Carlos, Urology, Madrid, Spain, 4Abbott Laboratories S.A., Medical Marketing, Madrid, Spain, 53d Health Research, Outcomes Research, Barcelona, Spain, 6Abbott Laboratories S.A, Medical Department, Madrid, Spain
INTRODUCTION & OBJECTIVES: To study the evolution of prostate-specific antigen (PSA) levels, biochemical progression (BP), adverse effects (AE), Health Related Quality of Life (HRQoL), and survival over 12 months in patients receiving different treatment for prostate cancer (PC) in conditions of usual clinical practice. MATERIAL & METHODS: Longitudinal, prospective, multicentre study in patients with PC. Patients were classified in 6 treatment groups: surgery, radiotherapy, chemotherapy, hormone therapy, combination therapy and other treatments. Biochemical markers were measured at 0, 6 and 12 months, PSA levels at 0 and 12 months, and AE at the 6 and 12 month visits. The number of patients who died during the study period, together with the cause of death (PC-related or otherwise) was recorded. HRQOL was measured with the SF-36 and UCLA Prostate Cancer Index (UCLA-PCI). RESULTS: 1483 patients were included. Mean age was 74.4 years (20-103; SD: 8.6). Data of BP at 6 and 12 months, PSA reduction at 12 months, survival rates, and HRQoL are shown in Table. A total of 499 and 420 AE were recorded at visit 2 and 3. The most frequent AE were hot flushes and sweating (17.2% and 15.4% of AE at visit 2and 3). Only 22 patients (1.48%) of the total sample died during follow-up, 11 due to prostate-related causes (0.74%) and 11 due to other causes. In the group of those who died, mean time from histological diagnosis of PC to death was 10.4 months (2–19; SD: 3.7). % patients who showed biochemical progression Treatment Group
% patients with a reduction in PSA
% patients who died
N (%) at 6 months
at 12 months
at 12 months
at 12 months
SF-36 At baseline At 12 months
UCLA-PCI At baseline At 12 months
PCS
MCS
UF
BF
SF
146 (10)
4.5
4.5
4.7
0
-
-
-
-
46 (26) 21 (21)
Radiotherapy
57 (3.9)
4.5
12.1
3.1
4.1
-
-
-
-
-
Chemotherapy
24 (1.6)
13.6
7.1
0
4.1
-
-
-
-
24 (22) 4 (10)
1028 (70.2)
2.3
Combination treatment
199 (13.6)
4
Other types
10 (0.7)
22.2
62.5
Total sample
1483
3.2
8.4
8.5 7.3
5.4 7.3 0
1.0 0.5
Krankenhaus Muenchen Harlaching, Department of Urology, Munich, Germany INTRODUCTION & OBJECTIVES: At least 8 different therapy modalities for the treatment of prostate cancer are widely spread over Europe and used according to the preference of each user. More and more cost calculations by administrative systems are influencing the decision for one or the other therapy. We want to show significant influence of often unmentioned factors on the cost profile of a therapy. Primary important medical and oncological factors as efficacy, side effects related costs are not included in this analysis. MATERIAL & METHODS: Critical analysis of the influence of often ignored cost inducing factors, as “indication range” resulting in therapies/year, necessity of “treatment in sterile OR”, “learning curve” induced additional costs, “treatment time” and “number of treatment connected staff ”, “sterilisation costs”, “special pre- or postoperative planning’s”, “treatment controls or intensive care”, and the ability of “out patient” treatment are shown for each therapy. RESULTS:
current PCa Treatments
% Pca as first Tx
Open surgery Lap surgery
learning curve Tx
Tx in OR
Tx time (min)
staff for Tx doc/ nurse/ anesthesist
hours manpower (h)
special pre/post procedures
steri-/ legalisation costs
mobile service/ outpatient
Costs/ Tx RPE =100%
45
50
Yes
180
2/3/1
18
post OR
Yes / No
No
100
45
200
Yes
240
2/3/1
24
post OR
Yes / No
No
150
Robot surgery
45
100
Yes
240
2/3/1
24
post OR
Yes / No
No
200
Cryo surgery
40
100
Yes
180
2/3/1
18
plan
No / No
Yes / No
150
Brachy LDR
30
100
Yes
180
3/2/1
18
plan/contr
No / Yes
Yes / Yes
200
Brachy HDR
20
50
Yes
240
3/3/1
28
plan/contr
No / Yes
No
200
Ext. radiation
30
50
No
300
2/1/0
15
plan
No / Yes
No / Yes
150
TURP+ Ablatherm
65
10
No
180
1/1/1
9
No
Yes / No
Yes / Yes
50
HRQoL*
Surgical
Hormone therapy
Thueroff S., Chaussy C.
43 (9) 44 (8)
-
-
-
81 (20) 86 (15)
-
-
85 (16) 80 (19)
23 (23) 8 (14) 36 (24) 12 (16)
0
-
-
-
-
-
22 (1.5)
-
-
82 (20) 86 (17)
-
27 (25) 10 (16)
*Only values with a statistically significant difference (p<0.05) from baseline are shown. In red those that showed an improvement. CONCLUSIONS: In this large sample of PC patients, rates of BP were relatively low after 6 and 12 months of treatment, PSA levels remained largely unchanged, and prostate-related mortality was generally low. There were few appreciable differences on these parameters between treatment groups.
CONCLUSIONS: This analysis shows topics, not to be forgotten, before in- / excluding prostate cancer treatments into the set up of a urological department. The “hidden costs” behind a therapy (disposables, service contracts, learning curve, training in use of ionizing material, number of staff needed, OR time, room availability, pre- and postoperative - not avoidable - preparations or controls should be known, calculated and taken in account.
Eur Urol Suppl 2006;5(2):281