| Literature DB >> 21519347 |
C B Roberts1, T L Jang, Yu-Hsuan Shao, S Kabadi, D F Moore, G L Lu-Yao.
Abstract
The aim of this study was to assess the treatment patterns and 3-12-month complication rates associated with receiving prostate cryotherapy in a population-based study. Men >65 years diagnosed with incident localized prostate cancer in Surveillance Epidemiology End Results (SEER)-Medicare-linked database from 2004 to 2005 were identified. A total of 21,344 men were included in the study, of which 380 were treated initially with cryotherapy. Recipients of cryotherapy versus aggressive forms of prostate therapy (ie, radical prostatectomy or radiation therapy) were more likely to be older, have one co-morbidity, low income, live in the South and be diagnosed with indolent cancer. Complication rates increased from 3 to 12 months following cryotherapy. By the twelfth month, the rates for urinary incontinence, lower urinary tract obstruction, erectile dysfunction and bowel bleeding reached 9.8, 28.7, 20.1 and 3.3%, respectively. Diagnoses of hydronephrosis, urinary fistula or bowel fistula were not evident. The rates of corrective invasive procedures for lower urinary tract obstruction and erectile dysfunction were both <2.9% by the twelfth month. Overall, complications post-cryotherapy were modest; however, diagnoses for lower urinary tract obstruction and erectile dysfunction were common.Entities:
Mesh:
Year: 2011 PMID: 21519347 PMCID: PMC3151329 DOI: 10.1038/pcan.2011.17
Source DB: PubMed Journal: Prostate Cancer Prostatic Dis ISSN: 1365-7852 Impact factor: 5.554
Adjusted1 Odds Ratios (95% Confidence Intervals) for factors associated with the selection of cryotherapy instead of aggressive standard therapy2 in men diagnosed with incident localized prostate cancer, SEER-Medicare.
| Characteristics | OR | 95% CI | p-value |
|---|---|---|---|
| 75+ | 1.58 | (1.27, 1.95) | <0.001 |
| 66–74 | Referent | ||
| Black/Other | 0.99 | (0.75, 1.29) | 0.910 |
| White | Referent | ||
| Unmarried/Unspecified | 1.66 | (1.33, 2.07) | <0.001 |
| Married | Referent | ||
| Lowest Tertile | 1.46 | (1.10, 1.93) | 0.008 |
| Middle Tertile | 1.35 | (1.03, 1.77) | 0.031 |
| Highest Tertile | Referent | ||
| South | 1.81 | (1.42, 2.31) | <0.001 |
| North Central | 0.55 | (0.37, 0.81) | 0.003 |
| Northeast | 0.45 | (0.31, 0.64) | <0.001 |
| West | Referent | ||
| 0.1–≤10 | Referent | ||
| 10.1–19.9 | 0.92 | (0.69, 1.21) | 0.544 |
| ≥ 20 | 0.95 | (0.65, 1.40) | 0.805 |
| 2–6 | Referent | ||
| 7 | 1.04 | (0.84, 1.29) | 0.732 |
| 8–10 | 0.60 | (0.41, 0.86) | 0.006 |
| T2 | 1.22 | (0.99, 1.50) | 0.059 |
| T1 | Referent | ||
| 0 | Referent | ||
| 1 | 1.41 | (1.10, 1.81) | 0.008 |
| 2+ | 1.15 | (0.77, 1.71) | 0.498 |
Adjusted for patient and tumor characteristics included in the Table.
Aggressive standard therapies include radical prostatectomy, external beam radiation therapy, and brachytherapy.
Unmarried consists of men reported being separated, divorced, or widowed
The adjusted1 association between the selection of cryotherapy instead of aggressive2 standard therapies in men diagnosed with incident localized prostate cancer, SEER-Medicare.
| NCCN Criterion | OR | 95% CI | p-value |
|---|---|---|---|
| High | 0.70 | (0.51, 0.96) | 0.026 |
| Intermediate | 1.00 | (0.80, 1.26) | 0.986 |
| Low | Referent | ||
Adjusted for age, race, marital status, income, region, and Charlson Co-morbidity Score.
Aggressive standard therapies include radical prostatectomy, external beam radiation therapy, and brachytherapy.
Patients were categorized into three risk groups on the basis of clinical classification, PSA level and Gleason score: low-risk (T1–T2a and PSA level <10 ng/mL and Gleason score 2–6), intermediate-risk (T2b–T2c or 10 ≤ PSA ≤ 20 ng/mL or Gleason score = 7) and high-risk (PSA level >20ng/mL or Gleason score 8–10).
Combined diagnoses and procedural related complications reported 3, 6, and 12 months after cryotherapy in men diagnosed with incident localized prostate cancer and no prior history of treatment related morbidity, SEER-Medicare.
| 3 months | 6 months | 12 months | ||||
|---|---|---|---|---|---|---|
| Complication | n | % | n | % | n | % |
| 78 | 23.7 | 90 | 27.4 | 94 | 28.7 | |
| 14 | 4 | 46 | 13.2 | 70 | 20.1 | |
| 14 | 3.8 | 29 | 7.9 | 36 | 9.8 | |
| <11 | <2.9 | <11 | <2.9 | 12 | 3.3 | |
| 0 | 0 | 0 | 0 | 0 | 0 | |
| 0 | 0 | 0 | 0 | 0 | 0 | |
| 0 | 0 | 0 | 0 | 0 | 0 | |
Lower Urinary Tract Obstruction included medical claim of dilation, urethrotomy, urethroplasty, sphincterotomy; transurethral prostate resection/destruction; urethral stent; or injection for stricture occuring. 328 men had no prior history of urinary obstruction prior to cryotherapy.
Erectile Dysfunction included medical claim for penile prosthesis or intracavernosal. 349 men had no Prior history of erectile dysfunction prior to cryotherapy.
Urinary incontinence included a medical claim of urethra sphincter injection, artificial sphincter, or incontinence repair (sling, urethroplasty) occuring. 368 men had no prior history of urinary incontinence prior to cryotherapy.
Bowel bleeding included hemorrhage or inflammation. 359 men did not have bowel bleeding prior to cryotherapy.
Hydronephrosis is distention of the renal pelvic and calices of the kidney with urine.
Bowel Fistula included medical claims of rectal repair, colostomy or ulcer.
Urinary Fistula was defined as medical claims with repair of bowel-bladder fistula or closure of urethrostomy or urethrocutaneous fistula occurring.
Characteristics of patients treated with cryotherapy and standard forms of therapy for incident localized prostate cancer, SEER-Medicare.
| Aggressive standard therapies | Non-aggressive standard therapies | ||||
|---|---|---|---|---|---|
| Characteristics | Cryotherapy | Radical | Radiation Therapy | ADT | Conservative |
| 66–74 | 61.3 | 92.2 | 62.6 | 31.2 | 45.6 |
| 75+ | 38.7 | 7.8 | 37.5 | 68.8 | 54.4 |
| White | 81.1 | 83.9 | 82.2 | 77.8 | 78.3 |
| Black | 12.1 | 8.0 | 10.4 | 13.6 | 14.7 |
| Other | 6.8 | 8.1 | 7.4 | 8.7 | 7.0 |
| Married | 66.8 | 81.8 | 75.0 | 56.4 | 57.3 |
| Unmarried | 22.1 | 14.5 | 19.6 | 23.0 | 24.0 |
| Unspecified | 11.1 | 3.7 | 5.3 | 20.7 | 18.8 |
| $44,315 | $51,582 | $49,526 | $43,257 | $46,088 | |
| Median (IQR) | ($33,090, $57,677) | ($39,208, $70,418) | ($36,371, $66,651) | ($31,507, $59,650) | ($33,294, 63,501) |
| South | 32.4 | 12.4 | 17.4 | 20.5 | 18.1 |
| North Central | 7.9 | 12.6 | 12.6 | 11.8 | 10.0 |
| Northeast | 10.0 | 10.4 | 26.5 | 17.8 | 15.2 |
| West | 49.7 | 64.7 | 43.5 | 49.9 | 56.7 |
| 0–2.5 | 3.7 | 5.7 | 5.4 | 4.5 | 6.3 |
| 2.6–≤4.0 | 6.4 | 8.4 | 6.3 | 3.6 | 6.3 |
| 4.1–≤10 | 65.3 | 66.8 | 60.8 | 36.8 | 57.0 |
| 10.1–19.9 | 16.6 | 13.4 | 18.2 | 24.8 | 17.5 |
| ≥ 20 | 8.2 | 5.8 | 9.3 | 30.3 | 13.0 |
| 2–6 | 46.1 | 36.8 | 48.5 | 32.7 | 64.3 |
| 7 | 44.2 | 49.8 | 36.7 | 37.3 | 24.8 |
| 8–10 | 9.7 | 13.4 | 14.9 | 30.0 | 10.9 |
| T1 | 50.5 | 55.3 | 57.1 | 44.2 | 52.7 |
| T2 | 49.5 | 44.7 | 42.9 | 55.8 | 47.3 |
| Low | 33.7 | 28.1 | 34.6 | 17.7 | 46.6 |
| Intermediate | 50.3 | 54.0 | 44.2 | 36.0 | 34.4 |
| High | 16.1 | 18.0 | 21.3 | 46.3 | 19.0 |
| 0 | 70.5 | 84.0 | 73.8 | 66.1 | 72.6 |
| 1 | 22.1 | 12.8 | 18.1 | 20.6 | 17.7 |
| 2+ | 7.4 | 3.2 | 8.1 | 13.3 | 9.8 |
IQR = Interquartile Range; ADT = Androgen Deprivation Therapy
Chi-square test used to assess the independence of patient demographic and clinical characteristics across treatment groups. All p-values were <0.001.
Radiation therapy includes external beam radiation therapy and brachytherapy
Unmarried consists of men reported being separated, divorced, or widowed
Patients were categorized into three risk groups on the basis of clinical classification, PSA level and Gleason score: low-risk (T1–T2a and PSA level <10 ng/mL and Gleason score 2–6), intermediate-risk (T2b–T2c or 10 ≤ PSA ≤ 20 ng/mL or Gleason score = 7) and high-risk (PSA level >20ng/mL or Gleason score 8–10).
Medical codes regarding diagnoses and corrective invasive procedures for complications occurring after cryotherapy as initial treatment for prostate cancer
Definitions of complications following cryotherapy.
| Medical Codes | |||
|---|---|---|---|
| Complications | Diagnoses | Procedures | |
| ICD-9-CM | ICD-9-CM | CPT/HCPCS | |
| Impotence, dysfunction | 607.84 | ||
| Penile Prosthesis | 64.94, 64.95, 64.96, 64.97 | 54400, 54401, 54402, 54405, 54407, 54408, 54409, 54410, 54411, 54415, 54416, 54417, C1007, C1813, C2622, C3500, C8514, C8516, C8534, L7900 | |
| Intracavernosal injection | 54231, 54235, J0270, J0275, J2440, J2760 | ||
| Stricture, obstruction, retention | 596.0, 598.x, 599.6, 788.2x | ||
| Dilation, urethrotomy, urethroplasty, sphincterotomy | 57.85, 57.91, 57.92, 58.0, 58.1, 58.3x, 58.44, 58.46, 58.47, 58.5, 58.6, 58.99, 60.95 | 52275, 52276, 52281,52510, 53010, 53400, 53405,53410, 53415, 53420, 53425, 53600, 53601, 53605, 53620, 53621 | |
| Transurethral prostate resection/destruction | 60.2x | 52601, 52612, 52614, 52620, 52630, 53850, 53852 | |
| Urethral Stent | 2282 | ||
| Injection for Stricture | 52283 | ||
| Incontinence, sphincter, deficiency | 788.3x, 599.82 | ||
| Urethra, sphincter injection | 59.72 | 51715 | |
| Artificial sphincter | 58.93 | 53445, 53447 | |
| Incontinence repair (sling, urethroplasty) | 59.3, 59.4, 59.5, 59.6, 59.71, 59.79 | 53440, 51840, 51841, 53442, 53443 | |
| 596.1, 596.2, 599.1 | 57.83, 57.84, 58.43 | 44660, 44661, 53520 | |
| Urethral fistula | 5991 | ||
| Intestinovesical fistula | 5961 | ||
| Vesical fistula NEC | 5962 | ||
| Repair of a bowel-bladder fistula or closure of urethrostomy | 5783, 5784, 5843 | 44660, 44661, 53520 | |
| Fistula, ulcer | 569.41, 569.81 | 48.73, 48.93 | 45800, 45805, 45820, 45825 |
| Rectal repair, colostomy | 46.1x, 48.31, 48.32, 48.33 | 45562, 45563 | |
| Distention of the renal pelvic and calices of the kidney with urine | 591 | ||
| Hemorrhage, inflammation | 558.1, 569.3, 578.9 | ||
ICD-9-CM = International Classification of Diseases, 9th revision, Clinical Modification
CPT = Current Procedural Terminology
HCPCS = Health Care Financing Administration Common Procedure Coding System