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Commentary on Incidence of Complications Other than Urinary Incontinence or Erectile Dysfunction After Radical Prostatectomy or Radiotherapy for Prostate Cancer: a Population-based Cohort Study.
SIU Academy®. Laguna P. 09/16/14; 63052 Topic: Complications/comorbidities
Prof. Pilar Laguna
Prof. Pilar Laguna
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Urinary incontinence and erectile dysfunction (ED) are the most extensively adverse or collateral events assessed after local treatment for prostate cancer (PCa) with curative intention by radical prostatectomy (RP) or external bean radiation therapy (EBRT). Other treatmentrelated complications, namely post-treatment urinary or rectal bleeding, infections, recto-urethral fistula, bladder neck stricture, and secondary interventions that compromise quality of life (QoL), have been scarcely described in observational series, particularly their longterm incidence.
As no randomized controlled trial (RCT) exists in PCa comparing effectiveness and side effects of RP versus EBRT, a non-biased comparison of any outcome, including adverse events, cannot be expected. Consequently, any comparison between these two techniques should be tempered by confounders and baseline differences among populations receiving one or another treatment.
However, observational retrospective studies may provide valid information when based on large samples. Those minimize differences among populations at baseline and in outcomes underscoring as statistically significant small differences between different treatment groups.
The present study investigates the incidence of five treatment-related outcomes/complications (hospital admissions; urological or rectal/anal procedures; open surgical procedures; and secondary malignancy) on a large population-based cohort from the Ontario Cancer Registry from 2002 to 2009, including 32,465 patients, half of whom were treated with open RP (ORP) and half with EBRT.
The Cancer registry data was linked to the hospital discharge abstract database of the Canadian Institute for Health Information and to the Ontario Health Insurance Plan (OHIP) claims that reimburse all medical procedures. Their results are likely to capture all figures on subsequent hospitalization or any kind of related intervention/procedures. However, only time for the first complication or procedure was recorded. Minor complications not requiring hospitalization or intervention are not captured by these databases. As a result, the figures hereby presented underestimate up to certain degree the long-term real complication rate.
Keeping in mind these limitations, the strength of the study resides not only on the large cohorts, but also on their matched comparison by age and year of treatment at a ratio 1:1 with controls from the general population of Ontario without history of PCa.
As expected and reported in other studies, patients receiving EBRT were older and had higher comorbidity rates than those receiving RP.
Basically their results show that, overall, the 5-year cumulative incidence of admission to hospital because of treatment-related complications was 22.2%, higher after EBRT (24.2%) than after RP (17.3%). Most of the hospital admissions (88.5%) lasted only one night, although again a higher proportion of patients with EBRT-related events stayed for more than one night, suggesting a higher clinical complexity of the complication requiring admission.
The most common reason for hospital admission was urinary obstruction (37% of all admissions). Most of the admissions in the surgical group were related to urinary obstruction and in the EBRT group to radiation proctitis.
The 5-year cumulative incidence of minimally invasive urological procedure was 32%, and the most common procedure was cystoscopy. Anal or rectal procedures were needed in 13.7% of the patients, and open surgical procedures related to urinary tract, rectum, or anus were observed in 0.9% of patients.
The prevalence of side effects remained stable along the study period for both treatment arms, although the time of presentation differed depending on treatment type. In multivariate analysis, older age, presence of comorbidity, and type of treatment at index treatment time were predictors for complications, hospital admission, and urological, rectal, or anal procedures. Age and comorbidity were not associated with open surgery, but the incidence of open surgery was extremely low, and thus difficult to find any meaningful association.
As expected, the risk for occurrence of these outcomes was significantly higher than in controls. After adjustment for age, comorbidity and year of inception, the hazard ratio (HR) on the PCa population against controls was 17.9 for hospital admission, 6.8 for urological procedures, 2.2 for rectal or anal procedures, and 6.0 for open procedures related to urinary tract, rectum, or anus.
Five-year cumulative incidence of second primary malignancies (all cancer sites) was 3%, and it was exclusively present in the population treated with EBRT. The most common secondary malignancies were gastrointestinal; however, an increased risk for lung, hematological, and genitourinary cancers was also observed.
Because the non-selected population was included, the present study is likely to reflect the real outcome incidence more accurately than data from centres of excellence. This data clearly shows that the 5-year cumulative rate of treatment-related complications (other than incontinence and ED) requiring admission after treatment with curative intention of PCa is high, and these figures should not be neglected during patient counseling. The complication profile differs depending on the type of treatment, with most complications presenting during the first year after RP and after 3 years in the EBRT group. Especially in the latter group, the higher incidence of secondary radiation induced cancers is of concern when long-term survival is expected.
A last comment deserves the attention of the reader. The above figures correspond to ORP, as the authors excluded any type of minimally invasive RP due to its low prevalence during the study period. Laparoscopic and robotic-assisted RP may have a different profile outcome (e.g. lower incidence of bladder neck stricture), and thus the figures hereby presented for the RP group refer exclusively to ORP. Conversely, modern radiotherapy templates and targeting techniques were not taken into account, and thus a different complication rate could also not be excluded for modern EBRT techniques.
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