Laparoscopic (Non Robotic) Radical Prostatectomy Versus Open Radical Prostatectomy in Localized Prostate Cancer

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; LOPEZ, A.; REY-ARES, L.; ALCARAZ, A.; BARDACH, A.; CIAPONI, A

Documento de Evaluacion de Tecnologias Sanitarias

IECS

Año: 2013 p. 1 - 30

1668-2793

Prostate cancer is the most commonly diagnosed non-cutaneous neoplasm in males. In Argentina, it is the second cause of cancer death in men. There are multiple therapies available for those stages in which the lesion is still confined to the gland, including active monitoring. Surgical options include Open Radical Prostatectomy (ORP), Laparoscopic Radical Prostatectomy (LRP) or Robot-assisted Radical Laparoscopic Prostatectomy (RALP).TechnologyLaparoscopy may be carried out transperitoneally or extra-peritoneally. LRP prevents the need to perform large incisions. It also enables performing lymphadenectomy and keeping the neurovascular bundles. It requires a considerable learning period to be able to acquire the required skills. The cost of this technology is significantly higher than that of ORP. Robot-assisted LRP is a development that incorporates the Da Vinci surgical robot and increases accuracy in handling surgical instruments.PurposeThe purpose of this report is to assess the evidence available on the efficacy, safety and coverage policy related aspects on the use of LRP versus ORP in patients with localized prostate cancer. The detailed RALP performance analysis has been excluded because it is described in another health technology assessment (HTA) conducted by the Institute for Clinical Effectiveness and Health Policy (IECS).MethodsA bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology and economic assessments (HTA), clinical practice guidelines (CPG) and coverage policies of other health systems. The inclusion criteria and search strategy used have been detailed.ResultsSeven systematic reviews (SR), three of them meta-analytical, two HTAs, two GCPs and two studies on quality of life have been identified.Tumor ResectionOne meta-analytical SR carried out in 2012 including more than 167,000 subjects randomized to ORP and more than 62,000 to LRP, based on studies published from 2002 to 2010, reported similar rates of positive surgical margins between the groups exposed to LRP and ORP (p=0.57). Another 2010 narrative review showed that the average rate of positive tumor margins was 21.3% and 24% for LRP and ORP respectively (no statistically significant tests were reported).Biochemical RelapseIn a SR, no statistically significant differential results were observed between the group of subjects treated with ORP and LRP.Urinary IncontinenceDirect rate comparisons are difficult due to the heterogeneity of the methods used and the follow up period. In the different case series assessed in a systematic review, the rates were 60.5 to 93.7% for ORP while they were 82.3 to 95% for LRP. One SR suggests that the rate of continence after both procedures is similar (RR: 0.87; 95%, CI: 0.54 to 1.39; p=0.56).Sexual ImpotenceThe assessment of this result is complex due to the disparity of the tools used to measure the existing results and the different surgical approaches used. One SR reported rates of 45-62% sexual potency after LRP and 44-75% after ORP.Blood Loss and the Need for TransfusionsTwo 2012 SRs showed a significantly lower blood loss and need for transfusions which was endorsed by the only RCT and several comparative observational studies collected for these reviews. One meta-analysis reported an average blood loss decrease of 557 mL (95% CI 227-837), which resulted in a lower incidence of transfusions.Surgical TimeSurgical time was significantly shorter in the LRP vs. ORP group (average 170 min vs. 235, p < 0.001) in the only RCT identified.Hospitalization PeriodIn the comparative studies identified by an SR, the hospitalization period was shorter with LRP than in ORP, with an average of 6.4 days (2-9,5) versus 8.9 days (3-15).Rate of General ComplicationsThe all-cause risk of death did not vary with both techniques according to a recent SR (p=0.40). One SR found a decrease in the rate of general complications favoring LRP (RR: 1.52; 95% CI 1.17?1.97; p=0.002).The 2010 European Urology Association clinical guidelines on prostate cancer state that, even though laparoscopic prostatectomy is replacing ORP as the reference surgical approach in several countries, its performance is not clear in terms of cancer, function and profitability results. A 2006 NICE HTA summarizes the evidence as of this year. No coverage policies specific for the studied technology have been identified.ConclusionsThe current moderate-quality evidence available on the safety and efficacy of LRP shows that it is a valid alternative, with a performance at least comparable to that of ORP in some cancer results assessed. Laparoscopy surgeons require special training and the results are operator-dependent.Although it implies a longer surgical time than open surgery, it is associated with a lower rate of intra-operative blood loss, decreased rates of blood transfusions and a shorter hospitalization period. However, there is no clear evidence to conclude that LRP is better than ORP in terms of prostate cancer survival, biochemical relapse or disease-free margins. The cost-effectiveness of those surgical approaches other than open radical prostatectomy has not been established in Argentina yet.